Researchers to Present Additional Data on Soliris(R) (Eculizumab) for the Treatment of PNH at the ASH Annual Meeting

CHESHIRE, Conn., Nov. 10 /PRNewswire-FirstCall/ — Alexion Pharmaceuticals, Inc. today announced that the American Society of Hematology (ASH) has published additional data relating to Soliris(R) (eculizumab) as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH). Data also have been published regarding initial experience with eculizumab in patients with two other rare diseases (Atypical Hemolytic Uremic Syndrome and Cold Agglutinin Disease). Abstracts will be presented at the 50th Annual Meeting of the American Society of Hematology, to be held December 6 to 9, 2008 at the Moscone Center in San Francisco.

The following abstracts will be presented as oral presentations on Monday, December 8, 2008. The abstracts and presentation information can be accessed through the links provided below.

   --  "Eculizumab Therapy Results in Rapid and Sustained Decreases in       Markers of Thrombin Generation and Inflammation in Patients with PNH,"       Dr. Ilene Weitz, et al.   Abstract: http://ash.confex.com/ash/2008/webprogram/Paper8206.html    --  "Eculizumab Reduces Pulmonary Hypertension Through Inhibition of       Hemolysis-Associated Nitric Oxide Consumption in Patients With       Paroxysmal Nocturnal Hemoglobinuria," Dr. Anita Hill, et al.   Abstract: http://ash.confex.com/ash/2008/webprogram/Paper9815.html   

The following abstracts will be presented in poster sessions on Monday, December 8, 2008.

   --  "Safety and Efficacy of the Terminal Complement Inhibitor Eculizumab       in Japanese Patients with Paroxysmal Nocturnal Hemoglobinuria: AEGIS       Phase II Clinical Study Results," Dr. Yuzuru Kanakura, et al.   Abstract: http://ash.confex.com/ash/2008/webprogram/Paper8331.html    --  "Modification of the Eculizumab Dose to Successfully Manage       Intravascular Breakthrough Hemolysis in Patients with Paroxysmal       Nocturnal Hemoglobinuria," Dr. Richard Kelly, et al.   Abstract: http://ash.confex.com/ash/2008/webprogram/Paper11166.html    --  "Effect of Reducing Intravascular Hemolysis on Ferritin Homeostasis in       Eculizumab Treated Paroxysmal Nocturnal Hemoglobinuria (PNH)       Patients," Dr. Alexander Roeth, et al.   Abstract: http://ash.confex.com/ash/2008/webprogram/Paper4867.html   

The following abstracts will be presented in poster sessions on Sunday, December 7, 2008.

   --  "Successful Treatment of Atypical Hemolytic Uremic Syndrome with the       Complement Inhibitor Eculizumab," Jens Nuernberger, et al.   Abstract: http://ash.confex.com/ash/2008/webprogram/Paper9272.html    --  "Long-term Efficacy of the Terminal Complement Inhibitor Eculizumab in       a Patient with Cold Agglutinin Disease (CAD)," Dr. Alexander Roeth, et       al.   Abstract: http://ash.confex.com/ash/2008/webprogram/Paper7013.html    The following abstract will be presented as an on-line publication.    --  "Efficacy of Eculizumab in a Plasmatherapy-Dependent Patient with       Atypical Hemolytic Uremic Syndrome with C3 mutation Following       Plasmatherapy Withdrawal," Dr Valerie Chatelet et al.    About Soliris  

Soliris is the first product approved for the treatment of patients with PNH in the U.S. and Europe. PNH is a rare, debilitating and life-threatening blood disorder defined by the destruction of red blood cells, or hemolysis. In patients with PNH, hemolysis can cause life-threatening thromboses, recurrent pain, kidney disease, disabling fatigue, impaired quality of life, severe anemia, pulmonary hypertension, shortness of breath and intermittent episodes of dark-colored urine (hemoglobinuria). Soliris, or eculizumab, is the only treatment that blocks this hemolysis.

Important Safety Information

Soliris is generally well tolerated. The most frequent adverse events observed in clinical studies were headache, nasopharyngitis (a runny nose), back pain and nausea.

The U.S. product label for Soliris also includes a boxed warning: “Soliris increases the risk of meningococcal infections. Vaccinate patients with a meningococcal vaccine at least two weeks prior to receiving the first dose of Soliris; revaccinate according to current medical guidelines for vaccine use. Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary.” During clinical studies, two out of 196 vaccinated PNH patients treated with Soliris experienced a serious meningococcal infection.

   Please see full prescribing information at http://www.soliris.net/.    About Alexion  

Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to develop and deliver life-changing drug therapies for patients with serious and life-threatening medical conditions. The Company is engaged in the discovery, development and commercialization of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic diseases, cancer and autoimmune disorders. In March 2007, the FDA granted marketing approval for the Company’s first product, Soliris for all patients with PNH. In June 2007, the European Commission granted marketing approval for Soliris in the European Union for all patients with PNH. The Company is evaluating other potential indications for Soliris, as well as other formulations of eculizumab for additional clinical indications. In addition, Alexion is pursuing development of an anti-CD200 monoclonal antibody as a treatment for patients with cancer, and evaluating development of other antibody product candidates in early stages of development. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: http://www.alexionpharma.com/.

[ALXN:G]

Alexion Pharmaceuticals, Inc.

CONTACT: Irving Adler, Sr., Director Corporate Communications of AlexionPharmaceuticals, Inc., +1-203-271-8210; or Mark Marmur of Makovsky & Company,+1-212-508-9670; or Rhonda Chiger of Rx Communications for Investors,+1-917-322-2569

Web Site: http://www.alexionpharma.com/http://www.soliris.net/

PARI Pharma Completes Successful Clinical Trials for Tobramycin 100 & Investigational eFlow for CF

MONTEREY, Calif., Nov. 10 /PRNewswire/ — PARI Pharma GmbH has successfully completed Phase I and Phase II clinical trials comparing its proprietary PARI Tobramycin 100 (150mg/1.5mL) formulation delivered via a customized Investigational eFlow Nebulizer System to TOBI (tobramycin 300mg/5mL) delivered with the PARI LC PLUS jet nebulizer. While key deposition and safety thresholds were maintained, the marked difference was a reduction in the average inhalation time to 4 – 4 1/2 minutes for the PARI Tobramycin 100, down from 16 – 17 minutes for the TOBI therapy. PARI Tobramycin 100 is an investigational therapy for cystic fibrosis patients with Pseudomonas aeruginosa infections.

Results for both formulations show no difference in the ratio of peripheral to central lung deposition. Maximum tobramycin serum levels were below recommended safety thresholds for systemic and inhaled tobramycin applications, and both tobramycin sputum concentrations and the adverse reaction rates were similar. It appears that, for a twice-daily treatment with PARI Tobramycin 100 delivered via an Investigational eFlow, approximately 10 hours+ per month of inhalation time can be saved compared to TOBI.

“We believe that advancements in our eFlow Technology platform can provide a significant reduction in treatment time while reducing the amount of drug needed to deliver an effective dose — a true advancement for patients with CF. The results of our Phase I and Phase II trials are encouraging for both the formulation and the optimized delivery device. Same lung deposition, less drug product, shorter inhalation times, and the chance to improve compliance – these are real life improvements. Focusing on drug formulation and device optimization as one project allows us to make these advancements. Our goal is to reduce the burden of treatment for CF patients,” said Dr. Manfred Keller, executive vice president and chief scientific officer at PARI Pharma.

“We were very pleased to see similar lung deposition and safety profiles while using a lower dose and volume of tobramycin,” said Dr. Allan Coates, lead researcher from the Hospital for Sick Kids in Toronto, Canada. “Technology is really working on the side of the patient with this formulation and the resulting reductions in treatment times. Lack of patient adherence to recommended therapy is a major challenge in cystic fibrosis, especially in adolescents, with the length of treatment time given as the major excuse. With equivalent delivery but in a much shorter time, there are improved chances for greater adherence to prescribed therapy.”

Based on the successful results of the Phase I and Phase II clinical trials, regulatory bodies in Europe welcomed the advantages and benefit of PARI Tobramycin 100 for CF patients and recommended moving forward with a Phase III study to demonstrate therapeutic efficacy and equivalence to TOBI.

PARI Pharma is currently in discussions with multinational pharmaceutical companies to evaluate the efficacy of PARI Tobramycin 100 in a Phase III clinical study and to ultimately make this next-generation treatment available to CF patients worldwide.

The Phase I clinical trial was a randomized, open label, crossover, single-dose deposition study of PARI Tobramycin 100 in an Investigational eFlow versus TOBI/LC PLUS in 16 cystic fibrosis patients, including 8 adults and 8 children. The study was conducted by Dr. Allan Coates at the Hospital for Sick Kids in Toronto, Canada. Tobramycin lung deposition for both applications was between 46mg and 47mg. There was also no difference in the ratio of peripheral to central lung deposition between both drug products and delivery systems. Results from the study were presented at the North American Cystic Fibrosis Conference in October.

The Phase II clinical trial, a randomized, open label, parallel group, non-inferiority, 28-day pharmacokinetic study evaluated the serum levels after twice daily inhalation of PARI Tobramycin 100 versus TOBI in 86 cystic fibrosis patients. The study was conducted in several CF centers in Germany and Poland. The primary endpoint was the maximum tobramycin serum level (Cmax) as safety surrogate parameter at day seven. The PARI Tobramycin 100 Cmax level for the overall, adult and non-adult population was 1.29, 1.21 and 1.36 mg/L, compared to 1.65, 1.81 and 1.52 mg/L, respectively, for the TOBI group. Based on a 30% margin and 90% confidence intervals, PARI Tobramycin 100 achieved non-inferiority in the overall, adult and children population (p

About PARI Tobramycin 100

PARI Tobramycin 100 is an investigational proprietary aqueous solution of 150mg tobramycin/1.5mL for inhalation delivery via a customized Investigational eFlow Nebulizer System, both developed by PARI Pharma, as a potential treatment for patients suffering from bacterial infections caused by Pseudomonas aeruginosa. Patents on both the drug formulation and device were granted in Europe and several other countries. Low volume/high concentration drug products such as PARI Tobramycin 100 delivered using eFlow Technology have shown to substantially shorten nebulized treatments and are believed to become a major relief in patients’ lives.

About the Investigational eFlow Nebulizer System and eFlow Technology

The Investigational eFlow Nebulizer System uses eFlow Technology to enable highly efficient aerosolization of liquid medications via a vibrating, perforated membrane that includes thousands of small holes that produce the aerosol mist. Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its silent mode of operation, small size (it fits in the palm of your hand), light weight, and battery use, products incorporating eFlow Technology reduce the burden of taking daily, inhaled treatments. The Investigational eFlow Nebulizer System and eFlow Technology are proprietary to PARI Pharma.

PARI Pharma partners with pharmaceutical companies to develop new or improved therapies with eFlow Technology and other advanced delivery platforms. Investigational eFlow Nebulizer Systems are optimized and customized per investigational drug product and are currently in clinical trials for cystic fibrosis, asthma, COPD, respiratory syncytial virus (RSV) infection, and treatments for lung transplant patients among other indications.

About PARI Pharma

PARI Pharma focuses on the development of aerosol delivery devices, drug formulations, and therapies. Based on PARI’s 100-year history working with aerosols, PARI Pharma develops treatments for pulmonary and nasal administration optimized with advanced delivery technologies, such as eFlow Technology.

PARI Pharma provides comprehensive inhalation drug development, including nebulizer formulation development and optimization, analytics, aerosol characterization, clinical protocol development, and regulatory guidance, all in compliance with CMC/GCP guidelines. PARI Pharma has several clinical development programs ongoing, either partnered or on its own. PARI Pharma, a PARI Medical Holding company, is located in Munich, Germany with a major presence in the United States. Online at http://www.paripharma.com/

PARI Pharma

CONTACT: Kirsten Ayars, +1-805-452-7909, or Geoff A. Hunziker,+1-831-372-3580, for PARI Pharma; or Dr. Robert Phelps, +49 89 742846-69, formore on PARI Tobramycin 100 and eFlow Technology

Web site: http://www.paripharma.com/

Perceptronix Medical Inc.: LungSign(TM) Study to Monitor Lung Cancer Recurrence

In this month of international Lung Cancer Awareness, Perceptronix Medical Inc. (Perceptronix) is pleased to announce the initiation of a new, longitudinal study with the Respiratory Department of Saint Paul’s Hospital (Vancouver, Canada). Dr. Pearce Wilcox, MD, FRCP and his team will evaluate the use of LungSign(TM) in monitoring for recurrence in subjects with recently re-sected lung cancer. Recurrence rate for lung cancer after resection can be in range from 5% to 15% thus early detection of recurrence among these patients could save many lives.

LungSign(TM) is a safe, virtually painless and convenient test to assess a patient’s risk of lung cancer based on an innovative marker in sputum that is highly correlated with the presence of lung malignancy – even in early stage, presymptomatic disease. LungSign(TM) is the first test in the market that provides both an independent result to help with early detection of lung cancer and a useful complement to current radiological diagnostic methods.

About Perceptronix Medical Inc.

Perceptronix Medical Inc (“Perceptronix” or the “Company”) is a privately owned, independent cytology laboratory and cancer diagnostics company specializing in the provision of innovative early cancer detection tests based on quantitative cytology. The Company’s DNA image cytometry technology was developed in partnership with the British Columbia Cancer Agency (BCCA) in Vancouver. Quantitative cytology provides physicians with an improved cytopathology assessment based on an objective measure of large-scale DNA abnormality that can indicate precancerous or cancerous changes. In addition to general quantitative cytology services, the company has developed innovative tests for the early detection of lung cancer and oral cancer.

 Contacts: Perceptronix Medical Inc. Bojana Turic, MD President & CEO (604) 629-8785 Email: [email protected]

SOURCE: Perceptronix Medical Inc.

FibroGen Announces New Research on HIF-PHI and Anti-CTGF Development Programs in Chronic Kidney Disease

FibroGen, Inc. today announced data from research on its therapeutic programs related to hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitors (PHI) and anti-connective tissue growth factor (anti-CTGF) were reported at the 41st annual meeting of the American Society of Nephrology (ASN) Renal Week November 6-9, 2008, in Philadelphia, PA.

HIF-PHI Anemia Research Presented at Renal Week

There were two presentations on FibroGen’s oral HIF-PH inhibitors, FG-2216 and FG-4592, investigational drugs designed to stimulate erythropoiesis for the treatment of anemia.

 -- FG-2216 treats anemia without exacerbation of hypertension in chronic kidney disease (CKD) model (Abstract #SA-PO2422)(1) In a study evaluating FG-2216 for its effects on anemia and hypertension associated with CKD, a rat remnant kidney model (5/6th nephrectomy) was used, and recombinant human erythropoietin (rHuEPO) was included for comparison. The doses of FG-2216 and rHuEPO employed induced comparable increases in hemoglobin in anemic rats that had undergone nephrectomy, but there was a differential effect of FG-2216 versus rHuEPO on exacerbation of hypertension associated with nephrectomy in this model. Treatment groups were prospectively stratified for comparable levels of hypertension prior to treatment with either FG-2216 or rHuEPO, and systolic blood pressure increased significantly in the rHuEPO group but decreased significantly in the FG-2216 group. Thus, treatment with either FG-2216 or rHuEPO alleviated the anemia associated with 5/6th nephrectomy; however, only FG-2216 was able to increase hemoglobin levels without increasing systolic blood pressure. Similar results were reported for FG-4592 at ASN Renal Week 2007(2).  A large majority of hemodialysis patients and nearly half of late stage CKD nondialysis patients have underlying hypertension, which contributes to progression of kidney disease and cardiovascular events. Erythropoiesis-stimulating agents (ESAs) currently available to treat anemic CKD patients are associated with significant (25-40%) rates of new or worsening hypertension. The results presented at ASN suggest that HIF-PHI may provide clinical benefit over ESAs by improving anemia without exacerbating hypertension. An anemia therapy with neutral effect of blood pressure could provide a significant cardiovascular outcome benefit for patients.  -- Beneficial and novel effects of HIF-PHI for treating anemia (Abstract #F-PO1835)(3) Preclinical data were reported demonstrating several novel and beneficial pharmacodynamic effects resulting from 'complete erythropoiesis' induced by HIF-PHI FG- 2216 and FG-4592 including coordinate regulation of genes that mediate erythropoiesis leading to production of EPO by cells in the kidney and liver; mobilization and proper utilization of iron stores; and erythropoiesis despite interference from chronic inflammation. The latter effect was demonstrated in a model of anemia of chronic disease and is consistent with previously reported data showing that HIF-PHI can suppress inflammatory pathways, such as IL-12-mediated T helper cell production of pro- inflammatory cytokines (e.g., TNF-(alpha) and IFN-(gamma)) and down-regulate hepcidin, a regulatory hormone that limits iron availability and thus suppresses erythropoiesis under conditions of inflammation.  Other data from preclinical and clinical studies were also reported demonstrating that HIF-PHI are orally active. In contrast to ESAs, which are administered by injection, orally bioavailable HIF-PHIs may make anemia care more accessible to the largely underserved anemic CKD patient population not yet on dialysis. Although the benefits of anemia treatment in CKD have become better known, anemia continues to be undertreated, largely due to the fact that while dialysis patients are under the care of nephrologists, most nondialysis CKD patients are treated by primary care physicians who do not have ready access to ESAs. Infrastructure concerns, including inventory and personnel costs, make ESAs impractical for primary care physicians and thus not accessible to their nondialysis patients. According to the 2008 USRDS Annual Data Report(4), only half of incident dialysis Medicare patients had seen a nephrologist 12 months prior to their initiating dialysis and none had seen a nephrologist two years prior. Further, only 10-12% of incident dialysis patients received ESA therapy during the year prior to their initiating dialysis, and these were primarily patients who had been referred to a nephrologist to prepare to initiate dialysis. Thus, there is an opportunity to improve care for anemic CKD patients prior to their reaching the latest stages of disease.  Clinical data were also reported demonstrating that HIF-PHI treatment increased blood hemoglobin concentration with induction of low circulating levels of endogenous EPO 10-40 fold lower than EPO levels associated with ESA therapy. Supraphysiologic levels of circulating EPO (hundreds of times above normal physiologic levels) observed with ESA therapy have been associated with poor patient outcomes, such as vascular access thrombosis and excess cardiovascular events, particularly in patients who do not respond well to ESAs and require large doses (so-called "ESA hypo- responders"). In contrast, the data presented at ASN suggest that circulating levels of endogenous EPO induced by HIF-PHIs are within the normal physiologic range and are only a small fraction of the levels associated with ESA therapy.  ESA hyporesponders represent 20% of dialysis and 10% of nondialysis CKD patients. Inflammation or infection is seen as the cause in nearly three-quarters of these patients. HIF-PHI efficacy in the presence of inflammation, as suggested by the preclinical data, may present a significant efficacy advantage for HIF-PHI compared to ESAs in hyporesponsive patients. 

CTGF Research Presented at Renal Week

In three presentations, FibroGen and collaborators reported results of nonclinical research on CTGF highlighting a new mechanism of fibrosis and new insights into CTGF signaling activity that could result in damage to the integrity of kidney filtration units and exacerbate proteinuria (abnormal presence of proteins in the urine) in diabetic kidney disease (DKD). In a fourth presentation, the association of increased levels of CTGF to peritoneal dialysis was described for the first time.

 -- Decreased BMP-signaling and podocyte markers in human DKD are associated with CTGF overexpression (Abstract #F-PO1323)(5) Bone morphogenetic protein-7 (BMP-7) is an important antifibrotic and proregenerative repair factor, which has been shown to prevent and reverse structural and functional changes of DKD. New data were reported showing that decreased BMP-7 signaling activity in podocytes (specialized kidney cells that maintain the filtration barrier) is associated with overexpression of CTGF in human DKD, and BMP-7 signaling activity was retained in diabetic mice with genetically impaired CTGF expression. Podocyte loss, another hallmark of DKD, was also associated with elevated CTGF expression in the study. These results support the idea that restoration of BMP-7 signaling via CTGF blockade is a new potential mechanism through which prevention or reversal of fibrosis could occur.  -- Molecular signaling activities of CTGF and implications for therapeutic intervention (Abstract #TH-PO123)(6) Although CTGF was recognized as a modular protein over a decade ago, it was only recently that studies began to unravel how the functional domains within the CTGF modules orchestrate signals and control key biological processes. This presentation provided further mechanistic insight into CTGF signaling involving CTGF-mediated activation of p42/44 MAPK, p38 MAPK, paxillin and Akt, at least partially, through the VWC domain.  -- Putative role for CTGF in loss of podocyte slit diaphragm integrity and actin rearrangement (Abstract #TH-PO124)(7) Podocytes are responsible for maintaining the integrity of slit diaphragms, which are critical components of the kidney filtration barrier. Podocyte loss associated with proteinuria is an early manifestation of DKD, and overexpression of CTGF in podocytes has been associated with worsening proteinuria and renal failure in experimental models of diabetes. This presentation of in vitro data provided new molecular insights regarding the ability of CTGF to cause polarization of human podocytes through effects on the cytoskeleton including actin rearrangement and redistribution of the actin-myosin contractile apparatus. Similar polarizing effects of CTGF on podocytes in vivo would have profound consequences for the integrity of the slit diaphragm and may mediate loss of proteins crucial to maintaining the slit diaphragm, such as podocin and nephrin.  -- Elevated CTGF levels in peritoneal dialysis (Abstract #F-PO1632)(8) Peritoneal fibrosis (PF) is an important complication of continuous ambulatory peritoneal dialysis therapy. PF often occurs in association with high transport rate and ultrafiltration failure, but little is known about the mechanistic relationship. This presentation described data from peritoneal dialysis patient samples and found that high peritoneal transport state was associated with high peritoneal CTGF expression. Further, in cultured mesothelial cells (specialized cells that form the lining of the abdominal cavity) that were isolated from peritoneal dialysis effluent, CTGF expression could be induced by TGF-(beta), and higher levels of CTGF induction were associated with high peritoneal transport state. Functional alteration of mesothelial cells may be involved in the progression of peritoneal fibrosis in high transport state. 

About Anti-CTGF Monoclonal Antibody FG-3019

FibroGen has developed a fully-human monoclonal antibody against CTGF, FG-3019. This agent has been in phase 1 clinical trials for idiopathic pulmonary fibrosis, focal segmental glomerular sclerosis (FSGS), and DKD microalbuminuric patients and is currently in a study involving macroalbuminuric patients.

About FibroGen

FibroGen, Inc. is a biotechnology-based drug discovery company using its expertise in the fields of tissue fibrosis, connective tissue growth factor (CTGF), and hypoxia-inducible factor (HIF) biology to discover, develop, and commercialize novel therapeutics for fibrotic disorders, diabetic complications, anemia, conditions associated with tissue damage or injury, cancer, and other areas of unmet medical need. FibroGen also develops and produces recombinant human collagens and gelatins using unique production technology that provides the basis for FibroGen’s proprietary cosmetic dermal filler and biomaterials supply business.

For more information about FibroGen, Inc., please visit www.fibrogen.com.

References

1. Guo G, et al. (2008) Correction of Anemia without Exacerbation of Hypertension in a Rat Model of Chronic Kidney Disease: Comparison of FG-2216 to Recombinant Erythropoietin. Presented at the 41st Annual Meeting of the American Society of Nephrology (Abstract SA-PO2422)

2. Frohna P, et al. (2007) Preliminary Results from a Randomized, Single-Blind, Placebo-Controlled Trial of FG-4592, a Novel Hypoxia Inducible Factor Prolyl Hydroxylase Inhibitor, in Subjects with CKD Anemia. JASN 18:763A

3. Klaus S, et al. (2008) Beneficial Pharmacodynamic Effects Resulting from ‘Complete Erythropoiesis’ Induced by Novel HIF Prolyl Hydroxylase Inhibitors FG-2216 and FG-4592. Presented at the 41st Annual Meeting of the American Society of Nephrology (Abstract F-PO1835)

4. U.S. Renal Data System, USRDS 2008 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2008

5. Turk T, et al. (2008) BMP-Signaling and Podocyte Markers Are Decreased in Human Diabetic Nephropathy in Association with CTGF Overexpression. Presented at the 41st Annual Meeting of the American Society of Nephrology (Abstract F-PO1323)

6. O’Donovan H, et al. (2008) Modular Signaling Activities of the CTGF/CCN2 Domain Structure: Implications for Therapeutic Intervention. Presented at the 41st Annual Meeting of the American Society of Nephrology (Abstract TH-PO123)

7. Browne M, et al. (2008) A Putative Role for Connective Tissue Growth Factor (CTGF) in Loss of Podocyte Slit Diaphragm Integrity and Actin Rearrangement. Presented at the 41st Annual Meeting of the American Society of Nephrology. (Abstract TH-PO124)

8. Mizutani M, et al. (2008) Connective Tissue Growth Factor (CCN2/CTGF) Is Increased in High Peritoneal Solute Transport Rate in Peritoneal Dialysis Patients. Presented at the 41st Annual Meeting of the American Society of Nephrology. (Abstract F-PO1632)

1918 Spanish Flu Records Could Help Solve Future Pandemics

Ninety years after Australian scientists began their race to stop the spread of Spanish flu in Australia, University of Melbourne researchers are hoping records from the 1918 epidemic may hold the key to preventing future deadly pandemic outbreaks.

This month marks the 90th anniversary of the return of Australian WWI troops from Europe, sparking Australian scientists’ race to try and contain a local outbreak of the pandemic, which killed 50 million people worldwide.

Researchers from the University of Melbourne’s Melbourne School of Population Health, supported by a National Health and Medical Research Council grant, are analyzing UK data from the three waves of the pandemic in 1918 and 1919.

They hope that modern high-speed computing and mathematical modeling techniques will help them solve some of the questions about the pandemic which have puzzled scientists for close to a century.

Professorial Fellow John Mathews and colleagues are analyzing the records of 24,000 people collected from 12 locations in the UK during the Spanish flu outbreak including Cambridge University, public boarding schools and elementary schools.

He says gaining a better understanding of how and why the virus spread will help health authorities make decisions about how to tackle future pandemics.

“In the 1918/19 pandemic, mortality was greatest among previously healthy young adults, when normally you would expect that elderly people would be the most likely to die,” Professor Mathews says “We don’t really understand why children and older adults were at lesser risk.

“One explanation may be that children were protected by innate immunity while older people may have been exposed to a similar virus in the decades before 1890 which gave them partial but long-lasting protection.

“Those born after 1890 were young adults in 1918. They did not have the innate immunity of children and as they weren’t exposed to the pre-1890 virus they had little or no immunity against the 1918 virus. We can’t prove it but it is a plausible explanation.”

Another striking feature is that the pandemic appeared in three waves, in the summer and autumn of 1918 and then the following winter.

One theory being examined to explain why some people were only affected in the second or third wave is that because of recent exposure to seasonal influenza virus they had short-lived protection against the new pandemic virus.

“The attack rates in the big cities weren’t as high and this is probably because many people had been exposed to ordinary flu viruses, giving short-lived immunity,” he says.

“In the English boarding schools, where there was social demarcation, children were probably less exposed to seasonal influenza viruses in earlier years; without that protection, pandemic attack rates were much higher than in ordinary government elementary schools.

“If we can provide a detailed time course of epidemics and the attack rates at different times, that information can be extremely useful in determining how a future pandemic might progress,” says Professor Mathews.

He says initial findings point strongly to the value of short-lived immunity to provide protection or partial protection against the early waves of a virus.

This is particularly important when considering the stockpiling of drugs and vaccines to protect the community against a virus.

“The early implications of our study are that there may be benefit in providing short-lived immunity that is broadly based rather than specific,” he says.

“If another flu pandemic were to come along and you have a vaccine, it may be better to use it even if it is against a different sub-type of the virus.”

Image Caption: The Spanish Influenza. Chart showing mortality from the 1918 influenza pandemic in the US and Europe. Courtesy of the National Museum of Health and Medicine

On the Net:

Sexual Intimacy A Problem For Young Breast Cancer Survivors

An Indiana University study found that young, female breast cancer survivors often suffer from sexual and intimate relationship issues and are interested in using sexual enhancement products to treat these problems.

The study, “Young Female Breast Cancer Survivors: Their sexual function and interest in sexual enhancement products and services,” was published Nov. 4 in the journal Cancer Nursing.

The study was funded by The Patty Brisben Foundation, a non-profit organization dedicated to furthering research related to women’s sexual health.

The study found that a significant number of women reported vaginal dryness, genital pain, premature menopause, fatigue and fertility problems. In addition, survivors experienced significant problems related to sexual arousal, desire and orgasm.

“Although previous work has documented the sexual difficulties faced by young breast cancer survivors, strikingly little work has addressed strategies women might take to address these sexual problems,” said Debby Herbenick, lead researcher and associate director of the Center for Sexual Health Promotion at IU Bloomington’s School of Health, Physical Education and Recreation.

Herbenick adds that more than 2 million breast cancer survivors are living in the United States, according to the National Cancer Institute.

“Given advances in early detection and treatment, more women survive breast cancer, which requires researchers to focus on important relationship and quality of life issues for survivors,” said Jessica Johnston, executive director of The Patty Brisben Foundation.

Most of the women surveyed reported interest in using personal lubricants and massage lotions/oils to help treat these issues. Half of the women surveyed were interested in using vibrators or dildos and more than one-third were interested in sex games.

The women in the study also indicated comfort in purchasing sexual enhancement products through in-home parties held in someone’s own home or during one’s regular breast cancer support group meeting, and to a lesser extent from adult Web sites and adult bookstores or novelty stores. Researchers conclude that these venues might be possible places for nurses, doctors and support group leaders to refer their clients.

“Documenting the sexual problems experienced by survivors is important, but we also need to understand the broad and diverse ways that women want to address these sexual problems so that they can experience their intimate lives in ways that feel comfortable, pleasurable and that enhance their relationships,” said Herbenick. “Many women expressed interest in these products, which makes sense given that so many had experienced genital pain, vaginal dryness, low desire or lack of orgasm.”

Questionnaires were administered to 115 women who were diagnosed with breast cancer before the age of 50.

On the Net:

Study Finds Headphones May Interfere With Pacemakers

New research shows that MP3 headphones placed within an inch of pacemakers and implantable cardioverter defibrillators (ICDs) may interfere with the devices.

In some cases they might even keep the defibrillator from delivering its lifesaving shock, according to doctors who tested them.

“Headphones contain magnets, and some of these magnets are powerful,” Dr. William Maisel, who led he study, told the Associated Press.

Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston and a heart device consultant to the federal Food and Drug Administration (FDA), presented the research on Sunday to the American Heart Association’s 2008 Scientific Sessions conference.

“I certainly don’t think people should overreact to this information,” but it’s wise to keep small electronics at least a few inches away from implanted medical devices.

“The headphone interaction applies whether or not the headphones are plugged in to the music player and whether or not the music player is on or off,” he said.

Nearly 2 million people throughout the world have pacemakers, defibrillators or other devices to help regulate their heartbeats.

FDA tests conducted earlier this year found that iPods and other music players pose no threat to the devices.  However, Maisel and his colleagues wanted to know if the same was true of headphones.

They tested eight headphone models, including earbuds and those that hook over the ear, in 60 people with heart devices. The study did not test larger or noise-canceling headphones, since the size of the headphone doesn’t necessarily relate to magnetic strength.  Indeed, small, portable headphones typically use neodymium, one of the most powerful and concentrated magnetic substances, said Maisel.

The researchers found that when the headphones were placed an inch from the device, interference was detected nearly 25 percent of the time – in 10 of the 33 patients with defibrillators and four of the 27 with pacemakers.

Although some patients might not feel such interference, some may have heart palpitations.  Either way, the interference could temporarily deactivate a defibrillator, preventing it from delivering a lifesaving shock if one were required.

