HOUSTON, Nov. 13 /PRNewswire/ — RediClinic LLC announced today that it is opening its 15th Houston-area convenient care clinic in the new H-E-B store located at Bunker Hill and I-10. The 926-sq.-ft. clinic, featuring three exam rooms and a room specifically designed for blood draws, is the largest RediClinic in operation. According to the Convenient Care Association (CCA), it is also the largest retail-based convenient care clinic in the U.S. RediClinics are in-store facilities that offer consumers easy access to high-quality, non-acute healthcare at affordable prices.

“We are delighted to be expanding our footprint in our home market with the opening of our 15th Greater Houston clinic,” said Web Golinkin, chief executive officer of RediClinic. “The larger clinic design in H-E-B’s new Bunker Hill store enables us to treat more patients and gives us more flexibility in adding new services.”

RediClinics are staffed by certified nurse practitioners who work with local physicians to diagnose, treat and prescribe medications for common medical conditions, such as strep throat and upper respiratory infections. They also administer a broad range of preventive services, including health screenings, medical tests, immunizations and basic physical exams.

Currently, RediClinic is providing flu vaccinations for $25.

“Easy access to affordable healthcare is a high priority for H-E-B customers,” said Scott McClelland, president H-E-B Houston, “and we are pleased that RediClinic will be providing this service at our newest Houston store.”

RediClinics are open seven days a week (including most holidays) and offer extended hours on weekdays. Adults and children over age two are welcome, no appointments are necessary, and a typical visit takes about 15 minutes.

RediClinic uses the athenahealth electronic medical record to facilitate, guide and document patient visits. This system ensures patient suitability to RediClinic’s limited scope of practice and ensures continuity of care when other clinicians are involved. Patients who cannot be treated at RediClinic, or who need ongoing treatment, are referred to their primary care provider, if they have one, or to other physicians in their communities.

RediClinic visits in Texas are covered by the nation’s four largest commercial health insurance carriers — Aetna, CIGNA, Humana and UnitedHealthcare — as well as by Medicare and Blue Cross Blue Shield of Texas. Those who are covered by health plans that do not currently have agreements with RediClinic receive specially-formatted receipts that can be filed for possible reimbursement.

   Current RediClinic Greater Houston Locations (inside H-E-B Stores):   Katy (Grand Parkway): 6711 South Fry Road at Grand Parkway   Houston (Blackhawk): 9828 Blackhawk Blvd. at South Belt Drive   League City (Bay Colony): 2955 South Gulf Freeway at Santa Fe   Tomball: 28520 Tomball Parkway (at Hwy 2920)   Spring (Woodlands-Sawdust): 130 Sawdust Road at Interstate 45   Woodlands (Indian Springs): 10777 Kuykendahl Road at Woodlands Parkway   Conroe: 2108 North Frazier at North Loop 336 W   Friendswood: 701 West Parkwood at Sunset Drive   Houston: 2660 Fountainview at Westheimer   Pasadena: 6210 Fairmont Parkway at Space Center Blvd   Sugar Land (River Park): 19900 Highway 59 at Grand Parkway   Pearland: 2805 Business Center Drive   Spring: 7310 Louetta at Hwy 249   Cypress: 6960 Barker Cypress at Hwy 290   Houston: 9710 Katy Freeway (Bunker Hill & I-10)    

In Greater Houston, Memorial Hermann provides physician oversight to RediClinic’s nurse practitioners and collaborates with RediClinic on clinical quality and consumer education initiatives. Memorial Hermann is the area’s largest healthcare provider

RediClinic operates 21 clinics in H-E-B stores in Houston and Austin, Texas; and 15 clinics in Wal-Mart stores in Atlanta, Ga., Fayetteville and Rogers, Ark., Richmond, Va., and Tulsa, Okla. For a complete list of locations, services, prices and additional information on RediClinic, visit http://www.rediclinic.com/.

About RediClinic LLC

Since 1989, RediClinic has provided people with easy access to high-quality, affordable healthcare in retail outlets and at employer worksites. Today the company is the nation’s largest independent operator of retail-based, ‘convenient care’ clinics. For more information, visit http://www.rediclinic.com/.

About the Memorial Hermann System

An integrated health system, Memorial Hermann is known for world-class clinical expertise, patient-centered care, leading edge technology, and innovation. The system, with its exceptional medical staff and 19,000 employees, serves southeast Texas and the greater Houston community. Memorial Hermann’s 11 hospitals include three hospitals in the Texas Medical Center, including a level 1 trauma center, a hospital for children and a rehabilitation hospital, as well as three heart & vascular institute locations and eight suburban hospitals. The system also operates an air ambulance, cancer, imaging and surgery centers, sports medicine and rehabilitation centers, outpatient laboratories, a Wellness Center, a chemical dependency treatment center, a home health agency, a retirement community and a nursing home. To learn more, visit http://www.memorialhermann.org/, or call 713-222-CARE.

RediClinic LLC

CONTACT: Katie Brazel of Fleishman-Hillard, +1-404-739-0150,[email protected], for RediClinic LLC

Web site: http://www.rediclinic.com/http://www.memorialhermann.org/

MOUNT LAUREL, N.J., Nov. 13 /PRNewswire-FirstCall/ — MedQuist Inc. , the leading provider of clinical documentation workflow technology and services, and Clario Medical Imaging Inc. announced today they have agreed to integrate Clario’s zVision(TM) software with MedQuist’s SpeechQ for Radiology(TM) speech recognition solution. This integration provides a single access point to manage workflow and dictate using SpeechQ for Radiology.

Clario creates software that can dramatically improve radiologists’ efficiency and accuracy by providing superior access to practice information, patient information and an extensive range of multi-vendor, best-of-breed software applications. zVision aggregates information from SpeechQ, as well as existing HIS and RIS, and builds a database precisely customized for the radiology practice. In addition, zVision provides intelligent tools for real-time monitoring of a practice, advanced searches, results communication, and quality assurance. MedQuist will be demonstrating this integration at the partner pavilion in its booth (#7113) at RSNA 2008 (Nov. 30-Dec. 4 in Chicago).

“zVision provides real-time, Web-based access to diagnostic imaging practice data through six pivotal tools: Dashboard, Worklist, Search, Results Communication, QA and Practice Summaries. Using advanced data mining techniques, zVision can help the physician search through all past patient records, including reports and notes,” says Carole Spangler, Clario vice president of business development.

“If a physician is dictating, they should be able to easily access prior patient information. Alternatively, they should be able to launch a new dictation while in a Clinical Imaging Processing (CIP) application. We are pleased to be able to offer these options to SpeechQ customers with the integration of zVision,” states Chris Spring, MedQuist director of speech recognition solutions.

Dr. Ed Weinberger of Seattle Children’s Hospital observes, “zVision provides us with a real-time dashboard of the state of our practice. We have used zVision to track more than 400,000 cases and have achieved tremendous gains in workflow efficiency. Not only does zVision give a single point of access for all patient imaging information, it also includes intelligent tools for quality assurance and patient follow-up.”

About Clario

Clario Medical Imaging Inc. develops radiology software products that increase efficiency and improve diagnostic accuracy. Clario’s cornerstone product, zVision, provides one point of access for both patient information and an extensive range of multi-vendor, best-of-breed specialty applications, at prices reasonable for even the smallest practices. For more information, visit http://www.clariomedical.com/.

About MedQuist

MedQuist is the largest Medical Transcription Service Organization (MTSO) in the world, and a leader in technology-enabled clinical documentation workflow. MedQuist’s enterprise solutions – including mobile voice capture devices, speech recognition, Web-based workflow platforms, and global network of medical editors – help healthcare facilities improve patient care, increase physician satisfaction, and lower operational costs. For more information, please visit http://www.medquist.com/.

“Safe Harbor” Statement under the U.S. Private Securities Litigation Reform Act of 1995: Statements in this press release regarding MedQuist’s business which are not historical facts are “forward-looking statements” that involve risks and uncertainties, including without limitation the risk that SpeechQ for Radiology does not perform as designed. Actual outcomes and results may differ materially from what is expressed or forecasted in forward-looking statements. As a result, forward-looking statements speak only as of the date they were made, and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

MedQuist Inc.

CONTACT: Kathleen Lang, Marketing Communications of MedQuist,+1-856-206-4725, [email protected]

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

ZaBeCor Pharmaceuticals, a biotechnology company, has announced that the FDA has approved the company’s investigational new drug application for the treatment of asthma.

This approval enables the company to proceed with Phase I clinical trials in humans for its asthma drug candidate, Excellair. The investigational new drug (IND) review included ZaBeCor’s clinical development plan, Phase I clinical trial protocols, manufacturing plans and extensive preclinical studies.

According to the company, Excellair focuses on applications of siRNA to the molecular protein Syk kinase, which initiates the release of biologically active mediators in many inflammatory pathways, including those operable in asthma.

Excellair is said to be part of ZaBeCor’s extensive intellectual property and is based upon research conducted at the University of Pennsylvania School of Medicine.

Alan Schreiber, chairman and CEO of ZaBeCor, said: “This is an important milestone for ZaBeCor and indicates confidence in our intellectual property and data. We are delighted to continue the development of our asthma drug candidate, Excellair, which we believe will be a treatment for patients worldwide.”

GARDASIL(R) (Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant), the cervical cancer vaccine from Merck & Co., Inc., prevented 90 percent of external genital lesions caused by human papillomavirus (HPV) types 6, 11, 16 and 18 in a pivotal Phase III study in men aged 16 to 26. These are the only data evaluating efficacy of any HPV vaccine in preventing disease in males, and were presented for the first time this week at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference.

The initial planned analysis of this study, an analysis of male study participants aged 16 to 26 who had not been infected with at least one of the four HPV types before the start of the study through one month after receiving their third dose of the vaccine or placebo, has been completed. This analysis was predetermined in the study protocol to be conducted after at least 32 cases of external genital lesions were observed. The study is ongoing, and additional data will be submitted to global regulatory agencies once available.

Merck remains on track to submit a supplemental Biologics License Application for GARDASIL to the U.S. Food and Drug Administration by the end of 2008 for the use of GARDASIL in boys and men ages 9 to 26 for the prevention of external genital lesions caused by HPV types 6, 11, 16 and 18. Other regulatory submissions around the world will occur as planned.

GARDASIL is not currently approved for males in the United States. GARDASIL is indicated for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.

GARDASIL Reduced External Genital Lesions in Males by 90 Percent

The placebo-controlled, Phase III study was designed to determine the efficacy of GARDASIL in males against HPV 6, 11, 16, and 18-related external genital lesions, a composite endpoint that included: 1) genital warts (condylomata), 2) penile/perineal/perianal intraepithelial neoplasia (or PIN; PIN 2/3 can be pre-cursors to cancer) and 3) penile/perineal/perianal cancer. Penile/perineal/perianal is defined as related to or affecting the penis (penile), the area between the anus and the scrotum (perineal), or the opening of the rectum to the outside of the body (perianal).

The study evaluated approximately 3,400 heterosexual males 16 through 23 years of age and approximately 600 men 16 to 26 years of age who have sex with men. Participants were randomized in a 1-to-1 ratio to receive either GARDASIL or placebo at day one, two months and six months, with 36 months of planned follow-up from day one. At the time of vaccination, participants had no evidence of genital lesions, no history of genital warts and five or fewer lifetime sexual partners.

In the study, GARDASIL was 90.4 percent effective at reducing external genital lesions (3 cases in the vaccine group vs. 31 cases in placebo group; 95 percent CI: 69.2, 98.1, p-value

No vaccine-related serious adverse events were reported in this study. A slightly higher proportion of study participants reported injection-site adverse events in the vaccine group compared to placebo (60.1 percent vs. 53.7 percent).

GARDASIL Also Achieved Statistical Significance on Both Secondary Endpoints

Two secondary endpoints also were evaluated in this pivotal study and results from these analyses were presented at EUROGIN. GARDASIL was 85.6 percent effective at reducing persistent infection (15 cases in the vaccine group vs. 101 cases in the placebo group; 95 percent CI: 75.1, 92.2, p-value

Additional Important Information about GARDASIL

GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.

The health care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening.

GARDASIL is not recommended for use in pregnant women.

Vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts, cervical, vaginal and vulvar cancers, cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN) or vaginal intraepithelial neoplasia (VaIN).

GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. GARDASIL has not been shown to protect against diseases due to HPV types not contained in the vaccine.

Not all vulvar and vaginal cancers are caused by human papillomavirus (HPV), and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV types 16 and 18.

The most common adverse reaction was headache. Common adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0 percent and greater than placebo were fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising.

In addition, syncope has been reported following vaccination with GARDASIL, sometimes resulting in falling with injury. Observation for 15 minutes after administration is recommended.

Dosage and Administration for GARDASIL

GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.

Human Papillomavirus: A Virus that Affects Both Men and Women

According to the Centers for Disease Control and Prevention, in the U.S. alone, an estimated 20 million men and women are currently infected with HPV, and another 6.2 million people become newly infected each year. For most, HPV goes away on its own. However, certain low-risk types of HPV can cause external genital lesions. More than one million cases of external genital lesions in men and women occur each year in the U.S. and more than 30 million occur each year worldwide. In addition for women, certain high-risk types of HPV, if unrecognized and untreated, can lead to cervical cancer.

HPV is a virus that can infect the genital region of men and women. There are an estimated 30 to 40 types of genital HPV. HPV transmission can happen with any kind of intimate genital contact with someone who has HPV; sexual intercourse is not needed. Most sexually active people will have HPV at some time in their lives.

Other Information about GARDASIL

In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck 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 Merck’s business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck’s Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company’s periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.

Full Prescribing Information and Patient Product Information for GARDASIL(R) are attached and are also available at www.gardasil.com.

GARDASIL(R) is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use GARDASIL safely and effectively. See full prescribing information for GARDASIL.

GARDASIL

(Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant)

Suspension for intramuscular injection

Initial U.S. Approval: 2006

RECENT MAJOR CHANGES

Indications (1) 9/2008

INDICATIONS AND USAGE

GARDASIL is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:

— Cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18

— Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

— Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS)

— Cervical intraepithelial neoplasia (CIN) grade 1

— Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3

— Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3

DOSAGE AND ADMINISTRATION

0.5-mL suspension for intramuscular injection at the following schedule: 0, 2 months, 6 months. (2.1)

DOSAGE FORMS AND STRENGTHS

— 0.5-mL suspension for injection as a single-dose vial and prefilled syringe (3) (11)

CONTRAINDICATIONS

— Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL. (11).

WARNINGS AND PRECAUTIONS

— Women who receive GARDASIL should continue to undergo cervical cancer screening. (17.1)

— GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. (14.2)

— GARDASIL is not intended to be used for treatment of active genital warts; cervical, vulvar, and vaginal cancers; CIN; VIN; or VaIN. (5.1)

— GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. (14.3)

— Not all vulvar and vaginal cancers are caused by HPV and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV 16 and 18.

ADVERSE REACTIONS

The most common adverse reaction was headache. Common adverse reactions (frequency of at least 1.0% and greater than AAHS control or saline placebo) are fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising. (6.1)

Syncope has been reported following vaccination with GARDASIL, sometimes resulting in falling with injury; observation for 15 minutes after administration is recommended. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Merck & Co., Inc. at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

DRUG INTERACTIONS

GARDASIL may be administered concomitantly with RECOMBIVAX HB. (7.1)

USE IN SPECIFIC POPULATIONS

Safety and effectiveness of GARDASIL have not been established in the following populations:

— Pregnant women. Physicians are encouraged to register pregnant women exposed to GARDASIL by calling 1-800-986-8999 so that Merck can monitor maternal and fetal outcomes (8.1).

— Children below the age of 9 years and pediatric males of any age. (8.4)

— Women 27 years of age and older. (14.4).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 09/2008

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Dosage

2.2 Method of Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Limitations of GARDASIL Use and Effectiveness

5.2 Immunocompromised Individuals

5.3 Managing Allergic Reactions

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-Marketing Experience

7 DRUG INTERACTIONS

7.1 Use with RECOMBIVAX HB

7.2 Use with Hormonal Contraceptives

7.3 Use with Systemic Immunosuppressive Medications

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Prophylactic Efficacy – HPV Types 6, 11, 16, and 18 in Women 16 Through 26 Years of Age

14.2 Effectiveness of GARDASIL in Prevention of HPV Types 6-, 11-, 16-, or 18-Related Disease in Women 16 Through 26 Years of Age, Regardless of Current or Prior Exposure to Vaccine HPV Types

14.3 Effectiveness of GARDASIL in Prevention of Any HPV Type Related Genital Disease in Women 16 Through 26 Years of Age, Regardless of Current or Prior Infection with Vaccine or Non-Vaccine HPV Types

14.4 Other Studies

14.5 Immunogenicity

14.6 Studies with RECOMBIVAX HB

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Information for the Patient, Parent, or Guardian

17.2 FDA-Approved Patient Labeling

*Sections or subsections omitted from the full prescribing information are not listed.

GARDASIL(R)

(Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant) 9682308

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

GARDASIL(R)1 is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:

— Cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18

— Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

— Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS)

— Cervical intraepithelial neoplasia (CIN) grade 1

— Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3

— Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3

2 DOSAGE AND ADMINISTRATION

2.1 Dosage

GARDASIL should be administered intramuscularly as a 0.5-mL dose at the following schedule: 0, 2 months, 6 months. (See Clinical Studies (14.5).)

2.2 Method of Administration

Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. GARDASIL should not be diluted or mixed with other vaccines. After thorough agitation, GARDASIL is a white, cloudy liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the product if particulates are present or if it appears discolored.

GARDASIL should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.

Do not administer GARDASIL intravenously, intradermally, or subcutaneously.

Syncope has been reported following vaccination with GARDASIL and may result in falling with injury; observation for 15 minutes after administration is recommended.

Single-Dose Vial Use

Withdraw the 0.5-mL dose of vaccine from the single-dose vial using a sterile needle and syringe and use promptly.

Prefilled Syringe Use With and Without Needle Guard (Safety) Device

Prefilled Syringe With Needle Guard (Safety) Device

Instructions for using the prefilled single-dose syringes preassembled with needle guard (safety) device

(OBJECT OMITTED)

NOTE: Please use the enclosed needle for administration. If a different needle is chosen, it should fit securely on the syringe and be no longer than 1 inch to ensure proper functioning of the needle guard device. Two detachable labels are provided which can be removed after the needle is guarded.

At any of the following steps, avoid contact with the Trigger Fingers to keep from activating the safety device prematurely.

Remove Syringe Tip Cap and Needle Cap. Attach Luer Needle by pressing both Anti-Rotation Tabs to secure syringe and by twisting the Luer Needle in a clockwise direction until secured to the syringe. Remove Needle Sheath. Administer injection per standard protocol as stated above under DOSAGE AND ADMINISTRATION. Depress the Plunger while grasping the Finger Flange until the entire dose has been given. The Needle Guard Device will NOT activate to cover and protect the needle unless the ENTIRE dose has been given. While the Plunger is still depressed, remove needle from the vaccine recipient. Slowly release the Plunger and allow syringe to move up until the entire needle is guarded. For documentation of vaccination, remove detachable labels by pulling slowly on them. Dispose in approved sharps container.

Prefilled Syringe Without Needle Guard (Safety) Device

This package does not contain a needle guard (safety device) or a needle. Shake well before use. Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe. Administer the entire dose as per standard protocol.

3 DOSAGE FORMS AND STRENGTHS

GARDASIL is a suspension for intramuscular administration available in 0.5-mL single dose vials and prefilled syringes. See Description (11) for the complete listing of ingredients.

4 CONTRAINDICATIONS

Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL. (See Description (11).)

5 WARNINGS AND PRECAUTIONS

5.1 Limitations of GARDASIL Use and Effectiveness

The health care provider should inform the patient, parent, or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.

GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. (See Clinical Studies (14.2).)

GARDASIL is not intended to be used for treatment of active genital warts; cervical, vulvar, and vaginal cancers; CIN; VIN; or VaIN.

GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. (See Clinical Studies (14.3).)

Not all vulvar and vaginal cancers are caused by HPV and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV 16 and 18.

GARDASIL does not protect against genital diseases not caused by HPV.

Vaccination with GARDASIL may not result in protection in all vaccine recipients.

5.2 Immunocompromised Individuals

The immunologic response to GARDASIL may be diminished in immunocompromised individuals (See Drug Interactions (7.3)).

5.3 Managing Allergic Reactions

Appropriate medical treatment and supervision must be readily available in case of anaphylactic reactions following the administration of GARDASIL.

6 ADVERSE REACTIONS

Overall Summary of Adverse Reactions

Headache, fever, nausea, and dizziness; and local injection site reactions (pain, swelling, erythema, pruritus, and bruising) occurred after administration with GARDASIL.

Syncope has been reported following vaccination with GARDASIL and may result in falling with injury; observation for 15 minutes after administration is recommended.

Anaphylaxis has been reported following vaccination with GARDASIL.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

Studies in Girls and Women 9 Through 26 Years of Age

In 5 clinical trials (3 Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS)-controlled, 1 saline placebo-controlled, and 1 uncontrolled), 8878 subjects were administered GARDASIL or AAHS control or saline placebo on the day of enrollment, and approximately 2 and 6 months thereafter, and safety was evaluated using vaccination report cards (VRC)-aided surveillance for 14 days after each injection of GARDASIL or AAHS control or saline placebo in these subjects. The subjects who were monitored using VRC-aided surveillance included 5088 girls and women 9 through 26 years of age at enrollment who received GARDASIL and 3790 girls and women who received AAHS control or saline placebo. Few subjects (0.1%) discontinued due to adverse reactions. The race distribution of the study subjects was as follows: 62.3% White; 17.6% Hispanic (Black and White); 6.8% Asian; 6.7% Other; 6.4% Black; and 0.3% American Indian.

Common Injection Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age

The injection site adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients are shown in Table 1.

 Table 1 Injection-Site Adverse Reactions* ---------------------------------------------------------------------- GARDASIL  AAHS    Saline Adverse Reaction                              (N =     Control Placebo (1 to 5 Days Postvaccination)                  5088)     **     (N = %      (N =      320) 3470)     % % ---------------------------------------------------------------------- Injection Site Pain                                           83.9     75.4    48.6 Swelling                                       25.4     15.8     7.3 Erythema                                       24.7     18.4    12.1 Pruritus                                       3.2      2.8      0.6 Bruising                                       2.8      3.2      1.6 ---------------------------------------------------------------------- * The injection-site adverse reactions that were observed among recipients of GARDASIL were at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients. **AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate 

Evaluation of Injection-Site Adverse Reactions by Dose in Girls and Women 9 Through 26 Years of Age

An analysis of injection-site adverse reactions in girls and women by dose is shown in Table 2. Overall, 94.3% of girls and women who received GARDASIL judged their injection-site adverse reaction to be mild or moderate in intensity.

 Table 2 Postdose Evaluation of Injection-Site Adverse Reactions (1 to 5 Days Postvaccination) ---------------------------------------------------------------------- GARDASIL        AAHS Control*    Saline Placebo (% occurrence)    (% occurrence)    (% occurrence) ====================================================================== Post- Post- Post- Post- Post- Post- Post- Post- Post- Adverse     dose  dose  dose  dose  dose  dose  dose  dose  dose Reaction       1     2     3     1     2     3     1     2     3 N** = N =   N =   N =   N =   N =   N =   N =   N = 5011  4924  4818  3410  3351  3295  315   301   300 ---------------------------------------------------------------------- Pain             63.4  60.7  62.7  57.0  47.8  49.6  33.7  20.3  27.3 Mild/Moderate    62.5  59.7  61.2  56.6  47.3  48.9  33.3  20.3  27.0 Severe            0.9   1.0   1.5   0.4   0.5   0.6   0.3   0.0   0.3 ---------------------------------------------------------------------- Swelling***      10.2  12.8  15.1   8.2   7.5   7.6   4.4   3.0   3.3 Mild/Moderate     9.6  11.9  14.2   8.1   7.2   7.3   4.4   3.0   3.3 Severe            0.6   0.8   0.9   0.2   0.2   0.2   0.0   0.0   0.0 ---------------------------------------------------------------------- Erythema***       9.2  12.1  14.7   9.8   8.4   8.9   7.3   5.3   5.7 Mild/Moderate     9.0  11.7  14.3   9.5   8.4   8.8   7.3   5.3   5.7 Severe            0.2   0.3   0.4   0.3   0.1   0.1   0.0   0.0   0.0 ---------------------------------------------------------------------- *AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate **N = Number of subjects with follow up ***Intensity of swelling and erythema was measured by size (inches): Mild = 0 to (1 to (2. 

Common Systemic Adverse Reactions in Girls and Women 9 Through 26 Years of Age

Headache was the most commonly reported systemic adverse reaction in both treatment groups (GARDASIL = 28.2% and AAHS control or saline placebo = 28.4%). Fever was the next most commonly reported systemic adverse reaction in both treatment groups (GARDASIL = 13.0% and AAHS control or saline placebo = 11.2%).

Adverse reactions that were observed among recipients of GARDASIL, at a frequency of greater than or equal to 1.0% where the incidence in the GARDASIL group was greater than or equal to the incidence in the AAHS control or saline placebo group, are shown in Table 3.

 Table 3 Common Systemic Adverse Reactions (GARDASIL => Control)* ---------------------------------------------------------------------- Adverse Reactions                                  GARDASIL   AAHS (1 to 15 Days Postvaccination)                      (N =     control** 5088)   or Saline %       Placebo (N = 3790) % ---------------------------------------------------------------------- Pyrexia                                            13.0      11.2 Nausea                                               6.7       6.5 Dizziness                                            4.0       3.7 Diarrhea                                             3.6       3.5 Vomiting                                             2.4       1.9 Cough                                                2.0       1.5 Toothache                                            1.5       1.4 Upper respiratory tract infection                    1.5       1.5 Malaise                                              1.4       1.2 Arthralgia                                           1.2       0.9 Insomnia                                             1.2       0.9 Nasal congestion                                     1.1       0.9 ---------------------------------------------------------------------- * The adverse reactions in this table are those that were observed among recipients of GARDASIL at a frequency of at least 1.0% and greater than or equal to those observed among AAHS control or saline placebo recipients. **AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate 

Evaluation of Fever by Dose in Girls and Women 9 Through 26 Years of Age

An analysis of fever in girls and women by dose is shown in Table 4.

 Table 4 Postdose Evaluation of Fever (1 to 5 Days Postvaccination) ---------------------------------------------------------------------- GARDASIL           AAHS Control* or Saline (% occurrence)                 Placebo (% occurrence) ====================================================================== Temperature   Postdose Postdose Postdose Postdose Postdose Postdose (            1        2        3        1        2        3 (degree)F)     N** =   N = 4804 N = 4671 N = 3681 N = 3564 N = 3467 4945 ---------------------------------------------------------------------- (>=)100 to =)102       0.3      0.5      0.5      0.2      0.4      0.5 ---------------------------------------------------------------------- *AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate **N = Number of subjects with follow up 

Serious Adverse Reactions in the Entire Study Population

A total of 237 subjects out of 25,274 total subjects (9- through 45-year-old girls and women; and 9- through 15-year-old boys) who received both GARDASIL (N = 13,686) and AAHS control (N = 11,004) or saline placebo (N = 584) reported a serious systemic adverse reaction following any vaccination visit during the clinical trials for GARDASIL.

Out of the entire study population (25,274 subjects), only 0.05% of the reported serious systemic adverse reactions were judged to be vaccine related by the study investigator. The most frequently reported serious systemic adverse reactions for GARDASIL compared to AAHS control or saline placebo and regardless of causality were:

Headache (0.02% GARDASIL (3 cases) vs. 0.02% AAHS Control (2 cases)),

Gastroenteritis (0.02% GARDASIL (3 cases) vs. 0.02% AAHS Control (2 cases)),

Appendicitis (0.03% GARDASIL (4 cases) vs. 0.01% AAHS Control (1 case)),

Pelvic inflammatory disease (0.02% GARDASIL (3 cases) vs. 0.04% AAHS Control (4 cases)),

Urinary tract infection (0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)),

Pneumonia (0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)),

Pyelonephritis (0.02% GARDASIL (2 cases) vs. 0.03% AAHS Control (3 cases)),

Pulmonary embolism (0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)).

One case (0.007% GARDASIL: 0.0% AAHS Control or Saline Placebo) of bronchospasm; and 2 cases (0.02% GARDASIL: 0.0% AAHS Control or Saline Placebo) of asthma were reported as serious systemic adverse reactions that occurred following any vaccination visit.

In addition, there was 1 subject in the clinical trials, in the group that received GARDASIL, who reported two injection-site serious adverse reactions (injection-site pain and injection-site joint movement impairment).

Deaths in the Entire Study Population

Across the clinical studies, 24 deaths were reported in 25,274 (GARDASIL N = 13,686; AAHS Control N = 11,004, saline placebo N = 584) subjects (9- through 45-year-old girls and women; and 9- through 15-year-old boys). The events reported were consistent with events expected in healthy adolescent and adult populations. The most common cause of death was motor vehicle accident (4 subjects who received GARDASIL and 3 AAHS Control subjects), followed by overdose/suicide (2 subjects who received GARDASIL and 2 subjects who received AAHS Control), and pulmonary embolus/deep vein thrombosis (1 subject who received GARDASIL and 1 AAHS Control subject). In addition, there were 2 cases of sepsis, 1 case of pancreatic cancer, 1 case of arrhythmia, 1 case of pulmonary tuberculosis, 1 case of hyperthyroidism, 1 case of post-operative pulmonary embolism and acute renal failure, and 1 case of systemic lupus erythematosus in the group that received GARDASIL; 1 case of asphyxia, and 1 case of acute lymphocytic leukemia in the AAHS Control; and 1 case of medulloblastoma in the saline placebo group.

Systemic Autoimmune Disorders in Girls and Women 9 Through 26 Years of Age

In the clinical studies, 9- through 26-year-old girls and women were evaluated for new medical conditions that occurred over the course of follow-up. New medical conditions potentially indicative of a systemic autoimmune disorder seen in the group that received GARDASIL or AAHS control or saline placebo are shown in Table 5. This population includes all subjects who received at least one dose of GARDASIL or AAHS control or saline placebo, and had safety data available.