The magnet’s effect declines rapidly with increasing distance from the device, and heart device function returns to normal as soon as the headphone moves out of range.

A separate study presented at the heart conference found no threat to heart devices from cell phones using Bluetooth wireless technology.  In the past, cell phones, anti-theft security devices and other electronics have created safety concerns.  But studies generally confirm no danger to heart devices with “ordinary, prudent use,” said Dr. Douglas Zipes, former president of the American College of Cardiology and a professor of cardiology at Indiana University.

“Reassurance to the public is what’s warranted. I still get questions, what about my microwave?” he told the AP.

“Keep your headphones on your ears and when they’re not on your ears, you shouldn’t put them over your chest or your pacemaker,” advised American Heart Association spokesman and device expert Dr. Kenneth Ellenbogen of Virginia Commonwealth University.

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Image Courtesy Of Google

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On The Net:


AAH


American College of Cardiology

Statins Prevent Heart Deaths in Low-Risk People

A large study has found the cholesterol pill Crestor significantly lowered the chance of death and heart attack among people with low cholesterol and no substantial risk factors for heart disease.

The study, published online by the New England Journal of Medicine, provides the most compelling evidence to date for using a new test to identify those who may need treatment, said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute. 

Experts reviewing current guidelines will also consider the new research.

For now, the findings have been praised as a watershed event in heart disease prevention, with doctors saying it may lead an additional 7 million more Americans to begin taking cholesterol-lowering statins such as Crestor, Zocor, Lipitor and the generic form of the drug. Crestor, made by British-based AstraZeneca PLC, is currently the strongest statin on the market.

“This takes prevention to a whole new level, because it applies to patients who we now wouldn’t have any evidence to treat,” Dr. W. Douglas Weaver, president of the American College of Cardiology, told the Associated Press.

However, some experts are urging caution, calling the idea of treating low-risk people “a difficult sell”. They say that while Crestor provided clear benefit in the study, so few heart attacks and deaths occurred among these low-risk people that treating everyone like them in the U.S. could cost up to $9 billion a year.

About 120 people would have to take Crestor for two years to prevent a single stroke, heart attack or death, according to Stanford University cardiologist Dr. Mark Hlatky, who wrote an editorial accompanying the study.

“Everybody likes the idea of prevention. We need to slow down and ask how many people are we going to be treating with drugs for the rest of their lives to prevent heart disease, versus a lot of other things we’re not doing,” he said.

Statins are the world’s top-selling drugs. Until now, all but Crestor had been shown to reduce the risk of heart attacks and death in those with high levels of LDL cholesterol.

However, since half of all heart attacks occur in those with normal or low cholesterol, doctors have been looking for other ways to assess risk.

One way is by performing an $80 blood test to determine levels of high-sensitivity C-reactive protein, or CRP. It is a measure of inflammation, which can indicate clogged arteries as well as less serious problems, such as injury or an infection.

Dr. Paul Ridker of Brigham and Women’s Hospital in Boston, a co-inventor on a patent of the test, led the new study.

A co-inventor on a patent of the test, Dr. Paul Ridker of Harvard-affiliated Brigham and Women’s Hospital in Boston, led the new study, which involved 17,802 participants with high levels of CRP and low LDL cholesterol in the U.S. and 25 other countries.

One-fourth were Hispanic or black, and 40 percent were women, an important distinction since previous studies with statin have not included significant numbers of women. The men were 50 or older, while the women were 60 or older. None of the participants had a history of diabetes or heart disease.

Each participant was randomly assigned to take either a placebo pill or Crestor, with none of the doctors or participants aware who was taking which.

The study was supposed to last five years but was halted in March, after about two years, when independent monitors noticed that those taking Crestor were faring much better than their counterparts taking dummy pills.

The study’s full results were announced Sunday during an American Heart Association conference. They showed that Crestor reduced a combined measure of heart attacks, strokes, heart-related deaths or hospitalizations or the need for an artery-opening procedure, by 44 percent.

“We reduced the risk of a heart attack by 54 percent, the risk of a stroke by 48 percent and the chance of needing bypass surgery or angioplasty by 46 percent,” Ridker said.

Viewed another way, there were 136 annual heart-related problems for every 10,000 people taking dummy pills compared with only 77 for those taking Crestor. Amazingly, every subgroup benefited from the drug.

“If you’re skinny it worked, if you’re heavy it worked. If you lived here or there, if you smoked, it worked,” said Ridker.

AstraZeneca funded the study, and Ridker acknowledged that he and other authors have consulted for the company and other statin makers.

One note of concern in the study was the fact that more people in the Crestor group saw their blood-sugar levels rise or became newly diagnosed with diabetes.

Dr. Sidney Wolfe of the consumer group Public Citizen said that Crestor also has the highest rate among all the statins of a rare but serious muscle condition. And there are probably safer and less costly ways to get the same benefits, said Wolfe, who has campaigned against the drug in the past.

“It is highly unlikely that (the benefits are) specific to Crestor,” Wolfe told the AP. 

Crestor costs $3.45 a day compared with less than a dollar for generic drugs.

Drs. James Stein and Jon Keevil of the University of Wisconsin-Madison used federal health statistics to estimate that 7.4 million Americans, or more than 4 percent of the adult population, are similar to the study’s participants. Treating all of them with Crestor would cost $9 billion a year and prevent about 30,000 heart attacks, strokes or deaths, they calculate.

“That’s pretty costly. This would be a very difficult sell,” said Dr. Thomas Pearson of the University of Rochester, unless a person also had a family history of heart disease or other risk factors.

Pearson co-chaired a joint government-heart association panel that established current guidelines for using CRP tests to determine treatment.

Researchers are not yet sure whether the study’s benefits were due to reducing CRP or cholesterol, since Crestor did both.

However, the study and two other government-sponsored ones reported on Sunday “provide the strongest evidence to date” for testing CRP. Augmenting traditional risk measures with CRP tests could identify millions more people who would benefit from statin treatment, Nabel said in a statement.

U.S. Crestor prescriptions were more than $420 million in the third quarter this year, a 23 percent increase from last year.   In the rest of the world, third quarter sales grew 33 percent to $520 million. Sales of Crestor have been rising despite the availability of generic forms of Zocor and Pravachol.
 

20 Percent of U.S. Soldiers Return with PTSD

Army Maj. Gen. David Blackledge’s bravery extends far beyond the battlefields of Iraq.  

The 54-year-old two-star Army Reserve general commanded a civil affairs unit during two tours in Iraq, and now works in the Pentagon as Army assistant deputy chief of staff for mobilization and reserve issues.

In February 2004 during his first deployment, Blackledge’s convoy was ambushed. In the tragedy he has since relived in flashbacks and recurring nightmares, his interpreter was shot through the head, his vehicle rolled over many times before Blackledge was able to crawl out of it with a crushed vertebrae and broken ribs –only to find himself in the middle of a firefight.  He and other survivors took cover in a ditch.

Upon returning home to the U.S., Blackledge sought counseling to help him with the psychological trauma, and is now helping others by speaking out on the issue of mental health problems and treatment. 

“It’s part of our profession … nobody wants to admit that they’ve got a weakness in this area,” Blackledge told the Associated Press, referring to mental health problems among troops returning from Iraq and Afghanistan.

“I have dealt with it. I’m dealing with it now,” said Blackledge, who suffers with post-traumatic stress.

“We need to be able to talk about it.”

Thousands of troops are returning from the wars with depression, anxiety and other emotional problems. Estimates show that up to one in five of the 1.7 million who have served in Iraq and Afghanistan have symptoms.  However, only half of those who need help actually seek it, according to studies.

Despite efforts to promote mental health treatment among returning military members, some officials fear generals and other senior leaders are unwilling seek such help, or even discuss it, out of fear it will hurt their chances for promotion.

That reluctance is also worrisome because it sends the wrong signal to younger officers and perpetuates the problem leaders are working to reverse.

“Stigma is a challenge,” said Army Secretary Pete Geren during a Pentagon news conference on Friday.

“It’s a challenge in society in general. It’s certainly a challenge in the culture of the Army, where we have a premium on strength, physically, mentally, emotionally.”

Chairman of the Joint Chiefs of Staff Adm. Mike Mullen called on military leaders to set an example for all soldiers, sailors, airmen and Marines.

“You can’t expect a private or a specialist to be willing to seek counseling when his or her captain or colonel or general won’t do it,” he said.

Brig. Gen. Loree Sutton, an Army psychiatrist who leads the defense center for psychological health and traumatic brain injury, is working to create a forum for people to tell their personal stories.   The initiative would allow troops, their families and others to express and share concerns and ideas via Web links and other programs.

Blackledge volunteered to help.  He and his wife, Iwona, herself an Air Force nurse, will address a medical conference next week on the subject.

Following his February 2004 ambush, Blackledge was visited by a psychiatrist within days of arriving at Walter Reed Army Medical Center in Washington.  He had several subsequent sessions with the doctor during his 11-month recovery from his physical injuries.
 
“He really helped me,” Blackledge said of his psychiatrist.

And that’s precisely his message to troops.

“I tell them that I’ve learned to deal with it,” he said.

“It’s become part of who I am.”

Although he still suffers from bad dreams about once a week, he no longer wakes from them in a sweat, and they are no longer as upsetting.

During his second tour to Iraq, Blackledge traveled to nearby Jordan to work with local officials on Iraq border issues.  He was staying at a hotel in Amman in November 2005 when suicide bombers attacked, killing more than 60 people and wounding hundreds more.

The bombing left Blackledge with a whiplash injury that took months to heal.  The experience, including a harrowing escape from the chaotic scene, regenerated his post-traumatic stress symptoms, though they were not as severe as those he’d suffered in the aftermath of the 2004 ambush.

As the nation marks Veterans Day on November 11, officials across all military service branches are working to improve access and discretion of mental health services for returning troops. Some have even embedded mental health teams directly into units. 

While they acknowledge it may take a while, they see signs that the stigma of post-traumatic stress is slowly fading away.

Quidel Announces Promotion of John Tamerius, Ph.D. To Senior Vice President, Clinical/Regulatory Affairs

Quidel Corporation (NASDAQ: QDEL), a leading provider of point-of-care rapid diagnostic tests, announced today that John D. Tamerius, Ph.D., currently vice president, clinical/regulatory affairs, has been promoted to senior vice president, clinical/regulatory affairs, effective November 10, 2008.

“It is a pleasure to recognize John’s expertise and success by naming him senior vice president, clinical/regulatory affairs. Under his leadership, the company has developed strong relationships with key thought leaders in the medical community and improved the clinical efficacy of our products. John’s promotion is well deserved,” said Caren Mason, president and chief executive officer of Quidel Corporation.

Dr. Tamerius has been an integral part of Quidel for 25 years. He has served as vice president, clinical/regulatory affairs since 2005, and previously held a variety of executive roles including responsibility for research and development and general management of Northern California operations.

Dr. Tamerius originally joined Quidel in 1983 with the acquisition of Cytotech, Inc. where he was president. Prior to working at Cytotech, Dr. Tamerius was a research associate at Scripps Clinic and Research Foundation. Dr. Tamerius has been awarded a Bachelor of Science, a Master of Science, and a Ph.D. in Microbiology and Immunology, all from the University of Washington.

About Quidel Corporation

Quidel Corporation serves to enhance the health and well being of people around the globe through the discovery, development, manufacturing and marketing of rapid diagnostic solutions at the point of care (POC) in infectious diseases and reproductive health. Marketed under the leading brand name of QuickVue(R), Quidel’s portfolio of products currently includes tests that aid in the diagnosis of several disease or condition states, including influenza, respiratory syncytial virus, Fecal Occult Blood, Strep A, pregnancy, bacterial vaginosis, H. pylori and Chlamydia. Quidel’s products are sold to healthcare professionals with a focus on the physician office lab and acute care markets through leading medical distribution partners on a worldwide basis. Quidel’s Specialty Products Group (SPG) develops research products in the fields of oncology and bone health with potential future point-of-care applications. By building value in rapid diagnostic tests, Quidel provides leadership to the industry and among healthcare professionals allowing for the movement of patient testing out of the central laboratory setting and into the physician office, urgent care and other outpatient settings where rapid testing and treatment has an impact on clinical outcomes and provides an economic benefit. For more information, visit www.flutest.com, www.quidel.com, or www.colorectal-test.com.

This press release contains forward-looking statements within the meaning of the federal securities laws that involve material risks, assumptions and uncertainties. Many possible events or factors could affect our future financial results and performance, such that our actual results and performance may differ materially. As such, no forward-looking statement can be guaranteed. Differences in actual results and performance may arise as a result of a number of factors including, without limitation, seasonality, the timing of onset, length and severity of cold and flu seasons, uncertainty surrounding the detection of novel influenza viruses involving human specimens, adverse changes in the competitive and economic conditions in domestic and international markets, actions of our major distributors and the level of success in our recent distributor incentive programs, technological changes and uncertainty with research and technology development, including any future molecular-based technology, the reimbursement system currently in place and future changes to that system, manufacturing and production delays or difficulties, adverse actions or delays in product reviews by the U.S. Food and Drug Administration (the “FDA”), intellectual property, product liability, environmental or other litigation, required patent license fee payments not currently reflected in our costs, potential inadequacy of booked reserves and possible impairment of goodwill, and lower-than-anticipated sales or market penetration of our new products. Forward-looking statements typically are identified by the use of terms such as “may,””will,””should,””might,””expect,””anticipate,””estimate,” and similar words, although some forward-looking statements are expressed differently. The risks described under “Risk Factors” in reports and registration statements that we file with the SEC from time to time should be carefully considered. You are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date of this press release. We undertake no obligation to publicly release the results of any revision or update of the forward-looking statements.

Data From Investigational Use of PROCRIT(R) (Epoetin Alfa) Presented at American Society of Nephrology Annual Meeting

PHILADELPHIA, Nov. 7 /PRNewswire/ — Data from an investigational, open-label, randomized study assessing extended dosing regimens of PROCRIT(R) (Epoetin alfa) in treating anemia in subjects with Stages 3 – 4 chronic kidney disease (CKD) were presented today at the American Society of Nephrology 41st Annual Meeting.

All three dosing groups, including the FDA-approved three-times-per-week (TIW) regimen, plus once-a-week (QW) and once-every-two-weeks (Q2W) investigational regimens, achieved a mean final hemoglobin (Hb) within the range of 11.0 – 11.9 g/dL. Based on the increases in Hb, the QW and Q2W investigational regimens were statistically non-inferior to the TIW regimen (lower limits of 95 percent confidence intervals [CIs] within the non-inferiority margin of -1 g/dL).

The percent of subjects with Hb exceeding 11.9 g/dL during the first 22 weeks of treatment was higher in the TIW group (86.2 percent) than in the QW (78.4 percent) and Q2W (71.2 percent) groups; the median per-subject frequency of Hb exceeding 11.9 g/dL was 6, 4 and 3 times for the TIW, QW and Q2W groups, respectively.

In the first 22 weeks of treatment, the proportion of subjects experiencing serious adverse events (SAEs) was 15 percent in the TIW group, compared with 22 percent in both the QW and Q2W groups. During the entire 44 weeks of treatment, the proportion of subjects experiencing SAEs was 29, 33 and 33 percent in the TIW, QW and Q2W groups, respectively. The number of subjects with investigator-confirmed thromboembolic vascular events (TVEs) over the first 22 weeks was 2 in the TIW, 2 in the QW and 3 in the Q2W groups; over 44 weeks, these numbers were 2, 5 and 8 in the TIW, QW and Q2W groups, respectively. The number of subjects who died during the first 22 weeks was 0 in the TIW, 6 in the QW and 3 in the Q2W groups. Over 44 weeks, 4, 6 and 4 subjects died, respectively. None of the deaths were considered related to the study drug.

“These data provide important insights into the potential use of extended-dosing regimens of Epoetin alfa in this patient population,” said Pablo E. Pergola, M.D., Ph.D., Division of Nephrology, University of Texas Health Science Center and Renal Associates, P.A., San Antonio, Texas.

Study Design

In the study, 375 subjects averaging 70 years of age were randomized equally to one of the three dosing groups (TIW, QW and Q2W) and treated for 44 weeks. Subjects receiving PROCRIT TIW were switched to QW dosing after 22 weeks. A dose-adjustment algorithm was used to achieve a target Hb of 11.0 to 11.9 g/dL. The primary efficacy endpoint was change in Hb from baseline to the average of the last eight weeks of treatment through Week 22. Additional analyses were performed using data through Week 44.

The mean baseline estimated glomerular filtration rate was 30 mL/min/1.73 m2 and the median weekly EPO doses (IU) were 4,382, 4,364 and 6,091 for TIW, QW and Q2W groups, respectively. For the TIW, QW and Q2W groups, the mean baseline Hb was 9.6, 9.7 and 9.8 g/dL, respectively; the mean Hb increase was 1.8, 1.6 and 1.3 g/dL, respectively, and the mean final Hb was 11.4, 11.3 and 11.1 g/dL, respectively.

About PROCRIT (Epoetin alfa)

PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.

Important Safety Information

WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, and increased risk of tumor progression OR recurrence

Renal failure: Patients experienced greater risks for death and

serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

   Cancer:    --  ESAs shortened overall survival and/or increased the risk of tumor       progression or recurrence in some clinical studies in patients with       breast, non-small cell lung, head and neck, lymphoid, and cervical       cancers (see WARNINGS: Table 1).    --  To decrease these risks, as well as the risk of serious cardio- and       thrombovascular events, use the lowest dose needed to avoid red blood       cell transfusion.    --  Use ESAs only for treatment of anemia due to concomitant       myelosuppressive chemotherapy.    --  ESAs are not indicated for patients receiving myelosuppressive therapy       when the anticipated outcome is cure.    --  Discontinue following the completion of a chemotherapy course.   

Perisurgery: PROCRIT (Epoetin alfa) increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

   Contraindications   --  PROCRIT is contraindicated in patients with uncontrolled hypertension       or with known hypersensitivity to albumin (human) or mammalian       cell-derived products.    Additional Important Safety Information   --  Patients with chronic renal failure experienced greater risks for       death and serious cardiovascular events (including myocardial       infarction, stroke, congestive heart failure, and hemodialysis       vascular access thrombosis) when administered ESAs to target higher       versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in       two clinical studies; these risks also increased in controlled       clinical trials of patients with cancer. A rate of hemoglobin rise of       1 g/dL over 2 weeks may contribute to these risks.   --  Dose of PROCRIT  

— Chronic renal failure patients: The dose of PROCRIT should be titrated for each patient to achieve and maintain hemoglobin levels between 10 to 12 g/dL. If a patient does not attain hemoglobin levels of 10 to 12 g/dL despite 12 weeks of appropriate PROCRIT therapy, see DOSAGE and ADMINISTRATION in the PROCRIT Prescribing Information.

— Cancer patients: PROCRIT therapy should not be initiated at hemoglobin levels greater than or equal to 10 g/dL. The dose of PROCRIT should be titrated for each patient to achieve and maintain the lowest hemoglobin level sufficient to avoid the need for blood transfusion. Discontinue if after 8 weeks of therapy there is no response as measured by hemoglobin levels or if transfusions are still required (see recommended Dose Modification section in DOSAGE and ADMINISTRATION of the PROCRIT Prescribing Information).

— HIV patients: The dose of PROCRIT should be titrated for each patient to achieve and maintain the lowest hemoglobin level sufficient to avoid transfusion and not to exceed the upper safety limit of 12 g/dL.

   --  Monitor hemoglobin regularly during therapy, weekly until hemoglobin       becomes stable.   --  Cases of pure red cell aplasia (PRCA) and of severe anemia, with or       without other cytopenias, associated with neutralizing antibodies to       erythropoietin have been reported in patients treated with PROCRIT;       predominantly in patients with chronic renal failure receiving PROCRIT       by subcutaneous administration.  If any patient develops a sudden loss       of response to PROCRIT, accompanied by severe anemia and low       reticulocyte count, and anti-erythropoietin antibody-associated anemia       is suspected, withhold PROCRIT and other erythropoietic proteins.        Contact ORTHO BIOTECH (1-888-2ASKOBI or 1-888-227-5624) to perform       assays for binding and neutralizing antibodies.  If erythropoietin       antibody-mediated anemia is confirmed, PROCRIT should be permanently       discontinued and patients should not be switched to other       erythropoietic proteins.   --  The safety and efficacy of PROCRIT therapy have not been established       in patients with a known history of a seizure disorder or underlying       hematologic disease (e.g., sickle cell anemia, myelodysplastic       syndromes, or hypercoagulable disorders).   --  In some female patients, menses have resumed following PROCRIT       therapy; the possibility of pregnancy should be discussed and the need       for contraception evaluated.   --  Prior to and regularly during PROCRIT therapy monitor iron status;       transferrin saturation should be greater than or equal to 20% and       ferritin should be greater than or equal to 100 ng/mL. During therapy       absolute or functional iron deficiency may develop and all patients       will eventually require supplemental iron to adequately support       erythropoiesis stimulated by PROCRIT.   --  Treatment of patients with grossly elevated serum erythropoietin       levels (e.g., >200 mUnits/mL) is not recommended.   --  During PROCRIT therapy, blood pressure should be monitored carefully       and aggressively managed, particularly in patients with an underlying       history of hypertension or cardiovascular disease.   --  In studies, the most common side effects included fever (pyrexia),       diarrhea, nausea, vomiting, swelling of hands or feet (edema), lack or       loss of strength or weakness (asthenia, fatigue), shortness of breath,       high blood pressure, headache, joint pain (arthralgias), abnormal skin       sensations (as tingling or tickling or itching or burning;       paresthesia), rash, constipation and upper respiratory infection.   

Please visit http://www.procrit.com/ for the full Prescribing Information, including the Boxed WARNINGS, and for the Medication Guide and Patient Instructions for Use.

About Ortho Biotech Products, L.P.

Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients’ health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit http://www.orthobiotech.com/

Ortho Biotech Products, L.P.

CONTACT: Bill Foster, +1-908-541-4057, +1-908-392-6057 (cell),[email protected], for Ortho Biotech Products, L.P.

Web Site: http://www.orthobiotech.com/http://www.procrit.com/

Sea Snakes Prefer To Drink Freshwater

Sea snakes may slither in saltwater, but they sip the sweet stuff.

So concludes a University of Florida zoologist in a paper appearing this month in the online edition of the November/December issue of the journal Physiological and Biochemical Zoology.

Harvey Lillywhite says it has been the “long-standing dogma” that the roughly 60 species of venomous sea snakes worldwide satisfy their drinking needs by drinking seawater, with internal salt glands filtering and excreting the salt. Experiments with three species of captive sea kraits captured near Taiwan, however, found that the snakes refused to drink saltwater even if thirsty “” and then would drink only freshwater or heavily diluted saltwater.

“Our experiments demonstrate they actually dehydrate in sea water, and they’ll only drink freshwater, or highly diluted brackish water with small concentrations of saltwater “” 10 to 20 percent,” Lilywhite said.

Harold Heatwole, a professor of zoology at North Carolina State University and expert on sea snakes, termed Lillywhite’s conclusion “a very significant finding.”

“This result probably holds the key to understanding the geographic distribution of sea snakes,” Heatwole said.

The research may help explain why sea snakes tend to have patchy distributions and are most common in regions with abundant rainfall, Lillywhite said. Because global climate change tends to accentuate droughts in tropical regions, the findings also suggest that at least some species of sea snakes could be threatened now or in the future, he added.

“There may be places where sea snakes are barely getting enough water now,” he said. “If the rainfall is reduced just a bit, they’ll either die out or have to move.”

Sea snakes are members of the elapid family of snakes that also includes cobras, mambas and coral snakes. They are thought to have originated as land-dwelling snakes that later evolved to live in oceans. Most spend all, or nearly all, of their lives in seawater, including giving birth to live young while swimming. A minority, including the kraits that Lillywhite studied, lay eggs and spend at least a small part of their lives on land.

In the lab studies, Lilywhite’s team kept snakes caught in the wild near Orchid Island, Taiwan, away from freshwater for two weeks. At the end of that period, dimpling of the snakes’ scales indicated they were dehydrated.

The researchers weighed the snakes, freed them in saltwater tanks for up to 20 hours, then weighed them again. None gained appreciably, indicating they didn’t drink, despite their thirst. But when the researchers freed the snakes to swim in freshwater tanks, most immediately drank significant amounts. More experiments revealed the snakes would drink only freshwater or highly diluted saltwater.

The kraits may get their freshwater from springs or streams around Orchid Island “” deed, the researchers observed far more sea snakes near these freshwater sources than in strictly marine sites, the paper says.

Lillywhite believes the sea snakes that spend their lives in the open ocean drink water from the “lens” of freshwater that sits atop saltwater during and after rainfall, before the two have had a chance to mix. That would explain why some seawater lagoons, where the waters are calmer due to protection from reefs, are home to dense populations of sea snakes “” the freshwater lens persists for longer periods before mixing into saltwater.

Rather than helping sea snakes gain water, the snakes’ salt gland may help the snakes with ion balance “” moving excess salts from the bloodstream, Lillywhite said.

Some sea snake species living in dry regions may already be suffering as a result of climate change. Lillywhite said a colleague in Australia, which is in the midst of a historic drought, has observed declines and possible extinctions in some species at Ashmore Reef, home to the most diverse and abundant population of sea snakes in the world.

“We are trying to look at rainfall in that region and see if there is a correlation,” Lillywhite said.

He added that his findings also raise questions about the accepted wisdom that other marine reptiles, including sea turtles, satisfy their freshwater needs by drinking saltwater.

Image Caption: A sea snake rests on rocks near at the shore of Orchid Island, Taiwan. A University of Florida zoologist has shown that the snake, a black-banded sea krait, and other sea snake species drink freshwater, contradicting the conventional view that they satisfy their drinking needs by sipping sea water. Harvey Lillywhite believes sea snakes seek out freshwater in springs, rivers or in the freshwater “lens” that develops briefly atop seawater shortly after it rains. (Leslie Babonis/UF Department of Zoology)

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JEWEL-OSCO(R) Extends Prescription Plus Rewards Program

ITASCA, Ill., Nov. 7 /PRNewswire/ — In the face of challenging economic times, JEWEL-OSCO PHARMACY(TM) is reinforcing its message to consumers that it actually pays to take their prescription medications properly and take preventative measures, such as flu immunizations, to maintain good health.

In response to customer feedback and demand, JEWEL-OSCO today announced that frequent pharmacy customers will have additional opportunities to reduce their grocery bills through the Prescription Plus pharmacy rewards program. JEWEL-OSCO PHARMACY will extend the limited life of Prescription Plus through January 31, 2009.

“As pharmacists, our foremost concern is helping our patients comply with their prescribed medication therapies,” said Tom Rousonelos, RPh, vice president, JEWEL-OSCO pharmacy operations. “We’re extending the length of Prescription Plus in response to a real need our pharmacy customers tell us they have for the continuous opportunities to reduce their grocery bills through this program.”

Prescription Plus offers customers a 10 percent discount coupon after every five prescriptions filled at the pharmacy, using their JEWEL-OSCO Preferred Card. New, transferred and refilled medication orders-including flu shots-all can count toward earning the valuable discount, which can be redeemed at the grocery checkout. Some restrictions apply.

Because Prescription Plus discounts apply to the customer’s future grocery purchases, the program stands to deliver more cost savings to consumers than competing discount drug programs.

“Prescription Plus is providing some relief to the economic pressures many of our patients are feeling in today’s economy. At a time when many people are giving careful consideration to every purchase they make, we want to make it easier for our customers to make wise food and pharmacy choices,” Rousonelos said.

All 185 Jewel-Osco locations in Illinois, Indiana and Iowa will continue the Prescription Plus program. Locations without in-store pharmacies will also honor the 10 percent discount. In addition to traditional prescription orders, immunizations, diabetes care service appointments and medication therapy management appointments in most cases can also count toward Prescription Plus discounts.

About Jewel-Osco Pharmacy

Jewel-Osco, a SUPERVALU company, operates 170 in-store pharmacies in Illinois, Iowa and Indiana. In addition to full-service prescription services, the pharmacy at Jewel-Osco provides immunizations, diabetes care services and health screenings, which are administered by specially trained Jewel-Osco pharmacists. For more information about Jewel-Osco Pharmacy, visit: http://www.oscopharmacy.com/.

Jewel-Osco Pharmacy

CONTACT: Cassie Richardson, Pharmacy Communications Manager ofJewel-Osco Pharmacy, +1-847-915-0601

Web site: http://www.oscopharmacy.com/

Scientists Create Black Hole Simulator

A team of theoretical and experimental physicists, with participants from Case Western Reserve University, have designed a new black hole simulator called BlackMax to search for evidence that extra dimensions might exist in the universe.

Information about BlackMax’s creation has been published in Physical Review Letters in the article, “BlackMax: A Black-Hole Event Generator with Rotation, Recoil, Split Branes and Brane Tension.”

Black holes are theorized to be regions in space where the gravitational field is so strong that nothing can escape its pull after crossing what is called the event horizon. BlackMax simulates these regions.

Approximately two years in the making, the computer program enables physicists to test theories about the production and decay of black holes and takes into account new types of effects on both the creation and evaporation of black holes at the new Large Hadron Collider (LHC) currently being commissioned at the European Center for Nuclear Research (CERN) in Geneva, Switzerland.

For example, black holes created at the LHC would be expected to start off spinning.

The spinning of the black hole increases the fraction of the black hole’s mass that is dissipated as gravitons”“elementary quanta of gravity, which could be used to provide a clue to the existence and structure of extra dimensions. Black holes are being studied with BlackMax by members of the ATLAS Experiment at LHC, one of the two principal large particle detectors at the new collider. Case Western Reserve physicists working with Glenn Starkman on the project are his former doctoral student Dejan Stojkovic, now a visiting professor on the faculty of the State University of New York (SUNY) at Buffalo, and De-Chang Dai, who recently graduated with his doctoral degree in physics, and is now a postdoctoral fellow working with Stojkovic. Other collaborators are experimental physicists Cigdem Issever and Jeff Tseng of Oxford University and Eram Rizvi from Queen Mary College at the University of London.

ATLAS works much like investigators who search the site of plane crash, and then piece together the debris to find the cause of the plane’s disintegration.

BlackMax, by predicting how those pieces will fall, should allow physicists looking at data from the ATLAS experiment to see whether the pattern of particles released into the detector matches what one would expect when a black hole is produced and then falls apart.

The ordinary non-gravitational collisions predicted by the Standard Model of particle physics tend to produce fragments of the proton clumped into a small number of jets.

Decays of black holes should produce more particles than usual. These particles should also come out unusually isotropically””in every direction””and the mix of particles should be more democratic – including for example electrons and similar particles that are not found within the proton.

Under certain circumstances, black hole decay should also produce many gravitons that would themselves pass unnoticed out of the ATLAS, but which would make the remaining emitted particles looking asymmetric and carrying less than the full event energy.

Starkman said that if black holes are found at the LHC it will enable scientists to understand the connection between gravity and quantum mechanics, resolving the inconsistency between two of the great intellectual triumphs of the 20th century – quantum mechanics and Einstein’s General Theory of Relativity.

It would also mean the existence of other dimensions to space, and explain why gravity is such a weak force compared to the other three fundamental forces of nature”“electromagnetism and the strong and weak nuclear forces.

According to Starkman, the black holes under study at LHC will be very small, extremely hot at more than billion times the temperature of the sun, and their lifespan will consequently be so short that they will decay within tiny fractions of a second of their creation.

He added that there is not enough time for the black hole to cross a human hair, “never mind leaving the detector,” he said.

“What’s more important is that the universe has been doing this experiment for billions of years by bombarding the earth’s atmosphere (not to mention all the myriad stars) with cosmic rays. So we know if black holes are made at the LHC, they are entirely safe,” said Starkman.

Image Caption: A growing black hole, called a quasar, can be seen at the center of a faraway galaxy in this artist’s concept. Astronomers using NASA’s Spitzer and Chandra space telescopes discovered swarms of similar quasars hiding in dusty galaxies in the distant universe. The quasar is the orange object at the center of the large, irregular-shaped galaxy. It consists of a dusty, doughnut-shaped cloud of gas and dust that feeds a central supermassive black hole. As the black hole feeds, the gas and dust heat up and spray out X-rays, as illustrated by the white rays. Beyond the quasar, stars can be seen forming in clumps throughout the galaxy. Other similar galaxies hosting quasars are visible in the background.

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WellSpring Pharmaceutical Corp. Announces Hire of Wayne Miller As Vice President, Sales & Marketing, Consumer Brands

BRADENTON, Fla., Nov. 7 /PRNewswire/ — WellSpring Pharmaceutical Corporation, a growing North American-based pharmaceutical manufacturer, today announced that Wayne Miller has been hired as the Vice President, Sales and Marketing, Consumer Brands.

Mr. Miller, an accomplished sales executive, will be responsible for designing and implementing the Company’s sales and marketing strategy in the United States for its newly acquired over-the-counter product line, which includes Micatin (R) (antifungal), Emetrol (R) (anti-nausea), and Gelusil (R) (antacid). Mr. Miller will also lead the United States launch of two products that the Company currently markets in Canada, Glaxal Base(TM) and Barriere.

Mr. Miller most recently held the position of Vice President, Sales and Marketing for a North American based over-the-counter consumer health company, Origin BioMed. During his tenure with Origin BioMed, Mr. Miller was the driving force behind the successful launch of products into North America, gaining entry into several national and regional drug chains, as well as negotiating viable relationships with the North American drug wholesalers, including AmerisourceBergen, McKesson and Cardinal Health.

Along with his team at Origin BioMed, Mr. Miller was recently awarded a Nova Scotia Professional Sales Award for Innovative Sales Team. These awards honor polished professional salespeople who are changing the perception of the profession and are the driving force behind their organization’s success.

“Mr. Miller is a valuable addition to our team. We are pleased to have him lead our Consumer Brands Sales and Marketing group,” said Dr. Robert Vukovich, WellSpring’s CEO and President. “His leadership experience, coupled with an innovative and energetic approach, makes him ideally suited to direct and guide our consumer health business.”

About the Company

WellSpring Pharmaceutical Corp. has made the development, marketing and sales of new and novel prescription and OTC drug products its strategic focus. WellSpring’s prescription drug products include Dyrenium (R) (diuretic) and Dibenzyline (R) (anti-hypertension) which are marketed in the US. The firm is an active acquirer of pharmaceutical brands and enhances their value through the development of product improvements and line extensions.

WellSpring is a privately held pharmaceutical company founded in 1999 by Dr. Robert A. Vukovich the firm’s CEO and Chairman. Dr. Vukovich previously founded and managed Roberts Pharmaceutical Corporation of Eatontown, NJ until its acquisition by Shire Pharmaceutical Group in 1999. WellSpring owns and operates an FDA approved manufacturing plant in Oakville, Ontario, Canada. Its administrative headquarters are located in Bradenton, Florida. The firm provides contract manufacturing services to the pharmaceutical industry and manufactures prescription and OTC drug products for both the US and Canada.

Contact:

Dr. Robert A. Vukovich, +1-941-552-7880, or +1-941-504-1229, or Wendy Shusko, +1-941-552-7881.

WellSpring Websites: http://www.wellspringpharm.com/, http://www.wpcoutsourcing.com/, http://www.wellskin.ca/.

Information regarding several of the newly acquired brands can be found at the following web addresses: http://www.micatin.com/, http://www.gelusil.com/ and http://www.emetrol.com/.

WellSpring Pharmaceutical Corporation

CONTACT: Dr. Robert A. Vukovich, +1-941-552-7880, or +1-941-504-1229, orWendy Shusko, +1-941-552-7881, both for WellSpring Pharmaceutical Corporation

Web site: http://www.wellspringpharm.com/http://www.wpcoutsourcing.com/http://www.wellskin.ca/

FUSILEV(TM) Receives Unique, Product-Specific J-Code From the Centers for Medicare and Medicaid Services (CMS)

Spectrum Pharmaceuticals, Inc., (NasdaqGM:SPPI) announced today that the Centers for Medicare and Medicaid Services (CMS), under the Medicare Part B benefit, has assigned a unique, product-specific billing code, or J-code, for FUSILEV(TM) (levoleucovorin). FUSILEV(TM) is the only commercially available formulation comprised only of the pharmacologically active isomer of leucovorin. The J-code J06410 becomes effective on January 1, 2009, and will assist providers in obtaining reimbursement for FUSILEV(TM).

The Healthcare Common Procedure Coding System (HCPCS) National Panel reviewed FUSILEV’s application submitted to CMS and decided to assign a unique, product-specific J-code for use by all payers. The HCPCS National Panel is made up of members of the private insurance industry, Medicaid, and Medicare.

“We are pleased to receive the unique J-code for FUSILEV(TM),” said Rajesh C. Shrotriya, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “The J-code should help providers bill accurately, which should enable more rapid reimbursement for FUSILEV(TM).”

About FUSILEV(TM) (levoleucovorin) for injection

FUSILEV, a novel folate analog, is available in 50-mg vials of freeze-dried powder. It is the pharmacologically active isomer of leucovorin. FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV (levoleucovorin or (6S)-leucovorin) is the only commercially available formulation comprised only of the pharmacologically active isomer of leucovorin.

Important FUSILEV (levoleucovorin) for injection Safety Considerations

FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Due to calcium content, no more than 16-mL (160-mg) of levoleucovorin solution should be injected intravenously per minute. FUSILEV enhances the toxicity of fluorouracil. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a placebo-controlled study. Allergic reactions were reported in patients receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy. FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.

Full prescribing information can be found at www.fusilev.com.

About Spectrum Pharmaceuticals

We are a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Our strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit our website at www.spectrumpharm.com.

Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum’s ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for our approved drugs, continuing to build our team, leveraging the expertise of partners around the world to assist us in the execution of our strategy, the safety and efficacy of FUSILEV(TM), that the J-code should help providers bill accurately, which should enable more rapid reimbursement for FUSILEV(TM), and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC.(TM), TURNING INSIGHTS INTO HOPE(TM), FUSILEV(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

(C) 2008 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

Acologix AC-200 Demonstrates Positive Effect on Bone in Preclinical Model of Chronic Kidney Disease

HAYWARD, Calif., Nov. 7 /PRNewswire-FirstCall/ — Acologix, Inc., a privately held biopharmaceutical company, will present data indicating that its therapeutic product candidate AC-200 improved bone architecture in a rat model of chronic kidney disease. AC-200, an endogenous human protein produced by bone cells, was evaluated in a well accepted rodent model of chronic kidney disease (CKD) in which bone loss is rapid and substantial. The data will be presented by David Rosen, Ph.D on November 8, 2008 at the 41st ASN (American Society of Nephrology) Annual Meeting in Philadelphia, PA.

The effects of AC-200 on bone and mineral metabolism were evaluated in partially nephrectomized rats (5/6 Nx). These rats have reduced renal function which leads to elevated levels of serum phosphate and parathyroid hormone (PTH). Bone loss is an important feature of the model, similar to renal osteodystrophy seen in CKD patients. Recombinant AC-200 (MEPE: Matrix Extracellular Phosphoglycoprotein) or vehicle control were administered for 14 days by intravenous injections to 5/6 Nx rats. Serum and urine biochemistry assays were performed to determine the effects on renal function and mineral metabolism. Femurs were analyzed by X-ray and histology to determine effects on both cortical and trabecular bone.

AC-200 administration resulted in marked reductions in serum phosphorus and PTH levels compared to those in vehicle treated controls. The vehicle treated 5/6Nx group showed the expected changes in bone architecture due to the loss of kidney function, such as thinner trabecular bone in the metaphysis, increased cortical bone resorption and increased fibrosis in the marrow space. In contrast, in rats administered AC-200, bone architecture resembled that of sham operated controls. These data suggest that AC-200 offers a unique dual benefit in CKD, potentially correcting not only mineral abnormalities but also reducing bone pathology associated with complications such as hip fracture in CKD patients.

“Results of AC-200 administration in this standardized CKD rodent model provide strong support for clinical development of AC-200” said Dr. Dawn McGuire, Chief Medical Officer of Acologix. “AC-200 offers a unique opportunity to address both hyperphosphatemia and pathologic bone loss, major complications of CKD, with a single agent.”

Acologix, Inc.

Acologix, Inc. a privately held biopharmaceutical company, is developing and commercializing novel biopharmaceuticals targeting osteo-renal indications, including the complications of chronic kidney disease and dialysis, bone and cartilage repair and regeneration, and general dental and oral care. The company’s most advanced program, AC-820 (TRK-820) is in Phase 3 and registration stages in the U.S. and Japan, respectively for the treatment of uremic pruritus in dialysis patients. The second program, AC- 100, a new class of hard tissue growth promoting molecule, has been studied in two Phase II clinical studies and demonstrated high safety profile and selective hard tissue formation activities in dental restoration procedures. Further studies have revealed more evidence that AC-100 selectively promotes bone and cartilage repair and regeneration. Acologix is also developing AC- 200 (Phosphatonin) to treat hyperphosphatemia and renal osteodystrophy. For more information, go to http://www.acologix.com/.

Poster Number SA-PO2781: “mAtrix extracellular Phosphoglycoprotein (MEPE) inhibits renal phosphate reabsorption and decreases bone porosity in a 5/6 nephrectomy rat model” by Birthe Schnegelsberg, Ph.D., Shakun P. Aswani, Marybeth George, Catherine Middleton-Hardie, Ph.D., David Rosen, Ph.D., of Acologix, Inc. Data presented by David Rosen, Ph.D on Saturday, November 8, 2008, at the 41st Annual Meeting of the American Society of Nephrology (Renal Week 2008) in Philadelphia, PA.

This press release contains “forward-looking” statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. Acologix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward- looking statements in this press release should be evaluated together with the many uncertainties that affect Acologix’ business.

Acologix, Inc.

CONTACT: Yoshi Kumagai, President and CEO of Acologix, Inc.,+1-510-512-7200, fax, +1-510-786-1116, [email protected]

Web site: http://www.acologix.com/

Rodman & Renshaw Annual Global Investment Conference Presenter Profiles

The Rodman & Renshaw Annual Global Investment Conference takes place November 10, 2008 – November 12, 2008 at the New York Palace Hotel in New York. Listed below are the Rodman & Renshaw Annual Global Investment Conference presenter profiles. For in-depth information about the event, visit http://www.rodmanandrenshaw.com/conferences?id=19

Business Wire is the official news wire for the Rodman & Renshaw Annual Global Investment Conference. Breaking news releases and photos are available at http://www.tradeshownews.com, Business Wire’s trade show, conference, and event news resource.