 Table 5 Summary of Girls and Women 9 Through 26 Years of Age Who Reported an Incident Condition Potentially Indicative of Systemic Autoimmune Disorder After Enrollment in Clinical Trials of GARDASIL Regardless of Causality ---------------------------------------------------------------------- GARDASIL    AAHS (N =     Control* 10,706)     or Saline Conditions                                Placebo (N = 9412) =================== n (%)     n (%) ====================================================================== Arthralgia/Arthritis/Arthropathy**                 120 (1.1) 98 (1.0) Autoimmune Thyroiditis                              4 (0.0)   1 (0.0) Coeliac Disease                                    10 (0.1)   6 (0.1) Diabetes Mellitus Insulin-dependent                 2 (0.0)   2 (0.0) Erythema Nodosum                                    2 (0.0)   4 (0.0) Hyperthyroidism***                                 27 (0.3)  21 (0.2) Hypothyroidism+                                    35 (0.3)  38 (0.4) Inflammatory Bowel Disease++                        7 (0.1)  10 (0.1) Multiple Sclerosis                                  2 (0.0)   4 (0.0) Nephritis
                                          2 (0.0)   5 (0.1) Optic Neuritis                                      2 (0.0)   0 (0.0) Pigmentation Disorderss.                            4 (0.0)   3 (0.0) Psoriasis#                                         13 (0.1)  15 (0.2) Raynaud's Phenomenon                                3 (0.0)   4 (0.0) Rheumatoid Arthritis++                              6 (0.1)   2 (0.0) Scleroderma/Morphea                                 2 (0.0)   1 (0.0) Stevens-Johnson Syndrome                            1 (0.0)   0 (0.0) Systemic Lupus Erythematosus                        1 (0.0)   3 (0.0) Uveitis                                             3 (0.0)   1 (0.0) ---------------------------------------------------------------------- All Conditions                                     245 (2.3) 218 (2.3) ---------------------------------------------------------------------- *AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate **Arthralgia/Arthritis/Arthropathy includes the following terms: Arthralgia, Arthritis, Arthritis reactive, and Arthropathy ***Hyperthyroidism includes the following terms: Basedow's disease, Goitre, Toxic nodular goitre, and Hyperthyroidism +Hypothyroidism includes the following terms: Hypothyroidism and thyroiditis ++Inflammatory bowel disease includes the following terms: Colitis ulcerative, Crohn's disease, and Inflammatory bowel disease 
Nephritis includes the following terms: Nephritis, Glomerulonephritis minimal lesion, Glomerulonephritis proliferative ss.Pigmentation disorder includes the following terms: Pigmentation disorder, Skin depigmentation, and Vitiligo #Psoriasis includes the following terms: Psoriasis, Pustular psoriasis, and Psoriatic arthropathy ++Rheumatoid arthritis includes juvenile rheumatoid arthritis. One subject counted in the rheumatoid arthritis group reported rheumatoid arthritis as an adverse experience at Day 130. N = Number of subjects enrolled n = Number of subjects with specific new Medical Conditions NOTE: Although a subject may have had two or more new Medical Conditions, the subject is counted only once within a category. The same subject may appear in different categories. 

Safety in Concomitant Use with RECOMBIVAX HB in Girls and Women 9 Through 26 Years of Age

The safety of GARDASIL when administered concomitantly with RECOMBIVAX HB hepatitis B vaccine (recombinant) was evaluated in an AAHS-controlled study of 1871 subjects with a mean age of 20.4 years. The race distribution of the study subjects was as follows: 61.6% White; 23.8% Other; 11.9% Black; 1.6% Hispanic (Black and White); 0.8% Asian; and 0.3% American Indian. The rates of systemic and injection-site adverse reactions were similar among subjects who received concomitant vaccination as compared with those who received GARDASIL or RECOMBIVAX HB hepatitis B vaccine.

6.2 Post-Marketing Experience

The following adverse events have been spontaneously reported during post-approval use of GARDASIL. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.

Blood and lymphatic system disorders: Autoimmune hemolytic anemia, lymphadenopathy.

Gastrointestinal disorders: Nausea, pancreatitis, vomiting.

General disorders and administration site conditions: Asthenia, death, fatigue, malaise.

Immune system disorders: Autoimmune diseases, hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria.

Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.

Nervous system disorders: Dizziness, Guillain-Barre syndrome, headache, motor neuron disease, paralysis, seizures, syncope sometimes resulting in falling with injury, transverse myelitis.

Vascular Disorders: Deep venous thrombosis, pulmonary embolus.

7 DRUG INTERACTIONS

7.1 Use with RECOMBIVAX HB

Results from clinical studies indicate that GARDASIL may be administered concomitantly (at a separate injection site) with RECOMBIVAX HB hepatitis B vaccine (recombinant) (See Clinical Studies (14.6)). Co-administration of GARDASIL with other vaccines has not been studied.

7.2 Use with Hormonal Contraceptives

In clinical studies, 13,293 subjects (GARDASIL N = 6644; AAHS control or saline placebo N = 6649) who had post-Month 7 follow-up used hormonal contraceptives for a total of 17,597 person-years (65.1% of the total follow-up time in the studies). Use of hormonal contraceptives or lack of use of hormonal contraceptives among study participants did not alter immune response in the per protocol efficacy (PPE) population.

7.3 Use with Systemic Immunosuppressive Medications

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines (See Warnings and Precautions (5.1)).

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category B:

Reproduction studies have been performed in female rats at doses up to 300 times the human dose (on a mg/kg basis) and have revealed no evidence of impaired female fertility or harm to the fetus due to GARDASIL. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, GARDASIL should be used during pregnancy only if clearly needed.

An evaluation of the effect of GARDASIL on embryo-fetal, pre- and postweaning development was conducted using rats. One group of rats was administered GARDASIL twice prior to gestation, during the period of organogenesis (gestation Day 6) and on lactation Day 7. A second group of pregnant rats was administered GARDASIL during the period of organogenesis (gestation Day 6) and on lactation Day 7 only. GARDASIL was administered at 0.5 mL/rat/occasion (approximately 300-fold excess relative to the projected human dose on a mg/kg basis) by intramuscular injection. No adverse effects on mating, fertility, pregnancy, parturition, lactation, embryo-fetal or pre- and postweaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted in this study. In addition, there were no treatment-related effects on developmental signs, behavior, reproductive performance, or fertility of the offspring. The effect of GARDASIL on male fertility has not been studied.

In clinical studies, women underwent urine pregnancy testing prior to administration of each dose of GARDASIL. Women who were found to be pregnant before completion of a 3-dose regimen of GARDASIL were instructed to defer completion of their vaccination regimen until resolution of the pregnancy.

GARDASIL is not indicated for women 27 years of age or older. However, safety data in women 16 through 45 years of age was collected, and 3620 women (GARDASIL N = 1796 vs. AAHS control or saline placebo N = 1824) reported at least 1 pregnancy each.

The overall proportions of pregnancies that resulted in an adverse outcome, defined as the combined numbers of spontaneous abortion, late fetal death, and congenital anomaly cases out of the total number of pregnancy outcomes for which an outcome was known (and excluding elective terminations), were 23.3% (423/1812) in subjects who received GARDASIL and 24.1% (438/1820) in subjects who received AAHS control or saline placebo.

Overall, 54 and 63 subjects in the group that received GARDASIL or AAHS control or saline placebo, respectively (3.0% and 3.5% of all subjects who reported a pregnancy in the respective vaccination groups), experienced a serious adverse reaction during pregnancy. The most common events reported were conditions that can result in Caesarean section (e.g., failure of labor, malpresentation, cephalopelvic disproportion), premature onset of labor (e.g., threatened abortions, premature rupture of membranes), and pregnancy-related medical problems (e.g., pre-eclampsia, hyperemesis). The proportions of pregnant subjects who experienced such events were comparable between the groups receiving GARDASIL and AAHS control or saline placebo.

There were 40 cases of congenital anomaly in pregnancies that occurred in subjects who received GARDASIL and 30 cases of congenital anomaly in pregnancies that occurred in subjects who received AAHS control or saline placebo.

Further sub-analyses were conducted to evaluate pregnancies with estimated onset within 30 days or more than 30 days from administration of a dose of GARDASIL or AAHS control or saline placebo. For pregnancies with estimated onset within 30 days of vaccination, 5 cases of congenital anomaly were observed in the group that received GARDASIL compared to 1 case of congenital anomaly in the group that received AAHS control or saline placebo. The congenital anomalies seen in pregnancies with estimated onset within 30 days of vaccination included pyloric stenosis, congenital megacolon, congenital hydronephrosis, hip dysplasia, and club foot. Conversely, in pregnancies with onset more than 30 days following vaccination, 35 cases of congenital anomaly were observed in the group that received GARDASIL compared with 29 cases of congenital anomaly in the group that received AAHS control or saline placebo.

Pregnancy Registry for GARDASIL

Merck & Co., Inc. maintains a Pregnancy Registry to monitor fetal outcomes of pregnant women exposed to GARDASIL. Patients and health care providers are encouraged to report any exposure to GARDASIL during pregnancy by calling (800) 986-8999.

8.3 Nursing Mothers

Women 16 Through 26 Years of Age

It is not known whether GARDASIL is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GARDASIL is administered to a nursing woman.

A total of 995 nursing mothers (vaccine N = 500, AAHS control N = 495) were given GARDASIL or AAHS control during the vaccination period of the clinical trials.

Overall, 21 and 10 infants of subjects who received GARDASIL or AAHS control, respectively (representing 4.2% and 2.0% of the total number of subjects who were breast-feeding during the period in which they received GARDASIL or AAHS control, respectively), experienced a serious adverse reaction.

In a post-hoc analysis of clinical studies, a higher number of breast-feeding infants (n = 6) whose mothers received GARDASIL had acute respiratory illnesses within 30 days post-vaccination of the mother as compared to infants (n = 2) whose mothers received AAHS control. In these studies, the rates of other adverse reactions in the mother and the nursing infant were comparable between vaccination groups.

8.4 Pediatric Use

Safety and effectiveness have not been established in pediatric patients below 9 years of age nor in pediatric males of any age.

Clinical studies of pediatric males 9 through 15 years of age were conducted and contributed safety data to the serious adverse reactions and deaths. (See Adverse Reactions (6.1).)

8.5 Geriatric Use

The safety and effectiveness of GARDASIL have not been evaluated in subjects aged 65 years and over.

10 OVERDOSAGE

There have been reports of administration of higher than recommended doses of GARDASIL.

In general, the adverse event profile reported with overdose was comparable to recommended single doses of GARDASIL.

11 DESCRIPTION

GARDASIL, Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant, is a non-infectious recombinant quadrivalent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, and 18. The L1 proteins are produced by separate fermentations in recombinant Saccharomyces cerevisiae and self-assembled into VLPs. The fermentation process involves growth of S. cerevisiae on chemically-defined fermentation media which include vitamins, amino acids, mineral salts, and carbohydrates. The VLPs are released from the yeast cells by cell disruption and purified by a series of chemical and physical methods. The purified VLPs are adsorbed on preformed aluminum-containing adjuvant (Amorphous Aluminum Hydroxyphosphate Sulfate). The quadrivalent HPV VLP vaccine is a sterile liquid suspension that is prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum-containing adjuvant and the final purification buffer.

GARDASIL is a sterile suspension for intramuscular administration. Each 0.5-mL dose contains approximately 20 mcg of HPV 6 L1 protein, 40 mcg of HPV 11 L1 protein, 40 mcg of HPV 16 L1 protein, and 20 mcg of HPV 18 L1 protein.

Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate,

After thorough agitation, GARDASIL is a white, cloudy liquid.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

HPV only infects human beings. Animal studies with analogous animal papillomaviruses suggest that the efficacy of L1 VLP vaccines may involve the development of humoral immune responses. Human beings develop a humoral immune response to the vaccine, although the exact mechanism of protection is unknown.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity.

GARDASIL administered to female rats at a dose of 120 mcg total protein, which corresponds to approximately 300-fold excess relative to the projected human dose, had no effects on mating performance, fertility, or embryonic/fetal survival.

14 CLINICAL STUDIES

CIN 2/3 and AIS are the immediate and necessary precursors of squamous cell carcinoma and adenocarcinoma of the cervix, respectively. Their detection and removal has been shown to prevent cancer; thus, they serve as surrogate markers for prevention of cervical cancer. In the clinical studies, cases of CIN 2/3 and AIS were the efficacy endpoints to assess prevention of cervical cancer. In addition, cases of vulvar and vaginal intraepithelial neoplasia (VIN 2/3 and VaIN 2/3) were the efficacy endpoints to assess prevention of HPV-related vulvar and vaginal cancers, and observations of external genital lesions were the efficacy endpoints for the prevention of genital warts.

Efficacy was assessed in 4 AAHS-controlled, double-blind, randomized Phase II and III clinical studies. The first Phase II study evaluated the HPV 16 component of GARDASIL (Protocol 005 or Study 1, N = 2391) and the second evaluated all components of GARDASIL (Protocol 007 or Study 2, N = 551). The Phase III studies evaluated GARDASIL in 5442 (Study 3 or Protocol 013 (FUTURE I)) and 12,157 (Study 4 or Protocol 015 (FUTURE II)) subjects. Together, these four studies evaluated 20,541 women 16 through 26 years of age at enrollment with a mean age of 20.0 years. The race distribution of the study subjects was as follows: 70.4% White; 12.2% Hispanic (Black and White); 8.8% Other; 4.6% Black; 3.8% Asian; and 0.2% American Indian. The median duration of follow-up was 4.0, 3.0, 3.0, and 3.0 years for Study 1, Study 2, Study 3, and Study 4, respectively. Subjects received vaccine or AAHS control on the day of enrollment and 2 and 6 months thereafter. Efficacy was analyzed for each study individually and for all studies combined according to a prospective clinical plan.

Overall, 73% of subjects were naive (i.e., PCR (Polymerase Chain Reaction) negative and seronegative for all 4 vaccine HPV types) to all 4 vaccine HPV types at enrollment.

A total of 27% of subjects had evidence of prior exposure to or ongoing infection with at least 1 of the 4 vaccine HPV types. Among these subjects, 74% had evidence of prior exposure to or ongoing infection with only 1 of the 4 vaccine HPV types and were naive (PCR negative and seronegative) to the remaining 3 types.

In subjects who were naive (PCR negative and seronegative) to all 4 vaccine HPV types, CIN, genital warts, VIN, and VaIN caused by any of the 4 vaccine HPV types were counted as endpoints.

Among subjects who were positive (PCR positive and/or seropositive) for a vaccine HPV type at Day 1, endpoints related to that type were not included in the analyses of prophylactic efficacy. Endpoints related to the remaining types for which the subject was naive (PCR negative and seronegative) were counted.

For example, in subjects who were HPV 18 positive (PCR positive and/or seropositive) at Day 1, lesions caused by HPV 18 were not counted in the prophylactic efficacy evaluations. Lesions caused by HPV 6, 11, and 16 were included in the prophylactic efficacy evaluations. The same approach was used for the other types.

14.1 Prophylactic Efficacy – HPV Types 6, 11, 16, and 18 in Women 16 Through 26 Years of Age

GARDASIL was administered without prescreening for presence of HPV infection and the efficacy trials allowed enrollment of subjects regardless of baseline HPV status (i.e., PCR status or serostatus). Subjects with current or prior HPV infection with an HPV type contained in the vaccine were not eligible for prophylactic efficacy evaluations for that type.

The primary analyses of efficacy with respect to HPV types 6, 11, 16, and 18 were conducted in the per-protocol efficacy (PPE) population, consisting of individuals who received all 3 vaccinations within 1 year of enrollment, did not have major deviations from the study protocol, and were naive (PCR negative in cervicovaginal specimens and seronegative) to the relevant HPV type(s) (Types 6, 11, 16, and 18) prior to dose 1 and through 1 month Postdose 3 (Month 7). Efficacy was measured starting after the Month 7 visit.

GARDASIL was efficacious in reducing the incidence of CIN (any grade including CIN 2/3); AIS; genital warts; VIN (any grade); and VaIN (any grade) related to vaccine HPV types 6, 11, 16, or 18 in those who were PCR negative and seronegative at baseline (Table 6).

In addition, individuals who were already infected with 1 or more vaccine-related HPV types prior to vaccination were protected from precancerous cervical lesions and external genital lesions caused by the other vaccine HPV types.

 Table 6 Analysis of Efficacy of GARDASIL in the PPE* Population** of 16- Through 26-Year-Old Women for Vaccine HPV Types ---------------------------------------------------------------------- GARDASIL   AAHS Control Population         -------------------- % Efficacy (95% CI) Number    Number N    of   N    of cases     cases ====================================================================== HPV 16- or 18-related CIN 2/3 or AIS ---------------------------------------------------------------------- Study 1***         755   0   750   12   100.0 (65.1, 100.0) ---------------------------------------------------------------------- Study 2           231   0   230   1   100.0 (-3744.9, 100.0) ---------------------------------------------------------------------- Study 3           2201  0   2222  36   100.0 (89.2, 100.0) ---------------------------------------------------------------------- Study 4           5306  2   5262  63    96.9 (88.2, 99.6) ---------------------------------------------------------------------- Combined Protocols++    8493  2   8464 112    98.2 (93.5, 99.8) ====================================================================== HPV 16-related CIN 2/3 or AIS ---------------------------------------------------------------------- Combined Protocols++    7402  2   7205  93    97.9 (92.3, 99.8) ====================================================================== HPV 18-related CIN 2/3 or AIS ---------------------------------------------------------------------- Combined Protocols++    7382  0   7316  29   100.0 (86.6, 100.0) ====================================================================== HPV 16- or 18-related VIN 2/3 ---------------------------------------------------------------------- Study 2           231   0   230   0       Not calculated ---------------------------------------------------------------------- Study 3           2219  0   2239  6    100.0 (14.4, 100.0) ---------------------------------------------------------------------- Study 4           5322  0   5275  4    100.0 (-50.3, 100.0) ---------------------------------------------------------------------- Combined Protocols++    7772  0   7744  10   100.0 (55.5, 100.0) ====================================================================== HPV 16- or 18-related VaIN 2/3 ---------------------------------------------------------------------- Study 2           231   0   230   0       Not calculated ---------------------------------------------------------------------- Study 3           2219  0   2239  5    100.0 (-10.1, 100.0) ---------------------------------------------------------------------- Study 4           5322  0   5275  4    100.0 (-50.3, 100.0) ---------------------------------------------------------------------- Combined Protocols++    7772  0   7744  9    100.0 (49.5, 100.0) ---------------------------------------------------------------------- HPV 6-, 11-, 16-, or 18-related CIN (CIN 1, CIN 2/3) or AIS ---------------------------------------------------------------------- Study 2           235   0   233   3   100.0 (-138.4, 100.0) ---------------------------------------------------------------------- Study 3           2241  0   2258  77   100.0 (95.1, 100.0) ---------------------------------------------------------------------- Study 4           5388  9   5374 145    93.8 (88.0, 97.2) ---------------------------------------------------------------------- Combined Protocols++    7864  9   7865 225    96.0 (92.3, 98.2) ====================================================================== HPV 6-, 11-, 16-, or 18-related Genital Warts ---------------------------------------------------------------------- Study 2           235   0   233   3   100.0 (-139.5, 100.0) ---------------------------------------------------------------------- Study 3           2261  0   2279  58   100.0 (93.5, 100.0) ---------------------------------------------------------------------- Study 4           5404  2   5390 132    98.5 (94.5, 99.8) ---------------------------------------------------------------------- Combined Protocols++    7900  2   7902 193    99.0 (96.2, 99.9) ====================================================================== HPV 6- and 11-related Genital Warts ---------------------------------------------------------------------- Combined Protocols++    6932  2   6856 189    99.0 (96.2, 99.9) ---------------------------------------------------------------------- * The PPE population consisted of individuals who received all 3 vaccinations within 1 year of enrollment, did not have major deviations from the study protocol, and were naive (PCR negative and seronegative) to the relevant HPV type(s) (Types 6, 11, 16, and 18) prior to dose 1 and through 1 month postdose 3 (month 7). **See Table 7 for analysis of vaccine impact in the general population ***Evaluated only the HPV 16 L1 VLP vaccine component of GARDASIL ++Analyses of the combined trials were prospectively planned and included the use of similar study entry criteria N = Number of subjects with at least 1 follow-up visit after Month 7 CI = Confidence Interval Note 1: Point estimates and confidence intervals are adjusted for person-time of follow-up Note 2: The first analysis in the table (i.e., HPV 16- or 18-related CIN 2/3, AIS or worse) was the primary endpoint of the vaccine development plan. Note 3: Study 1 = Protocol 005; Study 2 = Protocol 007; Study 3 = Protocol 013; and Study 4 = Protocol 015 Note 4: Table 6 does not include cases due to non-vaccine HPV types AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate 

Prophylactic efficacy against overall cervical and genital disease related to HPV 6, 11, 16, and 18 in an extension phase of Study 2, that included data through month 60, was noted to be 100% (95% CI: 12.3%, 100.0%) among subjects in the per protocol population naive to the relevant HPV types.

GARDASIL was efficacious against HPV disease caused by HPV types 6, 11, 16, and 18 in women who were naive for those specific HPV types at baseline.

14.2 Effectiveness of GARDASIL in Prevention of HPV Types 6-, 11-, 16-, or 18-Related Disease in Women 16 Through 26 Years of Age, Regardless of Current or Prior Exposure to Vaccine HPV Types

The clinical trials included women regardless of current or prior exposure to vaccine HPV types, and additional analyses were conducted to evaluate the impact of GARDASIL with respect to HPV 6-, 11-, 16-, and 18-related cervical and genital disease in these women. Here, analyses included events arising among women regardless of baseline PCR status and serostatus, including HPV infections that were present at the start of vaccination as well as events that arose from infections that were acquired after the start of vaccination.

The impact of GARDASIL in women regardless of current or prior exposure to a vaccine HPV type is shown in Table 7. Impact was measured starting 1 month Postdose 1. Prophylactic efficacy denotes the vaccine’s efficacy in women who are naive (PCR negative and seronegative) to the relevant HPV types at vaccination onset. Vaccine impact in women who were positive for vaccine HPV infection, as well as vaccine impact among women regardless of baseline vaccine HPV PCR status and serostatus are also presented. The majority of CIN and genital warts, VIN, and VaIN related to a vaccine HPV type detected in the group that received GARDASIL occurred as a consequence of HPV infection with the relevant HPV type that was already present at Day 1.

There was no clear evidence of protection from disease caused by HPV types for which women were PCR positive regardless of serostatus at baseline.

 Table 7 Effectiveness of GARDASIL against HPV 6, 11, 16, or 18 Related Disease in Women 16 Through 26 Years of Age, Regardless of Current or Prior Exposure to Vaccine HPV Types ---------------------------------------------------------------------- GARDASIL or HPV    AAHS 16 L1   Control   % Reduction Endpoints         Analysis     VLP                (95% CI) Vaccine ------------------ N  Cases N  Cases ====================================================================== Prophylactic Efficacy* 9346  4  9407 155 97.4 (93.3, 99.3) ----------------------------------------------- HPV 16- or 18-related    HPV 16 CIN 2/3 or AIS     and/or HPV              148** 18 Positive at Day 1  2870 142 2898            -- ----------------------------------------------- Women regardless of Current                     51.8 (41.1, or Prior                          60.7)+ Exposure to HPV 16 or 18 **   9836 146 9904 303 ====================================================================== Prophylactic Efficacy* 8642  1  8673 34  97.0 (82.4, 99.9) ----------------------------------------------- HPV 16- or 18-related    HPV 16 VIN 2/3 or VaIN 2/3   and/or HPV 18 Positive at Day 1  1880  8  1876  4         -- ----------------------------------------------- Women regardless of Current                     76.3 (50.0, or Prior                          89.9)+ Exposure to HPV 16 or 18***   8955  9  8968 38 ====================================================================== Prophylactic Efficacy* 8630 16  8680 309 94.8 (91.5, 97.1) ----------------------------------------------- HPV 6-, 11-, 16-, 18- HPV 6, HPV related CIN (CIN 1,   11, HPV 16, CIN 2/3) or AIS     and/or HPV     186++    213++ 18 Positive at Day 1  2466     2437            -- ----------------------------------------------- Women regardless of Current                     61.5 (54.6, or Prior                          67.4)+ Exposure to Vaccine HPV Types***  8819 202 8854 522 ====================================================================== Prophylactic Efficacy* 8761 10  8792 252 96.0 (92.6, 98.1) ----------------------------------------------- HPV 6-, 11-, 16-, or  HPV 6, HPV 18-related Genital    11, HPV 16, Warts          and/or HPV 18 Positive at Day 1  2501 51# 2475 55#        -- ----------------------------------------------- Women regardless of Current                     80.3 (73.9, or Prior                          85.3)+ Exposure to Vaccine HPV Types***  8955 61  8968 307 ---------------------------------------------------------------------- Prophylactic Efficacy* 7769  9  7792 246 96.4 (9
 

SAN DIEGO, Nov. 13 /PRNewswire/ — Ambrx Inc. today announced Phase I/II clinical trial data demonstrating that ARX201, the company’s long-acting human growth hormone (hGH) analogue developed in collaboration with Merck Serono, normalized insulin-like growth factor I (IGF-I) levels while delivering an acceptable safety and tolerability profile in adults with Growth Hormone deficiency. The results of this trial support further evaluation of ARX201 as an option for the treatment of adult growth hormone deficiency (AGHD).

In the 26-week study, normal levels of IGF-I, a marker for hGH activity, were maintained with injections given once a week. The clinical trial results were presented today at the International Congress of Endocrinology Conference in Rio de Janeiro by Andrew Hoffman, M.D., Professor of Medicine and Vice Chair for Academic Affairs at Stanford University.

“We are very excited by these promising clinical results and are hopeful that ARX201 will provide a better treatment option for patients with AGHD that currently require daily injections,” said Stephen Kaldor, Ph.D., president and CEO of Ambrx. “Additionally, this study provides proof of concept that protein analogues made using Ambrx’s ReCODE(TM) technology have retained potency with an improved pharmacological profile over conventional protein therapeutics. This opens the door for Ambrx to create more effective protein-based therapies across a broad range of treatment classes.”

The Phase I/II study of ARX201, analyzed 22 AGHD patients who had not received hGH replacement therapy in the six months prior to the trial. ARX201 was administered by subcutaneous injection on a weekly basis for 26 weeks. IGF-I levels increased to normal values and remained such throughout the course of the trial. Patients experienced a mean truncal fat loss of 5.6 percent and a mean total body fat loss of 1.3 percent. The mean increase in lean body mass was 3.6 percent. ARX201 was well tolerated with temporary pain at the injection site as the only reported side effect. No neutralizing antibodies to either PEGylated GH or to native GH were detected throughout the study.

About ARX201

ARX201 is a long-acting recombinant human growth hormone drug candidate currently developed by Ambrx and Merck Serono for the treatment of growth hormone deficiencies. ARX201 was generated through a lead optimization process using Ambrx’s ReCODE(TM) technology, which effectively enables protein medicinal chemistry. Through this approach, Ambrx was able to generate site specific mono-pegylated hGH molecules that were optimized for potency and time of action. Ambrx believes that ARX201 may have improved pharmacological performance over existing growth hormone products, including the potential for less frequent dosing.

In pre-clinical studies, ARX201 met or exceeded key end points in assays that are believed to be predictive of human pharmacokinetics and biological response. In February 2007, a Phase I/II clinical trial of ARX201 was initiated to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of this product candidate in adult patients with growth hormone deficiency following single-dose escalation and repeated dosing.

About Ambrx

Ambrx Inc. is a clinical stage biopharmaceutical company with a broad biologics platform that allows it to create best-in-class protein therapeutics, including improved versions of native proteins and therapeutic antibodies. Its most advanced product candidate, ARX201, is a long-acting human growth hormone drug candidate partnered with Merck Serono that has successfully completed initial clinical trials. The company has further validated its biologics platform through substantial partnerships with Eli Lilly and Company and Merck & Co. Ambrx is advancing a robust portfolio of product opportunities spanning multiple therapeutic areas that are highly optimized for efficacy, safety, and ease of use. For additional information, call 858.875.2400 or visit http://www.ambrx.com/.

   Media Contacts:   Heidi Chokeir or David Schull   Russo Partners, LLC   (619)814-3512   [email protected]   [email protected]  

Ambrx Inc.

CONTACT: Heidi Chokeir, [email protected], or DavidSchull [email protected], both of Russo Partners, LLC,+1-619-814-3512

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

Reportlinker.com announces that a new market research report related to the Pharmaceutical industry industry is available in its catalogue.

Global Pharmaceutical Markets

http://www.reportlinker.com/p096616/Global-Pharmaceutical-Markets .html

(Due to its length, this URL may need to be copied/pasted into your Internet browser’s address field. Remove the extra space if one exists.)

Reviews global markets for prescription and over-the-counter therapeutic drugs and forecasts sales through 2012. Analyzes epidemiological, technological, drug development, regulatory, and competitive factors expected to influence drug sales and offers a qualitative as well as quantitative picture of the world pharmaceutical market in 2012. Discusses epidemiology, treatment algorithms, and relevant major manufacturers for each indication, accompanied by an analysis of current sales, major trends and future sales within this indication. Indications include cardiovascular disease, cancer, diabetes, depression and anxiety, infectious diseases, and others. Drug classes selected for analysis include cholesterol and triglyceride reducers, anti-ulcerants, antidepressants, antirheumatic non-steroidals, antipsychotics, calcium antagonists, erythropoeitins, ACE inhibitors, selected anti-cancer therapeutics, and others. Covers novel therapeutic monoclonal antibodies, therapeutic vaccines, stem cell products, and engineered therapeutic foods. The report discusses both expected and alternative scenarios for selected drug classes. Includes market shares, competitive analysis, regulatory considerations, patent analyses, and complete company profiles.