   Company:                         4SC AG Ticker Symbol & Exchange:        VSC / Xetra Investor Relations Contact:      Bettina von Klitzing Investor Relations Contact Phone:                          49-89-700 763 0 Web:                             www.4sc.com Date of Presentation:            November 10th, 2008  4SC AG develops innovative drug candidates against inflammatory diseases and cancer. 4SC AG utilises its proprietary technology platform, to create a sustainable project pipeline of drug candidates, which are to be developed up to clinical proof of concept in early clinical phases. There are currently eight projects in development. A clinical phase IIa for the treatment of rheumatoid arthritis has already successfully been completed. An additional project for the treatment of various cancers is currently completing a clinical phase I trial. The company is listed at the Prime Standard of Frankfurt Stock Exchange since December 2005.   Company:                         Aastrom Biosciences, Inc. Ticker Symbol & Exchange:        NASDAQ: ASTM Investor Relations Contact:      Kris M. Maly/Kimberli O'Meara Investor Relations Contact Phone:                          (734) 930-5777 Web:                             www.aastrom.com Date of Presentation:            11/11/2008; 5:20 PM-5:45 PM  Aastrom is a leader in the development of autologous cell products for the repair or regeneration of human tissue. Aastrom's Tissue Repair Cell (TRC) based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient. The TRC technology platform has positioned Aastrom to advance multiple products into clinical development. The Company is currently focused on cardiovascular regeneration and is conducting a Phase II clinical trial with dilated cardiomyopathy (DCM) patients (the IMPACT-DCM trial) and a Phase IIb clinical trial with critical limb ischemia patients (the RESTORE-CLI trial).   Company:                         Access Pharmaceuticals, Inc. Ticker Symbol & Exchange:        ACCP.OB Investor Relations Contact:      Stephen B. Thompson Investor Relations Contact Phone:                          214-905-5100 Web:                             www.accesspharma.com Date of Presentation:            Tuesday, November 11, 2008  Access Pharmaceuticals, Inc. (ACCP.OB) is an emerging pharmaceutical company focused on the development and commercialization of proprietary products for the treatment and supportive care of cancer patients. Access has one approved product, MuGard(TM) for the management of oral mucositis that is partnered globally, and should commence sales in 4Q08. The company's lead oncology product is ProLindac(TM), a polymer-linked platinum cancer drug, which is in Phase 2 clinical testing in recurrent ovarian cancer patients. Angiolix(R) an antiangiogenic humanized monoclonal antibody, and Thiarabine, a novel nucleoside in trials in leukemia, are the company's lead oncology products. Access is also developing oral insulin and oral hGH using its proprietary Cobalamin(TM) oral drug delivery technology.   Company:                         Action Energy Inc. Ticker Symbol & Exchange:        AEC - TSX-V Investor Relations Contact:      Mr. Kelly D. Kerr - VP Finance Investor Relations Contact Phone:                          (403) 723-4454 Web:                             www.action-energy.com Date of Presentation:            11/10/2008  Action Energy Inc. is a Calgary Alberta based junior oil and natural gas exploration company focused on exploring the western Canadian sedimentary basin for properties with significant production and reserve potential. Action was incorporated in 2000 and to date has quickly grown to a company producing 1,500 - 1,600 boed through a combination of exploration and development drilling and mergers and acquisitions.  The Company has a portfolio mainly consisting of light oil properties focused on the Bakken and Midale plays in southeast Saskatchewan, heavy oil in the Lloydminster area of central Alberta and sweet natural gas properties in the Peace River Arch area of northwest Alberta. Action has captured large concentrated undeveloped land positions with high working interests in its primary plays giving the Company large upside potential.   Company:                         Active Biotech AB Ticker Symbol & Exchange:        ACTI; OMX Nordic Investor Relations Contact:      Mr Goran Forsberg Investor Relations Contact Phone:                          +46 46 19 11 54 Web:                             www.activebiotech.com Date of Presentation:            11/11/2008  Active Biotech AB (OMX NORDIC: ACTI), headquartered in Sweden, is a biotechnology company with R&D focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, as well as ANYARA for use in cancer targeted therapy, primarily renal cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer, 57-57 for SLE and RhuDex(R) for RA. Please visit www.activebiotech.com for more information.   Company:                         Acucela Inc. Investor Relations Contact:      Sayuri Refsland Investor Relations Contact Phone:                          425-527-3272 Web:                             www.acucela.com Date of Presentation:            11/12/2008  Acucela Inc. is a clinical-stage biotechnology company focused on developing new drug therapies for blinding eye diseases such as age- related macular degeneration (AMD), Stargardt disease, diabetic retinopathy and retinopathy of prematurity, as well as dry eye. The most advanced product candidate of our developing compounds, Rebamipide ophthalmic suspension, is currently in Phase III clinical trials for dry eye and is being co-developed with Otsuka Pharmaceutical in the U.S. We are also conducting a Phase I clinical trial of ACU-4429 for dry age-related macular degeneration (AMD), which is also being co-developed with Otsuka Pharmaceutical.   Company:                         Adanac Molybdenum Corporation Ticker Symbol & Exchange:        AUA & Frankfurt A9N Investor Relations Contact:      Connie Fischer/Peter Jones Investor Relations Contact       604.531.9639 or 604.535.6834 Phone: Web:                             www.adanacmoly.com Date of Presentation:            11/11/2008  Adanac Molybdenum Corporation is listed on the TSX and Frankfurt exchanges and owns the Ruby Creek Molybdenum Project in Northern British Columbia. The Company has advanced the project through feasibility studies, a production decision and has previously ordered $137 million of long-lead equipment, completed permitting for construction, constructed a road to the site and secured US$80 million in bridge financing. The Company is sourcing final construction funding and expects a site construction start in February 2009 and production in Q4, 2010. The mine will be the world's first new large scale molybdenum open pit mine in more than 25 years.   Company:                         AgFeed Industries, Inc. Ticker Symbol & Exchange:        FEED (NASDAQ) Investor Relations Contact:      Mr. Gerry Daignault Investor Relations Contact Phone:                          615-480-7847 Web:                             www.agfeedinc.com Date of Presentation:            11/10/2008 9:55 AM  AgFeed Industries, Inc. a US public company is the largest commercial hog producer and the largest premix feed company in China. With over 600 million hogs produced each year, compared to 100 million in the US, China represents more than 50% of the world's annual hog production as well as the world's largest and most profitable pork consumer markets. We are a strategic platform for accessing China's vast feed and hog raising industries. The pre-mix feed market in which AgFeed operates is an approximately $1.6 billion segment of China's $40 billion per year animal feed market.   Company:                         Alberta Oilsands Inc. Ticker Symbol & Exchange:        AOS Web:                             www.aboilsands.ca Date of Presentation:            November 12, 2008 at 10:20am  Alberta Oilsands Inc. (TSX-V: AOS) is a junior oil sands development company focused in the Athabasca oil sands region of northeast Alberta. The Company has acquired 89,920 gross (77,568 net) acres of prospective oil sands leases on the primary oil sands fairway.  AOS's strategy is to take advantage of its proven oil sands experience to delineate and prove up bitumen reserves sufficient to support a minimum 10,000 barrel per day in-situ project by 2012.  The company has four project areas, namely Clearwater, Hangingstone, Algar lake and Grand rapids which in aggregate hold nearly 5 billion barrels of bitumen in place. The Clearwater delineation drilling program in Q1-2009 provided the company with 320 million barrels of contingent recoverable bitumen resource over just 2800 acres and potentially two 10,000 barrels per day projects   Company:                         Alhambra Resources Ltd. Ticker Symbol & Exchange:        ALH - TSX Venture Investor Relations Contact:      Ihor P. Wasylkiw Investor Relations Contact Phone:                          1 (403) 508-4953 Web:                             www.alhambraresources.com Date of Presentation:            Tuesday, Nov 11/08 @ 2:50 PM EST  Alhambra is a Canadian based international exploration and gold production Corporation, celebrating its 7th year of operations in the Republic of Kazakhstan. Alhambra holds exploration and exploitation rights to a 2.7 million acre, 100% owned, property called the Uzboy Project, located in the prolific Charsk Gold Belt which hosts numerous world-class gold deposits. Alhambra is currently producing gold and has 14 years remaining of a 25 year license which is renewable for an additional 20 years and allows the Corporation to explore for all metals including gold, base metals, uranium and molybdenum.   Company:                         Allon Therapeutics Inc. Ticker Symbol & Exchange:        TSX:NPC Investor Relations Contact:      Aaron Keay Investor Relations Contact       Cell: (604) 323-6911, D: (604) 742- Phone:                           2540 Web:                             www.allontherapeutics.com Date of Presentation:            Monday, November 10, 2008 - 9:30am ET  Allon Therapeutics Inc. is a clinical-stage biotechnology company focused on developing the first drugs that impact the progression of neurodegenerative diseases. Allon's lead clinical program is focused on Alzheimer's disease. In February 2008 the Company announced positive results in a Phase IIa clinical study for amnestic MCI, a precursor to Alzheimer's disease, showing statistically significant, dose dependant, and durable efficacy on human memory. The Company also has a Phase II trial underway in schizophrenia cognitive impairment.  The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC" (Neuro Protection Company) and based in Vancouver.   Company:                         Allos Therapeutics, Inc. Ticker Symbol & Exchange:        NASDAQ: ALTH Investor Relations Contact:      Derek Cole Investor Relations Contact Phone:                          720.540.5367 Web:                             www.allos.com Date of Presentation:            Tuesday, November 11, 2008  Allos Therapeutics is a biopharmaceutical company focused on developing and commercializing small molecule therapeutics for the treatment of cancer. The Company's lead product candidate, PDX (pralatrexate), is a novel antifolate currently under evaluation in a pivotal Phase 2 (PROPEL) trial in patients with relapsed or refractory peripheral T-cell lymphoma. The Company expects to report top line results of the PROPEL trial by the end of 2008. The Company is also investigating PDX in patients with non-small cell lung cancer, bladder cancer and a range of lymphoma subtypes. The Company's other product candidate is RH1, a targeted chemotherapeutic agent currently being evaluated in a Phase 1 trial in patients with advanced solid tumors or non-Hodgkin's Lymphoma (NHL). Allos currently retains exclusive worldwide rights to PDX and RH1.   Company:                         Alphatec Spine Ticker Symbol & Exchange:        ATEC Investor Relations Contact:      Cheryl Monblatt Investor Relations Contact Phone:                          760 494 6746 Web:                             www.alphatecspine.com Date of Presentation:            Monday, November 10  Alphatec Spine is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. The Company's mission is to combine world-class customer service with innovative, surgeon-driven design that will help improve the aging patient's quality of life. The Company is poised to achieve its goal through new solutions for patients with osteoporosis and other aging spine deformities, improved minimally invasive products and techniques and integrated biologics solutions. In addition to its U.S. operations, The Company also markets its spine products in Europe.   Company:                         Amarin Corporation Ticker Symbol & Exchange:        AMRN (Nasdaq) Investor Relations Contact:      Darren Cunningham Investor Relations Contact Phone:                          35316699020 Web:                             www.amarincorp.com Date of Presentation:            11/11/08  Amarin is a clinical-stage biopharmaceutical company with a lead program entering Phase 3 for hypertriglyceridemia. Amarin's cardiovascular programs capitalize on its expertise in the field of lipid science and the known therapeutic benefits of essential fatty acids in cardiovascular disease.   Company:                         American Lorain Corporation Ticker Symbol & Exchange:        ALRC.OB Investor Relations Contact:      CCG Investor Relations Investor Relations Contact       Crocker Coulson, 646-213-1915 Phone: Web:                             www.lorainfood.com Date of Presentation:            November 10th at 3:15 pm ET  American Lorain Corp. is a major processed foods company located in China. The Company commenced operations of Shandong Lorain, its first operating subsidiary, in 1995, to manufacture chestnut products and over years, it expanded its product lines to include canned, frozen and bulk foods, and convenience foods sold to domestic and international customers. The Company now has four manufacturing facilities. In the highly fragmented processed foods industry, Lorain has gained competitive advantages through its proprietary brands and advanced technologies and currently sells over 192 products to19 provinces and administrative regions in China as well as to 42 foreign countries.   Company:                         American Tony Pharmaceuticals Inc Ticker Symbol & Exchange:        OTC BB/ATNY.OB Investor Relations Contact:      Leslie Wolf-Creutzfeldt Investor Relations Contact Phone:                          646-284-9472 Web:                             www.tmyy.com.cn Date of Presentation:            Nov 12 at 9:30am  Tongli Pharmaceutical (USA), Inc. develops, manufactures and markets pharmaceutical and health care products through its wholly-owned subsidiary, Harbin Tianmu Pharmaceutical Co., Ltd. ("Tianmu Pharmaceutical"). Tianmu Pharmaceutical was founded in 1999 in Harbin, hub of the Northern Pharmaceutical base of China. The company acquired the GMP certificate in 2003 and was listed on the OTC Bulletin Board on July 29, 2008. With a cohesive management team and committed staff, Tongli is providing the best quality pharmaceutical products at a very competitive price. The company is targeting the vast Chinese market with a vision of extending its footprint to East Asia and Russia.   Company:                         Anadis Limited Ticker Symbol & Exchange:        ASX: ANX Investor Relations Contact:      Dr. Oren Fuerst Investor Relations Contact Phone:                          646 259 3321 Web:                             www.anadis.com Date of Presentation:            11/12/2008  Anadis is a biopharmaceutical company focused on antigen-primed, dairy-derived health products. Anadis' proprietary and low-cost antibody manufacturing technology enables it to rapidly develop polyclonal antibody and other protein-based oral therapies to a range of important infectious and immune- mediated diseases.  Large target markets with products reaching the markets in 2-3 years, all using the same platform. -- Cancer therapy-related Mucositis (clinical trial in Israel started) -- HIV/AIDS (major clinical trial in Australia just announced) -- Diabetes (clinical trial to be initiated within a few months pending a transaction) -- Influenza (clinical trial to begin during the year) Commercial products : E.coliTravelers' Diarrhea and Rotavirus infection   Company:                         Argentex Mining Corporation Ticker Symbol & Exchange:        TSX-V:ATX;OTCBB:AGXM Investor Relations Contact:      Primoris Group Inc. Investor Relations Contact Phone:                          1-866-594-7687 Web:                             www.argentexmining.com Date of Presentation:            Tues. November 11, 2008, 11:10 a.m.  Argentex Mining Corporation is a junior mining exploration company with extensive holdings in Argentina's Patagonia region, including its flagship Pinguino property in Santa Cruz province. The company holds 100% mineral rights to this property, which has a unique commodity profile: gold, silver, lead, zinc and indium. Argentex's exploration team has taken Pinguino from the grassroots stage to a significant drill-tested deposit (30,000+ meters completed) in just a few years. Argentex also owns 100% mineral rights to more than 30 properties with over 377,490 acres (152,766 hectares) of prospective land located in Argentina's Santa Cruz and Rio Negro provinces.   Company:                         Arrow Energy Limited Ticker Symbol & Exchange:        AOE.AX (ASX) Investor Relations Contact:      Graham Yerbury Investor Relations Contact Phone:                          +61 7 31053466 Web:                             www.arrowenergy.com.au Date of Presentation:            Monday November 10, 2008  Arrow Energy is an ASX 100 listed Coal Bed Methane Company operating in Australia and South East Asia. Arrow's Australian tenements are estimated to have 70Tcf of gas in place. Arrow and it's joint venture partner Shell are moving towards developing the world's first CBM to LNG operation in the Gladstone port with initial plans for a 1.5mtpa plant in operation by 2012. Arrow has also integrated downstream into the production of electricity with access to 370MW of electricity offtake. Arrow is currently completing exploration and appraisal activity in India and Vietnam with business development opportunities in China and Indonesia.   Company:                         Asia Time Corporation Ticker Symbol & Exchange:        Amex: TYM Investor Relations Contact:      Brandi Floberg Investor Relations Contact Phone:                          310-277-4711 Web:                             www.asiatimecorp.com Date of Presentation:            November 10, 2008 at 10:20 a.m. ET  Asia Time is a Hong Kong distributor of timepiece movements. The Company currently distributes approximately 350 products, including both watch movements and complete watches, representing 30 vendors. These products are supplied to Asia Time's more than 300 customer manufacturers of globally branded watches. The Company's distribution centers and sales offices are located throughout Hong Kong and China.  Asia Time is well positioned to capitalize on growth opportunities in developed markets and especially in the under-penetrated market for watch movements and completed watches in China. The Company holds strong competitive advantages in quartz and mechanical movements, and it seeks to expand up the watch market value chain into low-cost China-based manufacturing of proprietary branded movements and complete watches.   Company:                         Aurora Oil & Gas Limited Ticker Symbol & Exchange:        "AUT" on ASX Investor Relations Contact:      Jon Stewart (Exec Chairman) Investor Relations Contact       [email protected], 61 89440 Phone:                           2626 Web:                             www.auroraoag.com.au Date of Presentation:            11/10/2008  Aurora Oil & Gas Limited is an Australian quoted public company (ASX: AUT) focused in North America. Aurora participates in advanced exploration/development opportunities with large size potential.  Aurora's principal asset is its substantial landholdings in the recently discovered Sugarkane Field in South Texas. Sugarkane Field is a potential multi TCFe gas and condensate resource.  The Sugarkane Field was discovered in 2006 with an exploration well that intersected a unique over pressured, porous condensate rich Austin Chalk formation within the region. Several follow up wells have been successfully drilled and appraisal and development drilling of this field is under way.   Company:                         Ausam Energy Corporation Ticker Symbol & Exchange:        AZE.V, ASMEF.OB Investor Relations Contact:      Mark G. Avery Investor Relations Contact Phone:                          1.863.678.2200 Web:                             www.ausamenergy.com Date of Presentation:            11/11/2008  Ausam is a public company engaged in oil and gas exploration and development. Ausam, through its U.S. subsidiary Noram Resources, Inc, has acquired a diverse portfolio of oil and gas leases and prospects in Texas, Louisiana, Mississippi, Alabama and Arkansas. Ausam's growth strategy includes the systematic development of its current holdings and selective corporate transactions. The Company trades under the symbol "AZE" on the TSX Venture Exchange and the symbol "ASMEF" on the OTC Bulletin Board   Company:                         Avanir Pharmaceuticals Ticker Symbol & Exchange:        AVNR / NASDAQ Investor Relations Contact:      Eric Benevich Investor Relations Contact Phone:                          (949)389-6776 Web:                             www.avanir.com Date of Presentation:            November 11, 2008 at 4:55pm ET  AVANIR Pharmaceuticals is a biopharmaceutical company focused on developing novel treatments for central nervous system conditions. AVANIR's lead product candidate, Zenvia(TM), is in Phase III development for two indications; pseudobulbar affect (PBA) and diabetic peripheral neuropathic (DPN) pain. Zenvia is the subject of an approvable letter from the FDA for the PBA indication. The Company is now conducting a confirmatory Phase III study testing a lower dose formulation intended to improve safety and tolerability. Top line results are expected in Q3 of 2009. Please review AVANIR's SEC filings or www.avanir.com for further information regarding risks and uncertainties affecting the Company.   Company:                         Bio-Bridge Science, Inc. Ticker Symbol & Exchange:        BGES - OTCBB Investor Relations Contact:      Chris Young Investor Relations Contact Phone:                          (630) 928-0869 Web:                             http://www.bio-bridge-science.com Date of Presentation:            11/12/2008  Bio-Bridge Science is a biotechnology company engaged in the commercial development of vaccines and related products for the prevention and treatment of human diseases. The company is currently developing oral vaccines against HIV, HPV and colon cancer. In addition, the Company has a subsidiary that produces bovine serum and plans to form a joint venture to produce cell culture medium for vaccine production.   Company:                         BioDelivery Sciences International Ticker Symbol & Exchange:        BDSI (NASDAQ) Investor Relations Contact:      Bryan Armstrong Investor Relations Contact Phone:                          312-553-6707 Web:                             [email protected] Date of Presentation:            Mon. November 10, 2008 at 10:20 am  BioDelivery Sciences is a specialty pharmaceutical company leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships, new applications of proven therapeutics.  The development strategy focuses on the utilization of the FDA's 505(b)(2) approval process to obtain timely and efficient approval of new formulations of previously approved therapeutics which incorporate the company's drug delivery technologies, BioErodible MucoAdhesive (BEMA) and Bioral.  BDSI is addressing important unmet market needs with a focus on formulations of pharmaceuticals aimed principally at treatment opportunities in areas such as pain and fungal infections. The company's lead product ONSOLIS (BEMA Fentanyl) is currently under review at FDA with an anticipated approval 1H 2009.   Company:                         BioSante Pharmaceuticals, Inc. Ticker Symbol & Exchange:        BPAX NASDAQ Investor Relations Contact:      Phillip Donenberg Investor Relations Contact       847-478-0500 ext 100 Phone: Web:                             www.biosantepharma.com Date of Presentation:            11/12/2008  BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante's lead products include LibiGel(R) (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin(TM) (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S. Also in development are Bio-T- Gel(TM), a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II clinical development using BioSante patented technology.   Company:                         Boots & Coots Ticker Symbol & Exchange:        NYSE Alternext: WEL Investor Relations Contact:      Jennifer Tweeton Investor Relations Contact Phone:                          281-931-8884 Web:                             www.boots-coots.com Date of Presentation:            November 11, 10:45 am Eastern  Boots & Coots provides a suite of integrated pressure control services to oil and gas exploration companies around the world. Our services are designed to enhance production and reduce the number and severity of critical well events such as well fires, blowouts or other losses of control at the well. Our Well Intervention segment includes services performed by hydraulic workover and snubbing units and the rental of pressure control tools. This segment also includes prevention and risk management services offered through our Safeguard and risk mitigation programs. Our Response segment consists of personnel, equipment and services provided during a critical well event.   Company:                         BPZ Energy Ticker Symbol & Exchange:        NYSE Alternext:BPZ Investor Relations Contact:      Greg Smith Investor Relations Contact Phone:                          281 752 1240 Web:                             www.bpzenergy.com Date of Presentation:            11/10/2008  Houston based BPZ Energy is an oil and gas exploration and production company which has exclusive license contracts for oil and gas exploration and production covering approximately 2.4 million acres in four properties in northwest Peru. It also owns a minority working interest in a producing property in southwest Ecuador. The Company is currently executing the development of the Corvina oil discovery, the redevelopment of the Albacora oil field, and the exploration of Block XIX, in parallel with the execution of an integrated gas-to-power strategy, which includes generation and sale of electric power in Peru and the development of a regional gas marketing strategy. The Company's website at www.bpzenergy.com provides additional information about the Company's plans, including photographs and other information with respect to its operat   Company:                         Bradmer Pharmaceuticals Inc. Ticker Symbol & Exchange:        BMR (TSX) Investor Relations Contact:      Ross Marshall, Equicom Group Investor Relations Contact       416-815-0700 x238 Phone: Web:                             http://www.bradmerpharma.com Date of Presentation:            11/12/08, 10:45 a.m.  Bradmer Pharmaceuticals is a biopharmaceutical company established in 2006 to advance a promising new drug for glioblastoma multiforme patients into a pivotal Phase III trial. Neuradiab(TM) (formerly referred to as "I-131 mu81C6" in scientific literature) is a radiolabeled monoclonal antibody that has been delivered to more than 200 patients in its significant Phase I and II clinical history at Duke University. It has been designed to deliver a precise localized radiation boost dose specifically to post-surgical residual cancer cells via single injection. Our multi-center randomized trial for patients with newly-diagnosed GBM is underway at leading brain tumor treatment centers across the US. This Phase III trial will investigate Neuradiab as an adjuvant therapy to surgery, external beam radiation and temozolomide.   Company:                         Bravo Venture Group Inc. Ticker Symbol & Exchange:        BVG-TSX.Venture Investor Relations Contact:      Jay Oness Investor Relations Contact Phone:                          1-888-456-1112/604-641-2771 Web:                             www.bravoventuregroup.com Date of Presentation:            Tuesday, November 11th at 2:25pm  The company is active in NW British Columbia, Alaska and Nevada. The VMS/Epithermal gold/silver Homestake Ridge project in BC is advancing with excellent drill results and an NI43-101 compliant technical report (being updated) which reported an inferred resource of +900,000 oz/Au. Recent certified assays from the now completed 8,400 metre drill program returned BONANZA grade intercepts;73metres averaging 21g/t gold with an intercept of 7.65metres averaging 181.58 g/t gold, as well, another intercept recorded 22.29metres of 513.7 g/t silver including a 2.71metre bonanza grade averaging 2,502 g/t silver.  Other project include the VMS Woewodski Island project in Alaska and 13 projects in Nevada.   Company:                         CanAlaska Uranium Ltd Ticker Symbol & Exchange:        TSX.V: CVV Investor Relations Contact:      Emil Fung, V.P. Corp. Dev. Investor Relations Contact Phone:                          604 688 3211 Web:                             www.canalaska.com Date of Presentation:            Tuesday, November 11th 2008 @ 14:00  CANALASKA URANIUM LTD. (CVV -- TSX.V) is undertaking uranium exploration in nineteen 100%-owned and two optioned uranium projects in Canada's Athabasca Basin, supplier of 30% of the world's uranium and home to the planet's richest uranium mines. Since September 2004, the Company has aggressively acquired one of the largest land positions in the region, comprising over 2,500,000 acres (10,117 sq. km or 3,906 sq. miles). To-date, CanAlaska has expended over Cdn$45 million and has delineated multiple uranium targets. The company is financially-supported by numerous strategic partners, including, Mitsubishi Development Pty, a subsidiary of Japanese conglomerate Mitsubishi Corporation, and a consortium of leading Korean energy companies comprising Hanwha Corp., KEPCO, KORES and SK Energy.   Company:                         Candax Energy Inc. Ticker Symbol & Exchange:        CAX: TSX Investor Relations Contact:      Lindsay Carpenter Investor Relations Contact       [email protected], 416-868-1079 ext. Phone:                           239 Web:                             www.candax.com Date of Presentation:            11/11/2008  Candax Energy Inc. is a Canadian based oil and natural gas company engaged in the exploration, acquisition, development and production of crude oil and natural gas, with emphasis on Africa and the Middle East. Candax has three producing fields in Tunisia: offshore at El Bibane, and onshore at Ezzaouia and Robbana and significant upside potential through its Deep Triassic play, its onshore Chaal gas discovery and its promising early exploration work in Madagascar. Candax's net production for Q3 is expected to average 1,600 boepd (1,200 bopd and 2 MMcf/d) and production for Q4 is forecast at 2,800 boepd (2,000 bopd and 4.7 MMcf/d).   Company:                         CAS Medical Systems, Inc. Ticker Symbol & Exchange:        CASM Investor Relations Contact:      Susan Carron Investor Relations Contact Phone:                          203-488-6056 Web:                             www.casmed.com Date of Presentation:            11/12/2008  CASMED is a leading developer and manufacturer of medical devices for non-invasive patient monitoring. The Company's FORE-SIGHT Absolute Cerebral Oximeter is the only cerebral oximeter available with FDA clearance for non-invasive, continuous measurement of absolute cerebral tissue oxygen saturation for neonates, infants, children and adults. This information helps avert brain damage or death during surgery and in critical care situations by allowing clinicians to identify patients with dangerously low levels of cerebral oxygen and intervene to reverse the condition.  The Company's product lines also include bedside patient vital signs monitors, proprietary non-invasive blood pressure measurement technology, blood pressure cuffs and products for neonatal intensive care.   Company:                         Cavico Corp. Ticker Symbol & Exchange:        OTCBB: CVIC Investor Relations Contact:      Roger Ellis Investor Relations Contact       Tel: 310-477-9800 Ext 106 Phone: Web:                             www.cavicocorp.com Date of Presentation:            11/11/2008  Cavico Corp. is a major infrastructure contractor with over 3,000 employees, including 700 engineers. Headquartered in Hanoi, Vietnam, Cavico operates nationwide in Vietnam with an expanding global presence through direct and indirect subsidiaries. Cavico is the only firm using the latest Tunnel Boring Machine (TBM) Technology in Vietnam. As an essential participant in the development of Vietnam's infrastrcuture to support Asia's second highest growth rate, Cavico has a focus on large construction projects for hydropower facilities, dams, bridges, tunnels, roads, and mines. Cavico also participates in ownership investments related to its core competency in energy, mining, cement plants, and urban development companies.   Company:                         Celsion Corporation Ticker Symbol & Exchange:        NASDAQ: CLSN Investor Relations Contact:      Geoffrey Grande, CFA Investor Relations Contact Phone:                          617-747-1721 Web:                             http://www.celsion.com/ Date of Presentation:            Nov. 11th, from 4:30 to 4:55 PM  Celsion Corporation is an oncology drug development company focused on addressing cancers of high unmet medical needs. The proprietary drug platform - heat activated liposomal technology - effectively targets high concentrations of chemotherapeutics to organs of interest. The lead drug candidate - ThermoDox - is currently in global Phase III trials for liver cancer in 7 countries. Additional drug candidates - liposomal docetaxel and liposomal carboplatin - are currently in preclinical development. Celsion has research, license or commercialization agreements with leading institutions such as the NIH-NCI, Philips, Duke, University of Hong Kong, Cleveland Clinic, North Shore-LIJ, and 40 other leading medical institutions worldwide.   Company:                         China Armco Metals, Inc. Ticker Symbol & Exchange:        OTC BB: CNAM Investor Relations Contact:      HC International, Inc. Investor Relations Contact       Alan Sheinwald, 914-669-5340 Phone: Web:                             www.armcometal.com Date of Presentation:            11/10/2008  China Armco Metals, Inc. imports, sells, distributes metal ores and non-ferrous metals throughout the PRC. Armco is also ennted into the metal recycling business. The Company's product lines include ferrous and non-ferrious ore such as iron ore, chrome ore, nickel ore, copper ore, magnese ore and steel billet. Raw materials are supplied from global suppliers in India, Hong Kong, Nigeria, Brazil, Turkey, the Philippines and Libya. Beginning in the second quarter 2009, Armco expects to begin operations in its steel recycling and scrap metal supply. The recycling facility is expected to be capable of recycling one million metric tons of scrap metal per year which will position the Company as one of the top 10 recyclers of scrap metal in China.   Company:                         China Direct, Inc. Ticker Symbol & Exchange:        NASDAQ: CDS Investor Relations Contact:      Lillian Wong Investor Relations Contact       954.363.7333 ext. 317 Phone: Web:                             www.ChinaDirectInc.com Date of Presentation:            11/10/2008  China Direct is a diversified management and advisory services organization which owns and consults business entities operating in the People's Republic of China. We operate two divisions: Management Services and Advisory Services. Our Management Services division acquires controlling interests of Chinese business entities. Our Advisory Services division provides consulting services to both Chinese entities seeking access to the U.S. capital markets and North American entities seeking business opportunities in the PRC. As a direct link to China, China Direct serves as a vehicle allowing investors to participate directly in the rapid growth of the Chinese economy. For more information, please visit www.ChinaDirectInc.com.   Company:                         China Green Agriculture Inc. Ticker Symbol & Exchange:        CGAG.OB Investor Relations Contact:      Ying Yang Investor Relations Contact Phone:                          626-623-2575 Web:                             www.cgagri.com Date of Presentation:            11/12/2008  China Green Agriculture, through its wholly-owned subsidiary Shaanxi TechTeam Jinong Humic Acid Product Co., Ltd, develops, manufactures and distributes humic acid-based liquid compound fertilizers in 27 provinces throughout China. The Company offers over 100 different varieties of fertilizers targeted to unique climate and soil specifications. China Green Agriculture's headquarters, based in Shaanxi Province, include extensive R&D facilities and cutting edge automated production lines. With one of the most recognizable brand names in Chinese green fertilizers today, the Company is one of the few fertilizer manufacturers in China that operates on a national scale.   Company:                         China Marine Food Group, Ltd. Ticker Symbol & Exchange:        OTC BB: CMFO Investor Relations Contact:      HC International, Inc. Investor Relations Contact       John Mattio, 914-669-5340 Phone: Web:                             www.china-marine.cn Date of Presentation:            11/10/2008  Founded in 1994, China Marine Food Group, Ltd. processes and distributes processed seafood snack-type products, fresh and frozen marine catch to five provinces in the PRC and select international markets. Since inception, China Marine has grown steadily, received "The Famous Brand" and "Green Food" awards, and positioned its "Mingxiang"brand as a category leader in 1,300 retail sales points in the PRC. The Company is committed to the highest standard of quality control and is strategically located in Fujian Province, one of the largest coastal provinces in the PRC and a vital navigation hub bewteen the East China Sea and the South China Sea. For the first six months ended June 30, 2008, revenue and net income increased 35.9% and 39.2% to $23.8 million and $6.0 million respectively.   Company:                         China North East Petroleum Holdings Ltd. Ticker Symbol & Exchange:        CNEH OTCBB Investor Relations Contact:      Chao Jiang Investor Relations Contact Phone:                          212-307-3568 Web:                             www.cnepetroleum.com Date of Presentation:            11/12/2008  China North East Petroleum Holdings Limited (OTCBB: CNEH), through its subsidiaries, engages in the extraction and production of crude oil in Northern China. The company was founded in 2002 and is based in Harbin China and New York. The company owns 20 years leasing rights in Jilin Qian'an Oil Field, an oil field located approximately 9 kilometers southwest of Qian'an city Jilin Province China with a total exploration area of approximately 11,663 acres. The Company has a guaranteed arrangement with the Jilin Refinery of PetroChina to sell its produced crude oil for use in the China marketplace. China North East Petroleum currently has about 312 employees and 214 wells within four oilfields in Northern China and has plans for additional well drilling projects.   Company:                         China Wind Systems, Inc. Ticker Symbol & Exchange:        CWSI.OB Investor Relations Contact:      Crocker Coulson Investor Relations Contact Phone:                          (646) 213-1915 Date of Presentation:            4:05 p.m. 11th November 2008  China Wind Systems, Inc. supplies forged rolled rings to the wind power and other industries and industrial equipment to the textile and energy industries in China. With its newly finished state-of- the-art production facility, the Company is expected soon to significantly increase its shipment of high- precision rolled rings and other essential components primarily to the wind power and other industries.   Company:                         China Yingxia International, Inc. Ticker Symbol & Exchange:        CYXI.OB Investor Relations Contact:      CCG Investor Relations Investor Relations Contact       Crocker Coulson, 646-213-1915 Phone: Web:                             www.chinayingxia.com Date of Presentation:            November 12th at 10:45 am  China Yingxia International, Inc. is primarily engaged in the development, production and sales of health food products in China. The Company sells over 235 stock keeping units (SKUs) in five product categories including soybean-based food and drinks, Longgu golden millet enriched products, raw cacti, cactus-based herbal supplements, personal care products, Nestle products and organic rice products. Yingxia was founded in 1998 and is headquartered in Harbin, Heilongjiang province, People's Republic of China.   Company:                         ChinaCast Education Corporation Ticker Symbol & Exchange:        CAST - NASDAQ Investor Relations Contact:      Michael Santos Investor Relations Contact Phone:                          202-361-3403 Web:                             www.chinacasteducation.com Date of Presentation:            Nov. 10, 2008  ChinaCast Educations Corporation is a leading for-profit, post- secondary education and e-learning services provider in China. We provide fully accredited four year degree and two year diploma post- secondary education programs through our university in Chongqing, the Foreign Trade and Business College (FTBC) of Chongqing Normal University. We provide our e-learning services to post-secondary institutions, K-12 schools, government agencies and corporations via our nationwide satellite broadband network. These services include interactive distance learning applications, multimedia education content delivery, English language training and vocational training courses.   Company:                         Cipher Pharmaceuticals Inc. Ticker Symbol & Exchange:        DND: TSX Investor Relations Contact:      Craig Armitage Investor Relations Contact       (416) 815-0700 x278 Phone: Web:                             www.cipherpharma.com Date of Presentation:            11/12/2008  Cipher Pharmaceuticals is an emerging specialty pharmaceutical company with a late-stage product portfolio. The Company is focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies.  Cipher's lead compound, CIP-FENOFIBRATE, received final approval from the U.S. Food and Drug Administration and Health Canada in the first quarter of 2006. The product is being marketed in the United States by Kowa Pharmaceuticals America (formerly ProEthic Pharmaceuticals) under the label Lipofen(R). In addition, Cipher is developing novel formulations of the pain reliever tramadol and the acne treatment isotretinoin.   Company:                         Clinuvel Pharmaceuticals Limited Ticker Symbol & Exchange:        ASX: CUV, ADR: CLVLY Investor Relations Contact:      Colin Mackie Investor Relations Contact Phone:                          61 3 9660 4900 Web:                             www.clinuvel.com Date of Presentation:            November 12, 2008 - 3:15PM Louis Rm  Clinuvel Pharmaceuticals Limited (Clinuvel) is an Australian biopharmaceutical company developing a first-in-class photoprotective drug afamelanotide* (CUV1647) for use in a range of UV and light related skin disorders.  Afamelanotide provides skin protection against UV radiation (UVR) as it stimulates the body's natural ability to produce eumelanin, the dark pigment of the skin which is known to have photoprotective properties.  Clinuvel has identified five indications and has two Phase III trials underway, aswell as three Phase II trials. Clinuvel aims to have afamelanotide in the market by 2010.   Company:                         Comanche Clean Energy Corp. Ticker Symbol & Exchange:        OTCBB:CGYYF Investor Relations Contact:      Todd M. Pitcher Investor Relations Contact Phone:                          760-798-4938 Web:                             www.comanchecleanenergy.com Date of Presentation:            November 10 at 10:20AM  Comanche Clean Energy is a Brazil-based producer of ethanol and biodiesel from multiple feed-stocks in its own facilities and grows the majority of the sugar-cane feedstock that it requires for producing ethanol, creating a vertically integrated model. The company's customers for ethanol are fuel distributors and trading companies and its current biodiesel sales are to Petrobras, the Brazilian oil company. Comanche owns and operates two ethanol facilities and one biodiesel facility in Brazil. Through the six months ended, June 30, 2008, revenues were $22.1 million, up from $1.1 million reported for the same period last year.   Company:                         CombinatoRx, Incorporated Ticker Symbol & Exchange:        CRXX Investor Relations Contact:      Gina Nugent Investor Relations Contact Phone:                          617-301-7099 Web:                             www.combinatorx.com Date of Presentation:            Nov. 10, 2008  CombinatoRx, Incorporated (CRXX) is pioneering the new field of synergistic combination pharmaceuticals and has a broad product portfolio in phase 2 clinical development. Going beyond traditional combinations, CombinatoRx creates product candidates with novel mechanisms of action striking at the biological complexities of human disease. The lead programs in the CombinatoRx portfolio are advancing into later stage clinical trials based on the strength of multiple positive phase 2a results. This portfolio is internally generated from the CombinatoRx proprietary drug discovery technology which provides a renewable and previously untapped source of novel drug candidates. The Company was founded in 2000 and is located in Cambridge, Massachusetts.   Company:                         Cougar Biotechnology, Inc. Ticker Symbol & Exchange:        NASDAQ: CGRB Investor Relations Contact:      Mariann Ohanesian Investor Relations Contact Phone:                          310-943-8040 Web:                             www.cougarbiotechnology.com Date of Presentation:            11/12/2008  Cougar Biotechnology is a development stage biopharmaceutical company based in Los Angeles, California that in-licenses novel therapeutics and develops such therapeutics for the treatment of cancer. Our strategy is to license technologies that have previously been tested in clinical trials, enabling us to obtain an initial indication of the drug's safety and biological activity in humans before committing capital to the drug's development.  Cougar's oncology portfolio includes CB7630, a targeted inhibitor of the 17alpha-hydroxylase/c17,20 lyase enzyme, which is currently being tested in a Phase III clinical trial in prostate cancer; CB3304, an inhibitor of microtubule dynamics, which is currently in a Phase I trial in multiple myeloma; and CB1089, an analog of vitamin D, which has been clinically tested in a number of solid tumor types.   Company:                         CPEX Pharmaceuticals, Inc. Ticker Symbol & Exchange:        NASDAQ : CPEX Investor Relations Contact:      Laura Okpala Investor Relations Contact       617-583-1306, [email protected] Phone: Web:                             www.cpexpharm.com Date of Presentation:            Tuesday November 11, 2008 2:30PM  CPEX Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company primarily focused on the development of Nasulin(TM), an intranasal insulin drug, currently in Phase II trials for diabetes. CPEX has a proprietary drug delivery platform technology, CPE- 215(R), which allows it to expand its internal pipeline of products beyond Nasulin and generate revenue from partnering. CPEX has licensed applications of CPE-215 to Auxilium Pharmaceuticals, which launched Testim(R) in 2003. CPEX received royalties of $11.1 million in 2007 from sales of Testim. In addition, CPEX has a partnership with Serenity Pharmaceuticals for the development of a urology product incorporating its CPE-215 platform technology.   Company:                         Crosshair Exploration & Mining Corp Ticker Symbol & Exchange:        CXZ:AMEX, CXX:TSX Investor Relations Contact:      Jennifer Richards Investor Relations Contact       604-681-8030 x.229 Phone: Web:                             www.crosshairexploration.com Date of Presentation:            11/12/2008 12:25  Crosshair is a leading junior exploration company focused on exploring and developing uranium in the Central Mineral Belt of Labrador, which is fast emerging as the next big uranium district in Canada.  Crosshair is demonstrating the multi-deposit potential of the project by successfully developing and drilling several new uranium targets and currently controls four existing NI 43-101 compliant resources.  Crosshair's gold and Volcanic Hosted Massive Sulphide projects in Newfoundland, are slated for a dividend spin-out to shareholders. Crosshair currently trades on the Toronto Stock Exchange (CXX:TSX) and the American Stock Exchange (CXZ:AMEX).   Company:                         Cue Energy Resources Limited Ticker Symbol & Exchange:        ASX : CUE Investor Relations Contact:      Pauline Moffatt Investor Relations Contact Phone:                          61 3 9670 8668 Web:                             www.cuenrg.com.au Date of Presentation:            11/11/2008  Cue is a small Australian independent, SE Asia and Australasian focussed, oil and gas exploration and production company. Cue has current oil production in Papua New Guinea and Indonesia with additional oil production beginning in New Zealand in late 2008. Gas production is expected to begin in Indonesia in 2009 and 2010. Appraisal drilling on other gas and oil discoveries is expected in 2009.  Cue also holds a balanced portfolio of exploration areas in Australia, Papua New Guinea, New Zealand and Indonesia in which there are ongoing seismic and exploration drilling programs, and has interests in approximately 280 net BCF of contingent gas resources in Australia and Papua New Guinea.   Company:                         Cyclacel Pharmaceuticals, Inc. Ticker Symbol & Exchange:        CYCC - NASDAQ Investor Relations Contact:      Corey Sohmer Investor Relations Contact Phone:                          908-517-7330 Web:                             www.cyclacel.com Date of Presentation:            11/12/2008  Cyclacel is a biopharmaceutical business dedicated to discovery, development and commercialization of novel, targeted drugs to treat cancer and other serious disorders. Three orally-available drugs are in clinical development: sapacitabine, in randomized Phase 2 studies for the treatment of elderly acute myeloid leukemia, myelodysplastic syndromes and cutaneous T-cell lymphoma; seliciclib, in randomized Phase 2 studies for the treatment of non-small cell lung and nasopharyngeal cancers; and CYC116, in Phase 1 for solid tumors. Cyclacel's ALIGN subsidiary sells three products in the US treating the effects of radiation or chemotherapy in cancer patients: Xclair(R) Cream, Numoisyn(TM) Liquid and Lozenges.   Company:                         Cytomedix Ticker Symbol & Exchange:        AMEX:GTF Investor Relations Contact:      Enrique Briz Investor Relations Contact Phone:                          212/888-4848 Web:                             http://www.cytomedix.com Date of Presentation:            Wednesday, Nov. 12, 2008 (2:25 pm)  Cytomedix is a biotechnology company that develops, sells, and licenses regenerative biological therapies, including the AutoloGel(TM) System, a device for the production of platelet rich plasma ("PRP") gel derived from the patient's own blood. The AutoloGel(TM) System is cleared by the Food and Drug Administration ("FDA") for use on a variety of exuding wounds. The Company is currently pursuing a multi-faceted strategy to penetrate the chronic wound market with its AutoloGel(TM) System. The Company is also moving forward with the development of other product candidates in its pipeline. Most notably is its CT-112 product, an anti- inflammatory peptide, that has shown promise in pre-clinical testing, and for which the Company is currently preparing an Investigational New Drug (IND) application for the FDA.   Company:                         Deer Consumer Products, Inc. Ticker Symbol & Exchange:        DCPI (OTC BB) Investor Relations Contact:      Ms. Yong MeiWang Investor Relations Contact Phone:                          86 755-86028285 Web:                             www.deerinc.com Date of Presentation:            11/10/2008 14:25  Deer Consumer Products, Inc. is a US public company headquartered in China. Supported by more than 75 patents, Deer is a market leader in the design, manufacture and sale of home and kitchen electronics targeting the vast Chinese domestic consumer markets as well as customers in more than 40 countries worldwide. Deer's product lines include blenders, juicers, pressure cookers and other home electronics designed to improve home lifestyles in today's fast paced society. With more than 100 global and domestic clients including Black & Decker, Disney, Toastmaster, Home Depot and Wal- Mart, Deer has enjoyed rapid sales and earnings growth.   Company:                         Delcath Systems, Inc. Ticker Symbol & Exchange:        DCTH NASDAQ Investor Relations Contact:      Strategic Growth International Investor Relations Contact       Richard Cooper, 212.838.1444 Phone: Web:                             www.delcath.com Date of Presentation:            11/11/2008  Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company is testing a proprietary, patented drug delivery system for the treatment of liver cancers. Delcath's novel drug delivery platform is testing the delivery of ultra-high doses of anti-cancer drugs to the liver while preventing these high doses of drug from entering the patient's bloodstream. The Company is currently enrolling patients in Phase III and Phase II clinical studies for the treatment of liver cancers using high doses of melphalan. The Company's intellectual property portfolio consists of twenty-eight patents worldwide, including the U.S., Europe, Asia and Canada.   Company:                         Derma Sciences Inc Ticker Symbol & Exchange:        DSCI OTCBB Investor Relations Contact:      Rudy Barrio @ Allen&Caron Inc Investor Relations Contact Phone:                          212 691 8087 Web:                             www.dermasciences.com Date of Presentation:            Wednesday, November 12, 2008 @ 2:00  Derma Sciences is a global manufacturer and marketer of advanced wound-care products. Its key product, MEDIHONEY, is sold throughout the world. The product has been shown to be effective in a variety of wounds and burns, and was recently the focus of a large-scale randomized controlled trial on leg ulcers. Derma has two products in development: the BIOGUARD(TM) line of barrier gauze dressings, and DSC127, the company's novel angiotensin analog for accelerated wound healing and scar reduction. The barrier technology was licensed from Quick-Med in Q1 of 2007 and is pending its initial FDA marketing clearance. DSC127 was licensed from The University of Southern California in Q4 of 2007 and is entering into a Phase II study, with anticipated initial patient enrollment to begin in 2008.   Company:                         DOR BioPharma, Inc. Ticker Symbol & Exchange:        DORB: OTCBB Investor Relations Contact:      Evan Myrianthopoulos Investor Relations Contact Phone:                          609-538-8200 Web:                             www.dorbiopharma.com Date of Presentation:            11/10/2008  DOR BioPharma is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec(R) (oral beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid being developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life- threatening complication of bone marrow transplantation. DOR anticipates market potential for orBec(R) for the treatment of GI GVHD to be approximately 60% of the more than 10,000 allogeneic hematopoietic cell transplantations that occur each year in the US, with similar numbers in Europe.   Company:                         ECU Silver Mining Inc. Ticker Symbol & Exchange:        TSX: ECU Investor Relations Contact:      Christopher Haldane Investor Relations Contact       416.868.1079 ex.237 Phone: Web:                             www.ecu.ca Date of Presentation:            11/10/2008  ECU Silver Mining Inc. is focused on the exploration, development and mining of gold, silver and base metals at its Velardena District Properties in Durango, Mexico. The district is well known for its mining history and ECU holds three properties that include five historical mines. ECU has measured and indicated resources of 38 million ounces and inferred resources of 179 million ounces of silver equivalent. ECU's goal is to establish a significant polymetallic mineral resource in the heart of Mexico's mining district. Our mission is to become a pre-eminent silver and gold producer through the development of existing, and additional potential resources at Velardena.   Company:                         eFuture Information Technology Ticker Symbol & Exchange:        Nasdaq:EFUT Investor Relations Contact:      Troe Wen Investor Relations Contact Phone:                          86 1051650988 Web:                             www.e-future.com.cn Date of Presentation:            11/11/2008  eFuture Information Technology Inc. (NASDAQ: EFUT) is a leading provider of front-end supply chain management software and services in China. eFuture provides integrated software and services to manufacturers, distributors, wholesalers, logistics companies and retailers in China's front-end supply chain market, especially in the retail and FMCG industries. eFuture serves over 1,000 clients, including 15 Fortune 500 companies, over 900 retailers and over 200 distributors in China. eFuture is one of IBM's premier business partners in Asia Pacific and also partners with Oracle, Microsoft, JDA, Motorola and Samsung Network China. eFuture has over 600 employees and 20 branch offices across China.   Company:                         Enable Holdings, Inc Ticker Symbol & Exchange:        ENAB Investor Relations Contact:      Ryan Calverley Investor Relations Contact       773.272.4414, Phone:                           [email protected] Web:                             www.EnableHoldings.com Date of Presentation:            11/10/2008  Enable Holdings Inc., is the world's leading excess inventory solutions company that links brand name sellers with customers around the globe. Enable Holdings, Inc. does this through its unique multi-channel asset-recovery solution that includes online auction platform solution uBid.com, fixed-price commerce solution RedTag.com, offline excess inventory solution RedTag Live!, business-to-business solution Dibu Trading Company, and private auction software solution Commerce Innovations. Brand name sellers are able to reduce distressed and excess inventories more efficiently and profitably than ever before, and achieve greater yield, while providing shoppers a connection to the world's most trusted brands at a value.   Company:                         Endocyte, Inc. Investor Relations Contact:      Vickey Buskirk Investor Relations Contact Phone:                          765-463-7175 Web:                             www.endocyte.com Date of Presentation:            11/10/2008  Great progress has been made in the development of new drugs to treat cancer and other serious illness. However, these therapies are often administered at suboptimal doses because of their side effects on healthy tissues. The value of these therapies is further diminished because of the inability to predict if a patient will respond to a particular therapy. Endocyte is addressing both of these issues using a new "drug guidance" technology that is designed to deliver drugs directly to diseased cells. This guidance system is composed of a targeting ligand that attaches to a drug and then binds to receptors over-expressed on the membranes of diseased cells.   Company:                         Energy Fuels, Inc. Ticker Symbol & Exchange:        TSX: EFR Investor Relations Contact:      Gary Steele Investor Relations Contact Phone:                          303-974-2147 Web:                             www.energyfuels.com Date of Presentation:            11/11/2008  Energy Fuels is pursuing a mission to build a fully integrated uranium and vanadium production company through exploration, development, mining, milling & sales. The Company is a conventional, underground miner, utilizing low risk techniques of drilling, split shooting, and diesel haulage of waste and ore to the surface. Current technology is applied wherever it will increase productivity, lower cost, and improve grade control. Primary activities include:  -- Developer and miner of southwest US U3O8 and V2O5 properties -- Prudent property acquisition to maintain full pipeline for production -- Property interests include six formerly producing U mines -- Aggressively refurbishing two of those mines to return them to production -- Licensing the 1000 tpd Pinon Ridge U/V mill, the first US mill for processing U to be built in 25 years   Company:                         Epic Energy Resources Ticker Symbol & Exchange:        EPCC - OTC BB Investor Relations Contact:      Lisa Elliott Investor Relations Contact       713- 529-6600, [email protected] Phone: Web:                             www.1epic.com Date of Presentation:            11/11/2008  EPiC Energy Resources is a Houston based integrated energy services company. EPiC provides consulting, engineering, construction management, operations, maintenance, specialized training and data management services focused primarily on the upstream and midstream energy infrastructure. Services are provided through Pearl, a diversified engineering and energy services company; Carnrite, a management consulting company focused on providing strategic and operational consulting services to the broad energy industry; and EIS, a global training and data management services company. Epic's Pearl operations oversee projects primarily in the Rockies and has ongoing projects in the Middle East. Unconventional gas exploration and oil discoveries in the Rocky Mountains and other markets in the U.S. has driven strong demand for its services.   Company:                    

EMD Serono Launches Landmark Patient Registry for Egg Freezing

ROCKLAND, Mass., Nov. 7 /PRNewswire/ — EMD Serono, Inc., an affiliate of Merck KGaA of Darmstadt, Germany, announced the launch of the Human Oocyte Preservation Experience (HOPE) Registry surrounding next week’s 64th Annual Meeting of the American Society for Reproductive Medicine (ASRM). The HOPE Registry is the only comprehensive national patient registry in the United States designed to study the safety and efficacy of oocyte cryopreservation procedures, commonly known as egg freezing.