MAY 2008

INTRODUCTION

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THE STUDY

AUDIENCE FOR THE REPORT

SCOPE AND FORMAT

METHODOLOGY AND INFORMATION SOURCES

BCC INFORMATION AND RELATED BCC STUDIES

AUTHOR’S CREDENTIALS

BCC ONLINE SERVICES

DISCLAIMER

SUMMARY

AGING POPULATIONS AND CHRONIC DISEASES

OVERALL GLOBAL PHARMACEUTICAL MARKETS

SUMMARY TABLE WORLDWIDE MARKET PHARMACEUTICAL PRODUCTS, THROUGH 2013 ($ BILLIONS)

SUMMARY FIGURE WORLDWIDE MARKET PHARMACEUTICAL PRODUCTS, 2006-2013 ($ BILLIONS)

OVERVIEW

BACKGROUND ON THE INDUSTRY

RECENT HISTORY

BENEFITS, PROBLEMS, AND REGULATION

CHANGES IN THE INDUSTRY

HEALTHCARE EXPENDITURES

TABLE 1 HEALTHCARE EXPENDITURES, COUNTRIES IN THIS REPORT, 2000 AND 2005 (% OF GDP)

THE PHARMACEUTICAL INDUSTRY

TABLE 2 WORLDWIDE LEADING ETHICAL PHARMACEUTICAL COMPANIES: SALES AND MARKET SHARE, 2006 AND 2007 ($ BILLIONS)

RESEARCH AND DEVELOPMENT EXPENDITURES

TABLE 3 WORLDWIDE LEADING PHARMACEUTICAL COMPANIES BY R&D SPENDING, 2006 AND 2007 ($ BILLIONS)

SECTOR PERFORMANCE

BRANDED PHARMACEUTICALS

TABLE 4 LARGEST PHARMACEUTICAL MARKETS (OVERALL), 2006 AND 2007 ($ BILLIONS, % OF TOTAL)

TABLE 5 LARGEST PHARMACEUTICAL MARKETS (BRANDED), 2006 AND 2007 ($ BILLIONS, % OF TOTAL)

TABLE 6 WORLDWIDE LEADING PHARMACEUTICAL LARGEST PHARMACEUTICAL MARKETS (GENERIC), 2006 AND 2007 ($ BILLIONS, % OF TOTAL)

TABLE 7 LARGEST PHARMACEUTICAL MARKETS (OTC), 2006 AND 2007 ($ BILLIONS, % OF TOTAL)

UNITED STATES

INTRODUCTION

TABLE 8 OVERALL PHARMACEUTICAL MARKET, U.S., THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 9 POPULATION TRENDS, U.S., THROUGH 2013 (MILLIONS)

FIGURE 1 U.S. POPULATION, 1998-2013 (MILLIONS)

TABLE 10 DEMOGRAPHIC TRENDS, U.S., THROUGH 2013 (MILLIONS)

THE U.S. HEALTHCARE SYSTEM

HEALTHCARE EXPENDITURES IN THE U.S

FIGURE 2 U.S. HEALTHCARE EXPENDITURES, 1980-2006 ($ BILLIONS)

TABLE 11 HEALTHCARE EXPENDITURE, U.S., 2000 AND 2006

TABLE 12 MOST EXPENSIVE MEDICAL CONDITIONS, U.S., 2004 ($ BILLIONS, %)

TABLE 13 PRESCRIPTION DRUG EXPENDITURES BY CATEGORY, 2006 ($ BILLIONS)

COMMON HEALTH PROBLEMS IN THE U.S.

TABLE 14 LEADING CAUSES OF DEATH, U.S. 1997-2005 (%)

ALZHEIMER’S DISEASE (AD) AND RELATED DEMENTIAS

OBESITY AND RELATED CONDITIONS

DIABETES

CARDIOVASCULAR DISEASE

TABLE 15 CARDIOVASCULAR DISEASE, U.S., 2005 (%)

SMOKING

CANCER

TABLE 16 INVASIVE CANCER, U.S., 2004 (%)

TABLE 16 (CONTINUED)

TABLE 17 CANCER DEATHS, U.S., 2004 (%)

TABLE 18 CANCER DEATHS, U.S., 2004 (RATIO OF DEATHS: NEW CASES)

HIV INFECTION

GOVERNMENT REGULATIONS

INTRODUCTION

DRUG DISCOVERY

Preclinical Testing and Submission of an IND

CLINICAL TRIALS

TIMELINE AND COSTS

SUBMISSION OF AN NDA OR BLA

POST-FDA APPROVAL

NEW DRUG APPROVALS

FIGURE 3 NME APPROVALS, 1997-2007

FIGURE 4 NME APPROVALS IN TWO SEVEN-YEAR PERIODS, 1994-2007

TABLE 19 NEW MOLECULAR ENTITIES APPROVED BY THE FDA, 1980 TO MARCH 20, 2007

DO CURRENT CORPORATE MANAGEMENT PRACTICES HAVE A ROLE IN R&D SHORTFALLS?

BLOCKBUSTER DRUGS

TABLE 20 NME APPROVALS BY DISORDER, 2004-MARCH 20, 2008

OTHER SUCCESSFUL THERAPEUTIC AGENTS

TABLE 21 BOTOX SALES, 1993-2012 ($ MILLIONS)

IS THE NIH FUNDING CRISIS CONTRIBUTING TO SHORTFALLS IN DRUG DISCOVERY?

PHARMACEUTICAL PRICING

FACTORS AFFECTING DRUG PRICES

PHARMACY BENEFIT MANAGERS (PBMS)

TABLE 22 MARKET SHARE: PHARMACY BENEFIT MANAGERS, 2007 (%)

Pharmacy Benefit Managers … (Continued)

PHARMACEUTICAL FLOW FROM MANUFACTURER TO PATIENT

PHARMACEUTICAL WHOLESALING

TABLE 23 MARKET SHARE: U.S. WHOLESALERS, 2007 (%, $ BILLIONS)

PHARMACEUTICAL RETAILING

TABLE 24 LEADING DRUG RETAILERS RX VOLUME, U.S., 2002 AND 2007 (RX MILLIONS)

EXPORT-IMPORT PROFILE

TABLE 25 EXPORT-IMPORT PROFILE, U.S., 1995-2006 ($ BILLIONS)

MARKET SECTORS

BRANDED PRESCRIPTION PHARMACEUTICALS

TABLE 26 BRANDED PHARMACEUTICAL MARKET, U.S., THROUGH 2013 ($ BILLIONS)

TABLE 27 TOP 10 SELLING U.S. DRUGS, 2006 AND 2007 ($ BILLIONS)

GENERIC DRUGS

TABLE 28 GENERIC PRESCRIPTION PHARMACEUTICAL MARKET, U.S., THROUGH 2013 ($ BILLIONS)

OVER-THE-COUNTER (OTC) MEDICATIONS IN THE U.S.

TABLE 29 OTC PHARMACEUTICAL MARKET, U.S., THROUGH 2013 ($ BILLIONS)

IMPORTANT ORGANIZATIONS IN THE U.S

PHRMA, THE PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

GPHA, GENERIC PHARMACEUTICAL ASSOCIATION

CHPA (CONSUMER HEALTHCARE PRODUCTS ASSOCIATION)

COMPANY PROFILES: UNITED STATES

ABBOTT LABORATORIES

BIOGEN IDEC

AMGEN

BRISTOL-MYERS SQUIBB

FOREST LABORATORIES

GENENTECH

GENZYME

JOHNSON & JOHNSON

ELI LILLY AND COMPANY

MERCK & CO. INC

PFIZER

WYETH PHARMACEUTICALS

TEVA PHARMACEUTICALS

Teva North America

CANADA

INTRODUCTION

TABLE 30 OVERALL PHARMACEUTICAL MARKET, CANADA, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 31 POPULATION TRENDS, CANADA, THROUGH 2013 (MILLIONS)

FIGURE 5 CANADA: POPULATION 1998-2013 (MILLIONS)

TABLE 32 DEMOGRAPHIC TRENDS, CANADA, THROUGH 2013 (MILLIONS)

THE CANADIAN HEALTHCARE SYSTEM

HEALTHCARE EXPENDITURE IN CANADA

TABLE 33 HEALTHCARE EXPENDITURE: CANADA, 2000 AND 2005

COMMON HEALTH PROBLEMS IN CANADA

ALZHEIMER’S DISEASE AND RELATED DEMENTIAS

OBESITY AND RELATED CONDITIONS

DIABETES

CARDIOVASCULAR DISEASE AND CANCER

HIV INFECTION

PHARMACEUTICAL PRICING

MARKET SECTORS

BRANDED PRESCRIPTION PHARMACEUTICALS

TABLE 34 BRANDED PHARMACEUTICAL MARKET, CANADA, THROUGH 2013 ($ BILLIONS)

GENERIC DRUGS

TABLE 35 GENERIC PHARMACEUTICAL MARKET, CANADA, THROUGH 2013 ($ BILLIONS)

OVER-THE-COUNTER (OTC) MEDICATIONS IN CANADA

TABLE 36 OTC PHARMACEUTICAL MARKET, CANADA, THROUGH 2013 ($ BILLIONS)

TABLE 37 TOP SELLING CATEGORIES OF OTC MEDICATIONS IN CANADA (%)

IMPORTANT ORGANIZATIONS IN CANADA

STATISTICS CANADA

RX&D, CANADA’S RESEARCH-BASED PHARMACEUTICAL COMPANIES

CGPA (CANADIAN GENERIC PHARMACEUTICAL ASSOCIATION)

NDMAC (THE NONPRESCRIPTION DRUG MANUFACTURERS ASSOCIATION OF CANADA)

COMPANY PROFILES: CANADA

ABBOTT LABORATORIES, LIMITED

ACTELION

ASTRAZENECA CANADA INC.

BAYER, INC

BRISTOL-MYERS SQUIBB CANADA

ELI LILLY CANADA INC.

GLAXOSMITHKLINE INC.

HOFFMANN-LA ROCHE LIMITED

LUNDBECK CANADA INC.

MERCK FROSST CANADA LTD

NOVARTIS PHARMACEUTICALS CANADA INC.

PFIZER CANADA INC.

PURDUE PHARMA (1956)

SANOFI-AVENTIS CANADA

SOLVAY PHARMA INC

WYETH PHARMACEUTICALS

Wyeth Pharmaceuticals (continued)

MEXICO

INTRODUCTION

TABLE 38 OVERALL PHARMACEUTICAL MARKET, MEXICO, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 39 POPULATION TRENDS, MEXICO, THROUGH 2013 (MILLIONS)

THE MEXICAN HEALTHCARE SYSTEM

HEALTHCARE EXPENDITURE IN MEXICO

TABLE 40 HEALTHCARE EXPENDITURE: MEXICO, 2000-2005

COMMON HEALTH PROBLEMS IN MEXICO

OBESITY AND RELATED CONDITIONS

DIABETES: THE LEADING CAUSE OF DEATH

HIV INFECTION

PHARMACEUTICAL REGULATION AND PRICING

MARKET SECTORS

BRANDED PRESCRIPTION PHARMACEUTICALS

TABLE 41 BRANDED PHARMACEUTICAL MARKET, MEXICO, THROUGH 2013 ($ BILLIONS)

GENERIC DRUGS

TABLE 42 GENERIC PHARMACEUTICAL MARKET, MEXICO, THROUGH 2013 ($ BILLIONS)

OVER-THE-COUNTER (OTC) MEDICATIONS IN MEXICO

TABLE 43 OTC PHARMACEUTICAL MARKET, MEXICO, THROUGH 2013 ($ BILLIONS)

IMPORTANT ORGANIZATIONS IN MEXICO

STATISTICS MEXICO: SISTEMAS NACIONALES ESTADISTICO Y DE INFORMACION GEOGRAFICA (SNEIG)

AFAMELA (ASOCIACION DE FABRICANTES DE MEDICAMENTOS DE LIBRE ACCESO AC)

AMIIF (ASOCIACION MEXICANA DE INDUSTRIALES DE INVESTIGACION FARMACEUTIA A.C., MEXICAN

ASSOCIATION OF PHARMACEUTICAL COMPANIES)

CANIFARMA (CAMARA NACIONAL DE LA INDUSTRIA FARMACEUTICA)

FIFARMA, THE LATIN AMERICAN FEDERATION OF THE PHARMACEUTICAL INDUSTRY

ILAR (INDUSTRIO LATINOAERMICANA DE AUTOMEDICACION RESPONSABLE)

BRAZIL

INTRODUCTION

TABLE 44 OVERALL PHARMACEUTICAL MARKET, BRAZIL, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 45 POPULATION TRENDS, BRAZIL, THROUGH 2013 (MILLIONS)

HEALTHCARE AND HEALTH PROBLEMS IN BRAZIL

THE HEALTHCARE SYSTEM (MEDICARE)

PHARMACEUTICAL PRICING

HEALTH PROBLEMS IN BRAZIL

MARKET SECTORS

BRANDED PRESCRIPTION PHARMACEUTICALS

TABLE 46 BRANDED PHARMACEUTICAL MARKET, BRAZIL, THROUGH 2013 ($ BILLIONS)

GENERIC DRUGS

TABLE 47 GENERIC PHARMACEUTICAL MARKET, BRAZIL, THROUGH 2013 ($ BILLIONS)

OVER-THE-COUNTER MEDICATIONS

TABLE 48 OTC PHARMACEUTICAL MARKET, BRAZIL, THROUGH 2013 ($ MILLIONS)

IMPORTANT ORGANIZATIONS IN BRAZIL

BRAZILIAN INSTITUTE OF GEOGRAPHY AND STATISTICS

EUROPE

HEALTHCARE IN EUROPE

REIMBURSEMENT OF PHARMACEUTICALS

POPULATION DEMOGRAPHICS IN EUROPE

POPULATION GROWTH, MEDIAN AGE, AND LIFE EXPECTANCY

EXCESS WEIGHT

LIFE EXPECTANCY IN EUROPE

PHARMACEUTICAL MARKETS IN EUROPE

TABLE 49 TOP FIVE PHARMACEUTICAL MARKETS, EUROPE, THROUGH 2013 ($ BILLIONS)

PROPRIETARY PRESCRIPTION MEDICATIONS (ALSO CALLED BRANDED MEDICATIONS AND ETHICAL PHARMACEUTICALS)

TABLE 50 BRANDED PRESCRIPTION PHARMACEUTICALS MARKET BY VALUE, EUROPE, THROUGH 2013 ($ BILLIONS)

DATA EXCLUSIVITY

GENERIC MEDICATIONS

TABLE 51 GENERIC PHARMACEUTICALS MARKET BY VALUE, EUROPE, THROUGH 2013 ($ BILLIONS)

GENERIC SMALL MOLECULES

BIOSIMILARS

OVER-THE-COUNTER MEDICATIONS

TABLE 52 OTC PHARMACEUTICALS MARKET BY VALUE, EUROPE, THROUGH 2013 ($ BILLIONS)

FRANCE

INTRODUCTION

TABLE 53 OVERALL PHARMACEUTICAL MARKET, FRANCE, THROUGH 2013 ($ BILLIONS)

DRIVERS OF PHARMACEUTICAL SALES GROWTH

POPULATION AND DEMOGRAPHICS

TABLE 54 POPULATION TRENDS, FRANCE, THROUGH 2013 (MILLIONS)

FIGURE 6 FRANCE: POPULATION, 1998-2013 (MILLIONS)

TABLE 55 DEMOGRAPHIC TRENDS, FRANCE, THROUGH 2013 (MILLIONS)

HEALTHCARE EXPENDITURE IN FRANCE

TABLE 56 HEALTHCARE EXPENDITURE: FRANCE, 2000-2005

COMMON HEALTH PROBLEMS IN FRANCE

ALZHEIMER’S DISEASE AND RELATED DEMENTIAS

TABLE 57 DEMENTIA IN FRANCE, 2005-2050 (MILLIONS OF PEOPLE)

OBESITY AND RELATED CONDITIONS

DIABETES

CARDIOVASCULAR DISEASE

TABLE 58 PERCENTAGE OF SPENDING ON PHARMACEUTICALS BY CLASS, FRANCE, 2006 (%)

PHARMACEUTICAL PRICING

FIGURE 7 VALUE BREAKDOWN OF PHARMACEUTICALS, FRANCE, 2005 (%)

FIGURE 7 (CONTINUED)

MARKET SECTORS

BRANDED PRESCRIPTION PHARMACEUTICALS

TABLE 59 BRANDED PHARMACEUTICAL MARKET, FRANCE, THROUGH 2013 ($ BILLIONS)

GENERIC DRUGS

TABLE 60 GENERIC PHARMACEUTICAL MARKET, FRANCE, THROUGH 2013 ($ BILLIONS)

FIGURE 8 LEADING GENERIC MANUFACTURERS, MARKET SHARE, FRANCE, 2006 (% SHARE)

DRIVERS AND RESTRAINTS

OVER-THE-COUNTER (OTC) MEDICATIONS IN FRANCE

TABLE 61 OTC PHARMACEUTICAL MARKET, FRANCE, THROUGH 2013 ($ BILLIONS)

TABLE 62 REASONS FOR ADULT PURCHASES OF OTC MEDICATIONS IN FRANCE (%)

EXPORT-IMPORT PROFILE

TABLE 63 PHARMACEUTICAL EXPORTS, FRANCE, 2000 AND 2006 ($BILLIONS)

TABLE 64 PHARMACEUTICAL IMPORTS, FRANCE, 2005 AND 2006 ($BILLIONS)

PHARMACEUTICAL DISTRIBUTION

WHOLESALERS

FIGURE 9 LEADING WHOLESALERS MARKET SHARE, FRANCE, 2006-2007 (% SHARE)

FRANCE’S PHARMACEUTICAL EXPORTS AND IMPORTS IN

EUROS

TABLE 65 PHARMACEUTICAL EXPORTS, FRANCE, 2000 AND 2006 (EUROS, MILLIONS)

TABLE 66 PHARMACEUTICAL IMPORTS, FRANCE, 2005 AND 2006 (EUROS, MILLIONS)

IMPORTANT ORGANIZATIONS IN FRANCE

INSEE (NATIONAL INSTITUTE FOR STATISTICS AND ECONOMIC STUDIES)

LEEM, THE FRENCH PHARMACEUTICAL COMPANIES ASSOCIATION

CSRP (SYNDICATE OF PHARMACEUTICAL DISTRIBUTORS:

FRANCE ALZHEIMER:

COMPANY PROFILES: FRANCE

BIOGARAN

CERP

MERCK GENERIQUES

SANDOZ: (SEE GERMANY)

SANOFI-AVENTIS

Sanofi-Aventis (Continued)

GERMANY

INTRODUCTION

TABLE 67 OVERALL PHARMACEUTICAL MARKET, GERMANY, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 68 POPULATION TRENDS, GERMANY, THROUGH 2013 (MILLIONS)

TABLE 69 DEMOGRAPHIC TRENDS, GERMANY, THROUGH 2013 (MILLIONS)

FIGURE 10 GERMANY: POPULATION 1998-2013 (MILLIONS)

THE GERMAN HEALTHCARE SYSTEM

HEALTHCARE EXPENDITURE IN GERMANY

TABLE 70 HEALTHCARE EXPENDITURE: GERMANY, 2000-2005

COMMON HEALTH PROBLEMS IN GERMANY

ALZHEIMER’S DISEASE AND RELATED DEMENTIAS

TABLE 71 DEMENTIA IN GERMANY, 2005-2050 (MILLIONS OF PEOPLE)

OBESITY AND RELATED CONDITIONS

DIABETES

CARDIOVASCULAR DISEASE

TABLE 72 EXPENDITURES BY THERAPY AREA, GERMANY (PERCENTAGE OF HEALTHCARE SPENDING, ROUNDED)

PRICING AND REIMBURSEMENT OF PHARMACEUTICAL AGENTS

FIGURE 11 VALUE BREAKDOWN OF PHARMACEUTICALS, GERMANY, 2005 (%)

FIGURE 11 (CONTINUED)

MARKET SECTORS

BRANDED PRESCRIPTION PHARMACEUTICALS

TABLE 73 BRANDED PHARMACEUTICAL MARKET, GERMANY, THROUGH 2013 ($ BILLIONS)

GENERIC DRUGS

TABLE 74 GENERIC PHARMACEUTICAL MARKET, GERMANY, THROUGH 2013 ($ BILLIONS)

DRIVERS AND RESTRAINTS

OVER-THE-COUNTER MEDICATIONS

TABLE 75 OTC PHARMACEUTICAL MARKET, GERMANY, THROUGH 2013 ($ BILLIONS)

TABLE 76 LEADING OTC PRODUCTS, GERMANY, 2006 (%)

PHARMACEUTICAL DISTRIBUTION

WHOLESALERS

FIGURE 12 LEADING WHOLESALERS MARKET SHARE, GERMANY, 2006-2007 (% SHARE)

GERMAN PHARMACEUTICAL EXPORTS AND IMPORTS IN EUROS

TABLE 77 PHARMACEUTICAL EXPORTS, GERMANY, 2005 AND 2006 (EUROS, MILLIONS)

TABLE 78 PHARMACEUTICAL IMPORTS, GERMANY, 2005 AND 2006 (EUROS, MILLIONS)

IMPORTANT ORGANIZATIONS IN GERMANY

DESTATIS (FEDERAL STATISTICAL OFFICE)

GERMAN FEDERAL MINISTRY FOR EDUCATION AND RESEARCH

DEUTSCHE DIABETES-UNION

PHARMA PRIVAT

BAH, BUNDESVERBAND DER ARZNEIMITTELHERSTELLER E.V

VFA, THE GERMAN ASSOCIATION OF RESEARCH-BASED PHARMACEUTICAL COMPANIES

COMPANY PROFILES: GERMANY

CELESIO AG

MERCK KGAA

SANDOZ

STADA ARZNEIMITTEL AG

UNITED KINGDOM (U.K.)

INTRODUCTION

TABLE 79 OVERALL PHARMACEUTICAL MARKET, U.K., THROUGH 2013 ($ BILLIONS)

DRIVERS OF PHARMACEUTICAL SALES GROWTH

POPULATION AND DEMOGRAPHICS

TABLE 80 POPULATION TRENDS, U.K., THROUGH 2013 (MILLIONS)

FIGURE 13 U.K. POPULATION, 1998-2013 (MILLIONS)

TABLE 81 DEMOGRAPHIC TRENDS, U.K., THROUGH 2013 (MILLIONS)

THE U.K. HEALTHCARE SYSTEM

HEALTHCARE EXPENDITURE IN THE U.K

TABLE 82 HEALTHCARE EXPENDITURE: U.K., 2000-2005

COMMON HEALTH PROBLEMS IN THE U.K.

ALZHEIMER’S DISEASE (AD) AND RELATED DEMENTIAS

TABLE 83 PREVALENCE OF DEMENTIA IN THE U.K. 2005-2050 (MILLIONS OF PEOPLE)

OBESITY AND RELATED CONDITIONS

DIABETES

CARDIOVASCULAR DISEASE (INCLUDING HEART DISEASE AND STROKE)

TABLE 84 PERCENTAGE OF PRESCRIPTION OF PHARMACEUTICALS BY TOP EIGHT CLASSES, U.K., 2006 (%)

TABLE 85 PERCENTAGE OF PRESCRIPTION OF PHARMACEUTICALS, BY CLASS, U.K., 2006 ($ MILLIONS)

BARRIERS TO PHARMACEUTICAL REVENUE GROWTH IN THE U.K. AND REVENUE BREAKDOWN

MARKET SECTORS

BRANDED PRESCRIPTION PHARMACEUTICALS

TABLE 86 BRANDED PHARMACEUTICAL MARKET, U.K., THROUGH 2013 ($ BILLIONS)

TABLE 87 LEADING PHARMACEUTICAL COMPANIES, U.K., 2004 (% OF TOTAL MARKET)

GENERIC DRUGS

TABLE 88 GENERIC PHARMACEUTICAL MARKET, U.K., THROUGH 2013 ($ BILLIONS)

DRIVERS AND RESTRAINTS

OVER-THE-COUNTER (OTC) MEDICATIONS IN THE U.K

TABLE 89 OTC PHARMACEUTICAL MARKET, U.K., THROUGH 2013 ($ BILLIONS)

TABLE 90 LEADING OTC CATEGORIES, 2006, U.K. (% OF TOTAL MARKET)

EXPORT-IMPORT PROFILE

TABLE 91 PHARMACEUTICAL EXPORTS-IMPORTS, U.K., 1997-2006 ($ BILLIONS)

PHARMACEUTICAL DISTRIBUTION

WHOLESALERS

TABLE 92 LEADING PHARMACEUTICAL DISTRIBUTORS, U.K. (%OF TOTAL MARKET)

U.K.’S PHARMACEUTICAL EXPORTS AND IMPORTS IN POUNDS STERLING

TABLE 93 PHARMACEUTICAL EXPORTS, U.K., 1997-2006 (GBP BILLIONS)

IMPORTANT ORGANIZATIONS IN THE U.K.

NATIONAL STATISTICS U.K.

ABPI, THE ASSOCIATION OF THE BRITISH PHARMACEUTICAL INDUSTRY

THE BRITISH ASSOCIATION OF PHARMACEUTICAL WHOLESALERS (BAPW)

COMPANY PROFILES: U.K

AAH PHARMACEUTICALS

GLAXOSMITHKLINE (GSK)

MAWDSLEY-BROOKS & CO. LTD.

PHOENIX HEALTHCARE DISTRIBUTION, LTD.

UNICHEM

Unichem (Continued)

ITALY

INTRODUCTION

TABLE 94 OVERALL PHARMACEUTICAL MARKET, ITALY, THROUGH 2013 ($ BILLIONS)

DRIVERS OF PHARMACEUTICAL SALES GROWTH

POPULATION AND DEMOGRAPHICS

TABLE 95 POPULATION TRENDS, ITALY, THROUGH 2013 (MILLIONS)

FIGURE 14 ITALY: POPULATION, 1998-2013 (MILLIONS)

TABLE 96 DEMOGRAPHIC TRENDS, ITALY, THROUGH 2013 (MILLIONS)

THE ITALIAN HEALTHCARE SYSTEM AND GROWTH DRIVERS

TABLE 97 HEALTHCARE EXPENDITURE: ITALY, 2000-2005

COMMON HEALTH PROBLEMS IN ITALY

ALZHEIMER’S DISEASE (AD) AND RELATED DEMENTIAS

OBESITY AND RELATED CONDITIONS

DIABETES

CARDIOVASCULAR DISEASE (INCLUDING HEART DISEASE AND STROKE)

TABLE 98 PERCENTAGE OF CLASS C PRESCRIPTION PHARMACEUTICALS BY CLASS, ITALY, 2006 (%)

BARRIERS TO PHARMACEUTICAL REVENUE GROWTH IN ITALY

REVENUE BREAKDOWN OF PHARMACEUTICAL PRODUCTS IN ITALY

FIGURE 15 VALUE BREAKDOWN OF PHARMACEUTICALS, ITALY, 2005 (%)

FIGURE 15 (CONTINUED)

MARKET SECTORS

BRANDED PRESCRIPTION PHARMACEUTICALS

TABLE 99 BRANDED PHARMACEUTICAL MARKET, ITALY, THROUGH 2013 ($ BILLIONS)

GENERIC DRUGS

TABLE 100 GENERIC PHARMACEUTICAL MARKET, ITALY, THROUGH 2013 ($ BILLIONS)

DRIVERS AND RESTRAINTS

OVER-THE-COUNTER MEDICATIONS

TABLE 101 OTC PHARMACEUTICAL MARKET, ITALY, THROUGH 2013 ($ BILLIONS)

TABLE 102 LEADING OTC CATEGORIES, ITALY, 2006 (% OF TOTAL MARKET)

EXPORT-IMPORT PROFILE

TABLE 103 PHARMACEUTICAL EXPORTS, ITALY, 2005 AND 2006 ($ BILLIONS, ROUNDED)

TABLE 104 LEADING DESTINATIONS OF ITALIAN PHARMACEUTICAL EXPORTS, 2006 (% OF TOTAL MARKET)

TABLE 105 PHARMACEUTICAL IMPORTS, ITALY, 2005 AND 2006 ($ BILLIONS)

TABLE 106 LEADING DESTINATIONS OF ITALIAN PHARMACEUTICAL IMPORTS, 2006 (% OF TOTAL MARKET)

ITALY’S PHARMACEUTICAL EXPORTS AND IMPORTS IN EUROS

TABLE 107 PHARMACEUTICAL EXPORTS, ITALY, 2005 AND 2006 (EUR BILLIONS)

TABLE 108 PHARMACEUTICAL IMPORTS, ITALY, 2005 AND 2006 (EUR BILLIONS)

IMPORTANT ORGANIZATIONS IN ITALY

NATIONAL INSTITUTE FOR STATISTICS (ISTITUTO NAZIONALE DI STATISTICA)

FARMINDUSTRIA, THE PHARMACEUTICAL MANUFACTURER’S ASSOCIATION OF ITALY

ASSOGENERICI, THE ITALIAN NATIONAL ASSOCIATION OF GENERIC PHARMACEUTICALS

SPAIN

INTRODUCTION

TABLE 109 OVERALL PHARMACEUTICAL MARKET, SPAIN, THROUGH 2013 ($ BILLIONS)

DRIVERS OF PHARMACEUTICAL SALES GROWTH

POPULATION AND DEMOGRAPHICS

TABLE 110 POPULATION TRENDS, SPAIN, THROUGH 2013 (MILLIONS)

FIGURE 16 SPAIN: POPULATION, 1998-2013 (MILLIONS)

TABLE 111 DEMOGRAPHIC TRENDS, SPAIN, THROUGH 2013 (MILLIONS)

THE SPANISH HEALTHCARE SYSTEM, PRICING, AND PHARMACEUTICAL GROWTH DRIVERS

THE HEALTHCARE SYSTEM

TABLE 112 HEALTHCARE EXPENDITURE: SPAIN, 2000-2005

DRUG PRICING POLICIES

COMMON HEALTH PROBLEMS IN SPAIN

ALZHEIMER’S DISEASE (AD) AND RELATED DEMENTIAS

OBESITY AND RELATED CONDITIONS

DIABETES

CARDIOVASCULAR DISEASE (INCLUDING HEART DISEASE AND STROKE)

TABLE 113 PERCENTAGE OF PRESCRIPTION OF PHARMACEUTICALS, BY CLASS, SPAIN, 2006

GROWTH DRIVERS

BARRIERS TO PHARMACEUTICAL REVENUE GROWTH IN SPAIN

REVENUE BREAKDOWN OF PHARMACEUTICAL PRODUCTS IN SPAIN

FIGURE 17 VALUE BREAKDOWN OF PHARMACEUTICALS, SPAIN, 2005 (%)

FIGURE 17 (CONTINUED)

MARKET SECTORS

BRANDED PRESCRIPTION PHARMACEUTICALS

TABLE 114 BRANDED PHARMACEUTICAL MARKET, SPAIN, THROUGH 2013 ($ BILLIONS)

GENERIC DRUGS

TABLE 115 GENERIC PHARMACEUTICAL MARKET, SPAIN, THROUGH 2013 ($ BILLIONS)

DRIVERS AND RESTRAINTS

OVER-THE-COUNTER MEDICATIONS

TABLE 116 OTC PHARMACEUTICAL MARKET, SPAIN, THROUGH 2013 ($ MILLIONS)

EXPORT-IMPORT PROFILE

TABLE 117 PHARMACEUTICAL EXPORTS, SPAIN, 2005 AND 2006 (%)

TABLE 118 PHARMACEUTICAL IMPORTS, SPAIN, 2005 AND 2006 (%)

IMPORTANT ORGANIZATIONS IN SPAIN

NATIONAL STATISTICS INSTITUTE (INSTITUTO NACIONAL DE ESTADISTICA)

FARMAINDUSTRIA, THE NATIONAL ASSOCIATION OF THE PHARMACEUTICAL INDUSTRY IN SPAIN

AESEG, THE SPANISH ASSOCIATION OF GENERIC PHARMACEUTICALS MANUFACTURERS

ANEFP, THE NATIONALS ASSOCIATION OF OVER-THECOUNTER MEDICATIONS

CEAFA, CONFEDERACTION ESPANOLA DE FAMILIARES ENFERMOS DE ALZHEIMER’S Y OTRAS DEMENCIAS

SMALLER PHARMACEUTICAL MARKETS IN EUROPE

GREECE

INTRODUCTION

TABLE 119 OVERALL PHARMACEUTICAL MARKET, GREECE, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 120 POPULATION TRENDS, GREECE, THROUGH 2013 (MILLIONS)

FIGURE 18 GREECE: POPULATION, 1998-2013

(MILLIONS)

TABLE 121 DEMOGRAPHIC TRENDS, GREECE, THROUGH 2013 (MILLIONS)

THE GREEK HEALTHCARE SYSTEM

Structure of the Healthcare System

Healthcare Expenditures

TABLE 122 HEALTHCARE EXPENDITURE: GREECE, 2000-2005

COMMON HEALTH PROBLEMS IN GREECE

Pharmaceutical Pricing

TABLE 123 PERCENTAGE OF PRESCRIPTION PHARMACEUTICALS, BY CLASS, GREECE, 2004

REVENUE BREAKDOWN OF PHARMACEUTICAL PRODUCTS IN GREECE

FIGURE 19 VALUE BREAKDOWN OF PHARMACEUTICALS, GREECE, 2005 (%)

Growth Drivers

Barriers to Pharmaceutical Revenue Growth in Greece

MARKET SECTORS

Branded Prescription Pharmaceuticals

TABLE 124 BRANDED PHARMACEUTICAL MARKET, GREECE, THROUGH 2013 ($ BILLIONS)

Generic Drugs

TABLE 125 GENERIC PHARMACEUTICAL MARKET, GREECE, THROUGH 2013 ($ BILLIONS)

Drivers and Restraints

Over-the-Counter Medications

TABLE 126 OTC PHARMACEUTICAL MARKET, GREECE, THROUGH 2013 ($ MILLIONS)

TABLE 127 LEADING OTC CATEGORIES, GREECE, 2006 (% OF TOTAL MARKET)

IMPORTANT ORGANIZATIONS IN GREECE

STATISTICS GREECE

THE HELLENIC ASSOCIATION OF PHARMACEUTICAL COMPANIES (SFEE)

EFEX, THE GREEK PROPRIETARY ASSOCIATION

THE NETHERLANDS

INTRODUCTION

TABLE 128 OVERALL PHARMACEUTICAL MARKET, NETHERLANDS, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 129 POPULATION TRENDS, NETHERLANDS, THROUGH 2013 (MILLIONS)

FIGURE 20 NETHERLANDS: POPULATION, 1998-2013 (MILLIONS)

TABLE 130 DEMOGRAPHIC TRENDS, NETHERLANDS, THROUGH 2013 (MILLIONS)

THE DUTCH HEALTHCARE SYSTEM

Structure of the Healthcare System

Healthcare Expenditures

TABLE 131 HEALTHCARE EXPENDITURE: THE NETHERLANDS, 2000-2005

COMMON HEALTH PROBLEMS IN THE NETHERLANDS

Drug Pricing

REVENUE BREAKDOWN OF PHARMACEUTICAL PRODUCTS IN THE NETHERLANDS

FIGURE 21 VALUE BREAKDOWN OF PHARMACEUTICALS, NETHERLANDS, 2005 (%)

MARKET SECTORS

Branded Prescription Pharmaceuticals

TABLE 132 BRANDED PHARMACEUTICAL MARKET, NETHERLANDS, THROUGH 2013 ($ BILLIONS)

Generic Drugs

TABLE 133 GENERIC PHARMACEUTICAL MARKET, NETHERLANDS, THROUGH 2013 ($ BILLIONS)

Drivers and Restraints

Over-the-Counter Medications

TABLE 134 OTC PHARMACEUTICAL MARKET, NETHERLANDS, THROUGH 2013 ($ MILLIONS)

TABLE 135 LEADING OTC CATEGORIES, NETHERLANDS, 2006 (% OF TOTAL MARKET)

IMPORTANT ORGANIZATIONS IN THE NETHERLANDS

STATISTICS NETHERLANDS

NEFARMA, THE ASSOCIATION OF INNOVATE PHARMACEUTICALS IN THE NETHERLANDS

BOGIN, THE ASSOCIATION OF DUTCH GENERIC MEDICATIONS INDUSTRY

NEPROPHARM, THE NETHERLANDS ASSOCIATION OF OVER-THE-COUNTER PRODUCTS

BELGIUM

INTRODUCTION

TABLE 136 OVERALL PHARMACEUTICAL MARKET, BELGIUM, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 137 POPULATION TRENDS, BELGIUM, THROUGH 2013 (MILLIONS)

FIGURE 22 BELGIUM: POPULATION, 1998-2013 (MILLIONS)

TABLE 138 DEMOGRAPHIC TRENDS, BELGIUM, THROUGH 2013 (MILLIONS)

THE BELGIAN HEALTHCARE SYSTEM

Structure of the Healthcare System

TABLE 139 HEALTHCARE EXPENDITURE: BELGIUM, 2000-2005

COMMON HEALTH PROBLEMS IN BELGIUM

DRUG PRICING

REVENUE BREAKDOWN OF PHARMACEUTICAL PRODUCTS IN BELGIUM

FIGURE 23 VALUE BREAKDOWN OF PHARMACEUTICALS, BELGIUM, 2005 (%)

MARKET SECTORS

Branded Prescription Pharmaceuticals

TABLE 140 BRANDED PHARMACEUTICAL MARKET, BELGIUM, THROUGH 2013 ($ BILLIONS)

Generic Drugs

TABLE 141 GENERIC PHARMACEUTICAL MARKET, BELGIUM, THROUGH 2013 ($ BILLIONS)

Over-the-Counter Medications

TABLE 142 OTC PHARMACEUTICAL MARKET, BELGIUM, THROUGH 2013 ($ MILLIONS)

TABLE 143 LEADING OTC CATEGORIES, BELGIUM, 2006 (% OF TOTAL MARKET)

IMPORTANT ORGANIZATIONS IN BELGIUM

STATISTICS BELGIUM

PHARMA.BE, THE GENERAL ASSOCIATION OF THE MEDICINES INDUSTRY

EUROGENERICS

POLAND

INTRODUCTION

TABLE 144 OVERALL PHARMACEUTICAL MARKET, POLAND, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 145 POPULATION TRENDS, POLAND, THROUGH 2013 (MILLIONS)

FIGURE 24 POLAND: POPULATION, 1998-2013 (MILLIONS)

TABLE 146 DEMOGRAPHIC TRENDS, POLAND, THROUGH 2013 (MILLIONS)

COMMON HEALTH PROBLEMS IN POLAND

THE POLISH HEALTHCARE SYSTEM

Structure of the Healthcare System

TABLE 147 HEALTHCARE EXPENDITURE: POLAND, 2000-2005

DRUG PRICING

MARKET SECTORS

Branded Prescription Pharmaceuticals

TABLE 148 BRANDED PHARMACEUTICAL MARKET, POLAND, THROUGH 2013 ($ BILLIONS)

Generic Drugs

TABLE 149 GENERIC PHARMACEUTICAL MARKET, POLAND, THROUGH 2013 ($ BILLIONS)

Over-the-Counter Medications

TABLE 150 OTC PHARMACEUTICAL MARKET, POLAND, THROUGH 2013 ($ MILLIONS)

TABLE 151 LEADING OTC CATEGORIES, POLAND, 2006 (% OF TOTAL MARKET)

IMPORTANT ORGANIZATIONS IN POLAND

POLISH CENTRAL STATISTICS OFFICE

POLFARMED, POLISH CHAMBER OF PHARMACEUTICALS INDUSTRY AND MEDICAL DEVICES

PASMI, THE POLISH ASSOCIATION OF THE SELFMEDICATION INDUSTRY

PORTUGAL

INTRODUCTION

TABLE 152 OVERALL PHARMACEUTICAL MARKET, PORTUGAL, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 153 POPULATION TRENDS, PORTUGAL, THROUGH 2013 (MILLIONS)

FIGURE 25 PORTUGAL: POPULATION, 1998-2013 (MILLIONS)

TABLE 154 DEMOGRAPHIC TRENDS, PORTUGAL, THROUGH 2013 (MILLIONS)

THE PORTUGUESE HEALTHCARE SYSTEM

Structure of the Healthcare System

TABLE 155 HEALTHCARE EXPENDITURE: PORTUGAL, 2000-2005

Pharmaceutical Pricing

FIGURE 26 VALUE BREAKDOWN OF PHARMACEUTICALS, PORTUGAL, 2005 (%)

FIGURE 26 (CONTINUED)

COMMON HEALTH PROBLEMS IN PORTUGAL

MARKET SECTORS

Branded Prescription Pharmaceuticals

TABLE 156 BRANDED PHARMACEUTICAL MARKET, PORTUGAL, THROUGH 2013 ($ BILLIONS)

Generic Drugs

TABLE 157 GENERIC PHARMACEUTICAL MARKET, PORTUGAL, THROUGH 2013 ($ BILLIONS)

Over-the-Counter Medications

TABLE 158 OTC PHARMACEUTICAL MARKET, PORTUGAL, THROUGH 2013 ($ MILLIONS)

TABLE 159 LEADING OTC CATEGORIES, PORTUGAL, 2006 (% OF TOTAL MARKET)

IMPORTANT ORGANIZATIONS IN PORTUGAL

STATISTICS PORTUGAL

APOGEN, PORTUGUESE ASSOCIATION OF GENERIC MEDICATIONS

APIFARMA, THE ASSOCIATION OF THE PORTUGUESE PHARMACEUTICAL INDUSTRY

SWITZERLAND

INTRODUCTION

TABLE 160 OVERALL PHARMACEUTICAL MARKET, SWITZERLAND, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 161 POPULATION TRENDS, SWITZERLAND, THROUGH 2013 (MILLIONS)

FIGURE 27 SWITZERLAND: POPULATION, 1998-2013 (MILLIONS)

TABLE 162 DEMOGRAPHIC TRENDS, SWITZERLAND, THROUGH 2013 (MILLIONS)

Common Health Problems in Switzerland

THE SWISS HEALTHCARE SYSTEM

Structure of the Healthcare System

TABLE 163 HEALTHCARE EXPENDITURE: SWITZERLAND, 2000-2005

Pharmaceutical Environment and Pricing

Pharmaceutical Environment …(Continued)

FIGURE 28 VALUE BREAKDOWN OF PHARMACEUTICALS, SWITZERLAND, 2005 (%)

MARKET SECTORS

Branded Prescription Pharmaceuticals

TABLE 164 BRANDED PHARMACEUTICAL MARKET, SWITZERLAND, THROUGH 2013 ($ BILLIONS)

Generic Drugs

TABLE 165 GENERIC PHARMACEUTICAL MARKET, SWITZERLAND, THROUGH 2013 ($ BILLIONS)

Over-the-Counter Medications

TABLE 166 OTC PHARMACEUTICAL MARKET, SWITZERLAND, THROUGH 2013 ($ MILLIONS)

TABLE 167 LEADING OTC CATEGORIES, SWITZERLAND, 2006 (% OF TOTAL MARKET)

IMPORTANT ORGANIZATIONS IN SWITZERLAND

SWISS FEDERAL STATISTICS OFFICE

COMPANY PROFILES

NOVARTIS INTERNATIONAL AG

SWEDEN

INTRODUCTION

TABLE 168 OVERALL PHARMACEUTICAL MARKET, SWEDEN, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 169 POPULATION TRENDS, SWEDEN, THROUGH 2013 (MILLIONS)

FIGURE 29 SWEDEN: POPULATION, 1998-2013 (MILLIONS)

TABLE 170 DEMOGRAPHIC TRENDS, SWEDEN, THROUGH 2013 (MILLIONS)

HEALTH PROBLEMS AND HEALTHCARE IN SWEDEN

The Healthcare System

TABLE 171 HEALTHCARE EXPENDITURE: SWEDEN, 2000-2005

Pharmaceutical Pricing

FIGURE 30 VALUE BREAKDOWN OF PHARMACEUTICALS, SWEDEN, 2005 (%)

Health Problems in Sweden

TABLE 172 LEADING THERAPEUTIC CATEGORIES, SWEDEN, 2006 (% OF TOTAL MARKET, BY VALUE)

MARKET SECTORS

Branded Pharmaceuticals

TABLE 173 BRANDED PHARMACEUTICAL MARKET, SWEDEN, THROUGH 2013 ($ BILLIONS)

Generic Drugs

TABLE 174 GENERIC PHARMACEUTICAL MARKET, SWEDEN, THROUGH 2013 ($ BILLIONS)

Over-the-Counter Medications

TABLE 175 OTC PHARMACEUTICAL MARKET, SWEDEN, THROUGH 2013 ($ MILLIONS)

IMPORTANT ORGANIZATIONS IN SWEDEN

STATISTICS SWEDEN

FGL, THE SWEDISH ASSOCIATION FOR GENERIC PHARMACEUTICALS

AUSTRIA

INTRODUCTION

TABLE 176 OVERALL PHARMACEUTICAL MARKET, AUSTRIA, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 177 POPULATION TRENDS, AUSTRIA, THROUGH 2013 (MILLIONS)

FIGURE 31 AUSTRIA: POPULATION, 1998-2013 (MILLIONS)

TABLE 178 DEMOGRAPHIC TRENDS, AUSTRIA, THROUGH 2013 (MILLIONS)

HEALTHCARE AND HEALTH PROBLEMS IN AUSTRIA

The Healthcare System

Pharmaceutical Pricing

TABLE 179 HEALTHCARE EXPENDITURE: AUSTRIA, 2000-2005

Health Problems in Austria

MARKET SECTORS

Branded Prescription Pharmaceuticals

TABLE 180 BRANDED PHARMACEUTICAL MARKET, AUSTRIA, THROUGH 2013 ($ BILLIONS)

Generic Drugs

TABLE 181 GENERIC PHARMACEUTICAL MARKET, AUSTRIA, THROUGH 2013 ($ BILLIONS)

Over-the-Counter Medications

TABLE 182 OTC PHARMACEUTICAL MARKET, AUSTRIA, THROUGH 2013 ($ MILLIONS)

IMPORTANT ORGANIZATIONS IN AUSTRIA

STATISTICS AUSTRIA

PHARMIG, THE

IGEPHA, THE AUSTRIAN SELF-MEDICATION INDUSTRY

HUNGARY

INTRODUCTION

TABLE 183 OVERALL PHARMACEUTICAL MARKET, HUNGARY, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

HEALTH PROBLEMS AND HEALTHCARE IN HUNGARY

The Healthcare System

Pharmaceutical Pricing

Health Problems in Hungary

MARKET SECTORS

Branded Prescription Pharmaceuticals

TABLE 184 BRANDED PHARMACEUTICAL MARKET, HUNGARY, THROUGH 2013 ($ BILLIONS)

Generic Drugs

TABLE 185 GENERIC PHARMACEUTICAL MARKET, HUNGARY, THROUGH 2013 ($ BILLIONS)

Over-the-Counter Medications

TABLE 186 OTC PHARMACEUTICAL MARKET, HUNGARY, THROUGH 2013 ($ MILLIONS)

IMPORTANT ORGANIZATIONS IN HUNGARY

HUNGARIAN CENTRAL STATISTICS OFFICE

MAGYOSZ, THE HUNGARIAN PHARMACEUTICAL MANUFACTURERS ASSOCIATION

FINLAND

INTRODUCTION

TABLE 187 OVERALL PHARMACEUTICAL MARKET, FINLAND, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 188 POPULATION TRENDS, FINLAND, THROUGH 2013 (MILLIONS)

TABLE 189 DEMOGRAPHIC TRENDS, FINLAND, THROUGH 2013 (MILLIONS)

HEALTH PROBLEMS AND HEALTHCARE IN FINLAND

The Healthcare System

PHARMACEUTICAL PRICING

Health Problems in Finland

MARKET SECTORS

TABLE 190 LEADING THERAPEUTIC CATEGORIES, FINLAND, 2006 (% OF TOTAL MARKET, BY VALUE)

Branded Prescription Pharmaceuticals

TABLE 191 BRANDED PHARMACEUTICAL MARKET, FINLAND, THROUGH 2013 ($ BILLIONS)

Generic Drugs

TABLE 192 GENERIC PHARMACEUTICAL MARKET, FINLAND, THROUGH 2013 ($ BILLIONS)

Over-the-Counter Medications

TABLE 193 OTC PHARMACEUTICAL MARKET, FINLAND, THROUGH 2013 ($ MILLIONS)

IMPORTANT ORGANIZATIONS IN FINLAND

STATISTICS FINLAND

IMPORTANT ORGANIZATIONS IN EUROPE

THE EUROPEAN FEDERATION OF PHARMACEUTICAL INDUSTRIES AND ASSOCIATIONS (EFPIA)

THE EUROPEAN GENERICS ASSOCIATION (EGA)

THE ASSOCIATION OF THE EUROPEAN SELFMEDICATION INDUSTRY (AESGP)

ASIA

JAPAN

INTRODUCTION

TABLE 194 OVERALL PHARMACEUTICAL MARKET, JAPAN, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 195 POPULATION TRENDS, JAPAN, THROUGH 2013 (MILLIONS)

TABLE 196 DEMOGRAPHIC TRENDS, JAPAN, THROUGH 2013 (MILLIONS)

FIGURE 32 JAPAN: POPULATION, 1998-2013 (MILLIONS)

THE JAPANESE HEALTHCARE SYSTEM

Healthcare Expenditures in Japan

TABLE 197 HEALTHCARE EXPENDITURE: JAPAN, 2000-2005

Common Health Problems in Japan

TABLE 198 LEADING CAUSES OF DEATH, JAPAN, 2005

Cancer

TABLE 199 LEADING FORMS OF CANCER, JAPAN, 2005

Alzheimer’s Disease and Related Dementias

Obesity and Diabetes

Cardiovascular Disease

Smoking

PHARMACEUTICAL PRICING

Pharmaceutical Pricing (Continued)

Pricing of Generic Drugs

MARKET SECTORS

Branded Prescription Pharmaceuticals

TABLE 120 BRANDED PHARMACEUTICAL MARKET, JAPAN, THROUGH 2013 ($ BILLIONS)

Generic Drugs

TABLE 201 GENERIC PHARMACEUTICAL MARKET, JAPAN, THROUGH 2013 ($ BILLIONS)

OVER-THE-COUNTER MEDICATIONS IN JAPAN

TABLE 202 OTC PHARMACEUTICAL MARKET, JAPAN, THROUGH 2013 ($ BILLIONS)

TABLE 203 LEADING OTC CATEGORIES, JAPAN

IMPORTANT ORGANIZATIONS IN JAPAN

STATISTICS BUREAU

MINISTRY OF HEALTH, LABOUR, & WELFARE

JPMA, JAPAN PHARMACEUTICAL MANUFACTURER’S ASSOCIATION

JSMI, JAPANESE SELF-MEDICATION INDUSTRY

COMPANY PROFILES

ASTELLAS PHARMA

SAWAI PHARMACEUTICAL COMPANY LTD

TAKEDA PHARMACEUTICAL COMPANY LTD.

CHINA

INTRODUCTION

TABLE 204 OVERALL PHARMACEUTICAL MARKET, CHINA, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 205 POPULATION TRENDS, CHINA, THROUGH 2013 (MILLIONS)

TABLE 206 DEMOGRAPHIC TRENDS, CHINA, THROUGH 2013 (MILLIONS)

HEALTHCARE AND HEALTH PROBLEMS IN CHINA

The Healthcare System

Pharmaceutical Pricing

Health Problems in China

MARKET SECTORS

Branded Prescription Pharmaceuticals

TABLE 207 PRESCRIPTION PHARMACEUTICAL MARKET, CHINA, THROUGH 2013 ($ BILLIONS)

Generic Drugs

Over-the-Counter Medications

TABLE 208 OTC PHARMACEUTICAL MARKET, CHINA, THROUGH 2013 ($ MILLIONS)

IMPORTANT ORGANIZATIONS IN CHINA

NATIONAL BUREAU OF STATISTICS OF CHINA

SOUTH KOREA

INTRODUCTION

TABLE 209 OVERALL PHARMACEUTICAL MARKET, SOUTH KOREA, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 210 POPULATION TRENDS, SOUTH KOREA, THROUGH 2013 (MILLIONS)

TABLE 211 DEMOGRAPHIC TRENDS, SOUTH KOREA, THROUGH 2013 (MILLIONS)

HEALTHCARE AND HEALTH PROBLEMS IN SOUTH KOREA

The Healthcare System

Pharmaceutical Pricing

Health Problems in South Korea

TABLE 212 LEADING CAUSES OF DEATH, SOUTH KOREA, 2003

MARKET SECTORS

Branded and Generic Prescription Pharmaceuticals

TABLE 213 PRESCRIPTION PHARMACEUTICAL MARKET, SOUTH KOREA, THROUGH 2013 ($ BILLIONS)

Over-the-Counter Medications

TABLE 214 OTC PHARMACEUTICAL MARKET, SOUTH KOREA, THROUGH 2013 ($ MILLIONS)

IMPORTANT ORGANIZATIONS IN SOUTH KOREA

KOREAN NATIONAL STATISTICAL OFFICE

AUSTRALIA

INTRODUCTION

TABLE 215 OVERALL PHARMACEUTICAL MARKET, AUSTRALIA, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 216 POPULATION TRENDS, AUSTRALIA, THROUGH 2013 (MILLIONS)

HEALTHCARE AND HEALTH PROBLEMS IN AUSTRALIA

The Healthcare System (Medicare)

Pharmaceutical Pricing

Health Problems in Australia

TABLE 217 LEADING CAUSES OF DEATH, MEN, AUSTRALIA, 2005 (% OF ALL DEATHS)

TABLE 218 LEADING CAUSES OF DEATH, WOMEN, AUSTRALIA, 2004 (% OF ALL DEATHS)

TABLE 219 COMMON CHRONIC CONDITIONS, AUSTRALIA, 2005 (% OF POPULATION)

MARKET SECTORS

Branded Prescription Pharmaceuticals

TABLE 220 BRANDED PHARMACEUTICAL MARKET, AUSTRALIA, THROUGH 2013 ($ BILLIONS)

Generic Drugs

TABLE 221 GENERIC PHARMACEUTICAL MARKET, AUSTRALIA, THROUGH 2013 ($ BILLIONS)

Over-the-Counter Medications

TABLE 222 OTC PHARMACEUTICAL MARKET, AUSTRALIA, THROUGH 2013 ($ MILLIONS)

TABLE 223 TOP OTC PURCHASES, AUSTRALIA (% OF THE POPULATION)

IMPORTANT ORGANIZATIONS IN AUSTRALIA

AUSTRALIAN BUREAU OF STATISTICS

DEPARTMENT OF INNOVATION, INDUSTRY, SCIENCE, AND RESEARCH

MEDICINES AUSTRALIA

INDIA

INTRODUCTION

TABLE 224 OVERALL PHARMACEUTICAL MARKET, INDIA, THROUGH 2013 ($ BILLIONS)

POPULATION AND DEMOGRAPHICS

TABLE 225 POPULATION TRENDS, INDIA, THROUGH 2013 (MILLIONS)

HEALTHCARE AND HEALTH PROBLEMS IN INDIA

Pharmaceutical Pricing

HEALTH PROBLEMS IN INDIA

MARKET SECTORS

Overview

TABLE 226 TOP INDIAN PHARMACEUTICAL COMPANIES BY REVENUES, 2006 ($ MILLIONS)

Barriers to Growth in India

Branded Prescription Pharmaceuticals

TABLE 227 PRESCRIPTION PHARMACEUTICAL MARKET, INDIA, THROUGH 2013 ($ BILLIONS)

Generics

Over-the-Counter Medications

TABLE 228 OTC PHARMACEUTICAL MARKET, INDIA, THROUGH 2013 ($ BILLIONS)

IMPORTANT ORGANIZATIONS IN INDIA

MINISTRY OF STATISTICS AND PROGRAMME IMPLEMENTATION

MINISTRY OF HEALTH

IDMA, THE INDIAN DRUG MANUFACTURERS ASSOCIATION

OPPI, THE ORGANISATION OF PHARMACEUTICAL PRODUCERS OF INDIA

COMPANY PROFILES

RANBAXY LABORATORIES, LTD

CIPLA LTD

DR. REDDY’S LABORATORIES LTD.