The objective of the HOPE Registry is to track the outcome of oocyte cryopreservation cycles and to validate the efficacy of the different techniques used to freeze and thaw eggs. The HOPE Registry will evaluate the two techniques commonly used in egg freezing, “slow-cooling” and “vitrification,” and assess the safety of these procedures by systematically capturing information to determine if the babies born from different egg freezing techniques are healthy. The data collected will be thorough in scope and will include patient demographics as well as specifics on the different laboratory procedures used to freeze, thaw and fertilize each oocyte and produce the transferable embryos. Additionally, pregnancy outcomes will be tracked and evaluated, as well as the health and development of the children following birth and at one year of age.

Although egg freezing remains an experimental procedure, in recent years the number of pregnancies resulting from the fertilization of thawed oocytes has increased. Estimates show that almost 500 children have been born worldwide from these techniques and only four of these children (0.8%) had a genetic abnormality. This success is due, in large part, to a better understanding of the physiology of eggs as well as advancements leading to improved freezing technologies. The HOPE Registry will help support the goals of the ASRM’s Practice Committee, which called for more studies on the health outcomes of children born from various egg freezing techniques in 2006.

“We need to validate the safety and efficacy of egg freezing for it to become a more widely available option for women who for a variety of reasons would like to preserve their fertility. The HOPE Registry is an exciting vehicle that will assist us in the evidence-gathering process and will facilitate the furthering of the science and the acceptance of oocyte cryopreservation as an effective clinical practice,” said Dr. Alan Copperman, Director of the Division of Reproductive Endocrinology and Vice-Chairman of the Department of Obstetrics, Gynecology, and Reproductive Science at Mount Sinai Medical Center in New York, and co-director of Reproductive Medicine Associates of New York.

One patient group that has benefited significantly from egg freezing is women who have been diagnosed with certain types of cancer during their reproductive years and wish to preserve their fertility before cancer treatments. This is one of the few viable options for these women, who require chemotherapy and/or radiotherapy treatments that may cause infertility and premature ovarian failure depending on their cancer diagnosis.

Lindsay Nohr Beck is a cancer survivor who used oocyte cryopreservation before starting chemotherapy. She is the Founder and Executive Director of Fertile Hope, a nonprofit organization dedicated to providing reproductive information and support to cancer patients and survivors.

“Each year, more than 140,000 people are diagnosed with cancer during their childbearing years,” said Ms. Nohr Beck. “The HOPE Registry is expected to substantiate egg freezing as an option, so that fertility is one less obstacle these patients may need to overcome in fulfilling their dreams of becoming a parent and living the lives they imagined prior to their cancer diagnosis.”

The HOPE Registry aims to enroll approximately 400 women of reproductive age over a three year period. Women participating in the Registry will have their oocytes frozen, thawed and the resulting fertilized embryos transferred. It is open to all qualified investigators across the country who are freezing and later thawing oocytes for embryo production. Local ethics committee or Institutional Review Board approval will be required for each participating center. The HOPE Registry will be conducted according to the principles of good clinical practice and the Declaration of Helsinki, and will be listed on clinicaltrials.gov.

“As a leader in fertility health, EMD Serono is proud to support the HOPE Registry to validate oocyte cryopreservation techniques that may prove to be a viable option to assist women in preserving their fertility,” said Fereydoun Firouz, President and CEO of EMD Serono. “We are thrilled to play a major role in accumulating data on this new fertility treatment.”

Data will be collected according to the protocol in a uniform manner for every enrolled patient. Systematic tracking will continue for an additional two years to obtain birth outcomes from patients who achieved pregnancy within the third year of enrollment. Cumulative results from the HOPE Registry will be presented and discussed during an annual investigators’ meeting. These results will subsequently be published to provide a widely accessible resource for patients and their caregivers regarding the safety and efficacy of the different egg freezing techniques, as well as the postnatal outcomes of the babies born from embryos generated from frozen/thawed oocytes.

Cancer patients should consult with an oncologist before considering oocyte preservation. Fertility treatment is not recommended for patients with sex hormone dependent tumors of the reproductive tract and accessory organs.

About EMD Serono, Inc.

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people’s lives. The company has strong market positions in neurodegenerative diseases, with Rebif(R) (interferon beta-1a), as well as in endocrinology, with Saizen(R) (somatropin (rDNA origin) for injection), Serostim(R) (somatropin (rDNA origin) for injection) and Zorbtive(TM) (somatropin (rDNA origin) for injection). EMD Serono is a leader in fertility treatments, with Gonal-f(R) (follitropin alpha for injection), Luveris(R) (lutropin alfa for injection) and Ovidrel(R) Prefilled Syringe (choriogonadotropin alpha injection). With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono’s US footprint continues to grow, with more than 950 employees around the country and fully integrated commercial, clinical and research operations in the company’s home state of Massachusetts.

   For more information, please visit http://www.emdserono.com/.    About Merck KGaA  

Merck is a global pharmaceutical and chemical company with total revenues of Euro 7.1 billion in 2007, a history that began in 1668, and a future shaped by 32,458 employees in 59 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit http://www.merck.de/.

EMD Serono, Inc.

CONTACT: Colleen Minden, +1-781-681-2192

Web site: http://www.emdserono.com/http://www.merck.de/http://clinicaltrials.gov/

Spectrum Pharmaceuticals Announces Receipt of $41.5 Million From Allergan, Inc. Per Collaboration Agreement for Apaziquone Announced on October 29th

Spectrum Pharmaceuticals, Inc., (NasdaqGM: SPPI) announced today that it has received $41.5 million from Allergan, Inc., (NYSE: AGN) in connection with the collaboration agreement for apaziquone (EOquin(R)) signed on October 28, 2008, and announced on October 29, 2008.

Under the terms of the agreement, Allergan paid Spectrum $41.5 million within 10 days of closing and will make additional payments of up to $304 million based on the achievement of certain clinical, regulatory and commercialization milestones. Spectrum retained exclusive rights to apaziquone in Asia, including Japan, China, and India. Allergan received exclusive rights to apaziquone for the treatment of bladder cancer in the rest of the world, including the United States, Canada and Europe. In the United States, Allergan and Spectrum will co-promote apaziquone and share in its profits and expenses. Allergan will also pay Spectrum royalties on all of its apaziquone sales outside of the United States. Spectrum will continue to conduct the apaziquone clinical trials pursuant to a joint development plan, with Allergan bearing sixty-five percent of these expenses.

About Spectrum Pharmaceuticals

We are a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Our strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit our website at www.spectrumpharm.com.

Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum’s ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for our approved drugs, continuing to build our team, leveraging the expertise of partners around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC. (TM), TURNING INSIGHTS INTO HOPE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

(C) 2008 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

Inflammation Can Cause Stomach Cancer

U.S. medical scientists say they’ve determined chronic inflammation can cause stomach cancer — the second leading cause of cancer deaths in the world.

The multi-center research team led by Columbia University Medical Center said it discovered, for the first time, that elevated levels of a single pro-inflammatory cytokine, an immune system protein called IL-1 Beta, can start the progression towards stomach cancer. The scientists said they hope their finding will lead to development of ways to block the process, thereby preventing cancer from developing.

“This study shows that accumulation of IL-1 Beta, which is induced by infection with the bacterium Helicobacter pylori in the gastrointestinal tract, is a significant contributor to the onset of stomach cancer,” said Dr. Timothy Wang, a professor of medicine and lead author of the study. “We show in this study that IL-1Beta works by activating a type of white blood cell known as myeloid derived suppressor cells, which in our study appeared to be strongly pro-inflammatory. Blocking IL-1Beta or the myeloid cells may represent a potential strategy to prevent stomach cancer.”

The study is reported in the journal Cancer Cell.

The F. Dohmen Co. Marks 150th Anniversary With Global Charitable Giving

Three charitable organizations that concentrate on providing healthcare products and services to the neediest parts of the world will receive donations totaling $750,000 from The F. Dohmen Co. Foundation, COO Cynthia LaConte announced today.

Each charity will receive $250,000. The donations are being made in conjunction with The F. Dohmen Co’s. 150th anniversary. The beneficiaries include:

— MAP International – During fiscal year 2008, MAP distributed more than $458 million in medicines and emergency medical supplies for underprivileged people in 117 countries across the globe. MAP also increased its shipment of Travel Packs to more than 3,000. Each portable pack contains approximately $14,000 in essential medicines and supplies designed for doctors traveling to hard-to-reach areas.

— IMA World Health – By providing healthcare services and products to people in need across the globe, IMA World Health envisions a world relieved of the burden of disease that results from poverty and instability. This is accomplished through direct provision to hospitals, clinics, programs, and other healthcare providers, and by strengthening health systems through training, education, and oversight.

— Vitamin Angels – Dedicated to providing vital nutrition in the form of supplements to developing countries, communities and individuals in need. Vitamin Angels plans to eliminate Vitamin A deficiency childhood blindness by the year 2020 through the systematic distribution of vitamin A to at-risk children. In 2007, Vitamin Angels reached more than 7 million children by providing nutritional supplements to programs in over 40 countries.

“In considering the altruistic achievements of these three outstanding organizations, we realized that they share one thing in common with our foundation: the desire to help fulfill the mission of connecting people in need with healthcare products and services,” LaConte said. “The F. Dohmen Co. Foundation is honored to help support their important goals.”

The recipients of the donations expressed their appreciation and discussed how the money will benefit those in need.

“The F. Dohmen Co.’s commitment to connecting vital healthcare with the people who need it most is completely aligned with Vitamin Angels’ mission to provide vital nutrition, especially vitamin A, to the children no one else is reaching,” said Howard B. Schiffer, President of Vitamin Angels. “With F. Dohmen’s support we will be reaching over 10 million children in 2009, and by providing essential nutrition, save millions of children’s lives.”

“On behalf of the 25 million program beneficiaries, we are indeed grateful to the F. Dohmen Co.’s generous gift in support of MAP’s work,” said Michael J. Nyenhuis, MAP International President & CEO. “This gift will help MAP reach those in greatest need with life-saving medicines and compassionate healthcare.”

The F. Dohmen Co. Foundation was created with an initial endowment of $3 million in 2007. The foundation will be funded by annually committing a percentage of corporate profits.

In all, The F. Dohmen Co. Foundation is making contributions totaling $1.5 million this year. The foundation also recently announced donations totaling $750,000 to the UW-Madison School of Pharmacy and the Wisconsin Historical Society.

The F. Dohmen Co. is celebrating its historic 150th anniversary Nov. 8 at the Grain Exchange in Milwaukee with an event for family, friends and employees of the Dohmen family of businesses. Attendees are scheduled to include Milwaukee County Executive Scott Walker, who will present a proclamation honoring the company for reaching its historic anniversary.

ABOUT THE F. DOHMEN CO.: Headquartered in Milwaukee, Wis., The F. Dohmen Co. is a fifth-generation, family-owned business, which has served the healthcare industry for 150 years. Started in 1858 as a retail/wholesale pharmacy, The F. Dohmen Co. has steadily grown in reach and focus, utilizing a strategy of innovation and diligent market analysis. The F. Dohmen Co. portfolio of service offerings now includes pharmaceutical logistics through DDN, and prescription benefit management through RESTAT. The F. Dohmen Co. takes pride in being an industry leader, focusing on consistently delivering outstanding value and quality. For more information, visit www.dohmen.com.

Xlear Promotes XyloSweet Benefits for American Diabetes Month

In recognition of American Diabetes Month, observed annually in November, Xlear, Inc. is promoting the benefits of XyloSweet as a healthy alternative to sugar for people with diabetes or who are at risk for diabetes. American Diabetes Month draws attention to the fact that 23.6 million Americans have diabetes, and one-quarter of them (or 5.9 million people) have yet to be diagnosed.

One way for people to enjoy sweet foods without the negative impacts of sugar is to use a sweetener such as XyloSweet. The health benefits of XyloSweet extend to those that have been diagnosed with diabetes and to the millions of Americans who are unknowingly at-risk. The ADA offers a free test at http://www.diabetes.org/risk-test.jsp to help people understand if they are at risk for diabetes.

“In addition to the staggering numbers of undiagnosed diabetics in the United States, approximately 41 million Americans have pre-diabetes, which means that their blood glucose (sugar) is higher than normal, but not high enough to be classified with diabetes,” stated Blaine Yates, president of Xlear, Inc. “Without intervention, individuals with pre-diabetes are at a much higher risk for developing diabetes. Given the growth of diabetes among adults, juvenile diabetes, obesity and tooth and gum problems, it would be wise for all of us to consume less sugar and incorporate a sweet alternative such as XyloSweet into our diets.”

With XyloSweet from Xlear, consumers will not only reduce their daily calories and carbohydrates, they can keep the sweet, flavorful foods in their diets. XyloSweet is an all-natural, 100 percent xylitol sweetener that provides a safe way for diabetics to sweeten everything from their morning beverage to an evening snack. XyloSweet can be exchanged for common table sugar at a one-to-one ratio, and because it dissolves, mixes and behaves like sugar, it can be used in most recipes that call for common sugar.

XyloSweet metabolizes without insulin, creating a significantly lower glycemic effect when eaten. It is absorbed slowly by the body, resulting in a low glycemic index of seven compared to sugar’s index of 87 or higher. Xylitol is considered a sugar alcohol and has zero net effective carbohydrates, which means xylitol is not digested and processed by the body as a dietary carbohydrate.

XyloSweet is available through Xlear in single serving packets, and one, three and five pound bags. The product can also be purchased through one of thousands of retail outlets across the country.

About Xlear, Inc.

Founded in 2000, Xlear, Inc. (pronounced “clear”) is recognized as one of the leading manufacturers of xylitol products, and one of the largest importers of xylitol in the United States. Xlear, Inc. is committed to providing consumers with the health benefits of xylitol by manufacturing all-natural, health-enhancing products. Xlear, Inc. offers Xlear Saline Nasal Spray with Xylitol, an award-winning, patented saline and xylitol solution; a complete line of dental health products under the Spry Dental Defense System brand; XyloSweet, raw xylitol crystals used as a sugar substitute in cooking, baking and general consumption; and Fine & Dandy Candy, a growing line of healthy, xylitol-based candies. Xlear, Inc. is a private company with headquarters in Orem, Utah.

 Xlear Media Contact: Kevin Wilson Email Contact 513.885.5520  

SOURCE: Xlear, Inc.

New Jersey Council of Teaching Hospitals Achieves Milestone

TRENTON, N.J., Nov. 6 /PRNewswire/ — The New Jersey Council of Teaching Hospitals (NJCTH) today announced that it had achieved a significant milestone in the 22-year history of the educational and advocacy organization as the last of the state’s major teaching medical facilities have agreed to join. Hackensack University Medical Center (HUMC) and Saint Peter’s University Hospital are now members of the NJCTH.

“This is an important day for the Council,” said William McDonald, Chief Executive Officer of St. Joseph’s Regional Medical Center and Chairman of the New Jersey Council of Teaching Hospitals. “All of the state’s major teaching hospitals are now united behind a single mission: To provide leadership in health care delivery, education, and research, and to serve as the optimal setting for the provision of outstanding patient care and for the education of health care professionals.”

“We look forward to working with Saint Peter’s and Hackensack in creating an advocacy and educational agenda that best serves the health care needs of our state,” said Dr. J. Richard Goldstein, MD, President of the New Jersey Council of Teaching Hospitals. “As a former Commissioner of the Department of Health, I understand how critical it is for our state’s medical education institutions to provide leadership on issues such as health care quality and professional development.”

The New Jersey Council of Teaching Hospitals (NJCTH) is the state’s premier teaching hospital network which was founded in 1986 to recognize the unique nature and special needs of teaching hospitals. With the addition of Hackensack and Saint Peter’s, the council now consists of Atlantic Health, Cooper University Hospital, Meridian Health, Robert Wood Johnson University Hospital, St. Joseph’s Regional Medical Center, Somerset Medical Center, UMDNJ-University Hospital, Warren Hospital, and Catholic Health East/New Jersey which includes St. Michael’s Medical Center, Inc. and Our Lady of Lourdes Medical Center.

“As one of the nation’s premier medical education centers, Hackensack is excited to be joining others in our state whose mission it is to promote the future of quality health care in New Jersey,” said John P. Ferguson, President and CEO, Hackensack University Medical Center.

Hackensack University Medical Center, a 775-bed teaching and research hospital affiliated with the University of Medicine and Dentistry of New Jersey — New Jersey Medical School, is the largest provider of inpatient and outpatient services in the state of New Jersey.

Founded in 1888 with 12 beds and as Bergen County’s first hospital, Hackensack University Medical Center has demonstrated more than a century of growth and progress. Hackensack University Medical Center is Bergen County’s largest employer with a work force of more than 7,200 employees and an annual budget of $1 billion. The more than 1,400 physicians and dentists on the medical and dental staff represent the full spectrum of specialties and subspecialties. Hackensack University Medical Center offers one of the region’s most modern campuses, which is continually updated and expanded to incorporate emerging clinical approaches, medicine, and technologies. On this campus, hundreds of specialized programs and services are delivered.

“Saint Peter’s commitment to quality medical education and advanced practices will be well served by our membership in the New Jersey Council of Teaching Hospitals,” said Alfred Glover, President and Chief Executive Officer of Saint Peter’s University Hospital.

For a century, Saint Peter’s University Hospital has been serving the health care needs of central New Jersey. From its incorporation in 1908, Saint Peter’s has grown to become a technologically-advanced, 478-bed teaching hospital, sponsored by the Roman Catholic Diocese of Metuchen. Saint Peter’s University Hospital is a member of the Saint Peter’s Healthcare System along with the Saint Peter’s Foundation and Saint Peter’s Health and Management Services. In support of its mission to provide quality medical education, Saint Peter’s is a sponsor of residency programs in obstetrics and gynecology, pediatrics and internal medicine and is an academic affiliate of Drexel University College of Medicine, the largest private medical school in the nation. Saint Peter’s is also a site for residency programs in radiology and orthopedic surgery in affiliation with the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School.

   About the New Jersey Council of Teaching Hospitals   (http://www.njcth.org/)  

Together, NJCTH institutions represent more than 54,000 health care professionals and 9,600 hospital beds; care for more than 562,000 inpatients and nearly 9,300,000 outpatients each year; total an aggregate budget in excess of $8.1 billion per year; and provide a significant amount of the state’s charity care. While constituting approximately 30 percent of the state’s hospitals, the Council’s members represent about 50 percent of all of the statewide volume. All three of New Jersey’s Level I Trauma Centers are NJCTH hospitals, as are three of the state’s seven Level II Trauma Centers. NJCTH member institutions are dedicated not only to high-quality patient care, but to health professions education and sophisticated research as well. In affiliation with the University of Medicine and Dentistry’s seven schools, NJCTH hospitals train more than 1900 resident physicians, physician assistants, and nurse practitioners each year.

Contact: Dr. J. Richard Goldstein (609-656-9600)

New Jersey Council of Teaching Hospitals

CONTACT: Dr. J. Richard Goldstein of New Jersey Council of TeachingHospitals, +1-609-656-9600

Web Site: http://www.njcth.org/

 

Wild Game Consumption Linked To Lead Poisoning

Pregnant women and young children in North Dakota are being advised to avoid eating meat from wild game killed with lead bullets, health officials said.

A study released Wednesday examined the lead levels in the blood of more than 700 state residents and found that those who ate wild game killed with lead bullets appeared to have higher lead levels than those who ate little or no wild game.

Although the elevated lead levels were not considered dangerous, pregnant women and children younger than 6 should avoid eating venison harvested using lead bullets, North Dakota officials said.

Both groups are more likely to get lead poisoning, which can cause learning problems and convulsions, and in severe cases can lead to brain damage and death.

Dr. Stephen Pickard, a CDC epidemiologist who works with the state health department, said the study is the first to connect lead traces in game with higher lead levels in the blood of game eaters.

Minnesota’s Department of Natural Resources previously found that fragments from lead bullets spread as far as 18 inches away from the wound.

Pickard said nobody was in trouble from the lead levels. “However, the effect was small but large enough to be a concern,” he said.

The study noted that the more recent the consumption of wild game harvested with lead bullets, the higher the level of lead in the blood.

A physician conducting tests using a CT scanner found lead in samples of donated deer meat, leading officials in North Dakota and other states to issue warnings about eating venison killed with lead ammunition since the spring.

North Dakota’s health department ordered food pantries to throw out donated venison after the findings were announced.

However, some groups that organize venison donations have called such actions premature and unsupported by science.

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Humana Awards $100,000 Grant to Odyssey House

Humana, one of Louisiana’s leading health benefits companies, awarded a $100,000 grant in its 2008 Louisiana Benefits charitable giving program on Oct. 16 to Odyssey House Louisiana of New Orleans.

The nonprofit behavioral health provider plans to use its one-time $100,000 Louisiana Benefits grant for expansion of its free community medical clinic in New Orleans so that it can provide affordable health care to more in the community.

With the expansion, the clinic will have two more examination rooms; one psychiatric exam room; an additional bathroom for patients; and, an administrative area for clinic staff.

For the second consecutive year, Humana’s Louisiana Benefits awarded a one-time, $100,000 signature grant to a nonprofit organization based in Louisiana that is doing valuable work to benefit the people who live in the state. Louisiana Benefits supports charitable organizations that are focused on improving health experiences or building healthy communities in the areas of mind, body or spirit.

Nearly 50 New Orleans business, civic and nonprofit leaders attended Humana’s 2008 Louisiana Benefits grant celebration event Oct. 16 at the Audubon Tea Room in New Orleans. Humana this fall received more than 70 applications from Louisiana nonprofit groups and charitable organizations seeking the $100,000 grant.

A diverse panel of local judges, comprised of community leaders, public officials and business representatives, worked with Humana to select the 2008 $100,000 grant recipient in Louisiana Benefits.

“We’re very pleased to present this year’s Louisiana Benefits grant to Odyssey House Louisiana, and know that their community medical clinic expansion will have a major impact on the health of the people they help every day in New Orleans,” said Humana Southern Division Vice President of Medicare Operations George Renaudin.

“This program is playing a significant role in promoting healthy lives and healthy communities for people in Louisiana,” said Humana Louisiana Commercial Market President Jamie Schlottman. “Since its start in 2005, when we were able to redirect funds to hurricane recovery efforts, to today, when we are extending the reach of an area nonprofit, Louisiana Benefits has been helping people day to day.”

“We could not be more appreciative of Humana and its Louisiana Benefits grant opportunity,” said Edward Carlson, chief executive officer of Odyssey House Louisiana. “This grant will truly have a positive impact on our client population and the community we serve by allowing us to offer premier medical services to those who need them most.”

Humana also awarded smaller grants on Oct. 16, recognizing the community efforts of the other 2008 Louisiana Benefits finalists, Boys & Girls Club of Greater Baton Rouge, and Junior Achievement of Greater New Orleans. Junior Achievement received a check for $15,000, and Humana presented Boys & Girls Club with a check for $5,000.

About the 2008 Humana Louisiana Benefits finalists

Odyssey House Louisiana is a New Orleans-based nonprofit behavioral health care provider with an emphasis on addiction treatment. Odyssey House was established in 1973 as a nonprofit residential substance abuse treatment facility with the mission of empowering people to conquer addiction.

Today, Odyssey House offers a professional, structured and caring therapeutic community with comprehensive services and effective support systems that enable individuals to chart new lives and return to their communities as contributing members.

For more information, go to www.ohlinc.org.

Boys & Girls Club of Greater Baton Rouge began in 1980 with a dream of local community and business leaders to provide a safe, positive place for youth that would have significant impact upon their lives. Today, the organization has grown to one with a more than $2 million budget, serving thousands of children annually.

Known as “the positive place for kids,” the Club provides guidance-oriented character development programs on a daily basis for children six to 18 years old, conducted by professional staff. Boys & Girls Club programs emphasize leadership development, education and career exploration, financial literacy, health and life skills, the arts, sports, fitness and recreation, and family outreach.

For more information, visit www.BRClubs.org.

Junior Achievement of Greater New Orleans is a leading financial education provider, reaching students from kindergarten through 12th grade. Founded in 1955 by businessman and philanthropist Percival Stern, Junior Achievement has taught nearly half a million young people in the New Orleans community about business and entrepreneurship, linking classroom learning to life in the real world.

Junior Achievement serves young people in 12 parishes in the Greater New Orleans area. In the current school year, Junior Achievement reached nearly 22,000 students.

For more on Junior Achievement, go online to www.jagno.org.

About Humana Health Benefit Plan of Louisiana, Inc.

Humana Health Benefit Plan of Louisiana is one of the largest health benefits plans in the New Orleans market and the third largest in the state of Louisiana with approximately 175,000 commercial medical members and more than 125,000 Medicare members.

About Humana

Humana Inc., headquartered in Louisville, Ky., is one of the nation’s largest publicly traded health and supplemental benefits companies, with approximately 11.5 million medical members. Humana is a full-service benefits solutions company, offering a wide array of health and supplementary benefit plans for employer groups, government programs and individuals.

Over its 47-year history, Humana has consistently seized opportunities to meet changing customer needs. Today, the company is a leader in consumer engagement, providing guidance that leads to lower costs and a better health plan experience throughout its diversified customer portfolio.

More information regarding Humana is available to investors via the Investor Relations page of the company’s Web site at www.humana.com.

Study From the University of Texas M.D. Anderson Cancer Center Demonstrates That AHCC(R) is Safe in Combination With Most Chemotherapeutic Agents

PURCHASE, N.Y., Nov. 6 /PRNewswire/ — A recently published study in the Journal of the Society for Integrative Oncology (Vol. 6, No. 3 (Summer), 2008: pp 105-109) by researchers at the University of Texas M.D. Anderson Cancer Center with the support of researchers from Amino Up Chemical Company in Sapporo, Japan has demonstrated that AHCC (Active Hexose Correlated Compound) can be safely used in combination with most chemotherapy agents. AHCC is a leading and commonly utilized dietary supplement for immune enhancement and cancer. The study was designed to determine on how AHCC interacts with select chemotherapy agents. As most chemotherapy agents undergo metabolism in the body through the CYP450 (Cytochrome P-450) pathway, this parameter was investigated in combination with four isoenzymes (3A4, 2C8, 2C9 and 2D6). This was followed by an evaluation of AHCC by including it as a substrate of these same isoenzymes.

The results of this in vitro metabolism study indicated that AHCC is not an inhibitor of the major CYP450 isoenzyme pathways. Therefore, AHCC is safe and unlikely to result in increased toxicity when used in combination with commonly used chemotherapeutic agents such as Cyclophosphamide, Ifosfamide, Paclitaxel, Docetaxel, Irinotecan, Vincristine, Interferon and Imatinib. It was demonstrated, that AHCC may have the potential for induce metabolism of drugs metabolized via the CYP450 2D6 pathway. Fortunately, the CYP450 2D6 is not a predominant pathway for metabolism of the most commonly used chemotherapy agents.

“Research shows that AHCC benefits cancer patients with its antitumor effects as well as its potential restorative effects on natural killer cells, macrophages and cytokines after anticancer chemotherapy,” said Judith Smith, Pharm.D., BCOP,FCCP, FISOPP, Department of Gynecologic Oncology, Division of Surgery with The University of Texas M.D. Anderson Cancer Center. “The safety of AHCC in combination with anti-cancer agents needed evaluation and this study confirms that AHCC is safe to administer with most chemotherapy agents.”

In addition to this study, research completed at other institutions with AHCC has shown that it activates important immune white blood cells including macrophages, Natural Killer (NK) cells and Lymphokine-Activated Killer (LAK) cells. AHCC also induces the production of cytokines that serve as chemical messengers between cells. AHCC has been the subject of over 80 research studies worldwide including studies completed at Harvard University’s Faulkner Hospital, Yale University and Columbia University Medical Center.

What is AHCC (Active Hexose Correlated Compound)?

AHCC is derived from the hybridization of several subspecies of medicinal mushroom, cultivated in Japan and then produced from a unique manufacturing process. AHCC is the leading immune-enhancing supplement in Japan and is utilized by over 700 hospitals and healthcare facilities worldwide as a standard preventative supplement for incoming patients to help reduce the risk of hospital infections as well as supporting the body’s fight against the formation of abnormal cells.*

AHCC is manufactured by Amino Up Chemical Company in Sapporo, Japan and is distributed in the United States by Maypro Industries. Maypro sells AHCC to a number of leading supplement companies including Quality of Life Laboratories, a subsidiary of Maypro.

The AHCC Research Association was founded in 1986 to promote further study. Each year since 1994, over 300 medical doctors and researchers have gathered in Sapporo, Japan for the AHCC Research Association Symposium to share and discuss the latest developments.

To learn more about AHCC, visit the AHCC Research Association Web site at http://www.ahccresearch.com/.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or mitigate disease.

AHCC Research Association

CONTACT: Steve Hanson of GRIP IDEAS, +1-602-430-7246,[email protected], for AHCC Research Association

Web Site: http://www.ahccresearch.com/

Hemametrics Announces New Study Demonstrating That Crit-Line Use May Contribute to Reduction of Hemoglobin Variability in Hemodialysis Patients

Two presentations during the American Society of Nephrology’s Renal Week demonstrated that frequently monitoring hemoglobin during hemodialysis will provide physicians with trending information that may reduce hemoglobin variability. The study demonstrated increased time-in-target range for hemoglobin in end-stage renal disease patients. The study suggests that increased frequency of hemoglobin monitoring may contribute to more accurate dosing for anti-anemia medication (e.g., erythropoietin stimulating agents, or ESAs) and lead to improved outcomes. The study used Hemametrics’s Crit-Line III TQA hematocrit monitor.

“This study demonstrates that a simple monitor, that can non-invasively measure hemoglobin each dialysis treatment, can provide physicians with real-time trending information. An upward or downward trend in hemoglobin can allow the physician to modify the ESA dose and prevent the patient from going above or below the target range indicated in the FDA label for ESAs, which recommends the target range of 10-12 g/dl.” says Michael J. Germain, MD, Professor of Medicine at Tufts University School of Medicine. “Using a monitor like Crit-Line that gives a real-time hemoglobin each treatment, as we did in these two studies, may allow doctors to use a more accurate algorithm to predict correct ESA dosing.”

“We were very pleased to be part of these studies, as they demonstrated the importance of hematocrit monitoring in the dialysis process and represent a new use for our Crit-Line system using exclusive Crit-Line software and a patented process,” comments Patrick Moriarty, CEO of Hemametrics. “Currently, Crit-Line allows customized volume, oxygen and anemia management during hemodialysis, providing clinicians with evidence-based criteria to obtain the ideal dry weight of each patient, which will ultimately reduce congestive heart failure symptoms and thereby hospitalization and mortality. We believe that expanding these criteria in order to help physicians determine hemoglobin trends, which may impact ESA dosing – and indeed this may be useful when bundling of services are mandated by CMS – only underscores the fact that Crit-Line should be in every dialysis clinic and available for every dialysis patient.”

About The Study

The study hypothesized that increased hemoglobin monitoring with fluid management and an investigational computer algorithm would reduce hemoglobin variability and increase the percentage of time patients were in target range. In this study, 44 dialysis patients in a single dialysis clinic were monitored using Crit-Line during their treatment regimen over the course of 15 months. The monitoring periods was phased over three periods. In Phase One, hemoglobin was recorded at each dialysis treatment but no changes were made in volume management. In the second phase, the dialysis center staff followed a strict protocol of fluid management based on the results of the Crit-Line readings. In the third phase, an investigational computer algorithm provided suggested EPO and iron doses based on a three-times-per-week hemoglobin value obtained from the Crit-Line device. Results of the study suggested that when these frequent hemoglobin values as determined by a fluid management system (Crit-Line) were used with a computer algorithm (AMIE Leeds England), intra-patient hemoglobin variability and the percentage of time in target were statistically significantly improved compared the baseline phases (patients served as their own controls).