SOME INTERESTING LINKS RELATED TO HEALTH, PHARMACEUTICALS, AND DISEASE

PHARMACEUTICAL MARKETS IN SELECTED COUNTRIES NOT COVERED IN DETAIL IN THIS REPORT

PHARMACEUTICAL MARKETS IN SELECTED COUNTRIES …

PHARMACEUTICAL MARKETS…(CONTINUED)

SOME INTERESTING LINKS RELATED TO HEALTH, PHARMACEUTICALS, AND DISEASE

LIST OF TABLES

SUMMARY TABLE WORLDWIDE MARKET PHARMACEUTICAL PRODUCTS, THROUGH 2013 ($ BILLIONS)

TABLE 1 HEALTHCARE EXPENDITURES, COUNTRIES IN THIS REPORT, 2000 AND 2005 (% OF GDP)

TABLE 2 WORLDWIDE LEADING ETHICAL PHARMACEUTICAL COMPANIES: SALES AND MARKET SHARE, 2006 AND 2007 ($ BILLIONS)

TABLE 3 WORLDWIDE LEADING PHARMACEUTICAL COMPANIES BY R&D SPENDING, 2006 AND 2007 ($ BILLIONS)

TABLE 4 LARGEST PHARMACEUTICAL MARKETS (OVERALL), 2006 AND 2007 ($ BILLIONS, % OF TOTAL)

TABLE 5 LARGEST PHARMACEUTICAL MARKETS (BRANDED), 2006 AND 2007 ($ BILLIONS, % OF TOTAL)

TABLE 6 WORLDWIDE LEADING PHARMACEUTICAL LARGEST

PHARMACEUTICAL MARKETS (GENERIC), 2006 AND 2007 ($ BILLIONS, % OF TOTAL)

TABLE 7 LARGEST PHARMACEUTICAL MARKETS (OTC), 2006 AND

2007 ($ BILLIONS, % OF TOTAL)

TABLE 8 OVERALL PHARMACEUTICAL MARKET, U.S., THROUGH 2013 ($ BILLIONS)

TABLE 9 POPULATION TRENDS, U.S., THROUGH 2013 (MILLIONS)

TABLE 10 DEMOGRAPHIC TRENDS, U.S., THROUGH 2013 (MILLIONS)

TABLE 11 HEALTHCARE EXPENDITURE, U.S., 2000 AND 2006

TABLE 12 MOST EXPENSIVE MEDICAL CONDITIONS, U.S., 2004 ($ BILLIONS, %)

TABLE 13 PRESCRIPTION DRUG EXPENDITURES BY CATEGORY, 2006 ($ BILLIONS)

TABLE 14 LEADING CAUSES OF DEATH, U.S. 1997-2005 (%)

TABLE 15 CARDIOVASCULAR DISEASE, U.S., 2005 (%)

TABLE 16 INVASIVE CANCER, U.S., 2004 (%)

TABLE 17 CANCER DEATHS, U.S., 2004 (%)

TABLE 18 CANCER DEATHS, U.S., 2004 (RATIO OF DEATHS: NEW CASES)

TABLE 19 NEW MOLECULAR ENTITIES APPROVED BY THE FDA, 1980 TO MARCH 20, 2007

TABLE 20 NME APPROVALS BY DISORDER, 2004-MARCH 20, 2008

TABLE 21 BOTOX SALES, 1993-2012 ($ MILLIONS)

TABLE 22 MARKET SHARE: PHARMACY BENEFIT MANAGERS, 2007 (%)

TABLE 23 MARKET SHARE: U.S. WHOLESALERS, 2007 (%, $ BILLIONS)

TABLE 24 LEADING DRUG RETAILERS RX VOLUME, U.S., 2002 AND 2007 (RX MILLIONS)

TABLE 25 EXPORT-IMPORT PROFILE, U.S., 1995-2006 ($ BILLIONS)

TABLE 26 BRANDED PHARMACEUTICAL MARKET, U.S., THROUGH 2013 ($ BILLIONS)

TABLE 27 TOP 10 SELLING U.S. DRUGS, 2006 AND 2007 ($ BILLIONS)

TABLE 28 GENERIC PRESCRIPTION PHARMACEUTICAL MARKET, U.S., THROUGH 2013 ($ BILLIONS)

TABLE 29 OTC PHARMACEUTICAL MARKET, U.S., THROUGH 2013 ($ BILLIONS)

TABLE 30 OVERALL PHARMACEUTICAL MARKET, CANADA, THROUGH 2013 ($ BILLIONS)

TABLE 31 POPULATION TRENDS, CANADA, THROUGH 2013 (MILLIONS)

TABLE 32 DEMOGRAPHIC TRENDS, CANADA, THROUGH 2013 (MILLIONS)

TABLE 33 HEALTHCARE EXPENDITURE: CANADA, 2000 AND 2005

TABLE 34 BRANDED PHARMACEUTICAL MARKET, CANADA, THROUGH 2013 ($ BILLIONS)

TABLE 35 GENERIC PHARMACEUTICAL MARKET, CANADA, THROUGH 2013 ($ BILLIONS)

TABLE 36 OTC PHARMACEUTICAL MARKET, CANADA, THROUGH 2013 ($ BILLIONS)

TABLE 37 TOP SELLING CATEGORIES OF OTC MEDICATIONS IN CANADA (%)

TABLE 38 OVERALL PHARMACEUTICAL MARKET, MEXICO, THROUGH 2013 ($ BILLIONS)

TABLE 39 POPULATION TRENDS, MEXICO, THROUGH 2013 (MILLIONS)

TABLE 40 HEALTHCARE EXPENDITURE: MEXICO, 2000-2005

TABLE 41 BRANDED PHARMACEUTICAL MARKET, MEXICO, THROUGH 2013 ($ BILLIONS)

TABLE 42 GENERIC PHARMACEUTICAL MARKET, MEXICO, THROUGH 2013 ($ BILLIONS)

TABLE 43 OTC PHARMACEUTICAL MARKET, MEXICO, THROUGH 2013 ($ BILLIONS)

TABLE 44 OVERALL PHARMACEUTICAL MARKET, BRAZIL, THROUGH 2013 ($ BILLIONS)

TABLE 45 POPULATION TRENDS, BRAZIL, THROUGH 2013 (MILLIONS)

TABLE 46 BRANDED PHARMACEUTICAL MARKET, BRAZIL, THROUGH 2013 ($ BILLIONS)

TABLE 47 GENERIC PHARMACEUTICAL MARKET, BRAZIL, THROUGH 2013 ($ BILLIONS)

TABLE 48 OTC PHARMACEUTICAL MARKET, BRAZIL, THROUGH 2013 ($ MILLIONS)

TABLE 49 TOP FIVE PHARMACEUTICAL MARKETS, EUROPE, THROUGH 2013 ($ BILLIONS)

TABLE 50 BRANDED PRESCRIPTION PHARMACEUTICALS MARKET BY VALUE, EUROPE, THROUGH 2013 ($ BILLIONS)

TABLE 51 GENERIC PHARMACEUTICALS MARKET BY VALUE, EUROPE, THROUGH 2013 ($ BILLIONS)

TABLE 52 OTC PHARMACEUTICALS MARKET BY VALUE, EUROPE, THROUGH 2013 ($ BILLIONS)

TABLE 53 OVERALL PHARMACEUTICAL MARKET, FRANCE, THROUGH 2013 ($ BILLIONS)

TABLE 54 POPULATION TRENDS, FRANCE, THROUGH 2013 (MILLIONS)

TABLE 55 DEMOGRAPHIC TRENDS, FRANCE, THROUGH 2013 (MILLIONS)

TABLE 56 HEALTHCARE EXPENDITURE: FRANCE, 2000-2005

TABLE 57 DEMENTIA IN FRANCE, 2005-2050 (MILLIONS OF PEOPLE)

TABLE 58 PERCENTAGE OF SPENDING ON PHARMACEUTICALS BY CLASS, FRANCE, 2006 (%)

TABLE 59 BRANDED PHARMACEUTICAL MARKET, FRANCE, THROUGH 2013 ($ BILLIONS)

TABLE 60 GENERIC PHARMACEUTICAL MARKET, FRANCE, THROUGH 2013 ($ BILLIONS)

TABLE 61 OTC PHARMACEUTICAL MARKET, FRANCE, THROUGH 2013 ($ BILLIONS)

TABLE 62 REASONS FOR ADULT PURCHASES OF OTC MEDICATIONS IN FRANCE (%)

TABLE 63 PHARMACEUTICAL EXPORTS, FRANCE, 2000 AND 2006 ($ BILLIONS)

TABLE 64 PHARMACEUTICAL IMPORTS, FRANCE, 2005 AND 2006 ($ BILLIONS)

TABLE 65 PHARMACEUTICAL EXPORTS, FRANCE, 2000 AND 2006 (EUROS, MILLIONS)

TABLE 66 PHARMACEUTICAL IMPORTS, FRANCE, 2005 AND 2006 (EUROS, MILLIONS)

TABLE 67 OVERALL PHARMACEUTICAL MARKET, GERMANY, THROUGH 2013 ($ BILLIONS)

TABLE 68 POPULATION TRENDS, GERMANY, THROUGH 2013 (MILLIONS)

TABLE 69 DEMOGRAPHIC TRENDS, GERMANY, THROUGH 2013 (MILLIONS)

TABLE 70 HEALTHCARE EXPENDITURE: GERMANY, 2000-2005

TABLE 71 DEMENTIA IN GERMANY, 2005-2050 (MILLIONS OF PEOPLE)

TABLE 72 EXPENDITURES BY THERAPY AREA, GERMANY (PERCENTAGE OF HEALTHCARE SPENDING, ROUNDED)

TABLE 73 BRANDED PHARMACEUTICAL MARKET, GERMANY, THROUGH 2013 ($ BILLIONS)

TABLE 74 GENERIC PHARMACEUTICAL MARKET, GERMANY, THROUGH 2013 ($ BILLIONS)

TABLE 75 OTC PHARMACEUTICAL MARKET, GERMANY, THROUGH 2013 ($ BILLIONS)

TABLE 76 LEADING OTC PRODUCTS, GERMANY, 2006 (%)

TABLE 77 PHARMACEUTICAL EXPORTS, GERMANY, 2005 AND 2006 (EUROS, MILLIONS)

TABLE 78 PHARMACEUTICAL IMPORTS, GERMANY, 2005 AND 2006 (EUROS, MILLIONS)

TABLE 79 OVERALL PHARMACEUTICAL MARKET, U.K., THROUGH 2013 ($ BILLIONS)

TABLE 80 POPULATION TRENDS, U.K., THROUGH 2013 (MILLIONS)

TABLE 81 DEMOGRAPHIC TRENDS, U.K., THROUGH 2013 (MILLIONS)

TABLE 82 HEALTHCARE EXPENDITURE: U.K., 2000-2005

TABLE 83 PREVALENCE OF DEMENTIA IN THE U.K. 2005-2050 (MILLIONS OF PEOPLE)

TABLE 84 PERCENTAGE OF PRESCRIPTION OF PHARMACEUTICALS BY TOP EIGHT CLASSES, U.K., 2006 (%)

TABLE 85 PERCENTAGE OF PRESCRIPTION OF PHARMACEUTICALS, BY CLASS, U.K., 2006 ($ MILLIONS)

TABLE 86 BRANDED PHARMACEUTICAL MARKET, U.K., THROUGH 2013 ($ BILLIONS)

TABLE 87 LEADING PHARMACEUTICAL COMPANIES, U.K., 2004 (% OF TOTAL MARKET)

TABLE 88 GENERIC PHARMACEUTICAL MARKET, U.K., THROUGH 2013 ($ BILLIONS)

TABLE 89 OTC PHARMACEUTICAL MARKET, U.K., THROUGH 2013 ($ BILLIONS)

TABLE 90 LEADING OTC CATEGORIES, 2006, U.K. (% OF TOTAL MARKET)

TABLE 91 PHARMACEUTICAL EXPORTS-IMPORTS, U.K., 1997-2006 ($ BILLIONS)

TABLE 92 LEADING PHARMACEUTICAL DISTRIBUTORS, U.K. (% OF TOTAL MARKET)

TABLE 93 PHARMACEUTICAL EXPORTS, U.K., 1997-2006 (GBP BILLIONS)

TABLE 94 OVERALL PHARMACEUTICAL MARKET, ITALY, THROUGH 2013 ($ BILLIONS)

TABLE 95 POPULATION TRENDS, ITALY, THROUGH 2013 (MILLIONS)

TABLE 96 DEMOGRAPHIC TRENDS, ITALY, THROUGH 2013 (MILLIONS)

TABLE 97 HEALTHCARE EXPENDITURE: ITALY, 2000-2005

TABLE 98 PERCENTAGE OF CLASS C PRESCRIPTION PHARMACEUTICALS BY CLASS, ITALY, 2006 (%)

TABLE 99 BRANDED PHARMACEUTICAL MARKET, ITALY, THROUGH 2013 ($ BILLIONS)

TABLE 100 GENERIC PHARMACEUTICAL MARKET, ITALY, THROUGH 2013 ($ BILLIONS)

TABLE 101 OTC PHARMACEUTICAL MARKET, ITALY, THROUGH 2013 ($ BILLIONS)

TABLE 102 LEADING OTC CATEGORIES, ITALY, 2006 (% OF TOTAL MARKET)

TABLE 103 PHARMACEUTICAL EXPORTS, ITALY, 2005 AND 2006 ($ BILLIONS, ROUNDED)

TABLE 104 LEADING DESTINATIONS OF ITALIAN PHARMACEUTICAL EXPORTS, 2006 (% OF TOTAL MARKET)

TABLE 105 PHARMACEUTICAL IMPORTS, ITALY, 2005 AND 2006 ($ BILLIONS)

TABLE 106 LEADING DESTINATIONS OF ITALIAN PHARMACEUTICAL IMPORTS, 2006 (% OF TOTAL MARKET)

TABLE 107 PHARMACEUTICAL EXPORTS, ITALY, 2005 AND 2006 (EUR BILLIONS)

TABLE 108 PHARMACEUTICAL IMPORTS, ITALY, 2005 AND 2006 (EUR BILLIONS)

TABLE 109 OVERALL PHARMACEUTICAL MARKET, SPAIN, THROUGH 2013 ($ BILLIONS)

TABLE 110 POPULATION TRENDS, SPAIN, THROUGH 2013 (MILLIONS)

TABLE 111 DEMOGRAPHIC TRENDS, SPAIN, THROUGH 2013 (MILLIONS)

TABLE 112 HEALTHCARE EXPENDITURE: SPAIN, 2000-2005

TABLE 113 PERCENTAGE OF PRESCRIPTION OF PHARMACEUTICALS, BY CLASS, SPAIN, 2006

TABLE 114 BRANDED PHARMACEUTICAL MARKET, SPAIN, THROUGH 2013 ($ BILLIONS)

TABLE 115 GENERIC PHARMACEUTICAL MARKET, SPAIN, THROUGH 2013 ($ BILLIONS)

TABLE 116 OTC PHARMACEUTICAL MARKET, SPAIN, THROUGH 2013 ($ MILLIONS)

TABLE 117 PHARMACEUTICAL EXPORTS, SPAIN, 2005 AND 2006 (%)

TABLE 118 PHARMACEUTICAL IMPORTS, SPAIN, 2005 AND 2006 (%)

TABLE 119 OVERALL PHARMACEUTICAL MARKET, GREECE, THROUGH 2013 ($ BILLIONS)

TABLE 120 POPULATION TRENDS, GREECE, THROUGH 2013 (MILLIONS)

TABLE 121 DEMOGRAPHIC TRENDS, GREECE, THROUGH 2013 (MILLIONS)

TABLE 122 HEALTHCARE EXPENDITURE: GREECE, 2000-2005

TABLE 123 PERCENTAGE OF PRESCRIPTION PHARMACEUTICALS, BY CLASS, GREECE, 2004

TABLE 124 BRANDED PHARMACEUTICAL MARKET, GREECE, THROUGH 2013 ($ BILLIONS)

TABLE 125 GENERIC PHARMACEUTICAL MARKET, GREECE, THROUGH 2013 ($ BILLIONS)

TABLE 126 OTC PHARMACEUTICAL MARKET, GREECE, THROUGH 2013 ($ MILLIONS)

TABLE 127 LEADING OTC CATEGORIES, GREECE, 2006 (% OF TOTAL MARKET)

TABLE 128 OVERALL PHARMACEUTICAL MARKET, NETHERLANDS, THROUGH 2013 ($ BILLIONS)

TABLE 129 POPULATION TRENDS, NETHERLANDS, THROUGH 2013 (MILLIONS)

TABLE 130 DEMOGRAPHIC TRENDS, NETHERLANDS, THROUGH 2013 (MILLIONS)

TABLE 131 HEALTHCARE EXPENDITURE: THE NETHERLANDS, 2000- 2005

TABLE 132 BRANDED PHARMACEUTICAL MARKET, NETHERLANDS, THROUGH 2013 ($ BILLIONS)

TABLE 133 GENERIC PHARMACEUTICAL MARKET, NETHERLANDS, THROUGH 2013 ($ BILLIONS)

TABLE 134 OTC PHARMACEUTICAL MARKET, NETHERLANDS, THROUGH 2013 ($ MILLIONS)

TABLE 135 LEADING OTC CATEGORIES, NETHERLANDS, 2006 (% OF TOTAL MARKET)

TABLE 136 OVERALL PHARMACEUTICAL MARKET, BELGIUM, THROUGH 2013 ($ BILLIONS)

TABLE 137 POPULATION TRENDS, BELGIUM, THROUGH 2013 (MILLIONS)

TABLE 138 DEMOGRAPHIC TRENDS, BELGIUM, THROUGH 2013 (MILLIONS)

TABLE 139 HEALTHCARE EXPENDITURE: BELGIUM, 2000-2005

TABLE 140 BRANDED PHARMACEUTICAL MARKET, BELGIUM, THROUGH 2013 ($ BILLIONS)

TABLE 141 GENERIC PHARMACEUTICAL MARKET, BELGIUM, THROUGH 2013 ($ BILLIONS)

TABLE 142 OTC PHARMACEUTICAL MARKET, BELGIUM, THROUGH 2013 ($ MILLIONS)

TABLE 143 LEADING OTC CATEGORIES, BELGIUM, 2006 (% OF TOTAL MARKET)

TABLE 144 OVERALL PHARMACEUTICAL MARKET, POLAND, THROUGH 2013 ($ BILLIONS)

TABLE 145 POPULATION TRENDS, POLAND, THROUGH 2013 (MILLIONS)

TABLE 146 DEMOGRAPHIC TRENDS, POLAND, THROUGH 2013 (MILLIONS)

TABLE 147 HEALTHCARE EXPENDITURE: POLAND, 2000-2005

TABLE 148 BRANDED PHARMACEUTICAL MARKET, POLAND, THROUGH 2013 ($ BILLIONS)

TABLE 149 GENERIC PHARMACEUTICAL MARKET, POLAND, THROUGH 2013 ($ BILLIONS)

TABLE 150 OTC PHARMACEUTICAL MARKET, POLAND, THROUGH 2013 ($ MILLIONS)

TABLE 151 LEADING OTC CATEGORIES, POLAND, 2006 (% OF TOTAL MARKET)

TABLE 152 OVERALL PHARMACEUTICAL MARKET, PORTUGAL, THROUGH 2013 ($ BILLIONS)

TABLE 153 POPULATION TRENDS, PORTUGAL, THROUGH 2013 (MILLIONS)

TABLE 154 DEMOGRAPHIC TRENDS, PORTUGAL, THROUGH 2013 (MILLIONS)

TABLE 155 HEALTHCARE EXPENDITURE: PORTUGAL, 2000-2005

TABLE 156 BRANDED PHARMACEUTICAL MARKET, PORTUGAL, THROUGH 2013 ($ BILLIONS)

TABLE 157 GENERIC PHARMACEUTICAL MARKET, PORTUGAL, THROUGH 2013 ($ BILLIONS)

TABLE 158 OTC PHARMACEUTICAL MARKET, PORTUGAL, THROUGH 2013 ($ MILLIONS)

TABLE 159 LEADING OTC CATEGORIES, PORTUGAL, 2006 (% OF TOTAL MARKET)

TABLE 160 OVERALL PHARMACEUTICAL MARKET, SWITZERLAND, THROUGH 2013 ($ BILLIONS)

TABLE 161 POPULATION TRENDS, SWITZERLAND, THROUGH 2013 (MILLIONS)

TABLE 162 DEMOGRAPHIC TRENDS, SWITZERLAND, THROUGH 2013 (MILLIONS)

TABLE 163 HEALTHCARE EXPENDITURE: SWITZERLAND, 2000-2005

TABLE 164 BRANDED PHARMACEUTICAL MARKET, SWITZERLAND, THROUGH 2013 ($ BILLIONS)

TABLE 165 GENERIC PHARMACEUTICAL MARKET, SWITZERLAND, THROUGH 2013 ($ BILLIONS)

TABLE 166 OTC PHARMACEUTICAL MARKET, SWITZERLAND, THROUGH 2013 ($ MILLIONS)

TABLE 167 LEADING OTC CATEGORIES, SWITZERLAND, 2006 (% OF TOTAL MARKET)

TABLE 168 OVERALL PHARMACEUTICAL MARKET, SWEDEN, THROUGH 2013 ($ BILLIONS)

TABLE 169 POPULATION TRENDS, SWEDEN, THROUGH 2013 (MILLIONS)

TABLE 170 DEMOGRAPHIC TRENDS, SWEDEN, THROUGH 2013 (MILLIONS)

TABLE 171 HEALTHCARE EXPENDITURE: SWEDEN, 2000-2005

TABLE 172 LEADING THERAPEUTIC CATEGORIES, SWEDEN, 2006 (% OF TOTAL MARKET, BY VALUE)

TABLE 173 BRANDED PHARMACEUTICAL MARKET, SWEDEN, THROUGH 2013 ($ BILLIONS)

TABLE 174 GENERIC PHARMACEUTICAL MARKET, SWEDEN, THROUGH 2013 ($ BILLIONS)

TABLE 175 OTC PHARMACEUTICAL MARKET, SWEDEN, THROUGH 2013 ($ MILLIONS)

TABLE 176 OVERALL PHARMACEUTICAL MARKET, AUSTRIA, THROUGH 2013 ($ BILLIONS)

TABLE 177 POPULATION TRENDS, AUSTRIA, THROUGH 2013 (MILLIONS)

TABLE 178 DEMOGRAPHIC TRENDS, AUSTRIA, THROUGH 2013 (MILLIONS)

TABLE 179 HEALTHCARE EXPENDITURE: AUSTRIA, 2000-2005

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Ekr Therapeutics, a specialty pharmaceutical company, has received the FDA approval for double concentration Cardene IV premixed injection.

These patented 200ml ready-to-use (RTU) intravenous bags contain 40mg of the calcium channel blocker nicardipine hydrochloride (0.2mg/ml) in either dextrose or sodium chloride.

Previously, the company received the FDA approval for standard, or single (1X), concentration Cardene IV RTU bags. The 1X preparations consist of 200ml premixed bags containing 20mg of nicardipine hydrochloride (0.1mg/ml) in either dextrose or sodium chloride.

Ekr has said that the shipments of 1X Cardene IV RTU bags have already begun and that the company is preparing to take orders for the new double concentration preparations. The company further noted that these premixed intravenous preparations support TJC and the American Society of Health-System Pharmacy standards to dispense medication in the most ready to administer form.

Howard Weisman, chairman and CEO of Ekr, said: “Prior to the launch of the first premixed bags of Cardene IV, the success of the product’s franchise has been primarily fueled by sales of Cardene ampules, and the product has established a 15 year legacy of effectively managing acute hypertensive episodes. We now have an exciting opportunity to build upon past successes of Cardene IV with the introduction of the premixed RTU bags.”

WOONSOCKET, R.I., Nov. 12 /PRNewswire-FirstCall/ — CVS Caremark today announced that it has appointed Troyen A. Brennan, MD, as executive vice president, chief medical officer. In this newly created role, Dr. Brennan will assume responsibility for the company’s MinuteClinic, Accordant Health Care, clinical and medical affairs, and health care strategy.

“Troy Brennan is a highly regarded national health care expert who not only understands the challenges of health care today, but has hands on experience with all aspects of the health care delivery system. As a former practicing physician, hospital administrator with background in quality care measurement, and leader of a top health care insurer, Troy’s experience will help strengthen our company’s integrated approach to improving access, affordability and quality of care,” said Tom Ryan, Chairman, CEO and President of CVS Caremark. “He is a great addition to our management team.”

Brennan said he is excited to join the nation’s largest pharmacy health care company. “CVS Caremark has integrated retail pharmacy, pharmacy management services and health care clinics to reach more than four million consumers every day. The company is positioned like no other to help improve outcomes and lower overall health care costs. I look forward to helping CVS Caremark further its mission to increase access to affordable, high quality pharmacy care through its proactive pharmacy care model,” he said.

Most recently, Brennan served as chief medical officer for Aetna Inc., the nation’s third largest health insurer. At Aetna, he was responsible for clinical operations, national quality management, disease management and other programs. Prior to Aetna, Brennan was President and CEO of Brigham and Women’s Physicians Organization in Boston, MA, and also previously served that hospital as Director of Quality Measurement and Improvement. He is a member of the Institute of Medicine of the National Academy of Sciences.

Brennan has his MD and MPH from Yale Medical School, a JD from Yale Law School and a Masters Degree from Oxford University, where he was a Rhodes Scholar. He graduated with a BS from Southern Methodist University in Texas. He has served on the faculties of Harvard Medical School, Harvard Law School and the Harvard School of Public Health.

About CVS Caremark

CVS Caremark is the largest provider of prescriptions in the nation. The Company fills or manages more than 1 billion prescriptions annually. Through its unmatched breadth of service offerings, CVS Caremark is transforming the delivery of health care services in the U.S. The Company is uniquely positioned to effectively manage costs and improve health care outcomes through its more than 6,800 CVS/pharmacy and Longs Drugs stores; its Caremark Pharmacy Services division (pharmacy benefit management, mail order and specialty pharmacy); its retail-based health clinic subsidiary, MinuteClinic; and its online pharmacy, CVS.com. General information about CVS Caremark is available through the Investor Relations section of the Company’s Web site, at http://cvscaremark.com/investors, as well as through the Newsroom section of the Company’s Web site, at http://cvscaremark.com/newsroom.

   Media Contact:                         Investor Contact:   Eileen Howard Dunn                     Nancy Christal   Senior Vice President                  Senior Vice President   Corporate Communications &             Investor Relations   Community Relations                    (914) 722-4704   (401) 770-4561  

CVS Caremark

CONTACT: Media Contact: Eileen Howard Dunn, Senior Vice PresidentCorporate Communications & Community Relations, +1-401-770-4561, or InvestorContact: Nancy Christal, Senior Vice President Investor Relations,+1-914-722-4704, both of CVS Caremark

Web site: http://cvscaremark.com/investors

MNI Nutraceuticals Inc. (PINKSHEETS: MNIA) is pleased to announce that Dr. Martin’s interview with popular morning health show on the CW network is now available for viewing on YouTube.com.

Dr. Martin was invited on as a guest of Andrea Jackson, who is a host of the popular morning show The Daily Buzz, a nationally syndicated morning news program produced by ACME Communications which is aired on the CW Network — which is a joint venture between CBS Corporation, and Warner Bros., a subsidiary of Time Warner. Dr. Martin took the opportunity to explain certain chapters of his new book, “Medical Crisis: Secrets Your Doctor Won’t Share With You.” Tony took the opportunity to speak about ways to better understand your body and how to make the environment surrounding you for a better health.

“Dr. Martin was terrific as usual in discussing topics of a healthy lifestyle,” stated Harvey Panesar, President. “It was an incredible opportunity for us at MNI Nutraceuticals to be able to get Dr. Martin on such a major network like the CW. This opportunity will not only add credibility to our company, but will continue to add growth to our vision of being a leader in natural health,” continued Mr. Panesar

The link to the CW feature can be viewed on Youtube.com with the following title: Dr. A.W. Martin on The Daily Buzz and the following link: http://ca.youtube.com/watch?v=he1Fadn6QKU.

For more information on Dr. Martin’s book Medical Crisis please visit the website at: www.medicalcrisisthebook.com.

About MNI Nutraceuticals Inc.

MNI Nutraceuticals Inc. is a company focused on providing a better health and lifestyle through natural products. MNI Nutraceuticals flagship products include Arthrizyme(TM) for general joint pain and Vital Slim, which is a proprietary formula for weight control and management.

In the past few months the company has been working on an Infomercial on best-selling author Dr. Anthony Martin’s new book “Medical Crisis: Secrets our Doctor won’t share with You.” This amazing new book provides Dr. Martin’s insights into the many things that an individual can eat and do in order to improve their health and wellness and that their medical doctor just does not have the time and resources to provide them. The book can be life-altering and even life-saving.

Safe Harbor Statement

This release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The risks and uncertainties that may affect the operations, performance development and results of the Company’s business include but are not limited to fluctuations in financial results, availability and customer acceptance of our products and services, the impact of competitive products, services and pricing, general market trends and conditions.

 Contact: Taylor Capitol, Inc. Stephen Taylor 973-351-3868 Email Contact

SOURCE: MNI Nutraceuticals

NORTH PALM BEACH, Fla., Nov. 12 /PRNewswire/ — Indications that the economy is leading to increased substance abuse, compulsive gambling and other addictive behaviors have led one of the nation’s premiere addiction rehabilitation facilities to create a charitable arm to provide financial support for people in need of addiction treatment.

(Photo: http://www.newscom.com/cgi-bin/prnh/20081112/CLW099 )

“The economy exerts a negative effect on the ability to fund alcohol detox and drug rehab programs, creating a double-edged sword of increased demand and diminishing resources,” said Dr. Mitchell Wallick, Ph.D. CAP CMHP ICADC CAGC FABFCE, Director of C.A.R.E. Addiction Recovery’s Florida rehab.

In announcing the formation of the C.A.R.E.’s charitable organization, C.A.R.E.’s Helps, Wallick said, “C.A.R.E. has always been moderately-priced in comparison to other rehabs and employs a need-based fee scale, but the formation of C.A.R.E.’s Helps enables us to take a much more proactive approach to combatting addiction.”

In its first major initiative, C.A.R.E.’s Helps will offer a full scholarship valued at $22,000 for 30 days of in-patient treatment at C.A.R.E. Addiction Recovery’s resort-style retreat in West Palm Beach, Florida. Listeners of Recovery Radio Live, a syndicated radio show about 12 step recovery, are invited to nominate themselves or a loved one who is battling with addiction to win the scholarship which will be awarded in December 2008. Contest rules at http://www.recoveryradiolive.com/ .

It was also announced that C.A.R.E. has pledged to match every dollar donated to the tax-exempt foundation, and for every $22,000 raised, C.A.R.E. will offer an additional fully paid 30 day scholarship. C.A.R.E. absorbs all administrative costs so that every dollar donated goes directly to treatment.

C.A.R.E. Addiction Recovery employs a holistic approach to addiction treatment that endeavors to treat the underlying psychological factors that predicate addictions. In addition to providing traditional addiction counseling, C.A.R.E. has long been at the forefront of incorporating acupuncture, Chinese herbal therapy and therapeutic grade essential oils into treatment.

C.A.R.E. has had enormous success applying many of these same principles to those suffering from eating disorders like anorexia, bulimia, or overeating as well as gambling addiction, sex addiction and Internet addiction. Unique among Florida drug detox programs, C.A.R.E. also offers a counseling enhanced outpatient opiate detoxification program. Additional information at http://www.careflorida.com/index.html

C.A.R.E.’s Helps is a charitable organization which maintains 501(c) (3) tax-exempt status. To make a donation or for additional information, visit: http://www.helpanaddict.org/

Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Mitchell Wallick, Ph.D., CAP, CMHP, ICADC, CAGC, FABFCE http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=82690

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20081112/CLW099AP Archive: http://photoarchive.ap.org/AP PhotoExpress Network: PRN15PRN Photo Desk, [email protected]

C.A.R.E. Addiction Recovery

CONTACT: Denise Sullivan, +1-305-804-3026, [email protected], forC.A.R.E.

Web site: http://www.recoveryradiolive.com/http://www.careflorida.com/index.htmlhttp://www.helpanaddict.org/

According to the Centers for Disease Control and Prevention (CDC), every 60 seconds a loved one dies from a heart attack in the U.S. Every 26 seconds, an American will suffer a heart attack. If the patient survives, more than half will suffer a recurrent attack leading to death or disability. So why are there no established national protocols to challenge the effects of a STEMI (ST-elevation myocardial infarction) event, a heart attack caused by complete obstruction of a coronary artery?

Leading STEMI expert Dr. Sameer Mehta and many of his colleagues argue it is a matter of national public health policy and that the U.S. lags behind some of its international counterparts in establishing STEMI protocols to effectively treat acute patients in ways that parallel our current national trauma system. Currently, there are more than 270 certified trauma centers in the U.S. offering Level I – Level IV care, each set up to meet the critical care needs of a trauma patient with specialists, equipment and a required number of surgeons and anesthesiologists on call 24 hours a day. By contrast, only a handful of certified STEMI Receiving Centers exist in the U.S. Unlike trauma care, there are no established national codes or procedures to effectively treat Americans fighting to survive a heart attack — the number one killer of men and women in the U.S.

“Time is of the essence. As the time that heart muscle is deprived of oxygenated blood increases, the likelihood the patient will die or be severely debilitated also increases,” says Dr. Sameer Mehta, LUMEN 2009 Program Director and author of the Textbook of STEMI Interventions. Dr. Mehta advocates angioplasty for STEMI patients instead of thrombolytic therapy (drugs) whenever possible.

In an effort to focus more resources on establishing a national initiative for creating/certifying STEMI Receiving Centers within hospitals, the North American Center for Continuing Medical Education (NACCME, LLC) will bring together the world’s top minds in the field of cardiology for LUMEN 2009: The Symposium on Optimal Treatments for Acute MI.

The meeting will take place February 26-28, 2009 at the Loews Miami Beach Hotel in Miami Beach, Florida and coincide with American Heart Month. The Presidential Address will be given by the President of the American College of Cardiology, Dr. W. Douglas Weaver. Dr. Weaver is the Division Head of Cardiovascular Medicine, the Darin Chair of Cardiology, Director of the Henry Ford Cardiovascular Institute at the Henry Ford Health System and Professor of Medicine at Wayne State University, Detroit, Michigan. He has been an outspoken advocate for healthcare reform in the U.S.

In addition to Dr. Weaver, LUMEN 2009 will include keynotes by international experts in the field of interventional cardiology — Dr. William W. O’Neill and Dr. Martin B. Leon.

Dr. O’Neill is the Professor and Executive Dean for Clinical Affairs, Division of Cardiology at the Leonard M. Miller School of Medicine at the University of Miami, Miami, Florida. Dr. O’Neill is recognized as a pioneer in balloon angioplasty and related techniques, having made fundamental contributions to the development of these procedures and their applications in patients with coronary artery disease and valvular heart disease.

Dr. Martin B. Leon is Founder and Chairman Emeritus of the Cardiovascular Research Foundation and Professor of Medicine at Columbia University Medical Center (CUMC), New York City, New York. Dr. Leon has served as principal investigator for numerous clinical trials that have helped shape the field of interventional vascular medicine and has had a major impact on the development of modern interventional vascular devices and therapies.

“For LUMEN 2009, I have sought the knowledge of world experts to create a robust CME program — four luminary co-directors, each a respective giant in interventional cardiology, door-to-balloon time processes, emergency medicine, and cardiovascular nursing,” adds Mehta.

Other programs will include the STEMI Processes Symposium, a session of the world’s top five STEMI programs presented by their directors — the first time at a single meeting. In addition, LUMEN 2009 has more than 12 innovative and pragmatic workshops where attendees can master techniques to achieve low door-to-balloon times (a measure of the time to treatment) for STEMI interventions. Finally, there will be two great debates on the two most critical questions in STEMI interventions — which type of stent to use and whether primary percutaneous coronary intervention (PCI) should be done only at tertiary centers.

LUMEN 2009: The Symposium on Optimal Treatments for Acute MI is an integrated STEMI educational rendezvous for paramedics, emergency department staff, critical care nurses, cardiovascular laboratory technologists and nurses, internists, general practitioners, hospitalists, intensivists, clinical and interventional cardiologists, cardiac and vascular surgeons, and hospital administrators. To learn more, visit www.LUMENami.com.

HMP Communications, LLC, a sister company to NACCME, LLC, has been contracted to manage logistics for the event, including audience generation and the acquisition and management of all corporate sponsorships and exhibits.

For information about attending LUMEN 2009: The Symposium on Optimal Treatments for Acute MI, February 26-28, 2009, please visit www.LUMENami.com or call Sheila Donato 800-237-7285 ext. 233 to request a brochure.

For information on sponsorship and exhibit opportunities, please contact HMP Communications, LLC directly at 800-237-7285 and ask for Jeff Martin.

NACCME, LLC is a leading accredited medical education and communications company. CME/CE activities sponsored by NACCME, LLC reach medical professionals in many different formats. Through meetings, publications, and web-based programming, thousands of healthcare practitioners participate in NACCME, LLC activities, expanding their clinical knowledge and competence by examining current medical issues, trends, therapies, and technologies. CME/CE activities sponsored by NACCME, LLC are produced to strengthen practitioner awareness of evidence-based patient care advances in a broad range of therapeutic areas. NACCME, LLC sponsors CME/CE activities for physicians, pharmacists, podiatrists, nurses, physician assistants, and other allied healthcare professionals. NACCME, LLC is committed to improving healthcare practitioner knowledge, competence, and performance, ultimately to improve patient care.

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 educational 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.

WASHINGTON, Nov. 12 /PRNewswire/ — Nurture(R) by Steelcase, a leading manufacturer of furniture for healthcare environments, today announced that it has earned its second consecutive prestigious Nightingale Award at the annual Healthcare Design 08 Conference in Washington, D.C. for its new caregiver workspace solution, SYNC(TM).

(Photo: http://www.newscom.com/cgi-bin/prnh/20081112/AQW138)

SYNC addresses the emerging needs of caregivers and clinical environments by seamlessly supporting people to technology and people to people work processes. Whether in a centralized or decentralized, new construction or retro-fit environment, SYNC work stations offer highly flexible and customizable ergonomic solutions that easily accommodate ever increasing technology demands. SYNC is a modular solution, it can be moved and re-used or reconfigured as needs change.

SYNC was designed in collaboration with HDR Architecture, Inc., a renowned leader and innovator in healthcare design.

Nurture designer and Director of Product Development Alan Rheault said, “We’re particularly proud that this product was singled out for recognition. SYNC is so critical to the caregiver and partners-in-care experience. We feel SYNC brings significant design innovation and functionality to the healthcare environment.”

SYNC addresses the new needs of what used to be called centralized and decentralized nurses stations. These needs were identified via the combination of the extensive experience of HDR Architecture and Nurture’s thorough research.

Steve LaHood, Vice President and Director of Product Development of HDR Architecture, Inc. said, “We were excited to collaborate with Nurture on a fresh approach to the typical nurses stations, one we knew would solve the emerging needs of caregivers. It was immensely rewarding to work with a manufacturer who could help transform our vision for a line of flexible systems furniture into a beautiful reality.”

The Nightingale Awards honor new healthcare products introduced to the U.S. market since November 2007. They are awarded based on the product’s contribution to the quality of healthcare, functionality, quality, aesthetics, environmental sustainability and pricing, and are judged by interior designers and architects that specialize in healthcare design. The Nightingale Awards product design competition is sponsored by Contract magazine in association with The Center for Health Design and The Healthcare Design Conference.

“Earning a Nightingale Award is a tremendous honor for Nurture. It reinforces our commitment to research-based solutions and our effort to continuously strive to offer the highest quality products,” said Michael Love, president of Nurture. “It’s gratifying that key industry leaders recognize our contribution to the healthcare industry.”

This is the second consecutive Nightingale Award for Nurture, as the company’s Opus(TM) Overbed Table won the award last year.

In addition to back-to-back Nightingale Awards, Nurture products have been honored with three consecutive “Gold” awards in the healthcare furniture category at the 2006, 2007 and 2008 “Best of NeoCon” competitions.

Nurture officially launched as a company in 2006, but the company is not new to healthcare. Years of research and partnerships with leading healthcare providers and organizations such as HDR, allow the company to tailor a wide variety of environmental solutions to specific settings.

The Nurture by Steelcase family of companies provides a comprehensive product portfolio that supports a wide variety of healthcare environments.

About Nurture

Nurture by Steelcase is a company focused on healthcare environments and how products within these environments can help make them more comfortable, efficient and conducive to the healing process. For more information, visit http://www.nurture.com/.

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20081112/AQW138PRN Photo Desk, [email protected]

Nurture by Steelcase

CONTACT: Libby Ferin of Nurture by Steelcase, +1-616-248-7038,[email protected]; or Michael Pflughoeft, +1-414-270-7136,[email protected], for Nurture by Steelcase

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

Michael L. Smith, former Executive Vice President and Chief Financial Officer (CFO) for Anthem, Inc., and its subsidiaries, Anthem Blue Cross and Blue Shield, has joined the Board of Directors for Carestream Health, Inc.

Carestream Health is a world leader in medical and dental imaging and information technology products, molecular imaging systems and non-destructive testing products.

Smith, who retired in 2005 from Anthem, one of the largest health benefits companies in the United States, previously served as Chief Operating Officer and CFO of American Health Network, a former Anthem subsidiary that provided physician practice management services to primary care practices in three states.

Prior to joining Anthem, Smith was Chairman, President and Chief Executive Officer (CEO) of transportation company, Mayflower Group, Inc. He began his career in the Indianapolis office of Arthur Andersen & Company after graduating from DePauw University in 1970.

Smith currently serves on the Boards of Directors for several businesses, including Emergency Medical Services Corporation, Inc., the nation’s largest emergency medical services provider; Kite Realty Group Trust, a real estate investment trust, or REIT; Vectren Corporation, a progressive energy-holding company; and HH Gregg Appliances, Inc., one of the nation’s leading retailers of home appliances and consumer electronics. He also serves on the Boards of Finishmaster, Inc., and its parent, Ldi Ltd., and Calumet Specialty Products Partners, L.P.

Additionally, Smith serves on the Board of the Central Indiana Community Foundation and is a member of the Board of Trustees of DePauw University, the Indiana Commission for Higher Education and the Lumina Foundation for Education.

Smith is a founding member of Cardinal Equity Partners, a mid-market private equity investment fund headquartered in Indianapolis, Ind.

“We are excited that Michael has joined our Board,” said Robert M. Le Blanc, Chairman of Carestream Health’s Board of Directors. “His solid understanding of the healthcare market and great track record in management and as a director will be invaluable to our company.”

With the addition of Smith, Carestream Health’s Board of Directors now has eight members. They are: Board Chairman Le Blanc, a Managing Director of Onex Corporation, one of Canada’s largest corporations; Joseph F. Dooley, former President of The Proctor & Gamble Company’s Duracell business and Gillette North America operations; Robert M. Haft, Chairman, MainStreet Lender, a direct national commercial lender; Kevin J. Hobert, Carestream Health’s CEO; James T. Kelly, a private investor, who previously served as President and CEO of Lincare Holdings Inc., a provider of in-home respiratory care, infusion therapy and medical equipment; Michael C. Pomeroy, CFO of Carestream Health; and Eliot L. Siegel, M.D., Professor and Vice Chair, University of Maryland School of Medicine, Department of Diagnostic Radiology, and Chief of Radiology and Nuclear Medicine for the Veterans Affairs Maryland Healthcare System.

Full bios of each board member can be found on Carestream Health’s web site, http://carestreamhealth.com/board-directors.html.

About Carestream Health, Inc.

Carestream Health, Inc., is a leading provider of dental and medical imaging systems and healthcare IT solutions; molecular imaging systems for the life science research and drug discovery/development market segments; and x-ray film and digital x-ray products for the non-destructive testing market. The company was formed in 2007 when Onex Corporation (TSX: OCX.TO) purchased Eastman Kodak Company’s Health Group. For more information about Carestream Health, contact your Carestream Health representative or visit www.carestreamhealth.com.

WESTPORT, Conn., Nov. 12 /PRNewswire/ — JD’s Cosmetic Essentials is proud to announce we will be supporting the Smilow Family Breast Health Center at Norwalk Hospital with a year-long effort to encourage our friends and customers to get a mammogram. Let us know when you had your mammogram and we will donate 10 percent of that day’s purchase to the Smilow Family Breast Health Center.

“Unfortunately we all know someone who is touched by breast cancer. It does not discriminate and does not take a holiday. We want every month to be Breast Cancer Awareness Month at JD’s,” said Elizabeth Genel, Founder and President of JD’s Cosmetic Essentials.

Did you know that 96% of women diagnosed with early-stage breast cancer are alive 5 years later? This is a staggering statistic and all the more reason to get your yearly mammogram. Early detection is critical in the fight against breast cancer, the faster the diagnosis the better. The Smilow Family Breast Health Center assists the patient in scheduling the necessary physician appointments, arranging one-to-one education with a Breast Health Navigator, and offering support throughout the diagnostic process. The Smilow Family Breast Health Center brings together surgery, oncology, radiation, nursing, clinical trials, prevention and education — in one state of the art program.

“We are thrilled JD’s Cosmetic Essentials is on our team. We salute their effort to encourage all to get that yearly mammogram. JD’s is part of the Fairfield County community. The stores provide an intimate setting where women go to get even more beautiful. What better place to address women’s breast health concerns. We look forward to a long relationship. The donation of 10 percent of that day’s purchase after a mammogram will go a long way in supporting breast health,” said Maureen Major Campos, RN, MS, Breast Health Navigator at Smilow Family Breast Health Center.

To donate directly to Smilow Family Breast Health Center please visit http://www.norwalkhospitalfoundation.org/ or http://www.jdscosmetics.com/. Your generous donation will help ensure that the Smilow Family Breast Health Center will continue to treat the entire individual — body, mind and spirit through an interconnected community of care and resources.

JD’s Cosmetic Essentials is New England’s pre-eminent beauty boutiques offering amazing products and award winning service. Founded in 1997 by Elizabeth Genel, JD’s Cosmetic Essentials offers four Connecticut locations: Westport, Darien, Ridgefield and West Hartford. JD’s Cosmetic Essentials, affectionately known as JD’s, offers the most exceptional make up, skin care, bath & body, hair care and cosmetic accessories available. While we offer a diverse selection of product lines, our favorites include Laura Mercier, Bobbi Brown, Trish McEvoy, Darphin, Kiehl’s and Bumble and Bumble. Elizabeth, a 22 year beauty industry veteran, has insured that all of her employees are rigorously trained on every item available in the boutiques as well as the latest beauty trends. We pride ourselves on educating customers on how use our products so they can look and feel beautiful every day. Please visit us at http://www.jdscosmetics.com/, and for glorious jewelry please visit our sister store, http://www.violetyork.com/.

JD’s Cosmetic Essentials

CONTACT: Alyse Frankenberg, +1-203-341-8570, for JD’s CosmeticEssentials

Web site: http://www.jdscosmetics.com/http://www.norwalkhospitalfoundation.org/http://www.violetyork.com/

Survey data on 400 payday loan users collected before and after the imposition of an interest-rate cap in Oregon suggest that the cap caused deterioration in the overall financial condition of the Oregon households. The results suggest that restricting access to expensive credit harms, rather than helps, consumers.

The study, conducted by Prof. Jonathan Zinman of Dartmouth College, seeks to evaluate the effects of interest-rate and loan-term restrictions imposed by the State of Oregon in 2007. Previously, payday lenders had been charging borrowers at least $15 per $100 for two-week loans; effective July 1, 2007, the maximum finance charge that can be imposed on Oregon borrowers is approximately $10 per $100, with a minimum loan term of 31 days. The effective yield to lenders was reduced by two-thirds as a result of the new regulatory scheme.

Most payday lenders have exited Oregon following the cap, and the study finds that payday borrowing has fallen dramatically as a result. It also finds evidence that some former payday borrowers turned to alternatives that can be even more costly than payday loans, such as overdrafts and late bill payments.

The study estimates the effects of the Oregon cap by comparing changes in key aspects of household finances before and after the effective date of the cap, using comparable households in Washington state (which retained consistent regulation) as a “control.” The study covers changes from late June 2007 to early December 2007.

The most important finding in the study is that, relative to their Washington counterparts, the Oregon households were far more likely to experience a change for the worse in the key financial outcomes measured by the survey: job status and respondents’ assessments of their recent and future financial situation. These results suggest that restricting access to payday loans harmed Oregon respondents over the term of the study.

“Like some other studies, these results suggest that access to credit, even if expensive, can help some people make productive investments and help others manage their cash flows through emergencies,” Prof. Zinman said. “There’s more work to do to reconcile these results with findings from other studies that suggest access to expensive credit can exacerbate financial distress.”

The data collection for the study was funded by a grant from Consumer Credit Research Foundation, which did not participate in the analysis of the data or the drafting of the study.

The complete working paper on the study is available online at http://www.dartmouth.edu/~jzinman/Papers/Zinman_RestrictingAccess_oct0 8.pdf. (Due to its length, this URL may need to be copied/pasted into your Internet browser’s address field. Remove the extra space if one exists.)

CLEVELAND, Nov. 12 /PRNewswire/ — Imagine if a simple blood test could detect recurrent cancer earlier, while also predicting a patient’s prognosis. Imagine if a device the size of two decks of cards could help a paraplegic breathe without a bulky ventilator. Or imagine if a machine could essentially keep harvested organs alive until they’re transplanted in the recipient.

Now imagine that these innovations already exist, because they do, along with seven other emerging technologies that make up Cleveland Clinic’s Top 10 Medical Innovations for 2009.

The list of breakthrough devices and therapies was selected by a panel of Cleveland Clinic physicians and scientists and was unveiled during Cleveland Clinic’s 2008 Medical Innovation Summit ( http://www.clevelandclinic.org/innovations/summit/default.htm ), which is currently underway. The innovations touch on avian influenza, electronic medical records, and various minimally invasive surgeries to treat uterine fibroids, to repair heart valves, and to remove organs through the body’s natural orifices.

“Once again, we are seeing a diverse list of technologies that have the potential to make an enormous medical impact in the near future,” said Michael Roizen, M.D., who chaired the Top 10 Medical Innovations List.

The Top 10 Medical Innovations for 2009

10. Private Sector National Health Information Exchange: A comprehensive system of electronic health records that link consumers, general practitioners, specialists, hospitals, pharmacies, nursing homes, and insurance companies is in the process of being established. Primarily a private-sector effort, this computerized system has the potential to replace paper-based medical files with digitized records of patients’ complete medical history.

9. Doppler-Guided Uterine Artery Occlusion: Fibroid tumors occur in upwards of 40% of women older than 35, triggering pelvic pain, pregnancy complications, and heavy bleeding. There is a new, non-invasive approach to treat fibroids called Doppler-guided uterine artery occlusion, or DUAO.

8. Integration of Diffusion Tensor Imaging (Tractography): Diffusion tensor imaging (DTI) is the new technology that allows neuroscientists to non-invasively probe the long-neglected half of the brain called white matter, with its densely packed collection of intertwining insulated projections of neurons that join all four of the brain’s lobes, allowing them to communicate with each other.

7. LESS and NOTES Applications: LESS (laparoendoscopic single-site surgery) takes laparoscopic surgery to an entirely new level by reducing the process to a small cut in the belly button. NOTES (natural orifice transluminal endoscopic surgery) bypasses normal laparoscopic incisions altogether. Instead, the surgeon gets to an appendix, prostate, kidney, or gallbladder through one of the body’s natural cavities, such as the mouth, vagina, or colon.

6. New Strategies for Creating Vaccines for Avian Flu: A newer vaccine approach that uses a mock version of the bird virus called a virus-like particle (VLP) may offer a better solution to protect people against infection from the deadly avian virus.

5. Percutaneous Mitral Valve Regurgitation Repair: Using a tiny barbed, wishbone-shaped device, the heart is fixed non-surgically from the inside out. A catheter is carefully guided through the femoral vein in the groin, up to the heart’s mitral valves. The clip on the tip of a catheter is then clamped on the center of the valve leaflets, which holds them together and quickly helps restore normal blood flow out through the leaflets.

4. Multi-Spectral Imaging Systems: The imaging system is attached to a standard microscope, where researchers can stain up to four proteins using different colors and look at tissue samples with 10 to 30 different wavelengths, allowing for the accumulation of more information than is currently available. This helps researchers to better understand the complicated signaling pathways in cancer cells, and to develop more targeted therapies, which might allow physicians to better personalize treatment for individual patients.

3. Diaphragm Pacing System: Four electrodes are connected to the phrenic nerves on the diaphragm. Wires from the electrodes run to and from a control box about the size of two decks of playing cards worn outside the body. When the electrodes are stimulated by current, the diaphragm contracts and air is sucked into the lungs. When not stimulated, the diaphragm relaxes and air moves out of the lungs.

2. Warm Organ Perfusion Device: Once a heart becomes available for transplant, surgeons have just four hours before the organ begins to decay. This device, though, recreates conditions within the body to keep the heart pumping for up to 12 hours.

1. Use of Circulating Tumor Cell Technology: A blood test that measures circulating tumor cells – cancer cells that have broken away from an existing tumor and entered the bloodstream – has the ability to detect recurrent cancer sooner, while also predicting how well treatment is working and the patient’s probable outcome. The test results will allow physicians to better monitor a patient’s progress, adjusting treatment if necessary.

“Cleveland Clinic was founded by innovators, and this Top Ten list reflects the continuing passion for innovation of its scientists and clinicians,” said Christopher Coburn, Executive Director, Innovations, the Cleveland Clinic’s corporate venturing arm. “This list is a natural outgrowth of the role of Clinic physicians as arbiters of innovation as they work to provide their patients the very best that the technology community has to offer. This list lets the public in on the thinking of top physicians working on the front lines of medicine.”

Four major criteria served as the basis for qualifying and selecting the Top 10 Medical Innovations. Nominated innovations were required to:

   -- Have significant potential for short-term clinical impact (either a      major improvement in patient benefit or an improved function that      enhances healthcare delivery).   -- Have a high probability of success.   -- Be on the market or close to being introduced.   -- Have sufficient data available to support its nomination.    

The Top 10 Medical Innovations for 2009 were announced today at the sixth annual Cleveland Clinic Medical Innovation Summit. In developing the Top 10, Cleveland Clinic enlisted the expertise of AlixPartners, LLP, an independent international management advisory firm. AlixPartners led the process to probe the opinions of Cleveland Clinic physicians and researchers, create a field of nominated innovative technologies for consideration, and develop a consensus perspective on the Top 10 Medical Innovations for 2009.

For more information about this year’s Medical Innovation Summit and the conference agenda, visit http://www.clevelandclinic.org/innovations/summit/default.htm .

About Cleveland Clinic Innovations

CC Innovations, the commercialization and innovation arm of Cleveland Clinic, organizes the Medical Innovation Summit, promotes innovation and is responsible for commercialization of all Cleveland Clinic technologies. CC Innovations advances product-oriented innovation and transforms promising therapies, devices and diagnostics into beneficial medical products, via spin-off companies, licensees and equity partnerships.

About Cleveland Clinic

Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit multispecialty academic medical center that integrates clinical and hospital care with research and education. Cleveland Clinic was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. Approximately 1,800 full-time salaried physicians and researchers at Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties. In 2007, there were 3.5 million outpatient visits to Cleveland Clinic and 50,455 hospital admissions. Patients came for treatment from every state and from more than 80 countries. Cleveland Clinic’s Web site address is http://www.clevelandclinic.org/ .

Cleveland Clinic

CONTACT: Brian Kolonick of Cleveland Clinic, +1-216-444-0898,[email protected]

Web site: http://www.clevelandclinic.org/

With the first day of Medicare open enrollment set for this Saturday, Nov. 15, Humana Inc. (NYSE: HUM) today announced some highlights of the Medicare Advantage and stand-alone prescription-drug plans it will offer to Medicare beneficiaries next year.

The company’s 2009 Medicare plans are designed to encourage members to take advantage of preventive health care services, better manage chronic conditions, and use programs that help members save money on prescription drugs.

To underscore the company’s emphasis on preventive care, members in most of Humana’s 2009 Medicare Advantage plans (plans that come with medical or medical and prescription drug coverage) will not incur a copayment for the following preventive care services:

— Routine physicals

— Prostate screening

— Mammograms

— Bone-mass measurement

— Pap/pelvic exams

— Colonoscopy

— Flu vaccine

“Getting appropriate preventive screenings is one of the most important things someone can do for his or her health,” said Philip Painter, M.D., chief medical officer of Humana’s Senior Products division. “Early detection typically gives you a better chance of recovery, no matter the condition. A mammogram, for instance, might reveal a mass that is too small to be detected by self-examination, greatly enhancing a person’s treatment options.”

Most Humana Medicare Advantage plans also feature care coordination and/or disease-management services, including HumanaFirst(SM) – a 24-hour-a-day medical information service. Callers to HumanaFirst can speak to a registered nurse who helps guide them to appropriate treatment or care, depending on their situation.

Another way Humana will help members manage their health in 2009 is by making diabetic-monitoring supplies available for a $0 copayment. This enhancement, which is available to most Humana Medicare Advantage members, includes test strips, lancets and glucometers. According to the Juvenile Diabetes Research Foundation, people with diabetes who frequently monitor blood-sugar levels and maintain tight glucose control experience far fewer complications from diabetes.

Humana is tackling the cost of prescription drugs by continuing to offer a $0 copayment to eligible members for Tier 1 (preferred generic) drugs ordered through the company’s mail-order pharmacy, RightSourceRx(SM). These savings are available to many Humana Medicare members, including the 1.6 million enrollees in the company’s Enhanced and Complete prescription-drug plans.

“Humana members have saved more than $15 million in copayments through this program this year,” said William Fleming, Pharm. D., vice president of Humana Pharmacy Solutions. “Most people understand that generics are comparable to their brand-name counterparts in terms of strength, purity and stability, and are just as effective. Additionally, more generics are constantly entering the marketplace to treat such common conditions as high cholesterol, high blood pressure and diabetes.”

Humana will also offer prescription-drug plans that feature discounts on over-the-counter drugs as well as vision, dental and hearing services. Additionally, Humana Medicare members receive regular SmartSummary statements which feature a prescription-benefits summary that warns members of potentially harmful drug interactions and informs them about ways to save money on their prescriptions.

Expanded plan offerings in several markets

Humana will offer new Medicare health plans in several markets in 2009. Health Maintenance Organizations, or HMOs, will be available in:

— Albuquerque, N.M.; Peoria, Ill., the Treasure Coast area of Florida (St. Lucie, Okeechobee and Brevard counties), and Las Vegas.

Local Preferred Provider Organizations, or LPPOs, will be introduced in:

— Evansville, Ind.; northern Indiana; north-central Pennsylvania; Erie, Pa.; Virginia Beach-Norfolk, Va.; Richmond, Va.; Charleston-Huntington, W. Va.; Columbus, Ohio; Cedar Rapids and Scott County, Iowa; Peoria, Ill.; Henry and Mercer counties, Illinois; Huntsville, Birmingham and Mobile, Ala.; the Gulf Coast of Mississippi; Jackson, Miss.; Chattanooga and Knoxville, Tenn.; Columbia, S.C.; Fort Collins-Greeley and Pueblo, Co.; Honolulu; Las Vegas; and three parishes in New Orleans.

Humana will pilot a new LPPO, Humana MyCare(SM), in New Orleans and Kansas City. MyCare healthcare providers have completed a course on senior sensitivity, motivational interviewing, advanced-care planning and management of multiple chronic conditions – continuing education designed to help doctors help Humana members be healthier and have a better experience with their doctor and the health care system.

For more information about Humana’s Medicare plans for individuals, visit http://www.humana-medicare.com.

About Humana

Humana Inc., headquartered in Louisville, Kentucky, is one of the nation’s largest publicly traded health and supplemental benefits companies, with approximately 11.7 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 http://www.humana.com , including copies of:

— Annual reports to stockholders

— Securities and Exchange Commission filings

— Most recent investor conference presentations

— Quarterly earnings news releases

— Replays of most recent earnings release conference calls

— Calendar of events (includes upcoming earnings conference call dates and times, as well as planned interaction with research analysts and institutional investors)

— Corporate Governance Information

In honor of their 25th Anniversary, Sierra Tucson, a unique treatment center dedicated to the prevention, education, and treatment of addictions and behavioral disorders, will be hosting a “Gratitude for Giving” Breakfast on Friday, November 14, 2008, from 8:30 – 10:00 a.m. at The Houstonian, 111 North Post Oak Lane, Houston, TX. Over 110 attendees are expected to join this celebration to pay tribute to their peers. Media are invited to attend free of charge.

Among those being recognized for their years of service to others are:

 --  Jason Powers, M.D., The Right Step --  Damien Duplechain, LPC, Center for Marriage and Family Relationships --  Crystal Moore, Magellan Employee Assistance --  Deborah Schonauer, BS, LCDC, Passages --  Susan Degner, M.P.H., Contemporary Medicine --  Pat Dugan, LCDC --  Janice Poplack, LCSW, Menninger Clinic --  Marylou Erbland, Ph.D., The Center for Success and Independence --  Carole Delongchamps, LCSW      

“Those who are called to work in the addictions and mental health field often do not receive recognition for the positive impact they have on our community,” states Christi Cessna, Sierra Tucson’s Marketing Director. “Sierra Tucson’s ‘Gratitude for Giving’ Breakfast is a way to honor the incredible people in the Houston area who work every day to help those who suffer from addictions and mental/behavioral disorders.”

Sierra Tucson is an internationally renowned, accredited treatment center and a dually licensed psychiatric hospital. Sierra Tucson is a leader in providing innovative, individualized treatment plans for coexisting addictions, mood and anxiety disorders, eating disorders, sexual and trauma recovery, and chronic pain. Located on 160 acres at the foot of the Santa Catalina Mountains near Tucson, Arizona, Sierra Tucson offers a beautiful natural healing environment and the highest level of confidentiality. For more information, call 800-842-4487.

Sierra Tucson is a member of CRC Health Group, the most comprehensive network of specialized behavioral care services in the nation. CRC offers the largest array of personalized treatment options, allowing individuals, families, and professionals to choose the most appropriate treatment setting for their behavioral, addiction, and therapeutic education needs. CRC is committed to making its services widely and easily available, while maintaining a passion for delivering advanced treatment. For over two decades, CRC programs have helped individuals and families reclaim and enrich their lives. For more information, visit www.crchealth.com.

 Contact: Ellen Savage, LCDC Clinical Outreach Manager Sierra Tucson 888-492-2348 Email Contactwww.SierraTucson.com

SOURCE: Sierra Tucson

HORSHAM, Pa., Nov. 12 /PRNewswire/ — Centocor, Inc. announced today the launch of MEDVERSATION(TM) (http://www.medversation.com/), an extensive web-based resource designed to facilitate more-informed conversations between U.S. physicians and their patients about the efficacy and safety of REMICADE(R) (infliximab).

This interactive web application, in development for the past three years and the first in its therapeutic class, provides physicians general information about the progression of certain inflammatory diseases. In addition, physicians can access detailed summaries of REMICADE clinical data and interactive tools to manage and customize information for discussions with patients.

“We recognize that health care conversations have become increasingly complex over the past few years, with physicians being faced with an escalating volume of information about drug benefits and risks from numerous sources,” said Thomas Schaible, Vice President, Medical Affairs, Centocor, Inc. “We hope MEDVERSATION will play a role in helping physicians access information on disease states and clinical data about REMICADE, to enable them to more readily participate in dialogue with an increasingly more informed and empowered patient population. We want all patients to receive treatment that it is right for them, regardless of whether or not the treatment may be ours.”