In a second presentation, the authors demonstrate that a robust mathematical model may be developed from this study data. This model forms the basis for the investigational computer algorithm on which revised software for the Crit-Line hemoglobin management system was based.

The study was supported as an Investigator-sponsored study to Dr. Michael Germain from Amgen, Inc. Crit-Line monitors for the study were provided by HemaMetrics, Inc.

About Crit-Line

Crit-Line III-TQA is a fluid management and access monitoring tool used during hemodialysis that incorporates photo-optical technology to non-invasively measure absolute hematocrit, percent blood volume change, continuous oxygen saturation and access recirculation. Using red blood cells as the marker, Crit-Line determines the fluid volume change in the bloodstream during a dialysis treatment, essentially using light to determine the ratio between hematocrit and extra fluid in the bloodstream.

This measurement helps physicians better determine both the length of a dialysis treatment and how effective it was. Using Crit-Line, patients report decreased fear of having symptoms, quicker post-dialysis recovery time, fewer medications and improved quality of life.

Further, Crit-Line’s improvement of dialysis treatment outcomes results in significantly increased gross revenues for facilities thru increased patient longevity, fewer cardiac related hospitalizations, and unpredicted missed treatments. In fact just two missed treatments per year per patient, pays for the device and disposables in three months or less. The Crit-Line and its associated products are FDA 510(k) cleared, carry the CE mark and are CLIA exempt.

About Hemametrics

Headquartered in Salt Lake City, Utah, HemaMetrics is a cutting-edge medical device company working from a base of strong existing patents in optical technology that provides solutions for non-invasive blood measurement. Its platform Crit-Line III TQA technology base enables non-invasive, optical measurement of absolute blood parameters, while the company continues research into further applications and new markets to improve outcomes for medical patients.

Impulse Monitoring and St Vincent’s Medical Sign IONM Agreement

Impulse Monitoring, a provider of intraoperative neuromonitoring services to hospitals, has signed an agreement with St Vincent’s Medical Center, Jacksonville, Florida.

Impulse Monitoring (IMI) will provide St Vincent’s with comprehensive intraoperative neuromonitoring (IONM) services including IMI-qualified neurophysiologists and real-time professional oversight experienced physicians.

IONM assesses neurological function involving the brain, spinal cord and related nerve structures during surgery. According to Impulse Monitoring, the use of IONM facilitates the surgical process and can reduce surgical risk by providing alerts to surgeons of potential harm to spinal cord or neural structure.

Kenneth Jones, director of neurosciences/orthopedics and administrative director of surgical services at St Vincent’s Medical Center, said: “Our goal is to provide the highest quality of care in the Jacksonville area. By selecting Impulse Monitoring to provide IONM services, we have made a key decision that will further our reputation for setting the standard of care in our region for all surgeries requiring neuromonitoring.”

APS Healthcare Relocates Headquarters to New York

APS Healthcare, a provider of specialty healthcare solutions, has moved its headquarters to 44 South Broadway in downtown White Plains, New York. The company was formerly located in Silver Spring, Maryland.

The company said that it now occupies 44,082sqft of space on the 12th floor of Westchester One. Ultimately, the move is slated to bring 200 new jobs to White Plains.

Jerry Vaccaro, president and COO of APS, said: “Westchester County is an excellent location for our organization. We are attracting a highly skilled and impressive workforce.”

Acologix Presents Findings From the UREMIC PRURITIS National Registry Study at the 41st Annual Meeting of the American Society of Nephrology

HAYWARD, Calif., Nov. 6 /PRNewswire/ — Acologix, Inc., a privately held biopharmaceutical company, and principal investigators presented key findings from the first ground breaking uremic pruritis (“Itch”) registry study of patients on hemodialysis. A total of four abstracts were accepted by the American Society of Nephrology describing key study outcomes with poster presentations by Drs. Michael Germain and James Tumlin. The Itch National Registry Study, the first-ever longitudinal study of uremic pruritus (UP), was designed to better understand the natural history and negative effects of UP, a severe unrelenting itching that complicates end-stage renal failure. According to large international cross-sectional studies, up to 45% of patients undergoing hemodialysis have moderate to severe UP and the condition is associated with increased mortality. The Itch National Registry Study evaluated itching severity with a visual analogue scale and several health-related quality of life measures. One-hundred three (103) hemodialysis patients from 13 U.S. dialysis units were studied over a 3.5 month period. Aspects of quality of life including emotional distress, social function, and sleep were strikingly and negatively affected by UP. Even relatively small incremental increases in pruritus intensity correlated with decrements in quality of life. The data will be presented on November 6, 2008 at the 41st ASN (American Society of Nephrology) Annual Meeting in Philadelphia, Pennsylvania.

It has been thought that UP is a consequence of inadequate dialysis or metabolic and hematologic abnormalities associated with end-stage renal failure. This study, however, found that in spite of excellent dialysis adequacy and appropriate management of their metabolic and hematologic abnormalities, 72% of study patients had severe pruritus and it often affected large parts of their body. Itching occurred daily or nearly daily in the majority and was unrelieved for more than one year in most patients despite the fact that many were taking antihistamines and/or using moisturizers and other dermatologic treatments for itching.

“The Itch National Registry Study demonstrates the significant affliction UP represents among hemodialysis patients. The need for a safe and effective treatment is clear,” commented Dr. Dawn McGuire, Chief Medical Officer of Acologix. “Data from this study is informing our North American development program for AC-820, an oral, kappa-selective opioid agonist with potent anti-pruritic effects. Among UP patients, Japanese clinical trials have shown significant reduction in itching for up to 52 weeks. In over 1100 patients on hemodialysis, AC-820 has demonstrated a consistently good safety profile. We are enthusiastic about developing AC-820 as a first-in-indication treatment, and have commitment to reducing the daily suffering of dialysis patients.”

Acologix, Inc.

Acologix, Inc., a privately held biopharmaceutical company, is developing and commercializing novel biopharmaceuticals targeting osteo-renal indications, including the complications of chronic kidney disease and dialysis, bone and cartilage repair and regeneration, and general dental and oral care. The company’s most advanced program, AC-820 (TRK-820) is in Phase 3 and registration stages in the U.S. and Japan, respectively for the treatment of uremic pruritus in dialysis patients. The second program, AC-100, a new class of hard tissue growth promoting molecule, has been studied in two Phase II clinical studies and demonstrated high safety profile and selective hard tissue formation activities in dental restoration procedures. Further studies have revealed more evidence that AC-100 selectively promotes bone and cartilage repair and regeneration. Acologix is also developing AC-200 (Phosphatonin) to treat hyperphosphatemia and renal osteodystrophy. For more information, go to http://www.acologix.com/.

Abstract Number 550565: “CORRELATION BETWEEN UREMIC PRURITUS INTENSITY AND QUALITY OF LIFE: A REPORT FROM THE NATIONAL ITCH REGISTRY STUDY,”

Abstract Number 551527: “TEMPORAL AND SPATIAL PATTERNS OF UREMIC PRURITUS: A RPEORT FROM THE ICTH NATIONAL REGISTRY STUDY,”

Presented by Michael Germain, M.D. and James Tumlin, M.D.

This press release contains “forward-looking” statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. Acologix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward- looking statements in this press release should be evaluated together with the many uncertainties that affect Acologix’ business.

Acologix, Inc.

CONTACT: Yoshi Kumagai, President and CEO of Acologix, Inc.,+1-510-512-7200, fax, +1-510-786-1116, [email protected]

Web site: http://www.acologix.com/

Tough Economic Times Call for Savvy Travelers

BALTIMORE, Nov. 6 /PRNewswire/ — Tough economic times should encourage travelers to plan smarter, safer trips, according to MEDEX Global Group. As individuals look for the most economical and sensible travel options, MEDEX advises vacationers and business travelers to avoid major risks and costs associated with medical emergencies while overseas.

“Nothing can put a family or business at risk like an international medical emergency,” says Bruce Kirby, CEO of MEDEX Global Group. “However, travelers can make informed decisions in advance to protect their health and financial assets.”

For as little as two dollars a day, travelers can purchase international travel insurance that covers emergency medical expenses such as hospital and physician fees, medical evacuation and emergency dental expenses. Without this coverage, travelers could be forced to max out their credit cards, tap dwindling home equities, deplete savings accounts, or suffer treatment delays.

“Too many people equate travel insurance with lost luggage and trip cancellation,” adds Kirby. “The dangers and expenses of a medical emergency far exceed the costs of lost luggage, and you can add baggage and trip coverage to most medical policies.”

Some travelers mistakenly think they already have coverage through existing policies, when they do not. These groups include people over 65 using Medicare, which does not cover overseas medical needs; business executives of small-to-mid-sized companies that may not carry group travel policies or may only cover evacuation costs; and mission-based travelers on volunteer trips through churches or other nonprofits that may not provide medical coverage.

To be a savvy, safe traveler, MEDEX recommends the following:

— Protect your finances by investing in a travel insurance package that includes comprehensive medical and evacuation coverage.

— Understand that protection against trip cancellation and lost baggage is a minor cost compared to emergency medical expenses. Compare policies of $50,000, $100,000 or more to protect against costly evacuations and medical fees.

— Make sure the insurance policy includes direct payment to the medical provider. Many international facilities and practitioners require cash up- front, and prior to treatment. Policies that reimburse individuals after they return home will not help when you need immediate cash and care.

— Ask who provides the emergency assistance included in most travel medical policies. Some insurers outsource to a 24-hour call center that may not have experience with serious medical emergencies. When you need help fast, you can’t afford delays caused by transferring calls, verifying benefits, or waiting for claims approval from a different office.

— Research your location before you go to understand what health risks are present at your destination and where to go for quality medical treatment. Preparing before you leave can go a long way in protecting your health and your wallet.

— Be aware that some insurance companies have been affected by the current banking crisis. While investigating insurance policies, confirm that you are working with a credible, well-established company and underwriter to avoid further risks.

ABOUT MEDEX Global Group

MEDEX is the oldest and largest independently owned provider of global travel security and medical assistance in North America. For more than 30 years, MEDEX has served individual business and leisure travelers, corporations, scholastic institutions, government agencies and humanitarian organizations. MEDEX services range from pre-trip intelligence and contingency planning to real-time medical case management and complex emergency evacuations.

MEDEX Global Group

CONTACT: Nicole Beach of MEDEX Global Group, +1-410-453-6391,[email protected]

Noven Announces 2008 Third Quarter Financial Results

Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced financial results for the three-month and nine-month periods ended September 30, 2008.

Noven reported net income of $5.2 million, or $0.21 diluted earnings per share, for the quarter ended September 30, 2008. Results for the third quarter of 2008 included the recognition of $5.0 million in operating income due to the reversal of an accrued liability for a Pexeva(R) contingent sales milestone payment and an aggregate $6.0 million in third quarter charges related to Daytrana(R) (each discussed in additional detail below). Excluding these items and related tax effects, Noven would have reported net income of $5.9 million, or $0.24 diluted earnings per share, for the third quarter of 2008.

Third Quarter Highlights

Stavzor(R). In July 2008, the U.S. Food and Drug Administration approved Noven’s Stavzor product (valproic acid delayed release capsules), and Noven Therapeutics commercially launched the product in August 2008.

Novogyne Joint Venture. At Novogyne Pharmaceuticals, Noven’s joint venture with Novartis Pharmaceuticals Corporation, net income for the third quarter of 2008 increased 25% and net revenues increased 18% compared to the same quarter in 2007. Total prescriptions for Novogyne’s Vivelle-Dot(R) product increased 7% in the third quarter of 2008 compared to the same quarter in 2007, while total prescriptions in the U.S. hormone therapy market decreased 5% for the same period. For the first nine months of 2008, Vivelle-Dot total prescriptions increased 7% over the same period in 2007, while total prescriptions in the U.S. hormone therapy market decreased 5% for the same period.

Balance Sheet. In August 2008, Noven received the third and final $25.0 million milestone payment on sales of Daytrana by Shire plc (“Shire”). Also in the 2008 third quarter, Novogyne distributed $11.7 million in cash to Noven, bringing year-to-date cash distributions from the joint venture to Noven to $29.0 million. At September 30, 2008, Noven’s cash, cash equivalents and non-current investments in auction rate securities had increased to $80.7 million, and Noven had no long-term debt.

Daytrana(R). Noven continues to test manufacturing solutions expected to address the peel force issue affecting certain lots of Daytrana. In addition, Noven is implementing new product release testing intended to identify Daytrana product lots at risk of not meeting the product’s peel force specification through its shelf life. Results for the third quarter of 2008 included a $1.7 million charge for Shire’s previously announced voluntary recall of Daytrana product. Results for the 2008 third quarter also included a $4.3 million reserve related to certain previously-manufactured Daytrana lots that are at risk of not meeting the peel force specification through the product’s shelf life and certain costs that Noven will be required to reimburse to Shire for the affected lots.

Pipeline Developments. In August 2008, Noven entered into global license and supply agreements with Procter & Gamble Pharmaceuticals, Inc. relating to the development and commercialization of prescription transdermal patches for the treatment of Hypoactive Sexual Desire Disorder (“HSDD”) in women. Also during the 2008 third quarter, Noven advanced preparations for a Phase 2 study of Mesafem(TM), Noven’s developmental non-hormonal product for vasomotor symptoms (hot flashes), and patient screening began in late October 2008.

New Appointment. In September 2008, Noven appointed Peter Amanatides as its new Vice President – Quality Assurance & Quality Control. Since June 2008, Noven has added four pharmaceutical industry veterans to lead the critical functions of QA/QC (Peter Amanatides), Marketing and Sales (Anthony Venditti), Transdermal Research and Development (Steven Dinh), and Clinical, Regulatory and Medical Affairs (Joel Lippman, M.D.).

CEO Comment

Peter Brandt, Noven’s President & CEO, said: “The third quarter of 2008 included a new product launch, another strong performance by Novogyne, receipt of a substantial cash milestone payment that further strengthened our balance sheet, a new senior-level appointment in a critical area of our operations, and meaningful progress in addressing both our challenges and our opportunities for growth.” Brandt continued: “In particular, working with our partner Shire, we continue to aggressively test manufacturing solutions to address the peel force issue affecting certain lots of Daytrana. If our testing is successful, we would expect to produce commercial product incorporating a solution in mid-2009. In the interim, we are implementing new product release testing intended to predict which Daytrana lots are at risk of developing peel force issues. In the third quarter, we established a $4.3 million reserve related to previously-manufactured Daytrana lots that are at risk of not meeting the peel force specification during the product’s shelf life, as well as costs that we expect to owe our partner for the affected lots. We do not expect that this issue will affect the availability of this important product at the pharmacy.”

Financial Results

Noven’s financial results for the third quarter and first nine months of 2008 included the results of operations of Noven Therapeutics (formerly JDS Pharmaceuticals), a specialty pharmaceutical company acquired by Noven on August 14, 2007.

Results for the third quarter and first nine months of 2008 benefited from the recognition of $5.0 million in operating income due to the reversal of a $5.0 million accrued liability (the “Pexeva Reversal”) related to a future Pexeva contingent sales milestone no longer expected to be achieved. Results for these periods also included (i) a $1.7 million third quarter charge and $1.95 million in charges in the first half of 2008 for reimbursements due to Shire for previously-announced voluntary recalls of Daytrana product, and (ii) a $4.3 million reserve related to previously-manufactured Daytrana product at risk of exceeding the product’s peel force specification during its shelf life (the “Daytrana Charges,” referred to together with the Pexeva Reversal as the “2008 Items”).

Results for the third quarter and first nine months of 2007 included (i) a one-time $100.2 million charge for the portion of the JDS Pharmaceuticals purchase price allocated to in-process research and development (the “IPR&D Charge”), and (ii) a $3.3 million charge related to reimbursements to Shire in connection with its voluntary withdrawal of certain lots of Daytrana (together with the IPR&D Charge, the “2007 Items”).

2008 Third Quarter Results

For the quarter ended September 30, 2008, Noven reported net income of $5.2 million ($0.21 diluted earnings per share), compared to a net loss of $59.0 million ($2.38 loss per share) for the same quarter in 2007. Excluding the 2008 and 2007 Items and the related tax effects, net income for the 2008 third quarter would have been $5.9 million ($0.24 diluted earnings per share) compared to $7.6 million ($0.30 diluted earnings per share) in the third quarter of 2007. A reconciliation of net income and earnings per share on a GAAP basis (defined below) to net income and earnings per share as adjusted to reflect the excluded items is attached to this press release.

Noven’s net revenues in the 2008 third quarter were $25.7 million, an 18% increase over the third quarter of 2007. This increase reflects a full quarter’s sales contribution from Noven Therapeutics’ products, and increased license and contract revenues, primarily due to amortization of deferred revenue from additional Daytrana sales milestone payments. The increase in net revenues was partially offset by a $1.3 million net revenue reduction in the third quarter of 2008, representing a portion of the Daytrana Charges.

Gross margin, as a percentage of total net product revenues, was 23% in the 2008 third quarter compared to 41% in the same quarter last year. Cost of products sold in the third quarter of 2008 included $1.6 million of the Daytrana Charges, as well as increased quality assurance activities and expenses, primarily related to Daytrana production. Daytrana production costs are expected to materially increase as a result of our implementation of new product release testing intended to identify and screen product at risk of exceeding the product’s peel force specification.

Research and development expenses in the 2008 third quarter increased $0.4 million to $4.0 million compared to the third quarter of 2007, reflecting slightly higher expenses at each of Noven Transdermals and Noven Therapeutics. The third quarter of 2007 included the $100.2 million IPR&D Charge. Selling and marketing expenses increased to $7.3 million from $3.1 million in the third quarter of 2007, reflecting a full quarter of selling and marketing expenses at Noven Therapeutics as well as the August 2008 launch of Stavzor. In the 2008 third quarter, general and administrative expenses increased $2.4 million, or 27%, reflecting $3.1 million of the Daytrana Charges and a full quarter of expenses at Noven Therapeutics.

Noven recognized $13.8 million in earnings from Novogyne in the third quarter of 2008, an increase of 26% compared to the $10.9 million recognized in the same quarter last year. Novogyne’s net income for the 2008 third quarter increased 25% to $28.3 million, compared to $22.5 million in the 2007 third quarter, and 2008 third quarter net revenues increased 18% to $45.8 million. Novogyne’s gross margin for the 2008 third quarter increased slightly to 81%, and its selling, general and administrative expenses increased 9% to $9.0 million.

2008 Nine-Month Results

Noven reported net income of $12.3 million ($0.50 diluted earnings per share) for the nine months ended September 30, 2008 (the “2008 Period”), compared to a net loss of $46.4 million ($1.87 loss per share) reported for the first nine months of 2007 (the “2007 Period”). Excluding the 2008 and 2007 Items and the related tax effects, net income for the 2008 Period would have been $14.3 million ($0.58 diluted earnings per share) compared to $20.2 million ($0.80 diluted earnings per share) in the 2007 Period.

Noven’s net revenues for the 2008 Period were $71.8 million, a 20% increase over the 2007 Period. This increase reflects three quarters of sales contribution from Noven Therapeutics’ products, and increased license and contract revenues, primarily due to amortization of deferred revenue from additional Daytrana sales milestones payments. The increase in net revenues was partially offset by a $1.5 million net revenue reduction in the 2008 Period, representing a portion of the Daytrana Charges.

Gross margin, as a percentage of total net product revenues, was 29% in the 2008 Period compared to 41% in the 2007 Period. Cost of products sold in the 2008 Period included $1.7 million of the Daytrana Charges, inventory write-offs and costs associated with an equipment failure in transdermal manufacturing in the first quarter of 2008, and increased quality assurance activities and expenses, primarily related to Daytrana production.

Research and development expenses in the 2008 Period increased $0.4 million to $10.7 million compared to 2007 Period, reflecting a $2.0 million increase in expenses at Noven Therapeutics, partially offset by a $1.6 million decrease in expenses at Noven Transdermals. The 2007 Period included the $100.2 million IPR&D Charge. Selling and marketing expenses increased to $17.5 million from $3.6 million in the 2007 Period, reflecting the addition of Noven Therapeutics. General and administrative expenses in the 2008 Period increased 39% to $27.1 million, reflecting $4.8 million of the Daytrana Charges, an increase in professional fees, and the addition of Noven Therapeutics.

Noven recognized $34.5 million in earnings from Novogyne in the 2008 Period, an increase of 38% over the 2007 Period. Novogyne’s net income for the 2008 Period was $76.6 million, a 33% increase from the $57.7 million reported in the 2007 Period. Novogyne’s net revenues for the 2008 Period increased 20% to $129.1 million. Novogyne’s gross margin for the 2008 Period increased slightly to 80%, and its selling, general and administrative expenses decreased 1% to $27.8 million.

Balance Sheet Information

At September 30, 2008, Noven had $65.3 million in cash and cash equivalents and $15.5 million in non-current investments in auction rate securities (“ARS”), representing an aggregate $80.7 million in cash, cash equivalents and non-current investments in ARS. This compares with $14.0 million in cash and cash equivalents and $54.4 million in investments in ARS at December 31, 2007, representing an aggregate $68.4 million in cash, cash equivalents and investments in ARS.

Noven’s investments in ARS at September 30, 2008 had a fair value of $15.5 million and all were classified as non-current on Noven’s balance sheet following failed auctions occurring since February 2008. Noven liquidated at par value $2.1 million and $39.0 million in ARS in the 2008 third quarter and 2008 Period, respectively. Noven’s ARS are collateralized primarily by tax-exempt municipal bonds and, to a much lesser extent, guaranteed student loans. Noven does not hold any ARS collateralized by mortgages or debt obligations. Noven believes its ARS are of high credit quality, as all are considered investment grade and the majority are rated AA or higher. Noven had recorded a temporary change in fair value of $0.5 million relating to its investments in ARS in the first quarter of 2008. Noven did not record any additional change in the fair value of its investments in ARS in either the second or the third quarters of 2008.

In the third quarter of 2008, Noven received the third and final $25.0 million milestone payment related to Shire’s sales of Daytrana. In the same quarter, Noven obtained a $15.0 million revolving credit facility. As of the date of this press release, no amounts had been borrowed under this facility.

Non-GAAP Financial Information

Under accounting principles generally accepted in the U.S. (“GAAP”), “net income” and “diluted earnings per share” include all charges and other items for the periods reported. In addition to results determined in accordance with GAAP, in this press release Noven has provided net income and diluted earnings per share for the periods presented excluding the 2008 and 2007 Items. Noven believes that comparing Noven’s period-to-period financial results without giving effect to the 2008 and 2007 Items may be helpful to investors to permit comparison of Noven’s period-to-period financial results on a more uniform basis. For the same reasons, management uses these non-GAAP financial measures to evaluate Noven’s current performance against its historical performance and to plan its future business activities. These measures should not be considered alternatives to measures computed in accordance with GAAP, nor should they be considered indicators of Noven’s overall financial performance. Adjusted net income and adjusted diluted earnings per share are limited by the fact that companies may not necessarily compute each in the same manner, thereby making these measures less useful than the same measures calculated in accordance with GAAP.

Conference Call

A conference call with management relating to Noven’s financial results will be webcast live on our website at www.noven.com beginning at 11:00 a.m. Eastern time this morning, November 6. Thereafter, a rebroadcast of the call will be accessible on our website for at least two weeks. A taped replay will be available beginning November 6 through November 8 by calling 877-660-6853 (from within the U.S.) or 201-612-7415 (from outside the U.S.) and entering the access code 286 and conference ID number 299214. The conference call is expected to contain forward-looking statements and information in addition to that contained in this press release.

About Noven

Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products. Noven’s business and operations are focused in three principal areas – transdermal drug delivery, the Novogyne joint venture, and Noven Therapeutics, Noven’s specialty pharmaceutical unit. For more information, visit www.noven.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

Except for historical information contained herein, the matters discussed in this press release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve substantial risks and uncertainties. Statements that are not historical facts, including statements that are preceded by, followed by, or that include, the words “believes,””anticipates,””plans,””expects” or similar expressions and statements are forward-looking statements. Noven’s estimated or anticipated future results, product performance or other non-historical facts are forward-looking and reflect Noven’s current perspective on existing trends and information. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the current expectations of Noven and are subject to a number of risks and uncertainties that are subject to change based on factors that are, in many instances, beyond Noven’s control.

By category and not necessarily listed in order of priority or probability, these risks and uncertainties include: Daytrana – the risk that manufacturing solutions currently in testing to address the Daytrana peel force issue may be delayed, unsuccessful, costly or take more time than expected to implement and the possibility that any implemented solution may not adequately resolve the issue; the risk that Noven’s assessment of the root cause of the Daytrana peel force issue may prove inaccurate, incomplete or otherwise incorrect; the risk that the new release testing intended to identify Daytrana lots that are at risk of developing peel force issues during the product’s shelf life may not accurately, completely or correctly identify such lots; the risk that the cost of additional product recalls may exceed the $4.3 million reserve established in the third quarter of 2008; the risk that Daytrana could be adversely affected by a number of factors, including: (i) Noven’s inability to adequately resolve the Daytrana-related issues raised by the FDA in the warning letter that Noven received in January 2008 and in the August 2007 Form 483, (ii) new market entrants, including other ADHD products marketed or under development by Shire, (iii) raw material supply interruptions and/or the inability to obtain the active ingredient methylphenidate, (iv) delays or inability to obtain necessary DEA methylphenidate procurement quota, and (v) increased production costs associated with the implementation and application of the new release testing procedures; and the risk that any adverse effect to the market for Daytrana due to the foregoing or other factors could adversely affect Noven’s reputation, results of operations and/or its financial position; Regulatory Matters – the risk that Noven’s response to the FDA warning letter that Noven received in January 2008 may not be acceptable to the FDA or adequately address the FDA’s concerns, and in such case, the risk that the FDA may take regulatory action against Noven, which may include fines, product seizures or recalls, injunctions, suspension of production and/or the withdrawal of product approval; and the likelihood that any fine or product recall, injunction, seizure, suspension of production and/or withdrawal of product approval would have a material adverse effect on Noven, including the loss of product sales, potentially significant costs associated therewith and the potential for litigation related to this matter; Noven’s Pipeline – uncertainties as to the cost, timing and success of ongoing and planned clinical trials, including with respect to Mesafem, and the risk that results from early-stage clinical trials may not be indicative of results in later-stage trials; the unproven safety and efficacy of products under development; the difficulty of predicting FDA approval of products, including timing; the possibility that product launches may be delayed; the risk that any expected period of exclusivity for a new product may not be realized; unexpected adverse events or side effects or inadequate efficacy of a product that could delay or prevent regulatory filings, approval or commercialization, or that could result in recalls or product liability claims of approved products; the difficulty of predicting acceptance and demand for new pharmaceutical products; the impact of competitive products and pricing; the risk that product acceptance may be less than anticipated as well as risks related to compliance with extensive, costly, complex and evolving governmental regulations and restrictions, and reimbursement policies of government and private health insurers and others; the possibility that patent applications may not result in issued patents, and that issued patents may not be enforceable or could be invalidated; and the impact of competitive responses to Noven’s sales, marketing and strategic efforts, and the risk that Noven’s development partners may have priorities that are different from or conflict with those of Noven, which may adversely impact their ability or willingness to assist in the development and commercialization of Noven’s products or to continue the development program; Liquidity – liquidity and investment risks related to Noven’s auction rate securities, including the risk that Noven’s liquidity will be adversely affected to the extent that auctions for its auction rate securities experience further failures and the risk that Noven would be required to record an additional impairment charge if Noven determines that it is necessary to lower the carrying value of its auction rate securities to reflect the prevailing fair market value; the risk that the recent volatility and disruptions in the global financial markets may adversely affect Noven’s ability to obtain financing in the future or access its credit facility, if required; and the risk that the current unstable economic conditions could harm the liquidity or financial position of Noven’s partners, customers or suppliers, which could in turn cause such parties to fail to meet their contractual or other obligations to Noven; HT Market – risks associated with increased competition in the HT market, including the possible emergence of generic competition for Novogyne’s products; any further impact on Noven’s HT business due to the announcement of additional negative clinical results or otherwise, which could reduce or eliminate any profit contribution by Novogyne to Noven and/or sales of HT products from Noven to Novogyne and Novartis Pharma; the risk that Novogyne may not be able to realize the full value of the marketing rights for Noven’s CombiPatch product; and risks and uncertainties related to the fact that Vivelle-Dot comprises a substantial majority of Novogyne’s aggregate total prescriptions.