Centocor created MEDVERSATION with the belief that informed conversations between health care professionals and patients diagnosed with serious inflammatory diseases are essential to quality care. To that end, Centocor has attempted to construct a useful resource for physicians to consider the multiple dimensions of individual medical decisions that involve our therapies now and in the future.

Content within MEDVERSATION is organized into four main sections, paralleling the core dimensions of a medical conversation:

   --  Natural History of Disease: Provides a wide array of research on and       data for rheumatoid arthritis, Crohn's disease, ulcerative colitis and       psoriasis.   --  Benefits of Treatments: Provides extensive clinical data, including       data from Phase IV trials, about the benefits of REMICADE.   --  Risks of Treatments: Provides extensive clinical data and       post-marketing experience regarding the potential risks of REMICADE.   --  Benefit:Risk Analysis: Helps physicians interpret and better       understand benefit and risk information.   In addition to these four content areas, MEDVERSATION offers:   --  Content update email alerts.   --  Customizable handouts about disease progression and the benefits and       risks of treatment.   --  Consumer-friendly content.   --  A personal library where physicians can bookmark and organize articles       and topics of interest from across the website.  

MEDVERSATION will be frequently updated to provide new data and information as it becomes available. Currently, MEDVERSATION includes information regarding REMICADE and its approved uses in the treatment of Crohn’s disease, rheumatoid arthritis, ulcerative colitis and psoriasis; information for additional approved uses in the treatment of ankylosing spondylitis, psoriatic arthritis and pediatric Crohn’s disease will be added over time. In addition, pending the approval of investigational therapies from Centocor, new content will be added to MEDVERSATION.

For more information about MEDVERSATION, please visit http://www.medversation.com/.

About REMICADE

REMICADE is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and is approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology. REMICADE has demonstrated broad clinical utility in Crohn’s disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn’s disease (PCD) and psoriasis (PsO). The safety and efficacy of REMICADE have been well established in clinical trials over the past 14 years and with more than one million patients treated worldwide through commercial experience.

   In the U.S., REMICADE is approved for the following indications:   --  Reducing signs and symptoms, inhibiting the progression of structural       damage and improving physical function in patients with moderately to       severely active RA, when administered in combination with       methotrexate.   --  Reducing signs and symptoms in patients with active AS.   --  Reducing signs and symptoms and inducing and maintaining clinical       remission in adult and pediatric patients with moderately to severely       active CD who have had an inadequate response to conventional therapy.   --  Reducing the number of draining enterocutaneous and rectovaginal       fistulas and maintaining fistula closure in adult patients with       fistulizing CD.   --  Reducing signs and symptoms, inducing and maintaining clinical       remission and mucosal healing, and eliminating corticosteroid use in       patients with moderately to severely active UC who have had an       inadequate response to conventional therapy.   --  Reducing signs and symptoms of active arthritis, inhibiting the       progression of structural damage and improving physical function in       patients with PsA.   --  Treatment of adult patients with chronic severe plaque PsO who are       candidates for systemic therapy and when other systemic therapies are       medically less appropriate.   

REMICADE is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. REMICADE is a two-hour infusion administered every 6 or 8 weeks (indication-dependent), following a standard induction regimen that requires treatment at weeks 0, 2 and 6. As a result, REMICADE patients may require as few as six treatments each year.

Important Safety Information

There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a TB test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE. REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, flu or warm, red or painful skin while taking REMICADE, tell your doctor right away. Also, tell your doctor if you are scheduled to receive a vaccine or if you have lived in a region where histoplasmosis or coccidioidomycosis is common.

Reports of a type of blood cancer called lymphoma in patients on REMICADE or other TNF blockers are rare but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. Children and young adults who have been treated for Crohn’s disease with REMICADE have developed a rare type of lymphoma that often results in death. These patients also were receiving drugs known as azathioprine or 6-mercaptopurine. If you take REMICADE or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should also tell your doctor if you have had or develop lymphoma or other cancers or if you have a lung disease called chronic obstructive pulmonary disease (COPD).

Many people with heart failure should not take REMICADE; so prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath, swelling of your ankles or feet, or sudden weight gain).

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blockers, such as REMICADE. Some of these cases have been fatal. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.

There have been rare cases of serious liver injury in people taking REMICADE, some fatal. Tell your doctor if you have liver problems and contact your doctor immediately if you develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever or severe fatigue.

Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding or paleness while taking REMICADE. Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, visual disturbances or seizures while taking REMICADE.

Allergic reactions, some severe, have been reported during or after infusions with REMICADE. Signs of an allergic reaction include hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills. Tell your doctor if you have experienced a severe allergic reaction. The most common side effects of REMICADE are: respiratory infections, such as sinus infections and sore throat, headache, rash, coughing and stomach pain.

Please read the Medication Guide for REMICADE and discuss it with your doctor.

About Centocor

Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients’ lives. Centocor has already brought innovation to the treatment of Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn’s disease and psoriasis.

The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.

For more information about Centocor, please visit http://www.centocor.com/.

Centocor, Inc.

CONTACT: Brian Kenney of Centocor, Inc., +1-215-325-2107, Mobile:+1-215-620-0111, [email protected]

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

Centice Corporation, a leader in drug verification technology, today announced successful implementations of its recently-launched flagship product, PASS Rx, at NC-based independent pharmacies, Prevo Drug, Inc. and Person Street Pharmacy. As early adopters of this innovative technology, Prevo and Person Street have demonstrated their commitment to providing customers with the highest quality standard of care.

Increased script volume, fewer resources, and higher costs of doing business can unfortunately result in greater risk for dispensing errors. Traditionally, pharmacists have relied on largely subjective manual checks based on visual appearance. PASS Rx is the only technology in the retail pharmacy marketplace that verifies the chemical composition of dispensed oral solid drugs. Core computational sensor and machine vision technologies confirm the accuracy of the majority of dispensed pharmaceuticals in a matter of seconds.

At Asheboro-based Prevo Drug, PASS Rx is incorporated at the end of the fulfillment process. After a prescription is filled, the pharmacist will place the bottled medication in the PASS Rx system. Upon verification, the medication is bagged and prepared for the customer, ensuring dispensing accuracy by minimizing opportunities for error.

“PASS Rx is going to provide our pharmacy with an invaluable competitive differentiator – absolute peace of mind that patients are getting their exact prescription,” commented Stan Haywood, Owner, Prevo Drug. “Our number one priority is patient safety and that’s why we’re investing in this technology.”

Raleigh-based Person Street Pharmacy has also integrated PASS Rx as the final step in its workflow routine. By verifying the bottled prescription as the last step in the fulfillment process, the pharmacist ensures an uninterrupted flow of verified medication directly to the patient.

“As an independent pharmacist, we are most interested in taking care of you as a patient as opposed to having you shop around for two hours while your prescription is being filled,” said Mike James, Owner, Person Street Pharmacy. “PASS Rx helps us transition from a fulfillment role back to our intended role as a true healthcare provider. When you come into our pharmacy, we’ve gone the extra step to ensure you’re getting exactly what was prescribed by your physician.”

Both Prevo and Person Street are members of the North Carolina Mutual Wholesale Drug Company cooperative. Centice recently announced a marketing collaboration with NC Mutual that enables members priority to acquire PASS Rx for their pharmacy operations. “As early adopters of PASS Rx, Prevo and Person Street have found that the system fits seamlessly into their everyday workflow, an attribute especially important in pharmacy where hectic schedules and an increasing number of scripts are the norm,” said Ray Swanson, president and CEO of Centice.

About Centice Corporation

Centice, founded in 2004 and headquartered in RTP, NC, is commercializing patented and patent-pending computational sensor and machine vision technology. The PASS Rx(TM) pharmaceutical authentication sensor system improves the verification process for dispensed medications, thereby increasing efficiency and optimizing workflow in the pharmacy. The company has received venture capital investments from The Aurora Funds, Inc., Novak Biddle Venture Partners, S-Group Direct Investments Ltd, and Innovation Ventures LP. More information on Centice can be found at http://www.centice.com.

ANN ARBOR, Mich., Nov. 12 /PRNewswire/ — MichBio, the association for Michigan’s biosciences industry, will gather industry leaders from across the state at its two-day Expo and Conference next Tuesday and Wednesday, Nov. 18-19, at the Rock Financial ShowPlace in Novi, MI. The Expo is the premier annual meeting for the industry.

“We have taken the Expo program to a new level this year, covering two full days and all facets of the industry,” said Stephen Rapundalo, Ph.D., MichBio President and CEO. “There are workshops and sessions for instruction and discussion; a policy summit for planning; showcase for new technologies to be introduced to investors; facility tours; a legislative update and a look at future trends and hot topics.

“We are particularly delighted to have Christine Poon, vice chair of Johnson & Johnson, as our keynote speaker on Wednesday,” he added. “Chris is one of the most respected professionals in the industry and we will be interested in hearing her perspective and viewpoint on ‘Maximizing What Biotechnology Offers.'”

Online Expo registration will be open until Thursday, Nov. 13 at 5:00 p.m. Onsite registration will be open throughout the Expo. For more information and to register online, please visit http://www.michbio.org/expo .

   Conference Overview:   Day One -- Nov. 18   8:15 -1:15 a.m.  -- Facility Tours   Southeast Michigan biosciences company tours:  

Molecular Innovations — manufactures over 300 products including enzymes, antibodies, enzyme inhibitors and immunological assay kits

Creative Technology Services — a contract manufacturer of the iBOT(TM) wheel chair among other products and a supply chain management company

Beaumont Commercialization Center — a hospital-based medical device development resource that helps manufacturers and inventors bring their ideas for new medical devices and technology to reality

Lumigen — the world’s largest supplier of chemiluminescent reagents to the clinical immunodiagnostics market

   12:30 - 5:00 p.m. -- Business Partnering Meetings   One-on-one meetings with business development representatives:  

Johnson & Johnson — Eli Lilly & Company — GE Healthcare — Pfizer — Terumo Cardiovascular Systems — Teva Pharmaceuticals

1 – 5:00 p.m. — Emerging Biosciences Showcase

Emerging companies introduce their technologies to an audience of investors, technology experts, and other entrepreneurs. Keynote address entitled, “Creating Shareholder Value: Executing on a Concept,” by Shelley Thunen, CFO of TherOx, Inc. Moderated by LeAnn Auer, executive director, Michigan Venture Capital Assoc.

Presenting companies include: AI Medical Devices, Inc., Armune BioScience, Inc., Aursos, Inc., Biotectix, LLC, CanCure Laboratories, LLC, HistoSonics, LLC, NamesforLife, LLC, Nephrion, Inc., NeuMedicine International, Inc., Next Generation Therapeutics, Inc., OcuSciences, Inc., OtoMedicine, Pharmaceutical Enhancement Technologies, SciTech Development, (NEW) ThreeFold Sensors, Wellness Indicators, Inc.

2 – 5:00 p.m. Michigan Biosciences Policy Summit: A Roadmap for the Future

Leaders of the state’s research institutions, scientists, entrepreneurs, CEOs of biosciences companies, economic development organizations, investors, policymakers, and others will convene to determine how to develop a roadmap for the future of Michigan’s biosciences industry. Panel:

   Richard Sheridan -- President & CEO, Menlo Innovations (Moderator)   James Quebbeman -- BioPharma Consultant, Integrated Compliance Solutions,    LLC   Stephen Munk, PhD -- President & CEO, Ash Stevens   William Worzel -- CEO & CTO, Genetics Squared   John McIntyre, PhD -- President & CEO, VenOmix, Inc.   Fred Reinhart -- Asst. Vice President, Wayne State University --    Technology Commercialization   Lisa Kurek -- Managing Partner, Biotechnology Business Consultants   Michael Long - CEO, Velcura Therapeutics Inc.   Dale Johnson - CEO, Emiliem, Inc.   Martyn Coombs - CEO, Asterand, plc   Robert Zerbe, MD - President & CEO, QuatRx Pharmaceuticals   Dolly Niles - President, QUEST Research Institute   James Medsker - Principal, Keystone Product Development   Charles Bisgaier, PhD - Founder, Michigan Life Ventures, LLC   Ronald Williams - President, Medbio, Inc.     5 - 7:00 p.m. -- Opening Reception  

Gala opening reception with welcomes by City of Novi Mayor, David Landry, and Michael Kurek, MichBio chairman. Presentation of “Legislator of the Year Award” by Stephen Rapundalo.

6:30 p.m. — CEO Dinner Forum: “Opportunities, Challenges & Future of the Biosciences Industry” to be Focus of Special High-Level Gathering

   Panelists:   Gilbert Omenn, Member of Board of Directors, Amgen Corp., Professor of    Internal Medicine, Human Genetics & Public Health, University of Michigan    (Moderator)   Gavin Samuels, Senior Partnering Director, Teva Pharmaceuticals   James LaDine, Director of New Technology Development, Thermo Fisher    Scientific   Mark Miller, Senior Director of Corporate Business Development, Eli Lilly   Jonathan Murray -- General Manager, Cross Business Programs, GE Healthcare    Day Two - Nov. 19  

8 – 9:15 a.m. — Breakfast Forum Hospitals of the Future – Biotech Meets Patient Care

Welcomes by L. Brooks Patterson, Oakland County Executive, and Virinder K. Moudgil, Senior Vice President, Academic Affairs & Provost, Oakland University

   Panelists:   Frank Giblin, Ph.D., Professor, Director, Eye Research Institute, Oakland    University (Moderator)   Ken Matzick, President & CEO, Beaumont Hospitals   Michael Wiemann, M.D., Executive Vice President, Providence Region,    Providence Hospital   James Woolliscroft, M.D., Dean, University of Michigan Medical School   Kris White, Vice President of Patient Affairs, Spectrum Health   Thomas Simmer, M.D., Sr. Vice President and CMO, Blue Cross Blue Shield of    Michigan    

For a list of all Day Two speakers and session descriptions, please visit http://www.michbio.org/expo

9:15 – 9:45 a.m. — Legislative Update

An update on key patent-reform legislation, the latest on follow-on biologics or biosimilars regulation, drug/medical device safety, SBIR reauthorization and eligibility requirements, R&D tax credits, drug marketing and disclosure, etc.

   9:45 - 10:00 a.m. -- Networking Break   10 - 11:45 a.m. -- Concurrent Workshops  

R&D: Outsourcing Your R&D Activities — Working with Contract Research Organizations

Emerging Business: Love At First Sight — How to Become an Attractive Partner for Industry

   Manufacturers: Joining the Medical Device Supply Chain    11:45 - 1:00 p.m. - Networking Lunch  

Presentation of “Innovator of the Year” and “Good to Great” Awards. Innovator of the Year is presented to an individual in the Michigan’s biosciences community who has made a significant contribution to the advancement of knowledge and understanding of biological processes through a technology, process, or product, either in an academic or commercial setting. Good to Great is given to a biosciences company in the state whose business concept, entrepreneurialism, leadership, and work ethic, have melded in just the right way to produce a leap forward in the past year that either has now, or has the potential to have an important quality of life impact for people.

1 – 2:00 p.m. — Track Sessions

R&D: Data Capture & Records — Managing Information Along Your R&D Pipeline

Medical Affairs & Markets: Driving Effective Product Development and Targeting Through a Market Research Approach

Emerging Business: USPTO Rule Changes: Impacting Your IP Protection & Value

   Manufacturers: Medical Devices -- Not Your Typical Manufacturing    2 - 3:00 p.m. -- Track Sessions   R&D: Nanomedicine -- Revolutionizing Devices, Diagnostics & Therapeutics  

Medical Affairs & Markets: FDA’s Critical Path Initiative — Driving New Strategies in Medical Product Safety

Emerging Business: Living in Obscurity — Raising Capital Outside of Biotech Hotbeds

   3:00 - 3:15 p.m. -- Networking Break    3:15 - 4:00 p.m. -- Future Trends & Technologies:  Hot Topics    4:00 - 5:00 p.m. -- Keynote Address: "Maximizing What Biotech Offers"                       Christine Poon, Vice Chair, Johnson & Johnson    5:00 - 6:00 p.m. - Closing Reception    

MichBio is committed to driving the growth of Michigan’s biosciences industry and fostering the collective impact of its members by serving as their unified voice and providing them with education, information, connections and other services. MichBio members include biosciences companies, academic and research institutions, biosciences service providers, and related organizations.

   Expo Exhibitors   Hall Hours: 4-7 p.m. Nov. 18 and 8:00 a.m. -- 3:30 p.m., Nov. 19     Ash Stevens                          MEDC   Assay Designs, Inc.                  MichBio   Aursos, Inc.                         Michigan State University-                                         Pharmacology & Toxicology   Beaumont Hospital                    Miller Canfield   Biotechnology Business               Monal Labs    Consultants   Biotectix, LLC                       MPI Research   Brooks Kushman P.C.                  NamesforLife, LLC   Business Review                      Oakland University   C.A.S.                               OcuSciences, Inc.   CanCure Laboratories, LLC            Office Depot   Central Michigan University    Research Corporation                OtoMedicine                                        Pharmaceutical Enhancement   Cornerstone                           Technologies   DNA Software, Inc                    PharmOptima   Drug & Laboratory Disposal, Inc.     ProPharma Group   Dykema                               SciTech Development   Elsevier                             Siemens Building Technologies   Farnell Equipment Company            Sigma Aldrich   Fulcrum Pharma                       SMG Promotional Products   Fullscope                            Switchback   GLTaC, Inc.                          Threefold Sensor   GVSU Professional Science    Masters Program                     Trialon   Harness, Dickey & Pierce, PLC        Varnum, Riddering, Schmidt & Howlett   HistoSonics, LLC                     VTS Consultants   Hylant                               VWR International   Invitrogen                           Wellness Indicators, Inc.   KAR Bioanalytical,Inc   Lumigen  

MichBio

CONTACT: Jayne Berkaw, Director, Marketing-Communications of MichBio,+1-734-527-9147, [email protected]

Web site: http://www.michbio.org/http://www.michbio.org/expo

EarlySense, developer of continuous, contact-free supervision systems for hospital and home use, announced today the results of a clinical study of the EverOn(R) supervision system conducted at the Tel Aviv Medical Center, Sackler School of Medicine in Israel. The data were recently published by Drs. Patrick Sorkine, Nimrod Adi and Josef Ben-Ari at the European Respiratory Society Conference in Berlin in a presentation titled, New Device for Continuous and Contact-Free Monitoring of Heart and Respiratory Rates in Hospitalized Patients.

The objective of the study was to evaluate the accuracy of EverOn in comparison to standard ICU methods, for measuring heart and respirations rates and its ability to alert staff to significant changes. EverOn’s contact-free sensor was placed under the mattresses of more than 40 patient beds with the data displayed on EverOn’s control unit. The system continuously and automatically supervises patients without adding to the workload of the medical team. Patients were simultaneously monitored by the ICU’s standard of care monitors: ECG for heart rate and end tidal CO2 (= a gold standard) and impedance to measure respiration rate. Trained technicians also manually examined respiration rate.

EverOn’s advanced sensing and software technology was shown to provide the desired level of accurate readings while limiting the rate of false alerts. More specifically, when compared against the gold standard, the EverOn measured heart rates accurately over 92% of the time with an aRE=4.1% and respiration rates over 82% of the time with an aRE=7.7% . Moreover, EverOn’s accuracy in measuring respiration rate was higher than that of the standard monitor measurement, utilizing the thoracic impedance method with standard ECG leads. EverOn was found to be an easy to use and accurate tool for measuring respiration rate and heart rate in the critical care environment.

Dr. Adi said, “We are happy to have had the opportunity to share results that show that a contact-free system was able to conveniently and accurately measure respiratory and heart rates as well as provide timely identification of respiratory and cardiac related patient deteriorations. Study results show that continuous supervision of patients has the potential to significantly improve patient care.”

Dr. Ben Ari continued, “In addition to the potential benefit of a continuous supervision system on the medical/surgical floors, a system that measures respiratory rate accurately may also bring value for the care of non-intubated patients in the ICU environment. The EverOn also measures patient motion information, a measurement which may enhance patient care in the ICU and general care/acute care environments. Results of the EverOn motion analysis capability will be presented at upcoming scientific conferences.”

“Approximately 80% of patients in the general wards of hospitals are left unattended between rounds, especially at night when the hospital is short staffed. This situation increases the risk of potential safety events and crises for those hospitalized. Continuous supervision of vital signs has the potential to reduce such risks and improve the overall quality of care. The EverOn system is the next natural step in the ongoing efforts of hospitals to improve patient safety and quality of care. Contact-free, continuous supervision technology turns the hospital bed into a safe place,” said EarlySense CEO Mr. Avner Halperin.

About EarlySense

EarlySense is bringing to market a pioneering technology designed to advance proactive and preventive patient supervision to enable better patient outcomes. The company’s flagship product, EverOn, is an automatic, continuous, contact-free patient supervision device that follows and documents a patient’s movement and basic vital signs. The system is currently being clinically evaluated at several medical centers in the USA and Israel. EarlySense was founded in 2004 by experienced entrepreneurs and is headquartered in Ramat-Gan, Israel. For additional information, please visit www.earlysense.com or contact Marjie Hadad, Media Liaison, at +972-54-536-5220 or [email protected].

Today New York City Mayor Michael R. Bloomberg honored the International AIDS Vaccine Initiative (IAVI) at a ribbon-cutting ceremony for its new AIDS Vaccine Design and Development Laboratory–a 36,000 square foot, state-of-the-art facility located within a planned new bioscience center at the historic Brooklyn Army Terminal. IAVI’s Design Lab is the only facility in the world to be dedicated exclusively to the design and development of an AIDS vaccine.

Scientists at the Design Lab-together with partners in academia, the private sector and government- will design, compare, prioritize and advance promising AIDS vaccine strategies, towards the ultimate goal of ending the AIDS epidemic through an effective vaccine, accessible to all. The Design Lab is the latest addition to IAVI’s global AIDS vaccine discovery network. The programs at the lab will complement those IAVI has with both the private sector and academic partners throughout the world.

“New York City-already home to many of the world’s finest healthcare and research institutions-is getting a major boost as a global center of science and innovation with the opening of the International AIDS Vaccine Initiative’s state-of-the-art Design Lab,” said Mayor Michael Bloomberg. “We have taken a wide range of steps to promote new industries and diversify our economy, and the New York City Bioscience Initiative and our efforts to grow that sector are among the most important. Even more imperative is the work that will go on inside the new facility, as dedicated researchers and scientists advance efforts to develop an AIDS vaccine and help rid the world of the HIV epidemic.”

New York City has been at the heart of efforts to combat AIDS since HIV was found to be the cause of the disease 25 years ago. Its activists and leaders mobilized support for HIV prevention efforts and for affordable, antiretroviral drug therapy, which was pioneered in the City. With the establishment of IAVI’s Design Lab, New York City will make an additional contribution, not just to reduce and treat AIDS, but to reverse and ultimately end the pandemic.

“With 7,500 people around the globe becoming newly infected with HIV every day, it’s clear that current prevention and treatment efforts, while critical, are not going to end the AIDS pandemic,” said Dr. Seth Berkley, President and CEO of IAVI. “We need a vaccine to bring an end to AIDS. I am hopeful that scientists at IAVI’s Design Lab, working together with partners around the world, will develop a new generation of AIDS vaccine candidates that will bring us closer to our goal of a world without AIDS.”

IAVI created the Design Lab, which is affiliated with the State University of New York (SUNY) Downstate Medical Center, to bridge the translational gap that exists between the basic research that is conducted in academic settings and the late-stage product development that occurs within the pharmaceutical industry. While academic researchers are in an ideal position to generate original vaccine concepts, they typically do not have the resources to translate these discoveries into actual vaccine candidates. The pharmaceutical industry has the resources and experience, but often lacks the profit incentive to invest in AIDS vaccine development, given that the scientific challenges appear cost prohibitive and that the market for an AIDS vaccine is mostly in the developing world.

Addressing this gap is one of the goals of IAVI’s Design Lab. The lab’s scientists, with external partners, will explore innovative ideas from academia, basic research and beyond, using the tried and true methods of industry to speed the development of a public good: an AIDS vaccine for use throughout the world.

“Collaboration is essential to driving scientific innovation,” said Dr. Tachi Yamada, President of the Global Health Program at the Bill & Melinda Gates Foundation, one of the early supporters of IAVI. “Collaborative efforts like the Design Lab promise to accelerate progress toward an HIV vaccine, our best long-term hope for controlling the global AIDS epidemic.”

The New York City Economic Development Corporation (NYCEDC) provided US$12 million for the construction of IAVI’s space at the Brooklyn Army Terminal, the site of the planned new bioscience center and a joint project of New York City, New York State and private entities. Working with the NYCEDC, IAVI has been able to raise an additional US$5 million in funds through federal tax programs to cover the costs of renovating the new facility.

“Bioscience is an important and growing sector in New York City’s economy,” said Deputy Mayor Robert C. Lieber. “Two major centers for commercial laboratory space, totaling more than one-and-a-half million square feet, are currently under construction in the City. We are excited that IAVI, as the first occupant of the new bioscience center at Brooklyn Army Terminal, will be working to help solve one of the greatest public health challenges we face today, both globally and right here in our backyard.”

An estimated 33 million people are living with HIV around the world today, a number equivalent to the populations of New York, Delhi, Lagos and London combined. AIDS is the fourth leading cause of death in the world and is number one in sub-Saharan Africa. A vaccine, even a partially-effective one, remains the world’s best hope for turning the tide on the pandemic.

About IAVI

IAVI’s AIDS Vaccine Design and Development Laboratory was made possible thanks to many generous donors. These include the New York City Economic Development Corporation, the Bill & Melinda Gates Foundation, The Starr Foundation, The New York Community Trust, the James B. Pendleton Charitable Trust and the government of the Netherlands. Becton Dickinson (BD) and Thermo Fisher Scientific have also made generous product donations.

The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996 and operational in 24 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI’s financial and in-kind supporters include the Alfred P. Sloan Foundation, the Bill & Melinda Gates Foundation, the Foundation for the National Institutes of Health, The John D. Evans Foundation, The New York Community Trust, the James B. Pendleton Charitable Trust, The Rockefeller Foundation, The Starr Foundation, The William and Flora Hewlett Foundation; the Governments of Canada, Denmark, India, Ireland, The Netherlands, Norway, Spain, Sweden, the United Kingdom, and the United States, the Basque Autonomous Government as well as the European Union; multilateral organizations such as The World Bank; corporate donors including BD (Becton, Dickinson & Co.), Bristol-Myers Squibb, Continental Airlines, Google Inc., Henry Schein, Inc., Merck & Co., Inc., Pfizer Inc and Thermo Fisher Scientific Inc.; leading AIDS charities such as Broadway Cares/Equity Fights AIDS and Until There’s A Cure Foundation; other private donors such as The Haas Trusts; and many generous individuals from around the world. For more information, visit www.iavi.org.

About The New York City Economic Development Corporation

New York City Economic Development Corporation (NYCEDC) is the City’s primary vehicle for promoting economic growth in each of the five boroughs. NYCEDC’s mission is to stimulate growth through expansion and redevelopment programs that encourage investment, generate prosperity and strengthen the City’s competitive position. NYCEDC serves as an advocate to the business community by building relationships with companies that allow them to take advantage of New York City’s many opportunities.

About SUNY Downstate Medical Center

SUNY Downstate Medical Center, the only academic medical center in Brooklyn, comprises Colleges of Medicine, Nursing, and Health Related Professions; a School of Graduate Studies; a Graduate Program in Public Health; and the University Hospital of Brooklyn. SUNY Downstate is a leader in clinical care for patients with or at risk for HIV/AIDS, with special services for women, children, and teenagers. Downstate also provides HIV/AIDS training programs for health care workers internationally.

MIAMI, Nov. 12 /PRNewswire/ — The Miami Jewish Home and Hospital, Berma Research Group, and Segal Institute for Clinical Research today announced that they are actively enrolling patients in the CONNECTION study, a Phase 3 clinical trial that is evaluating the safety and efficacy of the investigational drug Dimebon as a treatment for mild-to-moderate Alzheimer’s disease.

According to new estimates from the Alzheimer’s Association, more than 5 million people in the United States are living with Alzheimer’s disease, a progressive, debilitating and deadly disease that destroys brain cells and affects areas of the brain involved in memory, cognition, judgment, language and behavior. As the baby boomer population ages, the incidence of Alzheimer’s disease is expected to increase dramatically. Currently available therapies for Alzheimer’s treat the symptoms with modest effect, and there is no evidence that these medications alter the course of the underlying disease process.

“New therapies are urgently needed to more effectively treat the symptoms of Alzheimer’s disease,” said Dr. Marc Agronin, director of mental health services at the Miami Jewish Home and Hospital and associate professor of psychiatry at the University of Miami Miller School of Medicine. “Results from a previous study of Dimebon in Alzheimer’s disease were encouraging, and we look forward to further assessing Dimebon’s promise in the fight against Alzheimer’s disease in the CONNECTION study. We encourage local patients and caregivers to learn more about this trial.”

About Dimebon

Dimebon is an investigational therapy in clinical development for the treatment of Alzheimer’s disease. It targets Alzheimer’s disease differently than currently available therapies. Mitochondria (a cell’s primary source of energy) are the target of Dimebon’s mechanism of action.

Medivation, Inc., the company developing Dimebon and sponsoring the CONNECTION study, previously announced efficacy and safety results from the first pivotal trial showing that Dimebon improved the clinical course of Alzheimer’s disease. In that study, patients treated with Dimebon showed significant improvement over patients treated with placebo (sugar pill) in each of the five most important aspects of Alzheimer’s: memory, thinking, behavior, activities of daily living (such as eating and hygiene) and overall function. These improvements were seen after as little as 12 weeks of treatment with Dimebon and were maintained over a full year of treatment. Dimebon was well tolerated throughout the one-year treatment period.

About the CONNECTION Study

The CONNECTION study will enroll 525 patients in the United States — as well as sites in Europe and South America — to test the effects of Dimebon in patients with mild-to-moderate Alzheimer’s disease. The study will evaluate the impact of Dimebon on cognition (thinking and awareness), memory, daily functioning, behavior and the ability to care for oneself.