For additional information regarding these and other risks associated with Noven’s business, readers should refer to Noven’s Annual Report on Form 10-K for the year ended December 31, 2007 as well as other reports filed from time to time with the Securities and Exchange Commission. Unless required by law, Noven undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

 Noven Pharmaceuticals, Inc. and Subsidiaries  Three Months Ended   Nine Months Ended Consolidated Statements of      September 30,        September 30, Operations Data:             ------------------- -------------------- (amounts in thousands, except   2008      2007      2008       2007 per share amounts)           -------- ---------- --------- ---------- (unaudited) Revenues: Product revenues - Novogyne: Product sales, net        $ 5,945  $   5,801  $ 13,929  $  15,974 Royalties                   2,258      2,100     6,787      5,764 -------- ---------- --------- ---------- Total net product revenues - Novogyne                   8,203      7,901    20,716     21,738 Product revenues, net - third parties               11,131      8,789    34,357     25,620 -------- ---------- --------- ---------- Total net product revenues   19,334     16,690    55,073     47,358 License and contract revenues                     6,371      5,125    16,717     12,611 -------- ---------- --------- ---------- Total net revenues           25,705     21,815    71,790     59,969  Costs and Expenses: Cost of products sold - Novogyne                   3,994      4,286    10,783     10,530 Cost of products sold - third parties             10,933      5,525    28,236     17,522 -------- ---------- --------- ---------- Total cost of products sold       14,927      9,811    39,019     28,052 Acquired in-process research and development       -    100,150         -    100,150 Research and development    4,041      3,649    10,653     10,300 Selling and marketing       7,326      3,103    17,485      3,564 General and administrative            11,147      8,770    27,075     19,439 -------- ---------- --------- ---------- Total costs and expenses            37,441    125,483    94,232    161,505 Reversal of contingent milestone liability            5,000          -     5,000          - -------- ---------- --------- ---------- Loss from operations           (6,736)  (103,668)  (17,442)  (101,536)  Equity in earnings of Novogyne                      13,849     10,948    34,545     25,025 Interest income, net              344      1,306     1,466      4,751 -------- ---------- --------- ---------- Income (loss) before income taxes                          7,457    (91,414)   18,569    (71,760) Provision (benefit) for income taxes                   2,253    (32,377)    6,263    (25,335) -------- ---------- --------- ---------- Net income (loss)             $ 5,204  $ (59,037) $ 12,306  $ (46,425) ======== ========== ========= ========== Basic earnings (loss) per share                        $  0.21  $   (2.38) $   0.50  $   (1.87) ======== ========== ========= ========== Diluted earnings (loss) per share                        $  0.21  $   (2.38) $   0.50  $   (1.87) ======== ========== ========= ========== Weighted average number of common shares outstanding: Basic                        24,638     24,792    24,600     24,787 ======== ========== ========= ========== Diluted                      24,766     24,792    24,703     24,787 ======== ========== ========= ========== 

 As Of ------------------ September December Consolidated Balance Sheet Data:                       30,       31, (amounts in thousands) (unaudited)                    2008      2007 --------- -------- Cash and cash equivalents                          $ 65,288 $ 13,973 Investments in auction rate securities               15,460   54,400 Investment in Novogyne                               27,173   24,310 Total assets                                        307,183  286,698 Deferred license and contract revenues              115,072  105,244 Stockholders' equity                                149,373  134,294 

 Novogyne Pharmaceuticals (a/k/a Vivelle Ventures LLC)  Three Months Ended      Nine Months Ended September 30,     September 30, ---------------- ----------------- Condensed Statements of Operations    2008    2007     2008     2007 Data:                              -------- ------- -------- -------- (amounts in thousands) (unaudited) Gross revenues                      $ 53,281 $45,224 $148,629 $125,432  Sales allowances                       7,024   5,770   18,579   16,769 Sales return allowances                  432     781      931      772 -------- ------- -------- -------- Sales allowances and returns           7,456   6,551   19,510   17,541 -------- ------- -------- -------- Net revenues                          45,825  38,673  129,119  107,891 Cost of sales                          8,893   8,152   25,489   22,994 Selling, general and administrative expenses                               9,013   8,278   27,823   27,990 -------- ------- -------- -------- Income from operations                27,919  22,243   75,807   56,907 Interest income                          341     286      782      783 -------- ------- -------- -------- Net income                          $ 28,260 $22,529 $ 76,589 $ 57,690 ======== ======= ======== ========  Noven's equity in earnings of Novogyne                           $ 13,849 $10,948 $ 34,545 $ 25,025 ======== ======= ======== ======== 

 Noven Pharmaceuticals, Inc. Reconciliation of Non-GAAP Measures to GAAP  Statements of Operations Data: (amounts in thousands, except per share amounts)     Three Months Ended         Three Months Ended (unaudited)        September 30, 2008         September 30, 2007 ------------------------ ---------------------------- Non-  Adjust-            Non-   Adjust- GAAP(1)  ments  GAAP(3)  GAAP(2)   ments    GAAP(3) ------------------------ ----------------------------  Net revenues     $27,016 $(1,311)$25,705  $22,641 $    (826)$  21,815  Costs and expenses: Cost of products sold   13,338   1,589  14,927    9,499       312     9,811 Acquired in- process research and development          -       -       -        -   100,150   100,150 Research and development      4,041       -   4,041    3,649         -     3,649 Selling and marketing        7,326       -   7,326    3,103         -     3,103 General and administrative   8,014   3,133  11,147    6,650     2,120     8,770 ------------------------ ---------------------------- Total costs and expenses     32,719   4,722  37,441   22,901   102,582   125,483 Reversal of contingent milestone liability            -   5,000   5,000        -         -         - ------------------------ ---------------------------- Loss from operations       (5,703) (1,033) (6,736)    (260) (103,408) (103,668)  Equity in earnings of Novogyne         13,849       -  13,849   10,948         -    10,948 Interest income, net                 344       -     344    1,306         -     1,306 ------------------------ ---------------------------- Income (loss) before income taxes             8,490  (1,033)  7,457   11,994  (103,408)  (91,414) Provision (benefit) for income taxes      2,565    (312)  2,253    4,396   (36,773)  (32,377) ------------------------ ---------------------------- Net income (loss)          $ 5,925 $  (721)$ 5,204  $ 7,598 $ (66,635)$ (59,037) ======================== ============================ Basic earnings (loss) per share           $  0.24 $ (0.03)$  0.21  $  0.31 $   (2.69)$   (2.38) ======================== ============================ Diluted earnings (loss) per share           $  0.24 $ (0.03)$  0.21  $  0.30 $   (2.68)$   (2.38) ======================== ============================ Weighted average number of common shares outstanding: Basic           24,638       -  24,638   24,792         -    24,792 ======================== ============================ Diluted(4)      24,766       -  24,766   25,028      (236)   24,792 ======================== ============================  (1) Non-GAAP amounts for the three months ended September 30, 2008 exclude (i) the recognition of $5.0 million in operating income from reversal of an accrued liability related to a future Pexeva contingent sales milestone, (ii) a $1.7 million third quarter charge associated with Shire's voluntary market withdrawal of a portion of the Daytrana product, and (iii) a $4.3 million charge related to previously manufactured Daytrana product at risk of exceeding the product's peel force specification during its shelf life.  (2) Non-GAAP amounts for the three months ended September 30, 2007 exclude acquired IPR&D of $100.2 million which was immediately expensed following the completion of the acquisition of JDS as well as amounts associated with Shire's voluntary market withdrawal of a portion of the Daytrana product.  (3) Reflects operating results in accordance with accounting principles generally accepted in the United States (GAAP).  (4) Diluted weighted average number of shares outstanding for the three months ended September 30, 2007 on a non-GAAP basis have been adjusted to include shares that were excluded from the GAAP calculation because such shares were antidilutive on a GAAP basis. 

 Noven Pharmaceuticals, Inc. Reconciliation of Non-GAAP Measures to GAAP  Statements of Operations Data: (amounts in thousands, except per share amounts)     Nine Months Ended           Nine Months Ended (unaudited)        September 30, 2008         September 30, 2007 -------------------------- --------------------------- Non-   Adjust-            Non-   Adjust- GAAP(1)  ments   GAAP(3)  GAAP(2)  ments    GAAP(3) -------------------------- ---------------------------  Net revenues    $ 73,271 $(1,481)$ 71,790  $60,795$    (826)$  59,969  Costs and expenses: Cost of products sold             37,347   1,672   39,019   27,740      312    28,052 Acquired in- process research and development           -       -        -        -  100,150   100,150 Research and development      10,653       -   10,653   10,300        -    10,300 Selling and marketing        17,485       -   17,485    3,564        -     3,564 General and administrative   22,245   4,830   27,075   17,319    2,120    19,439 -------------------------- --------------------------- Total costs and expenses  87,730   6,502   94,232   58,923  102,582   161,505 Reversal of contingent milestone liability             -   5,000    5,000        -        -         - -------------------------- --------------------------- Income (loss) from operations (14,459) (2,983) (17,442)   1,872 (103,408) (101,536)  Equity in earnings of Novogyne         34,545       -   34,545   25,025        -    25,025 Interest income, net               1,466       -    1,466    4,751        -     4,751 -------------------------- --------------------------- Income (loss) before income taxes            21,552  (2,983)  18,569   31,648 (103,408)  (71,760) Provision (benefit) for income taxes      7,269  (1,006)   6,263   11,438  (36,773)  (25,335) -------------------------- --------------------------- Net income (loss)         $ 14,283 $(1,977)$ 12,306  $20,210$ (66,635)$ (46,425) ========================== =========================== Basic earnings (loss) per share          $   0.58 $ (0.08)$   0.50  $  0.82$   (2.69)$   (1.87) ========================== =========================== Diluted earnings (loss) per share          $   0.58 $ (0.08)$   0.50  $  0.80$   (2.67)$   (1.87) ========================== =========================== Weighted average number of common shares outstanding: Basic             24,600       -   24,600   24,787        -    24,787 ========================== =========================== Diluted(4)        24,703       -   24,703   25,263     (476)   24,787 ========================== ===========================  (1) Non-GAAP amounts for the nine months ended September 30, 2008 exclude (i) the recognition of $5.0 million in operating income from reversal of an accrued liability related to a future Pexeva contingent sales milestone, (ii) $3.65 million of charges associated with Shire's voluntary market withdrawal of a portion of the Daytrana product, and (iii) a $4.3 million charge related to previously manufactured Daytrana product at risk of exceeding the product's peel force specification during its shelf life.  (2) Non-GAAP amounts for the nine months ended September 30, 2007 exclude acquired IPR&D of $100.2 million which was immediately expensed following the completion of the acquisition of JDS as well as amounts associated with Shire's voluntary market withdrawal of a portion of the Daytrana product.  (3) Reflects operating results in accordance with accounting principles generally accepted in the United States (GAAP).  (4) Diluted weighted average number of shares outstanding for the nine months ended September 30, 2007 on a non-GAAP basis have been adjusted to include shares that were excluded from the GAAP calculation because such shares were antidilutive on a GAAP basis. 

Prescription Financial Aid for People With Blood Cancers

CIGNA Pharmacy Management (CIGNA) and the Leukemia & Lymphoma Society (LLS) are joining forces to promote LLS’s efforts to help blood cancer patients cover the costs of prescription co-pays and health insurance premiums.

The costs of cancer are significant. According to the National Cancer Institute, direct medical costs for cancer care in 2004 totaled more than $72 billion. When considering the impact of indirect costs, such as lost productivity due to illness or premature death, the total economic burden reached $190 billion in 2004.

CIGNA is now making the LLS information available through their nurse case managers who work directly with individuals who have cancer. “This is a wonderful service for people who have blood cancers as it has the potential to lift a huge burden off people’s shoulders at a time when they should be concentrating on just getting well,” said Dr. David Ferriss, CIGNA medical officer for clinical program development. “People with blood cancers are often too sick to continue to work or perform their daily functions, putting a huge strain on an individual and their family. This will be a great resource for these families.”

The LLS program offers assistance to blood cancer patients and their families by covering the costs of their private health insurance premiums, co-payment obligations, Medicare Part B, Medicare Part D, Medicare Supplementary Health Insurance and Medicare Advantage premiums or co-payment obligations. Providing up to $5,000 in assistance, the program is designed for individuals who meet certain financial and disease criteria.

“LLS is very grateful that CIGNA is helping to get this critical information out to individuals with blood cancer,” said Nancy L. Klein, chief marketing and revenue officer for LLS. “Together we will be able to assist many more people who are struggling to cover the costs of their treatments.” For more information about the program, including eligibility and how to apply, visit www.lls.org/copay.

The efforts with LLS are part of CIGNA’s continuing efforts to assist people who have cancer or are at risk for getting cancer. Some of the programs include:

Comprehensive Oncology Program(R): The program addresses cancer prevention and education, as well as active management of members diagnosed with cancer. Through this program, CIGNA reaches out to at-risk individuals who are overdue for recommended screenings to remind them to schedule appropriate tests, and provides counsel and support to help them adopt healthier lifestyles. The program also supports cancer victims and survivors through prevention, diagnosis, treatment and recovery, with access to specialized nurses, health educators and behavioral health experts. Services include helping cancer victims and their families cope with the emotional impact of cancer, helping them receive family counseling, organizing and preparing for treatment, and end-of-life planning, as needed.

Collaboration with the Lance Armstrong Foundation: CIGNA provides individuals in its comprehensive oncology program with added personal support to cope with the effects on physical, emotional, financial and spiritual health that living with cancer brings. By also providing the LIVESTRONG(TM) Survivorship Notebook and educational materials, the program helps cancer victims become more knowledgeable, informed and empowered participants in their own care.

HopeLab: HopeLab’s ground-breaking video game Re-Mission(TM) is designed to help young people better manage their health while undergoing cancer treatment. Research has shown that the game helps teens and young adults stick to their treatment regimens, and CIGNA is offering Re-Mission(TM) at no charge to young patients and their families who are confronting cancer. www.CIGNA.com/re-mission.

Childhood Leukemia Foundation’s (CLF) Hope Binder: CIGNA teamed up with the Childhood Leukemia foundation to offer CLF’s Hope Binder free of charge to parents of children with cancer at 160 hospitals nationwide. The Hope Binder helps parents manage the overwhelming amount of information related to their child’s care including worksheets and resources to help document treatment protocols, medicines, doctor’s appointments, blood counts, physicians, hospitals, nutrition concerns, and insurance benefits – all the details that come with facing leukemia, including free telephone calling cards and informational booklets. CIGNA has added a free copy of the video game Re-Mission(TM) in every Hope Binder.

Colorectal Cancer Screening Program: CIGNA sends at-risk individual customers free colorectal cancer home screening kits to encourage people who are over-due for screening to take the test. Individuals covered by CIGNA receive InSure(R) fecal immunochemical test (FIT) kits with the support of Quest Diagnostics. The test helps members screen at home for gastrointestinal bleeding which is often an early indicator for potentially deadly colorectal cancer. Early testing and diagnosis is important as according to the American Cancer Society, colorectal cancer is “Preventable, Treatable, Beatable,” and yet over 50,000 Americans die of colon cancer every year.

Walt Disney World Marathon presented by CIGNA: CIGNA, as presenting sponsor of The Walt Disney World Health and Fitness Expo, a three-day celebration focused on health and fitness that involves celebrity runner appearances, seminars on training, racing, and nutrition, along with the opportunity to experience the latest in running and fitness equipment. The Walt Disney World Marathon Weekend benefits the Leukemia & Lymphoma Society (LLS). With the yearly support of thousands of volunteers, the Walt Disney World Marathon Weekend has helped Team in Training (TNT) raise millions of dollars for the LLS. The Walt Disney World Marathon Weekend is LLS’s largest fundraising event.

CIGNA Pharmacy Management:

CIGNA Pharmacy Management employs a consultative approach to help plan sponsors design pharmacy benefit plans that achieve lower net costs while providing industry-leading pharmacy clinical programs to help improve health outcomes. “CIGNA,””CIGNA Pharmacy Management,””CIGNA Tel-Drug” and the “Tree of Life” logo are registered service marks of CIGNA Intellectual Property, Inc., licensed for use by CIGNA Corporation and its operating subsidiaries. All products and services are provided exclusively by such operating subsidiaries and not by CIGNA Corporation. Such operating subsidiaries include Connecticut General Life Insurance Company, Tel-Drug, Inc., Tel-Drug of Pennsylvania, L.L.C., and HMO or service company subsidiaries of CIGNA Health Corporation.

The Leukemia & Lymphoma Society:

The Leukemia & Lymphoma Society(R), headquartered in White Plains, NY, with 68 chapters in the United States and Canada, is the world’s largest voluntary health organization dedicated to funding blood cancer research and providing education and patient services. The LLS mission: Cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and their families. Since its founding in 1949, LLS has invested more than $600 million in research specifically targeting leukemia, lymphoma and myeloma. Last year alone, LLS made 6.3 million contacts with patients, caregivers and healthcare professionals. For more information about blood cancer, visit www.LLS.org or call the LLS Information Resource Center (IRC), a call center staffed by master’s level social workers, nurses and health educators who provide information, support and resources to patients and their families and caregivers. IRC information specialists are available at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. ET.

Diabetes-Friendly Meal Debuts at Salad Creations With Sugar Free VitaZest Water During National Diabetes Month

HOLLYWOOD, Fla., Nov. 6 /PRNewswire/ — In recognition of National Diabetes Month, Salad Creations, VITAZEST(R) Water and the Diabetes Research Institute Foundation have teamed up to create a diabetes-friendly, create-your-own-salad meal that is available in Salad Creations restaurants around the country. While Salad Creations is already a fresh alternative to fast-food, the new diabetes-friendly menu takes the concept one step further by identifying the food options that are lower in carbs, sugar, sodium, fat and calories. Featured menu items were selected and approved by dietitians at the Diabetes Research Institute (DRI), a center of excellence at the University of Miami Miller School of Medicine and a recognized world leader in cure-focused research.

“This menu is a good option for people with diabetes because the choices are high in fiber and are nutrient-dense, which means the foods provide good nutritional value without excess calories,” stated Elizabeth Capo, a dietitian at the DRI. “We also made sure that the portions were sensible and that the ingredients were fresh and all-natural.”

Customers can top off the meal with a vitamin and fruit enriched water by VitaZest. Exotic and tropical choices like Kiwi Strawberry, Passion Fruit and Pomegranate, among others, are certain to whet appetites.

“Millions of people are suffering with diabetes. We are happy that we could team up with VitaZest and the Diabetes Research Institute Foundation to provide a valuable service and educational tool for our customers,” stated Jeff Levine, founder and CEO of Salad Creations. “Not all people with diabetes have the benefit of discussing meal plans with a dietitian. The diabetes-friendly meal just alleviates any guess work.”

Diabetes is growing at an epidemic rate. In this country alone, nearly 24 million children and adults have diabetes, and an additional 57 million have pre-diabetes. Studies show that a combination of exercising and eating right leads to good health, and small changes in diet can make a big impact. For those already affected by diabetes, the Diabetes Research Institute is committed to finding a cure, and leads the world in bringing promising treatments to patients in the safest and fastest way possible. To learn more about the DRI’s life-saving work, visit http://www.diabetesresearch.org/.

The new menu is available at Salad Creations restaurants now and will continue to be available throughout the year at most locations. For more information or to find the nearest location, visit http://www.saladcreations.net/.

About Salad Creations

Salad Creations is a national franchise offering a fresh alternative of quality made-to-order salads for today’s healthy lifestyle. Salad Creations was recently named the number one salad franchise in Entrepreneur Magazine’s “2008 Franchise 500” ranking. In addition, Salad Creations was also listed among the top 50 brands in Franchise Business Review’s “2008 Franchisee Satisfaction Awards.” Headquartered in Margate, FL, Salad Creations has more than 50 locations open across the United States, Brazil, Trinidad and Kuwait. For more information, visit Salad Creations.

About VitaZest VitaZest is a delicious blend of fruit, vitamins and water and comes in nine delicious flavors including: Pomegranate, Kiwi Strawberry, Passion Fruit, Blueberry, Pineapple Mango and Green Tea. VitaZest contains all natural fruit flavors and natural coloring. VitaZest also contains significant levels of the Recommended Daily Allowance of 10 vitamins and minerals. Just as important as what VITAZSET has is what it doesn’t have–no carbs, no calories, no sugar, no preservatives and no caffeine.

About the Diabetes Research Institute and Foundation

The mission of the Diabetes Research Institute Foundation is to provide the DRI with the funding necessary to cure diabetes now. The Diabetes Research Institute, a center of excellence at the University of Miami Miller School of Medicine, is a recognized world leader in cure-focused research. Since its inception in the early 1970s, the DRI has made significant contributions to the field of diabetes research, pioneering many of the techniques used in islet transplantation. From innovations in islet isolation and transplant procedures to advances in cell biology and immunology, the DRI is now harnessing the power of emerging technologies to develop new cell-based therapies to restore insulin production. For the millions of families already affected by diabetes who are looking to the world of science for answers, the Diabetes Research Institute is the best hope for a cure.

   Media Contact:   Lauren Schreier / DRI Foundation   954.964.4040 / [email protected]   Chad Cohen / Salad Creations   954.893.9150 ext. 13   [email protected]  

Diabetes Research Institute

CONTACT: Lauren Schreier of DRI Foundation, +1-954-964-4040,[email protected], or Chad Cohen of Salad Creations, +1-954-893-9150 ext.13, [email protected]

Web Site: http://www.diabetesresearch.org/http://www.saladcreations.net/

University of Washington Medicine Implements the DocuSys Solution to Deliver Surgical Patient Safety Technology

DocuSys, Inc., the market-leading provider of the most innovative systems for anesthesia information management, medication management and presurgical care management, today announced that the University of Washington’s UW Medicine health care system went live on DocuSys’ anesthesia solutions in 26 anesthetizing locations in University of Washington Medical Center, including the medical center’s Surgery Pavilion and UW Medical Center’s Roosevelt Clinic. Harborview Medical Center, also part of UW Medicine, has been using DocuSys since the spring of 2008. University of Washington Medical Center is ranked as one of the top 10 hospitals in America according to the U.S. News & World Report’s 2008 honor roll. The medical center is also a Magnet Hospital acknowledging its excellence in nursing care.

“At UW Medicine, our commitment to patient safety is our top priority, including delivering the safest anesthesia care to each of our patients,” said Debra A. Schwinn, chair of Anesthesiology and Pain Medicine at UW Medicine. “The implementation of the DocuSys solution helps further our patient safety initiatives and provides UW Medicine with a comprehensive electronic anesthesia record that integrates well into our workflow.”

“UW Medicine is an important regional healthcare provider and has a long history of providing outstanding patient care,” said DocuSys President and Chief Executive Officer (CEO) Robert Watson. “We are proud to partner with UW Medicine to provide their patients with new technology that reinforces safety efforts throughout the entire surgical care experience.”

Also deployed across the UW Medicine enterprise are a coding module for documenting comorbid conditions and capturing professional fees and a case viewing module which will provide medical staff the ability to remotely view a case that is currently in progress or has been closed. The combination of these technologies support UW Medicine’s patient safety initiatives and facilitate the capture of detailed information, such as preexisting conditions, which can have positive impacts on reimbursement.

“With the automated documentation inherent in the AIMS application combined with the supporting modules, workflow will become more efficient throughout the care cycle,” Watson added. “Comprehensive reporting will also help UW Medicine to effectively demonstrate quality performance compliance, understand medication utilization and analyze productivity.”

About UW Medicine

Part of the University of Washington, UW Medicine works to improve the health of the public by advancing medical knowledge, providing outstanding primary and specialty medical care to people of the region, and preparing tomorrow’s physicians, scientists and other health professionals. UW Medicine owns or operates Harborview Medical Center, University of Washington Medical Center, University of Washington School of Medicine, UW Medicine Neighborhood Clinics and UW Physicians.

About DocuSys

DocuSys is the market-leading anesthesia information management system (AIMS), medication management system and presurgical care management system provider, maximizing both the quality of care and return on investment in surgery. The company provides solutions that address all stages of the anesthesia care delivery process, including the presurgical evaluation process. Additional benefits of the system include ease of use, billing and charge capture automation, and aligning such quality measures as CMS’ pay-for-performance (P4P) program with financial objectives. DocuSys’ modular design permits integration with existing hospital information systems, electronic medication dispensing cabinets, infusion pumps, physiologic monitors and other systems in those settings where intravenous drug delivery is key. The company has received 510(k) clearance from the Food and Drug Administration (FDA) to market its technology and is a registered medical device manufacturer in accordance with FDA guidelines. For more information, visit www.docusys.net.

National Diabetes Month Book Suggestions From Black Expressions(R) Book Club

NEW YORK, Nov. 6 /PRNewswire/ — According to the American Diabetes Association, 23.6 million Americans suffer from diabetes. The African American community is one of the groups hardest hit by this disease, with over 3.7 million diagnosed. With November being National Diabetes Month, Black Expressions(R) Book Club has put together a few books that raise awareness about diabetes and offer information about prevention, nutrition and diet tips.

DR. NEAL BERNARD’S PROGRAM FOR REVERSING DIABETES (Dr. Neal Bernard, Rodale Press) offers a holistic approach to treating diabetes. Bernard provides an overview of diabetes and an approach that treats it without prescriptions. Bernard explores why some foods lead to steady weight loss by lowering blood sugar and cholesterol. He also includes a 7-day meal plan with recipes, tips to tracking your progress and advice on exercise, supplements, and vitamins.

Most people know to get a second opinion, but what happens when both your first and second opinions leave vital information out? WHAT YOUR DOCTOR MAY NOT TELL YOU ABOUT DIABETES (Dr. Steven V. Joyal, Hachette Book Group USA) investigates the genes and changes to cells in the body that cause diabetes. Joyal looks at ways to reverse pre-diabetes and recommends prescription drugs that could change the course of diabetes. He also includes key self-tests, exercise and nutrition guidelines and suggests “superfoods” for building your immune system. This book is packed with information for both the newly diagnosed and current sufferers of diabetes.

Sometimes the tipping point of a person’s recovery rests with their diet. However, no one wants the limitations of their diet to make the rest of the family unhappy. THE NEW FAMILY COOKBOOK FOR PEOPLE WITH DIABETES (Simon & Schuster, Inc) is the newly revised and updated cookbook from the American Dietetic Association and the American Diabetic Association. Boasting over 370 recipes, this classic cookbook aims to please everyone at mealtime. New lower-fat ingredients and unsaturated fats are used wherever they can be substituted, and each recipe provides the most current diabetes exchange information.

Carol Mackey, editor of Black Expressions(R) Book Club, comments, “I make it a point to offer books that help Black Expressions(R) members manage the disease and live healthier lives.” All of these titles and more are available at Black Expressions(R) Book Club (http://www.blackexpressions.com/). Individuals who wish to join now can get 5 books for $2 with membership.

Black Expressions Book Club

CONTACT: Kate Parrish for Black Expressions Book Club, +1-212-930-4418

Web site: http://www.blackexpressions.com/

XLHealth Appoints New CFO, Adds Two Additional Executives

BALTIMORE, Nov. 5 /PRNewswire/ — XLHealth, owner of one of the nation’s largest Medicare chronic condition special needs plans and a leader in improving the quality of care for seniors with chronic illness, announced today that it has appointed Mete Sahin to serve as chief financial officer (CFO). The company also announced it has hired two additional executives — Kevin Vetter to serve as vice president of operations and technology and Anita McCreavy to serve as director of clinical quality.

“Mete has a strong background in corporate and healthcare finance; his leadership as CFO is a significant asset to the company,” said Frederick C. Dunlap, chief executive officer for XLHealth. “In addition, Kevin and Anita are both high-quality players within the managed care arena, and we welcome their expertise.”

Sahin, who joined XLHealth in 2007, has more than 15 years of experience in the healthcare finance industry. Sahin previously served as CFO for multiple UnitedHealth Group companies, overseeing finance, legal, underwriting, and actuarial functions for its Medicaid, dental and vision companies. Sahin has served in executive positions with a number of leading healthcare institutions.

Vetter has over eight years of experience as a CIO for commercial and Medicare health plans. As vice president of operations and technology for XLHealth, Vetter is responsible for overseeing the organization’s IT operations as well as the development of technology solutions and informational strategies to support XLHealth’s Medicare health plan offerings. Prior to joining XLHealth, Vetter served as associate vice president of applications management and support for Amerigroup Corporation.

As director of quality improvement for XLHealth, McCreavy is responsible for overseeing all aspects of quality auditing and reporting for the organization’s Medicare health plan products, and for ensuring that patient care meets or exceeds accreditation standards. Prior to joining XLHealth, McCreavy worked for the organization as a consultant, and was instrumental in the company’s successful 2008 NCQA submissions. McCreavy previously worked for AmeriChoice.

About XLHealth

XLHealth (http://www.xlhealth.com/), a Baltimore-based organization focused on improving the healthcare of chronically ill seniors, is the owner and operator of Care Improvement Plus, one of the nation’s largest chronic condition special needs plans. Care Improvement Plus provides a complete Medicare Advantage Part D health plan including disease management services to Medicare beneficiaries living with heart failure, diabetes, chronic obstructive pulmonary disease and/or end-stage renal disease. XLHealth has earned Full Accreditation from the National Committee for Quality Assurance (NCQA) under its standards for patient and practitioner-oriented accreditation of disease management programs.

XLHealth

CONTACT: Heather Rudo for XLHealth, +1-410-962-6446,[email protected]

Web Site: http://www.xlhealth.com/

HMP Communications Announces Strategic Management Realignments; Launches Dermatology Division

HMP Communications, the authoritative source for comprehensive information and education serving the healthcare industry, announced today several strategic initiatives that will enable the company to develop a larger, more diversified portfolio of communication products in the fields of Dermatology and Wound Care.

“Medical communications must move at the speed of technological advancements and innovations,” says HMP Communications Holdings LLC’s Chairman & Chief Executive Officer Paul Mackler. “In order to create a more nimble organization, it is essential that we build an internal infrastructure that is agile and responsive to the specialties we serve.”

Bill Norton, formerly Vice President, Meetings & Trade Shows, will succeed Peter Norris as President of HMP Communications. Norton has more than 20 years of experience in various senior management roles, and joined the company in January 2008. His background and experience include publishing, trade show production and management, healthcare and biopharmaceutical conference development and association management. He has also partnered with leading trade associations and professional societies in the nursing, pharmaceutical and a variety of other medical fields. Norton will be responsible for day-to-day management of HMP Communications.

“The medical communications sector is evolving and changing,” says Norton. “HMP Communications is in a position to lead and I look forward to continuing to work with our talented management team and committed staff as we build HMP’s footprint in this exciting industry.”

Norris will lead both the Dermatology and Wound Care Divisions as Executive Vice President of HMP Communications. He will be responsible for planning and content initiatives as well as have primarily responsibility in the development of strategy, association management and society relations for both divisions.

“For the past several years, Peter has effectively led HMP Communications and helped establish HMP’s publications and web portals as the best in their industries,” says Jeff Hennessy, President & Chief Operating Officer of HMP Communications Holdings LLC. “His keen knowledge and expertise are key as HMP develops these divisions.”

“Dermatology and Wound Care are fields that will continue to see new growth and cutting-edge treatments as America’s population ages,” says Norris. “The staff of both divisions has already established solid reputations of delivering the necessary information and data our audience requires. I’m looking forward to participating in their expansion.”

Steve Gephart, former Group Publisher, Long Term Care (LTC) Division, has been appointed Group Publisher for Skin & Aging, an award-winning journal that reaches nearly 12,000 dermatologists and delivers both clinical and practical information to medical professionals who work in the field. Gephart will also spearhead the development of a newly created Dermatology Division with planned launches of dermatology-focused meetings and communication products in 2009 and 2010.

Skin & Aging provides dermatologists with both practical information to assist them in running their day-to-day practices as well as the most up-to-date clinical information necessary to successfully treat their patients. It is well respected in the field, connecting with clinicians in print, online and at eight major dermatology meetings including the American Academy of Dermatology Annual Meeting, American Society for Laser Medicine and Surgery, Symposium on Advanced Wound Care, American Academy of Dermatology Summer Meeting, Fall Clinical Dermatology Conference, American Society for Dermatologic Surgery, Society of Dermatology Physician Assistants, and the Hawaii Winter Clinical Meeting. Specialized newsletters produced by Skin & Aging include Derm Nurse, Derm Resident, Derm PA, Derm Practice, Extensions – An Educational Newsletter for Physician Assistants and Nurse Practitioners in Dermatology and Pathways, which offers practical career advice for dermatology residents.

Gephart and Jeremy Bowden, Vice President/Group Publisher of HMP’s Wound Care Division will report to Norris.

HMP Communications’ Wound Care Division has experienced tremendous growth and success over the past 12 months, adding Podiatry Today to its portfolio and a second Symposium on Advanced Wound Care Fall (SAWC) scheduled for September 16-18, 2009, at the Gaylord National Hotel and Convention Center in Washington, D.C. The Symposium on Advanced Wound Care and Wound Healing Society (SAWC/WHS), along with the Association for the Advancement of Wound Care (AAWC), has served the industry for more than two decades and hosts the largest audience of wound care specialists in the United States.

The Wound Care Division portfolio also includes WOUNDS, the most widely read, peer-reviewed journal focusing on wound care and research; Ostomy Wound Management (OWM), the only peer-reviewed, multidisciplinary publication specifically dedicated to the advanced wound care practitioner; and Today’s Wound Clinic; a journal developed to serve the specific needs of clinicians and administrators of outpatient within the growing wound clinics marketplace.

HMP Communications Holdings LLC, is the parent company of wholly-owned subsidiaries HMP Communications LLC and NACCME LLC (North American Center for Continuing Medical Education). Both companies serve the vital needs of the medical community through various business models.

HMP Communications, LLC has spent the past 2 decades focusing on advances in the clinical care and treatment in some of the world’s most debilitating diseases and medical conditions. Today, healthcare professionals consider HMP Communications, LLC medical journals, websites, meetings and symposia as authoritative sources for comprehensive information in the fields of wound care, dermatology, podiatry, cardiovascular care, electrophysiology, long term care, managed care, diabetes, arthritis, and specialized primary care. HMP Communications, LLC journals are both peer-reviewed and non-peer-reviewed to best disseminate critical content in the most effective manner for readers. In addition to online and print media, the company produces and manages tradeshows, conferences, symposia, digital programs and customized programs.

Mubadala and LabCorp to Establish National Reference Laboratory in Abu Dhabi

Mubadala Healthcare, the specialist division of Mubadala Development Company, and Laboratory Corporation of America Holdings, more commonly known as LabCorp, have announced their agreement to establish the national reference laboratory in Abu Dhabi, United Arab Emirates.

Scheduled for completion by the end of 2009, the national reference laboratory (NRL) will be the first of its kind in the region to provide a centralized solution for laboratory testing. A complete range of services will be offered including routine and esoteric laboratory tests that are currently being sent to Europe and elsewhere.

The laboratory will be fully automated and include a IT backbone. In addition, the NRL will be designed and operated to ensure record turn-around time on critical tests, which in many cases is less than two hours, as well as achieve international accreditation from the College of American Pathologists.

With the creation of the NRL, Mubadala Healthcare aims to implement international best practices in laboratory testing processes, set a new benchmark in terms of superior quality standards, and increase the spectrum, coverage and overall efficiency of clinical testing in the region.

Mark Erhart, executive director of Mubadala Healthcare, said: “I am delighted to announce our partnership with LabCorp to create the region’s first dedicated reference laboratory. Providing international quality laboratory testing services in the region will reduce the delay of diagnosis and treatment and better support the UAE’s rapidly growing healthcare services market and increasing population.”

Zannos Grekos, MD to Present Clinical Results of Regenerative Stem Cell Treatments to the Dubai Congress on Anti-Aging and Aesthetic Medicine

WASHINGTON, Nov. 5 /PRNewswire/ — The Repair Stem Cell Institute (RSCI; http://www.repairstemcells.org/) today announced that its Science Advisory Board member Zannos G. Grekos, MD, FAAP will present Emerging Frontiers in Regenerative Stem Cell Therapy: Current Clinical Experience with Autologus Adult Stem Cells in the Treatment of Various End Stage Diseases, at the 2008 Dubai Congress on Anti-Aging and Aesthetic Medicine (DCAAAM) in Dubai, United Arab Emirates on Saturday, November 8, 2008 at 3:00 p.m. UTC. According to RSCI Chairman Don Margolis, “Dr. Grekos is taking his groundbreaking work in regenerative biomedical technology to an international arena that has never before seen the dramatic clinical success achieved with his end-stage disease patients. RSCI is proud to have Dr. Grekos on its advisory board and there isn’t a company or an institute in the world with the Repair Stem Cell treatment skills and experience that he and its other members bring.”

In this Dubai presentation, Dr. Grekos will illustrate regenerated tissue and repaired function at six months and one year post-treatment with Adult Stem Cells. He will also present preliminary results from patients treated within several days through three month follow up. Results include the existence of viable myocardium where previously heart tissue had been destroyed and blood flow through new vessels generated by the injected Stem Cell population. “We have literally saved the lives of patients who prior to the development of Adult Stem Cell therapy, had no option available to them through medical science,” states Grekos. “With a minimally invasive treatment, the risks of which are equal to a cardiac catheterization, we are more than doubling cardiac patients’ ejection fraction, improving kidney and pulmonary function, saving limbs from amputation by creating new circulation pathways and most recently reversing the life-threatening effects of metabolic heart disease.”

Dr. Grekos plans to also announce upcoming clinical trials with prospective candidates in currently untreated illness classifications, including several neurologically based diseases and macular degeneration.

Dr. Zannos Grekos is an Interventional Cardiologist with a private practice in Florida. He is Chief Medical Officer for Regenocyte Therapeutic, one of the world’s leading Adult Stem Cell centers, and is Associate Clinical Professor of Cardiology for Nova Southeastern University. Having collaborated with major international treatment and research centers, he has been active in the development of both research and treatment protocols. In February 2007, he was invited to Washington DC to brief the United States Senate Health Advisory Staff on the current state of stem cell research and therapy.

Paul Schwartz, Chief Operating Officer for Regenocyte Therapeutic, states the company “is extremely pleased with the invitation to speak in Dubai. It is a symbol,” Schwartz explains, “of the worldwide medical community’s embrace of Dr. Grekos’ forging of new territory and the notoriety Regenocyte is rapidly gaining through its amazing treatment results.”

About the Repair Stem Cell Institute

The Repair Stem Cell Institute LLC (RSCI) is a global public service firm dedicated to educating the public about repair stem cell/adult stem cell research and treatments worldwide. RSCI was founded in April 2008 and is headquartered in Bangkok, Thailand with offices in Dallas, Texas and Washington, D.C.

About Regenocyte Therapeutic

Regenocyte(TM) Therapeutic LLC is one of the only clinically treating Adult Stem Cell Therapy centers in the world today. An experienced team of Board Certified physicians use cutting edge technology, paralleling that of Universities and major medical facilities, to prolong and improve the quality of life of patients living with diseases including Congestive Heart Failure, Cardiomyopathy, Peripheral Artery Disease, Coronary Artery Disease, Kidney Disease, Ischemic Heart Disease, Pulmonary Disease and Early Senile Dementia. For patient information or consultation, call 866-216-5710.

The Repair Stem Cell Institute

CONTACT: Jack Wynn, Director of Communications & Government-PoliticalAffairs of The Repair Stem Cell Institute LLC for Don Margolis,+1-703-623-4288, [email protected]; or Beth S. Kalvin, Communications &Education Director of Regenocyte Therapeutic LLC for Zannos Grekos,+1-239-495-2252 ext. 306, [email protected]

Web Site: http://www.repairstemcells.org/

Mylan Wins FDA Approval for Generic Keppra

Mylan, a generic pharmaceutical company, has announced that its subsidiary Mylan Pharmaceuticals received final approval from the FDA for its abbreviated new drug application for levetiracetam tablets, 250mg, 500mg and 750mg. Levetiracetam tablets are the generic version of UCB Pharma’s Keppra.

Mylan and UCB Societe Anonyme and UCB Pharma have previously entered into an agreement to settle pending litigation relating to levetiracetam tablets.

Pursuant to the settlement, Mylan was given the right to market the 250mg, 500mg and 750mg strengths of levetiracetam tablets in the US, provided that UCB obtained pediatric exclusivity for Keppra and Mylan’s abbreviated new drug application obtained final approval from the FDA. UCB was granted pediatric exclusivity relating to the patent, which extends to January 14, 2009.

Robert Coury, vice chairman and CEO of Mylan, said: “We are extremely pleased to be able to monetize another first-to-file opportunity and to offer a more affordable alternative for patients. In addition, after our very strong performance in the third quarter, the launch of levetiracetam is another significant step toward the continued execution on our stated goals for 2009 and beyond.”

Corgenix to Exhibit AspirinWorks(R) Test, Discuss New CHARISMA Trial Results at AHA 2008 Meeting

DENVER, Nov. 5 /PRNewswire-FirstCall/ — Corgenix Medical Corporation (BULLETIN BOARD: CONX) , a worldwide developer and marketer of diagnostic test kits, has announced it will be exhibiting its AspirinWorks(R) Test November 9 – 11 in booth No. 2536 at the American Heart Association Scientific Sessions 2008 in New Orleans, La.

New CHARISMA trial findings recently published in the American Heart Association’s peer-reviewed medical journal Circulation confirm that elevated urinary levels of the biomarker 11-dehydro thromboxane B2 (11dhTxB2) indicate an increased risk of heart attack, stroke and cardiac death.

The AspirinWorks Test by Corgenix is the only FDA-cleared test that measures urinary 11dhTxB2 to accurately determine the effect of aspirin in apparently healthy individuals. 11dhTxB2 is a metabolite of thromboxane A2, the target of aspirin therapy.

“The American Heart Association conference is an ideal forum in which to discuss the findings on the relationship between elevated 11dhTxB2 levels and cardiovascular risk from the powerful and respected CHARISMA trial,” said Gordon Ens, clinical director of Corgenix Medical Corporation. “This well-designed, prospective outcome study demonstrates the potential value of the AspirinWorks Test for optimizing an individual’s aspirin therapy.”

CHARISMA is a multinational, multicenter, randomized, parallel group, double-blind trial involving 15,603 patients with either clinically established cardiovascular disease or multiple risk factors. The CHARISMA sub-study involved a total of 3,261 aspirin-treated patients from 224 sites in 12 countries.

The AspirinWorks Test was launched in the U.S. in June 2007 following FDA 510(k) clearance, and it is now available nationwide through major medical laboratories as well as direct to consumers through HealthCheckUSA (http://www.healthcheckusa.com/). The test targets a potential U.S. market of over 60 million individuals and a potential global market exceeding 200 million individuals who take aspirin for prevention.

Unlike functional platelet tests, which require freshly drawn blood that must be evaluated within at least four hours, the AspirinWorks Test only requires a urine sample that can be obtained in any doctor’s office or patient service center, making the test convenient for both physician and patient.

Physicians and laboratories interested in ordering the test can call 1-800-729-5661 x180, or e-mail: [email protected]. More information is also available at http://www.aspirinworks.com/.

About Corgenix Medical Corporation

Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases and bone and joint disorders, including the world’s only non-blood-based test for aspirin effect. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network and has significant experience advancing products through the FDA process. More information is available at http://www.corgenix.com/.

Statements in this press release that are not strictly historical facts are “forward looking” statements (identified by the words “believe”, “estimate”, “project”, “expect” or similar expressions) within the meaning of the Private Securities Litigation Reform Act of 1995. These statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company’s products and services in the marketplace, competitive factors, changes in the regulatory environment, and other risks detailed in the Company’s periodic report filings with the Securities and Exchange Commission. The statements in this press release are made as of today, based upon information currently known to management, and the Company does not undertake any obligation to publicly update or revise any forward-looking statements.

Corgenix Medical Corporation

CONTACT: William Critchfield, Senior VP and CFO of Corgenix MedicalCorp., +1-303-453-8903, [email protected]; or Media, Dan Snyders, VicePresident and Public Relations Supervisor of Armada Medical Marketing,+1-303-623-1190, ext. 230, Fax, +1-303-623-1191, [email protected], forCorgenix Medical Corporation

Web site: http://www.corgenix.com/http://www.aspirinworks.com/http://www.healthcheckusa.com/

IMC Announces Hiring of Tom Neville to the Position of Senior Vice President, Operations

Tom Neville has joined IMC HealthCare, Inc. (IMC) — a leading provider of on-site health centers and on-site wellness centers for large and mid-sized, self-insured companies — in the newly designed role of Senior Vice President of Operations. IMC created Tom’s role to address increasing demands from companies seeking the newest, most convenient and cost-effective on-site healthcare delivery models. As a national provider, IMC offers primary care, urgent care, occupational health, wellness and preventive care and pharmaceutical services to clients’ employees, dependents and retirees.

“Tom brings a wealth of healthcare management and industry-specific experience to our team,” says Todd Keller, CEO of IMC. “And he brings a new level of expertise and well-established industry relationships to help IMC deliver the highest-quality health and wellness experiences to our patients, while using a cost-effective, convenient delivery system for our clients,” adds Terry L. MacMath, MD, Chief Medical Officer.

Following his service in senior positions with Towers Perrin, Hewitt Associates, Value Health and Cigna, Tom was Vice President of Business Development for the Southeastern United States for Take Care Employee Solutions. Take Care, a division of Walgreens, acquired Whole Health Management in March 2008.

He received his bachelor’s and master’s degrees in Health Services Administration from Florida International University. Tom and his family are relocating to Jacksonville from metropolitan Detroit.

About IMC HealthCare

IMC HealthCare is a leading innovator of company-sponsored on-site employee health centers. For more than 20 years, IMC has been helping corporate America lower healthcare costs by bringing healthcare into the worksite. As a physician-owned and physician-managed company, IMC sets the standard for high quality healthcare delivered in a convenient, cost-effective model. IMC’s unique ability to create customized health centers to match each client’s unique culture and specific needs sets it apart. Services include primary care; occupational care; wellness and prevention; pharmacy and more — all delivered at the worksite for employees and dependents.

HealthFitness Launches New Preventive Health Solution for Small Employers

MINNEAPOLIS, Nov. 5 /PRNewswire/ — Small employers now have a cost-effective solution to reduce employee health risks, lower health care costs and stay competitive by attracting and retaining talent. Today HealthFitness (NYSE Alternext US: FIT) introduced HealthFitness’ Partner Program – a powerful combination of its eHealth portal, INSIGHT(R) Health Risk Assessment and EMPOWERED(TM) Health Coaching.

(LOGO: http://www.newscom.com/cgi-bin/prnh/20070830/HFLOGO)

HealthFitness is an award-winning provider of integrated fitness management and health promotion solutions for on-site and dispersed employee populations.

“While many employers see the value in health improvement programs, a sizable percentage – especially small companies – fall short when it comes to implementation,” said Gregg O. Lehman, CEO and president, HealthFitness. “For many small businesses, the reason is cost. HealthFitness’ Partner Program addresses the cost issue and allows these employers to realize the benefits associated with a health improvement program without having to make a substantial investment.”

HealthFitness’ Partner Program is a turnkey health improvement solution offered through third-party administrators to smaller organizations (up to 1,500 employees) at a competitive price. With the Partner Program, brokers receive special pricing allowances and a comprehensive sales package that includes support from a HealthFitness account manager, eight hours of training, administrative eHealth access and print-ready participant promotion templates.

“Our Partner Program allows third-party administrators to offer small employers a more comprehensive product than what major health plans offer–and at a more competitive price,” Lehman said.

According to a study by PricewaterhouseCoopers Health Research Institute,(1) both large and small employers see the value of offering wellness programs; however, only 50 percent of small businesses – compared to 74 percent of large companies – were satisfied with the wellness program offered by their health plan.

The report suggests the difference in satisfaction levels between large and small companies could be attributed to the bigger selection of customized plans offered to larger employers, combined with the higher cost per employee that smaller employers must pay. The study also indicates that it is more difficult for small employers to purchase strategic and innovative services such as health promotion programs because small employers tend to be more focused on immediate issues such as the cost of coverage.

   With HealthFitness' Partner Program, small employers receive:    --  Health promotion and interactive educational tools through the       HealthFitness eHealth platform;   --  The INSIGHT Health Risk Assessment - a confidential, user-friendly       health risk assessment that provides personalized health information       about modifiable risks that are under an employee's control to       prevent;   --  EMPOWERED Health Coaching to support employees to change behaviors in       12 focus areas, including physical activity, healthy eating and stress       management. Employees can access their health coach via phone and/or a       private, secure online message board; and   --  Annual aggregate reports to evaluate the effectiveness of the program       at their site.   

“During the next three to five years, studies show a majority of employers plan to make significant investments in longer-term solutions aimed at improving the health and productivity of their workers,” Lehman said. “Our Partner Program provides small employers with tools to cultivate a positive culture of health, empowering them to retain and optimize human capital, and to ensure their company’s ability to remain competitive in the current economy.”

About HealthFitness

HealthFitness is a leading provider of employee health improvement services to Fortune 500 companies, the health care industry and individual consumers. Serving clients for more than 30 years, HealthFitness partners with employers to effectively manage their health care and productivity costs by improving individual health and well-being. HealthFitness serves more than 300 clients globally via on-site management and remotely via Web and telephonic services. HealthFitness provides a complete portfolio of health and fitness management solutions including a proprietary health risk assessment platform, screenings, EMPOWERED(TM) Health Coaching and delivery of health improvement programs. HealthFitness employs more than 3,000 health and fitness professionals in national and international locations who are committed to the company’s mission of “improving the health and well-being of the people we serve.” For more information on HealthFitness, visit http://www.hfit.com/.

(1) “What employers want from health insurers–now,” PricewaterhouseCoopers Health Research Institute, October 2008

Photo: http://www.newscom.com/cgi-bin/prnh/20070830/HFLOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, [email protected]/

HealthFitness

CONTACT: Karla Hurter of Health2Resources, +1-703-319-0957,[email protected], for HealthFitness

Web Site: http://www.hfit.com/

Prolexys Pharmaceuticals Successfully Completes Private Placement of USD 20 Million With Friedli Corporate Finance

Prolexys Pharmaceuticals, Inc. has raised $20 million in a Preferred Series A1 round led and managed by Friedli Corporate Finance.

Included among the purchasers of the shares is Peter Friedli, our Chairman, individually. The Board of Directors of the Company, including all of the Company’s independent directors, but with Mr. Friedli abstaining, unanimously approved the offering and sale of the shares, including the sale of a portion of the shares to Mr. Friedli.

“Raising the new capital under such favorable terms was an excellent opportunity for Prolexys to further advance the clinical development of PRLX 93936, a novel small molecule with potent and selective anti-tumor activity in the disease models representative of Colon, Lung (NSCLC), Pancreatic, and Ovarian cancer, several Sarcoma sub-types and Multiple Myeloma,” said Sudhir Sahasrabudhe, Ph.D., the scientific founder and Chief Scientific Officer. “The additional resources will also allow the company to develop back-up molecules to PRLX 93936, extend the PRLX 93936 franchise by leveraging the unique mechanism of action of PRLX 93936. This new investment by Mr. Friedli underscores his confidence and long-term commitment to support the development of novel cancer therapeutics at Prolexys. We are grateful for his continued guidance and support.”

PRLX 93936 shows impressive activity in disease models representative of cancers with high unmet medical need and large market potential. The current Phase 1 study assesses the safety, pharmacokinetics, and pharmacodynamics of PRLX 93936 administered intravenously over 1 hour daily for 5 days in patients with advanced solid tumors. Patients are evaluated prior to dosing, during dosing and following dosing, on a 28-day cycle. Tumor response is evaluated every other cycle. Three patients are assigned per dose level until the Maximum Tolerated Dose (MTD) is reached or a Dose-Limited Toxicity (DLT) is encountered. Fifteen patients have been dosed to-date and a total of six patients have received multiple cycles of treatment. Overall, the drug seems to be well tolerated. The next cohort (Cohort 5) will deliver a dose of 15 mg/meters squared, a dose that produces drug exposure levels at which significant anti-tumor activity has been observed in the mouse models of human cancer.

About Prolexys

Prolexys Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering small molecule drugs using its proprietary proteomics technology platform. The company’s therapeutic focus is on cancer where Prolexys has identified novel therapeutic targets. Small molecules that act at these targets have been identified and tested in cell and animal models of disease.

PRLX 93936, a small molecule with a unique mechanism of action and selective anti-tumor activity in a broad range of human cancers, is the most advanced clinical program at Prolexys. This drug candidate is currently being dosed in Phase 1 clinical trials for patients with advanced solid tumors. Several back-up candidates have been identified in the PRLX 93936 program to fully capitalize on the unique mechanism of action. In addition, novel small molecules with significant anti-tumor activity against biological models of colon cancer are being tested to facilitate the selection of a clinical lead. More information can be found on the company’s website, www.Prolexys.com.

About Friedli Corporate Finance

Friedli Corporate Finance was founded by Peter Friedli in 1986 and is one of the leading Swiss venture capital firms. Since its inception, Friedli Corporate Finance has invested in over 170 biotechnology and technology companies, primarily based in the US. Friedli Corporate Finance manages several investment companies. Friedli Corporate Finance has been the primary source of financing for Osiris Therapeutics since inception.

 Contacts: Sudhir Sahasrabudhe CSO Tel: 801-303-1717  Chad Bello Director of Finance Tel: 801-303-1718  

SOURCE: Prolexys Pharmaceuticals

MedImmune: RSV Vaccine Progresses

Only one product is currently available for the prophylaxis of respiratory syncytial virus infections and the need for a vaccine is high. The Phase I/IIa trial for MedImmune’s investigational vaccine MEDI-559 is therefore a big step in the right direction. However, the hurdles for this compound will only increase as it progresses in development.

MedImmune has initiated a Phase I/IIa clinical trial of its live attenuated intranasal vaccine (MEDI-559) in healthy children 1-12 months of age to help prevent severe respiratory syncytial virus (RSV) infections. MedImmune is also developing other live attenuated intranasal vaccines, such as MEDI-560 for the prevention of lower respiratory tract infections (LRTIs) caused by parainfluenza virus type 3 (PIV3) and MEDI-534 for the prevention of LRTIs in young infants that is caused by RSV and PIV3.

Although RSV usually only causes an upper respiratory tract infection similar to a common cold, it can also cause more serious LRTIs such as bronchiolitis that can result in hospitalization and sometimes death. Populations at higher risk for severe LRTI caused by RSV include the elderly, people with underlying disease, premature infants and children under four years of age.

The RSV market is currently dominated by another of MedImmune’s products, Synagis (palivizumab), a prophylactic monoclonal antibody. Synagis is the only commercially successful drug available for the prevention of RSV and reached sales of more than $1 billion in 2007 in the seven major markets (US, Japan, France, Germany, Italy, Spain and the UK). However, due to its high costs, Synagis is only prescribed to a very limited group, namely premature infants and children with chronic lung disease or congenital heart disease.

Despite the high need for an RSV treatment or vaccine, many large pharmaceutical companies have abandoned their efforts over the years, including Wyeth, Sanofi-Aventis, GlaxoSmithKline and Roche. In some cases, the problem has been financial: approved respiratory antivirals have struggled to meet sales expectations because of the relative cost of the product versus the typically mild illness suffered. However, the main reasons are more clinically oriented.

Aside from the major problem of diagnosing RSV and administering an antiviral product early enough to make a difference, developers face moral and ethical dilemmas in testing new drugs on infants and potentially premature babies. Furthermore, the respiratory syncytial virus itself has several characteristics that make the development of vaccines difficult. So although the progression of MEDI-559 to the next phase of development is a welcome advance, the vaccine is still some way from being available to those who need it.

Bioheart Adds Key Senior Members to Its Team

SUNRISE, Fla., Nov. 5, 2008 (GLOBE NEWSWIRE) — Bioheart, Inc. (Nasdaq:BHRT) announced today two key appointments to its leadership team including a new vice president of sales and marketing and a new board member. Matt Fendrich has joined the company as Vice President of Sales & Marketing. Mr. Fendrich was previously Senior Product Sales Executive for Siemens Medical where he helped lead Siemens’ entryway into cardiology accounts here in the United States. Prior to that, he served as Vice President of Marketing for PSS World Medical, Inc. (Physician Sales & Service), having been with the firm for 12 years. As vice president with PSS, he was responsible for 52 branch managers and 850 sales representatives nationwide. Mr. Fendrich has a BS in Economics from Florida State University. At Bioheart, Mr. Fendrich will immediately begin leading the sales launch of the Bioheart 3370 Heart Failure Monitor and the Bioheart-Monebo Cardiobelt(tm) Arrhythmia and A-Fib Remote Monitoring System in the United States.

On October 22, 2008, the company also appointed Alan P. Timmins to serve as a member of its Board of Directors until the Company’s 2009 Annual Meeting of Shareholders or until his successor is duly elected and qualified. The addition of Mr. Timmins brings the Board’s membership to eight. Mr. Timmins was also appointed to the Audit Committee of the Board effective as of the same date. Mr. Timmins is a seasoned biotechnology executive having previously served as President of AVI BioPharma from 2000 to 2008. During his career, Mr. Timmins helped raise more than $250 million of capital. He has a BBA in Accounting and Management from the University of Portland and an MBA from Stanford University.

“Bioheart continues to seek out the best and brightest to join our organization,” said Howard J. Leonhardt, Chairman, CEO and CTO of Bioheart. “These recent new additions to our team are designed to assist us in transitioning from being a development-stage, research-focused company to being a profitable commercial enterprise. Matt brings solid sales leadership experience. He has beaten nearly every sales goal set for him in his career. He has a goal at Bioheart to achieve more than $20 million in sales in 2009. Alan Timmins has a great track record at raising capital in the biotech/medtech field.”

About Bioheart, Inc.:

Bioheart, Inc. (Nasdaq:BHRT) is committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases. Its goals are to improve a patient’s quality of life and reduce health care costs and hospitalizations. Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. Its lead product candidate, MyoCell(r), is an innovative clinical muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient’s heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. The Company’s pipeline includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose tissue-derived stem cell treatment for acute heart damage, and MyoCell(r) SDF-1, a therapy utilizing autologous cells that are genetically modified to express additional potentially therapeutic growth proteins. For more information on Bioheart, visit www.bioheartinc.com.

MyoCell and MyoCell SDF-1 are trademarks of Bioheart, Inc.

Forward-Looking Statements:

Except for historical matters contained herein, statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Without limiting the generality of the foregoing, words such as “may”, “will”, “to”, “plan”, “expect”, “believe”, “anticipate”, “intend”, “could”, “would”, “estimate”, or “continue” or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

Investors and others are cautioned that a variety of factors, including certain risks, may affect our business and cause actual results to differ materially from those set forth in the forward-looking statements. These risk factors include, without limitation, (i) our ability to secure additional financing; (ii) the timely success and completion of our clinical trials; (iii) the occurrence of any unacceptable side effects during or after preclinical and clinical testing of our product candidates; (iv) regulatory approval of our product candidates; (v) our dependence on the success of our lead product candidate; (vi) our inability to predict the extent of our future losses or if or when we will become profitable; (vii) our ability to protect our intellectual property rights; and (viii) intense competition. The Company is also subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2007, as amended by Amendment No. 1 on Form 10-K/A and its quarterly reports on Form 10-Q for the quarters ended March 31, 2008 and June 30, 2008.

This news release was distributed by GlobeNewswire, www.globenewswire.com

 CONTACT:  Bioheart, Inc           William Kline, Chief Financial Officer           (954) 835-1500            Monebo, Inc           Patrick Kothe, Vice President, Chief Marketing Officer           (512) 732-0235 x112            RedChip Companies, Inc.           Bioheart Investor Relations:           Len Hardison           (800) REDCHIP (733-2447), Ext. 118           [email protected] 

 

Regal Life Adds Luxury Spa/Resort Management Veteran and Ayurveda Spa Treatment Expert

Regal Life Concepts, Inc. (OTCBB: RGLC) is pleased to announce that it has added Thailand-based Ronald Decter to the Company’s Advisory Board. Mr. Decter will assist Regal Life by helping to identify and evaluate spa / resort acquisition opportunities throughout Thailand, Vietnam and Bali.

Mr. Decter is a hospitality industry veteran. In addition to an impressive track record as General Manager and Spa Consultant in luxury 5-star resorts, he is also an expert in traditional Ayurveda health programs. Having received extensive academic training, in India and the Netherlands, in Ayurveda, its traditional spa therapies and herbal preparations, Mr. Decter is the ideal person to spearhead the development of the Regal Life Ayurveda Spa Resort brand.

Previously, Mr. Decter has served as General Manager at the award winning Mandala Spa & Villas, based in Boracay Island, Philippines; Spa Consultant at The Mandarin Oriental Hotel — Manila, Philippines, Business Development Manager at the Jamu Traditional Spas — headquartered in Bali, Indonesia, and founding president of the Bali Spa Association.

Under the guidance of Mr. Decter, Regal Life’s objective in the Health and Wellness Destination Resort sector is to establish the first truly authentic, all-Ayurveda luxury spa resort in Asia. Once an acquisition or strategic investment is complete, Mr. Decter will assume the position of General Manager and oversee future openings and developments.

Health and wellness have always been a natural and integral part of Mr. Decter’s lifestyle. He has been a practitioner of the Transcendental Meditation (TM) Program (TM) and Yoga since his teens, and held a senior executive position at the TM global offices, in Switzerland and the Netherlands, for over 20 years. As a respected member of the international TM organization, which has a worldwide membership of over 6 million, he will help bring awareness of Regal Life Ayurvedic therapies to its members.

In addition to being a teacher of TM and its advanced programs, he also holds the distinction of having been the personal executive assistant to His Holiness Maharishi Mahesh Yogi — founder of Transcendental Meditation and Maharishi Ayurveda.

Eric Wildstein, Regal’s CEO stated: “We strongly believe that Ronald’s experience in the luxury resort management business in Asia coupled with his in-depth knowledge of traditional Ayurveda therapies make him an ideal choice as an advisor to the board of directors.”

Wellness and Health Tourism

The Company intends to diversify its business efforts in 2009 to focus on the health, wellness and lifestyle arena. The World Tourism Organization forecasts that international tourism will continue growing at the average annual rate of 4 percent and as much as 7% of the world’s population will participate in international travel over the next decade. As the Western baby boom generation reaches retirement age, the market for both medical and health and wellness tourism is growing. Tourists are increasingly looking for travel offering relaxation, healthy nutrition, gentle physical activity, beauty and wellness.

This orientation towards health, activity and consumption corresponds to the spirit of the time, whereby this trend is not only due to the demographic development, under which the population is becoming older and thus the need for medical services rises. The trend is oriented towards the entire population, the seniors and the young persons, who demand a healthier life style and better well-being. Stress in everyday life has led to an acute need to recover in a “well-being” atmosphere far from the everyday environment. This development is bringing benefits to the health tourism industry and is translating into added opportunities for new trends like medical tourism.

Further Information

Please feel free to call Investor Communications toll-free on 1-866-790-0821 or at 1-480-773-9967 to obtain further information.

About Regal Life Concepts, Inc.

Regal Life Concepts, Inc. is a publicly traded company with headquarters in Phoenix, Arizona. Regal Life Concepts, Inc. is strategically positioning itself in the health and wellness tourism, as well as lifestyle products and services sectors and is investigating further opportunities in Asia. Regal Life Concepts, Inc. trades on the NASDAQ OTC BB under the ticker symbol RGLC.

On behalf of the Board

Eric Wildstein, President

Forward-Looking Statements

Statements in this news release that are not historical facts are forward-looking statements that are subject to risks and uncertainties. Words such as “expects,””intends,””plans,””may,””could,””should,””anticipates,””likely,””believes” and words of similar import also identify forward-looking statements. Forward-looking statements are based on current facts and analyses and other information that are based on forecasts of future results, estimates of amounts not yet determined and assumptions of management, including, but not limited to, the Company’s belief that Regal Life Concepts, Inc. can identify and successfully negotiate business prospects in Asia, and that the Company can successfully operate such prospects. Actual results may differ materially from those currently anticipated due to a number of factors beyond the reasonable control of the Company. Additional information on risks and other factors that may affect the business and financial results of the Company can be found in filings of the Company with the U.S. Securities and Exchange Commission.

 Contacts: Regal Life Concepts, Inc. Investor Communications Toll Free: 1-866-790-0821 General: 1-480-773-9967  

SOURCE: Regal Life Concepts, Inc.

D.C. Hospital Installs Radiation Detectors

By Mimi Hall

WASHINGTON — The largest private hospital in the nation’s capital on Tuesday began installing sophisticated new radiation detectors in an effort to better prepare for a terrorist attack with a radiological “dirty bomb.”

The sensors, which will be placed out of public view at the 926-bed Washington Hospital Center, will immediately let doctors, nurses and other hospital staff know if someone contaminated with dangerous radiation enters the emergency room or other areas of the hospital.

The goal is to prevent victims of an attack from compounding the disaster by contaminating the hospitals and emergency workers who are there to treat them.

“If they’re contaminated and you don’t know it, you’ve got another enormous problem,” says Susan Eckert, who is in charge of nurse preparedness at the hospital, which treated Pentagon victims of the 9/11 attacks. It also treated anthrax victims a month later.

The sensors, which can differentiate between dangerous radiation and the radiation used in cancer treatments, will be tested for several months to see how well they work. They are designed not to trigger an alarm if patients — such as those treated for cancer — walk past.

Other tests of radiation-detection equipment have been done at hospitals in Washington and in New York City, both of which are considered top terrorism targets. None has used sensors that can identify radioactive isotopes. The system can also send text messages to cellphones of hospital employees, notifying them of an alarm.

The sensors also would go off if someone tried to take radioactive waste or material used for cancer treatments out of the hospital.

This fall, the Homeland Security and Energy departments began a program to secure the machines that house radioactive material in hospitals to try to prevent someone from stealing it to make a bomb. Although a “dirty bomb” would not kill many people, it would cause sickness by spreading radiation.

“This is an important potential threat … and there are two different problems for a hospital: what comes in and what goes out,” says former envoy to Iraq Paul Bremer, chairman of Splinternet Holdings. The company, based in Norwalk, Conn., makes the sensors being tested. (c) Copyright 2008 USA TODAY, a division of Gannett Co. Inc. <>