Patients age 50 and older who are not taking any other Alzheimer’s prescription medications may be eligible for the six-month study. Patients will randomly be chosen to receive either Dimebon or placebo. After six months of treatment, all patients — including those receiving placebo — will be offered the opportunity to receive Dimebon in an extension trial.

For more information on eligibility and enrollment, patients and caregivers can contact:

    Miami Jewish Home & Hospital: 305-514-8503, http://www.mjhha.org/    Berma Research Group: 305-702-9453, http://www.bermaresearch.com/    Segal Institute for Clinical Research: 1-877-SEGAL-88,    http://www.segaltrials.com/    CONNECTION study: 1-877-888-6386, http://www.connectionstudy.com/  

Miami Jewish Home & Hospital; Berma Research Group; Segal Institute

CONTACT: Larry Lentz of Miami Jewish Home & Hospital,+1-305-762-1511, [email protected], or Vanessa Lopetegui of Segal Institute forClinical Research, +1-305-722-8444, ext. 2272, [email protected],or Jessica Alleyne of Berma Research Group, +1-305-702-9453,[email protected]

Web site: http://www.mjhha.org/http://www.bermaresearch.com/http://www.segaltrials.com/http://www.connectionstudy.com/

SAN DIEGO, Nov. 12 /PRNewswire/ — New payment systems being implemented by Medicare will enhance the role of nurses as hospital revenue generators, according to a new survey.

Conducted by AMN Healthcare, the largest healthcare staffing company in the nation, the survey of 305 hospital Chief Nursing Officers (CNOs) looks at hospital nurse staffing patterns and the emerging role of nurses as financial rainmakers.

CNOs were asked about an ongoing Medicare effort to tie hospital reimbursement to patient satisfaction scores as tracked through the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. Sixty-two percent of CNOs surveyed indicated that patient satisfaction-based payment systems would enhance the status of nurses.

CNOs also were asked how Medicare’s 2008 Inpatient Prospective Payment System rules, which stipulate Medicare will not pay hospitals for care provided to patients as a result of various hospital-acquired conditions known as “never events,” will affect the status of nurses. Over 54 percent of CNOs said the new rules would enhance the status of nurses.

“Many hospitals in the past have considered nurses to be a cost,” notes Marcia Faller, Chief Nursing Officer of AMN Healthcare. “Under the new payment systems, they are more likely to be seen as an investment.”

According to Faller, hospitals with a full complement of nurses may be less likely to experience costly “never events” than hospitals that are understaffed. In addition, patient satisfaction scores may be higher in hospitals fully staffed with nurses than in hospitals that are understaffed. In both cases, hospital revenue will be more dependent on nurses than it has been in the past, according to Faller.

CNOs responding to the survey generally agreed with this statement. When asked how the new payment systems will affect the way nurses are viewed at their facilities, 70 percent of CNOs said nurses will be considered more important as a source of revenue.

The survey also asked CNOs to comment on their use of travel nurses. Over 62 percent of CNOs said their hospitals had used travel nurses to supplement their staffs during the last 12 months. About 44 percent of CNOs indicated their facilities currently are using travel nurses. When asked to rate the quality of travel nurses, over 70 percent of CNOs rated travel nurses as either “excellent” or “good,” about 28 percent rated them as “fair,” while less than two percent rated travel nurses as “poor.”

Complete results of the survey are available on AMN Healthcare’s web site at http://tinyurl.com/6g5cvd.

AMN Healthcare Services, Inc. is the largest healthcare staffing company in the United States and the largest nationwide provider in all three of its business segments: travel nurse and allied staffing, locum tenens staffing (temporary physician staffing), and physician permanent placement services. AMN Healthcare recruits healthcare professionals both nationally and internationally and places them on variable lengths of assignments and in permanent positions at acute-care hospitals, physician practice groups and other healthcare settings throughout the United States. For more information, visit http://www.amnhealthcare.com/.

AMN Healthcare Services, Inc.

CONTACT: Phil Miller, +1-469-524-1420, [email protected], for AMNHealthcare Services, Inc.

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

 

Illumina, Inc. (NASDAQ:ILMN) today unveiled a new product for DNA Analysis: the Infinium(R) HD Human660W-Quad BeadChip. This four-sample BeadChip features 2.6 million genetics markers and was developed in collaboration with The Centre for Applied Genomics at the Hospital for Sick Children in Toronto, Canada and the Wellcome Trust Sanger Institute in the United Kingdom. The Human660W-Quad BeadChip builds on the content from Illumina’s HumanHap550+ BeadChip to target over 5,000 regions in the human genome known to be associated with copy number variation (CNV). First customer shipments of the Human660W-Quad are expected in December 2008.

“When conducting whole-genome disease association studies, we want to ensure that we incorporate not only SNPs, but also coverage of common CNV regions in the genome. For that reason, we included 5,000 common CNV regions discovered as part of the Genome Structural Variation consortium on this array. Our goal is to identify those regions that may play a causative role in common diseases such as multiple sclerosis, schizophrenia, and asthma,” said Matt Hurles, Ph.D., of the Wellcome Trust Sanger Institute.

The Human660W-Quad and Human1M-Duo BeadChips are being used by researchers for a new 90,000 sample initiative funded by the Wellcome Trust. This new series of genome-wide association studies is collectively the world’s largest genetic research initiative to date, and is expected to uncover more than 120 billion points of genetic information.

“Recent studies confirm that copy number variation adds another layer of complexity to the human genome and can be directly correlated to the development of various human diseases. With the Human660W-Quad BeadChip we have the ability to link common structural variation with a diverse range of phenotypes,” says David van Heel, Ph.D., Professor of Gastrointestinal Genetics at Barts and The London School of Medicine. “We have published SNP associations in celiac disease using the HumanHap300 BeadChip and believe that the addition of known common CNV content to the Human660W-Quad BeadChip is a natural progression for our research needs. The multi-sample format of the array combined with a simple workflow will save us study time and allow us to rapidly publish our data.”

Infinium HD products dramatically increase sample throughput and reduce handling time in the lab, with industry-leading data quality that reduces errors and data mining tasks. Additionally, HD BeadChips require 70 percent less DNA input per sample.

“Recent studies confirm that copy number variation plays a vital role in the development of complex human diseases. The base content of the Human660W-Quad BeadChip has been successfully used in over 30 studies linking various SNPs to a wide range of diseases and phenotypes,” said Joel McComb, General Manager of Illumina’s Life Sciences Business Unit. “By collaborating with researchers at the Wellcome Trust Sanger Institute we expanded our High-Density product line to include a product that specifically helps researchers incorporate pre-selected common CNV regions into their association studies.”

About Infinium High-Density (HD) DNA Analysis

Illumina’s genotyping solutions offer a flexible BeadChip design and high-density architecture. The revolutionary Infinium HD Assay combined with the Infinium HD BeadChip allows large-scale interrogation of variations in the human genome, accelerating the ability of researchers to cost-effectively unlock the genetic basis of disease. Infinium HD products provide a powerful complement to Illumina’s genotyping offering. For more information on Illumina’s HD genotyping products, please visit www.illumina.com/dna.

About The Wellcome Trust

The Wellcome Trust is the largest charity in the United Kingdom (UK). It funds innovative biomedical research, in the UK and internationally, spending around GBP 650 million each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and wellbeing. More information about The Wellcome Trust can be accessed at www.wellcome.ac.uk.

About Illumina

Illumina (www.illumina.com) is a leading developer, manufacturer, and marketer of next-generation life-science tools and integrated systems for the analysis of genetic variation and biological function. Using our proprietary technologies, we provide a comprehensive line of products and services that currently serve the sequencing, genotyping, and gene expression markets, and we expect to enter the market for molecular diagnostics. Our customers include leading genomic research centers, pharmaceutical companies, academic institutions, clinical research organizations, and biotechnology companies. Our tools provide researchers around the world with the performance, throughput, cost effectiveness, and flexibility necessary to perform the billions of genetic tests needed to extract valuable medical information from advances in genomics and proteomics. We believe this information will enable researchers to correlate genetic variation and biological function, which will enhance drug discovery and clinical research, allow diseases to be detected earlier, and permit better choices of drugs for individual patients.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: this release may contain forward-looking statements that involve risks and uncertainties. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are Illumina’s ability (i) to develop and commercialize further our BeadArray(TM), VeraCode(R), and Solexa(R) technologies and to deploy new sequencing, gene expression, and genotyping products and applications for our technology platforms, (ii) to manufacture robust instrumentation and reagents technology, together with other factors detailed in our filings with the Securities and Exchange Commission including our recent filings on Forms 10-K and 10-Q or in information disclosed in public conference calls, the date and time of which are released beforehand. We disclaim any intent or obligation to update these forward-looking statements beyond the date of this release.

Ingenix, a leading health information, technology and consulting services company, today announced it is uniting its health care and human services consulting businesses, including Reden & Anders and Healthia Consulting, to create a new organization and brand, Ingenix Consulting. This global organization is dedicated to helping payers, physicians and hospitals, employers, state and federal government agencies, and pharmaceutical companies solve the most complex challenges facing their businesses.

“We are in the business of helping health care organizations across the industry achieve real results in challenging times,” said Andy Slavitt, CEO of Ingenix. “Our independence, expertise and resources help clients with their critical issues: demonstrating quality and value in the face of constant pressure on costs and rapidly evolving policy.”

With an exclusive health care focus, Ingenix Consulting brings together unique capabilities to serve its clients. The firm employs more than 1,000 associates worldwide including medical professionals, epidemiologists, biostatisticians, policy experts, data analysts, actuaries, health economists and management consultants. These diverse experts have access to Ingenix’s patented analytical tools and methodologies and one of the largest medical, pharmaceutical and laboratory data repositories.

Some of the well-recognized areas where Ingenix Consulting has expertise are:

-Actuarial and financial management

-Electronic medical records (EMRs)

-Medicare Part D and Medicare Advantage program development

-Public policy research and evaluation

-Data warehousing and decision support

-Health care quality measurement

-Clinical engagement and improvement

-Transaction efficiency, coding, privacy and security

-Health outcomes and safety evaluation

-Implementation and integration services

Ingenix Consulting clients include more than 300 national, regional and Medicaid/Medicare health plans; over 100 federal and state agencies, associations and foundations; over 100 Fortune 500 employers; and more than 50 health care delivery systems.

“Ingenix Consulting is helping clients modernize the exchange of secure health information, improve patient safety and health quality outcomes, comply with regulatory guidelines, find operational efficiencies and contain rising medical costs,” commented Ted Chien, CEO of Ingenix Consulting.

For more information on Ingenix Consulting, visit http://www.ingenixconsulting.com.

About Ingenix

Ingenix, a wholly-owned subsidiary of UnitedHealth Group (NYSE: UNH), transforms organizations and improves health care through information and technology. Organizations rely on its innovative products, services and consulting to improve the delivery and operations of their business. More information about Ingenix can be obtained at http://www.ingenix.com.

Forward-Looking Statements

This press release may contain statements, estimates, projections, guidance or outlook that constitute “forward-looking” statements as defined under U.S. federal securities laws. Generally the words “believe,””expect,””intend,””estimate,””anticipate,””plan,””project,””will,””should” and similar expressions, identify forward-looking statements, which generally are not historical in nature. These statements may contain information about financial prospects, economic conditions, trends and uncertainties and involve risks and uncertainties. We caution that actual results could differ materially from those that management expects, depending on the outcome of certain factors, including the effectiveness of Ingenix Consulting in helping health care professionals and providers solve health care challenges.

COLLEGE STATION, Texas, Nov. 11 /PRNewswire/ — Altus Healthcare Management Systems receives three honors from the 4th annual “Aggie 100” list of the fastest-growing companies owned and operated by Texas A&M University former students. Clarus Imaging Center of Houston, Oprex Surgery Center of Houston, Zerenity Sleep Lab of Houston are among the firms selected for the award. The program is sponsored by Mays Business School’s Center for New Ventures and Entrepreneurship.

Founded in January 2003 by Taseer Badar, CEO and 1995 Aggie graduate, the three companies are entities of Altus Healthcare Management Systems.

Recognized as number 31 on the list of 100 honorees, Clarus Imaging Center is a multi-modality radiology facility that offers advanced diagnostic services through cutting edge imagery technology. With high precision and performance, Clarus aims to provide clarity into each patient’s medical disorder, within a caring environment.

Recognized as number 41 on the list of 100 honorees, Oprex Surgery Center is a free-standing outpatient surgery facility certified by the Medicare and Accreditation Association for Ambulatory Health Care (AAAHC). It’s true commitment to the wellbeing of its patients is the major drive behind our exceptional performance in surgical treatment.

Recognized as number 45 on the list of 100 honorees, Zerenity Sleep Lab’s mission is to decrease the risk of medical and psychological complications associated with sleep disorders and to improve the quality of life. It currently averages 65-70 patients per month at its Houston location.

The 100 companies with the highest compound annual revenue growth from 2005 to 2007 were recognized at a formal luncheon at The Zone Club at Texas A&M University’s Kyle Field on Friday, October 31, 2008. The honorees are also featured in the November 2008 issue of Texas Aggie published by The Association of Former Students.

“Texas A&M is proud of making the Aggie 100 an annual event to celebrate Aggies who have gone on to create businesses that are thriving not only in the U.S., but also around the world,” says Richard Scruggs, Director of the Mays Business School’s Center for New Ventures and Entrepreneurship.

Altus Healthcare Management Systems

CONTACT: Kraig W. Killough, Executive Vice President of Altus HealthcareManagement Systems, +1-713-773-0556, cell, +1-281-772-9242,[email protected]; or Tanya Jacobson of Steward Marketing,+1-281-210-2452, [email protected], for Altus HealthcareManagement Systems

Every single second, someone suffers a devastating stroke, more than 600,000 annually in the United States alone, leaving more than four million stroke survivors — half of whom are left with left with lifelong infirmities affecting speech, movement and even thought.

Roger Maxwell, author of the new book “Taking Charge of Your Stroke Recovery: A Personal Recovery Workbook” (www.takingchargebooks.com), suffered a massive stroke in his late 40s. Advised he could only “cross his fingers and wait” when insurance-paid hospital rehab ended leaving him severely disabled, Maxwell realized he had to take charge of his own stroke recovery.

In the course of his research through reams of medical literature, Maxwell developed unique methods to rehabilitate his physical health and mental functions. He succeeded, teaching himself to speak and walk again, to jog and ultimately to run marathons.

“Taking Charge of Your Stroke Recovery: A Personal Recovery Workbook” is a step-by-step, home-based recovery method that reveals clinically proven recovery techniques, and includes these little-known facts:

1. Far more stroke survivors can fully recover from the effects of stroke than currently do. The brain’s structure and function are virtually the same in everyone, so each person has the same capacity to recover if the right things are done, as confirmed by many scientific studies.

2. Good brain nutrition is important. We know that cutting off oxygen to the brain for ten minutes can cause irreparable damage. Likewise, the presence or absence of certain nutrients can have a rapid and profound effect on your brain.

3. Doing the right exercises the right way is key. Intensive, aggressive and repetitive exercise and practice are the best at helping people improve anything, including recovering from stroke disabilities.

Roger Maxwell says that when he first suffered the stroke, all his functions were affected except for thinking. As an experienced patent attorney who understands research, he was able to develop the “right things” to do, including forms of exercise, nutrition, thinking skills rehabilitation and how your caregiver can best help. Maxwell’s book is available at www.takingchargebooks.com.

To interview Roger Maxwell, or request a copy of “Taking Charge of Your Stroke Recovery: A Personal Recovery Workbook,” contact Rachel Friedman at (727) 443-7115 ext. 206 or email [email protected] Please include name, publication, and mailing address with your request.

 Contact: Rachel Friedman 727-443-7115, ext. 206 [email protected]

SOURCE: Roger Maxwell

Center for Medicine in the Public Interest (CMPI) has released a statement by its Vice President and Director of Programs Dr. Robert Goldberg regarding the recent coverage by CBS Evening News linking vaccines and autism:

“In recent years Katie Couric and the CBS Evening News have gone after vaccine makers and the make-believe link between vaccines and autism, taking up the cause of trial attorneys on the one hand and glossing over the scientific data demonstrating no relationship on the other.”

Goldberg points out CBS Evening News has aired six stories over the past two-and-a-half years that included extremist views of vaccines and autism. Specifically, he highlights a CBS Evening News segment that aired on July 15, 2005 that included commentary by environmental extremist Robert F. Kennedy, Jr.; another segment that aired on June 11, 2007 that reported on hardships of the parents of an autistic child and their fight to win money from a federal fund for “vaccine damages”; and the most recent segment that aired in June 2008 that attempted to discredit scientists and organizations who support immunization because they receive support from vaccine companies.

Additionally, Goldberg notes CBS Evening News gave little fanfare to a press release distributed by the California Department of Public Health that summarized the findings of a recent report citing the lack of data supporting thimerosal as a cause of autism.

Goldberg contends the arrival of reporter Heather Won Tesoriero to CBS Evening News is another signal the program will continue to air unsubstantiated stories that needlessly scare people about their health. Goldberg notes Heather Won Tesoriero has a “history of covering attacks that were started by big class-action law firms” and in her past work as a Wall Street Journal health reporter she covered health claims that were allegedly the result of environmental conditions and other purported health fraud topics.

Goldberg concludes, “No one should be surprised if she brings the same sources, bias and unbalanced reporting to CBS.”

About CMPI:

Center for Medicine in the Public Interest is a research-based organization that analyzes the value of new medicines and genomic and molecular-based medical innovation from the consumer’s perspective. On the Web at http://www.cmpi.org and http://www.drugwonks.com.

More on Vaccines and Autism:

CDC Vaccines and Autism: http://www.cdc.gov/ncbddd/autism/vaccines.htm

AAP FAQ: Immunizing Your Child: http://www.cispimmunize.org/fam/facts/SafetyFAQ.pdf

 Contact: Robert Goldberg, PhD Vice President The Center for Medicine in the Public Interest 212-417-9169 [email protected]

SOURCE: Center for Medicine in the Public Interest

A new study has found that the bacteria responsible for causing diarrhea is commonly found in many U.S. hospitals.

As many as 13 out of every 1,000 hospital patients are infected with Clostridium difficile, according to the report from the Association for Professionals in Infection Control and Epidemiology.

This amounts to about 7,000 patients on any given day.

The study represents the largest, most comprehensive nationwide study of the prevalence of CDI in healthcare facilities, researchers said.

They added that the new report findings were as much as 20 times greater than previous estimates.

Researchers collected data from almost 648 healthcare facilities in 47 states. They presented their findings on Tuesday at the Association for Professionals in Infection Control and Epidemiology (APIC’s) conference, “Clostridium difficile:  A Call to Action,” in Orlando, Florida. A total of 1,443 patients were identified with CDI.

Those who are older and more frail are at a greater risk of serious CDI that can lead to death, according to health-care epidemiologist Dr. William Jarvis, who led the study.

“You can get disease that ranges all the way from simple diarrhea all the way to perforation of the bowel requiring surgery, … shock and death,” Jarvis said.

According to the survey, 54.4 percent of patients with CDI were identified within 48 hours of admission and 84.7 percent were on the medical services, meaning they were being treated for general medical conditions like diabetes, pulmonary or cardiac problems and were on wards throughout the hospital.

Researchers found that only bleach-based cleaners were effective at eliminating CDI.

“Antibiotics don’t kill it and most germicides used for environmental cleaning don’t kill it. Only bleach does,” Jarvis said.

Even antibiotics allow invaders such as CDI to flourish. And by the time patients are diagnosed, they have had a day or two to contaminate their rooms and everyone who has had contact with them, he said.

“This study shows that C. difficile infection is an escalating issue in our nation’s healthcare facilities,” said Jarvis. “Clearly, preventing the development and transmission of CDI should be a top priority for every healthcare institution.” 

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Image Caption: This photograph depicts Clostridium difficile colonies after 48hrs growth on a blood agar plate; Magnified 4.8X. C. difficile, an anaerobic gram-positive rod, is the most frequently identified cause of antibiotic-associated diarrhea (AAC). It accounts for approximately 15-25% of all episodes of AAC. (CDC)

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On the Net:

Association for Professionals in Infection Control and Epidemiology

Helion Biotech, which was founded based on research from Aarhus University, Denmark, announced today that it has received funding from leading Danish life science investor group, SEED Capital Denmark. The proceeds will be used to continue further development of the company’s lead project, recombinant human protein MASP-2, which is in pre-clinical development.

Many patients with suppressed immune systems, such as cancer patients undergoing chemotherapeutic treatment, currently receive G-CSF, which limits the window of susceptibility to infections. MASP-2 replacement therapy would provide an additional targeted therapeutic alternative or supplement to prevent or treat infections in patients deficient in MASP-2.

“We are of course very excited to be able to progress with our pre-clinical recombinant MASP-2 project,” said co-founder and CEO of Helion Biotech, Jeppe Vesti Christensen. “As many may know, the idea of correcting immune factor deficiencies has already been established by another recombinant protein in development, Mannan Binding Lectin (MBL), which is currently in Phase 2 clinical trials. We believe the MASP-2 protein replacement case will have equivalent importance in the clinic, but for another segment of the patient population.”

Christensen continued, “From a partnering perspective, MASP-2 protein replacement therapy provides one of the rare, novel product opportunities in the neutropenia segment of cancer supportive care, which we believe will be appreciated when partnering discussions are eventually initiated.”

“Our analysis of the current situation in the cancer supportive care market, suggests to us that this area will offer investors attractive returns. This, combined with a specific, rare and well documented product offering that may prove highly beneficial to patients prompted us to invest in Helion Biotech,” said Investment Manager Ole Bitsch-Jensen, SEED Capital Denmark.

About MASP-2 Deficiency in Cancer Supportive Care

It is expected that 5-10% of all patients have a clinically relevant MASP-2 deficiency. Under normal circumstances, this deficiency does not translate into increased susceptibility to infections due to the very effective and specific cell- and antibody- based (adaptive) part of the immune system. However, with the introduction of modern medicine the cell-based part of the immune system may be compromised as a consequence of medical treatments such as chemotherapy. In such an immune-compromised state, patients rely on the remaining part of their immune system, e.g., the plasma protein-based immune system. A clinical study has found a strong correlation between MASP-2 deficiency and an increased susceptibility to infections in patients undergoing chemotherapy, indicating that for immune-compromised patients, a well functioning plasma protein based immune system is an important last line of defense against a wide range of invading organisms.

About Helion Biotech (www.helionbiotech.com)

Helion Biotech is a drug development company based in Copenhagen, Denmark, with the aim of developing a recombinant protein, MASP-2, from the immune system for therapeutic use initially in supportive care in cancer. MASP-2 is a central component of the immediate and innate immune defense against micro-organisms. The primary targeted indication is prevention of infectious episodes in MASP-2-deficient patients undergoing chemotherapy.

About SEED Capital Denmark (www.seedcapital.dk)

SEED Capital Denmark was formed in 2004 and manages direct investments totaling above EUR 130 million, distributed to just under 70 companies in all stages of lifecycle. The Company’s investment focus is predominantly on early-phase, technology-based Life Science, ICT and Cleantech projects and companies with considerable business potential.

America is about to be hit with runny noses, sore throats and coughs, but recently a new, naturally safe solution has been introduced in the U.S. that is clinically proven to shorten the duration and reduce the severity of the common cold.

Zucol, a naturally-safe cold remedy produced by German pharmaceutical company, Schwabe, uses as its active ingredient an extract of pelargonium sidoides, which is one of the most researched plant-based pharmaceutical ingredients. Grown in South Africa, pelargonium has been used for generations as a remedy throughout Europe and Africa. The benefits of pelargonium have been featured in several U.S. medical journals including the American Family Physician and The Journal of Family Practice.

“For hundreds of years African Zulu tribes have used pelargonium sidoides preparations to treat coughs and upper respiratory symptoms, and it is the top-selling active ingredient for upper respiratory tract infections sold in Germany and most of Europe. It was only a matter of time that Zucol would arrive in the United States,” said David Gumner, Vice President Mass Market at Nature’s Way, Schwabe’s U.S. subsidiary. “Extensive clinical research has proven the safety and efficacy of pelargonium, which justifies its use to reduce the need for typical OTC medications that merely mask symptoms of the common cold.”

Zucol is produced according to exacting FDA-drug standards and is approved in the U.S. for the treatment of colds and upper respiratory tract infections related to the common cold.

Taken at the earliest signs of a cold, Zucol has been proven to end cold symptoms sooner and reduce the likelihood of secondary infections. The natural active ingredient in Zucol has been the subject of 18 published clinical studies involving over 2,500 patients. These studies concluded that cold sufferers were able to return to their normal routines a full two days faster than those who simply treated their symptoms with OTC medications. Pelargonium sidoides halted the development of symptoms related to the common cold and patients felt better faster without experiencing the worst cold symptoms.

Despite the benefits of Zucol, American families will still spend more than $3 billion annually on cold remedies, and will miss approximately 22 million school days, according to Information Resources, Inc. and the Centers for Disease Control and Prevention, respectively.

“Zucol is powerful medicine to fight colds, and this plant-based extract has been studied extensively and found to be safe for children. In Germany, it is prescribed to adults of all ages and children beginning at two years of age — though we recommend that when used for children younger than six, you consult your family doctor,” said Dr. David Riley, MD, Clinical Associate Professor, University of New Mexico Medical School and Founder of the Integrative Medicine Institute. “With all of the recent warnings from the FDA about conventional cough and cold medications in children, it seems prudent to use a safe and effective alternative.”

Unlike competing zinc-based products, Zucol is a gentle, quick-dissolve lozenge, which should be taken three-times-a-day for six full days. The product will not irritate membranes, upset the stomach or leave a lingering unpleasant taste in the mouth. And with no known drug interactions, Zucol helps eliminate unnecessary worry when taken with other remedies or medicines. Like any medication, Zucol is only effective if used as directed.

Zucol will be available nationwide in January at Walgreens and is currently available in all Rite Aid, Duane Reade, Meijer Stores, and regional drug stores and pharmacies across the US.

About Schwabe Pharmaceuticals

Schwabe Pharmaceuticals, based in Karlsruhe Germany, is a leading phyto-pharmaceutical company and purveyor of leading OTC medicines in Germany and worldwide. Schwabe leads in the research, development and commercialization of the most effective plant-based remedies. As a vertically integrated pharmaceutical company, Schwabe carefully controls the manufacturing process from growing and harvesting the plants to the production and finished goods. Schwabe products are sold in over 60 countries worldwide

About Nature’s Way

Nature’s Way was founded in 1968 and has improved the lives of millions of consumers by bringing the healing power of nature through herbal formulations. Nature’s Way is headquartered in Springville, Utah and its products are sold throughout the US.

   For more information on Zucol, please log onto Zucol.com.    CONTACT:   Jenna Kantrowitz   Fish Consulting   646-454-9708   [email protected]  

Zucol

CONTACT: Jenna Kantrowitz of Fish Consulting, +1-646-454-9708,[email protected]

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

HealthTeacher, a leading provider of online health education resources to schools, announced today that the company has become a Corporate Partner of the National Association of Children’s Hospital and Related Institutions (NACHRI). As a Corporate Partner, HealthTeacher will leverage its role as a leader in childhood health education by providing multifaceted support of key NACHRI events, educational programs and publications.

“HealthTeacher’s corporate partnership with NACHRI presents a tremendous opportunity to further support children’s hospitals and the important work they are accomplishing in improving the health of children in the communities they serve,” said Scott McQuigg, CEO of HealthTeacher. “We look forward to adding value for NACHRI members by sharing our experiences of working with nearly 20,000 teachers who utilize HealthTeacher to teach health in the classroom.”

HealthTeacher served as a sponsor of the NACHRI 2008 Annual Meeting (October 14-17 in Salt Lake City) and will share their expertise with children’s hospitals at the NACHRI 2009 Creating Connections Conference (March 22-25 in Nashville) and the NACHRI 2009 Annual Meeting (October 11-14 in Orlando, Fla.). Additionally, HealthTeacher will lead a series of webinars focused on helping hospitals initiate strategies to address childhood health education.

“With a rich history steeped in children’s health education, HealthTeacher will serve as a valuable Corporate Partner as we continue to innovate and provide the most relevant educational programming to our membership,” said Lawrence A. McAndrews, president and CEO of NACHRI. “There is much work to be done and we are excited that HealthTeacher will lend its expertise as our organization embarks on a new year.”

About the National Association of Children’s Hospitals and Related Institutions

NACHRI is a membership organization of children’s hospitals with more than 217 members in the United States, Canada, Australia, China, Italy and the United Kingdom. NACHRI promotes the health and well-being of children and their families through support of children’s hospitals and health systems that are committed to excellence in providing health care to children. It does so through education, research, health promotion and advocacy.

About Health Teacher

HealthTeacher is a leading provider of online health education resources for kindergarten through 12th grade used by nearly 20,000 teachers and 8,000 schools. HealthTeacher provides teachers the resources, tools and background material to educate students about making healthy lifestyle choices through more than 300 lesson plans that are aligned to National Health Education Standards and cover the Center for Disease Control’s Core Health Topics. HealthTeacher believes “Good Health is Contagious (TM)” and works with hospitals and hospital foundations to create partnerships with school districts and teachers to teach children the knowledge and skills they need to pursue healthy lifestyles. HealthTeacher is an operating unit of ConnectivHealth, a leading provider of digital content solutions focused on advancing health and wellness. To learn more, visit www.healthteacher.com/community.

Potentia Pharmaceuticals, a privately held biotechnology company, has reported positive Phase I data from the ASaP clinical trial for the company’s lead drug candidate, POT-4, which is being developed for the treatment of age-related macular degeneration.

The ASaP trial is a first-in-man, multi-center, single escalating dose study. The interim results of this trial revealed no drug-related toxicity based on clinical signs, ophthalmic examinations, or laboratory results at any time point monitored in patients treated with up to 150mcg/dose of POT-4. Additionally, no serious adverse events and no identifiable intraocular inflammation were reported.

Preliminary results indicate that intravitreal POT-4 is safe, and the data accumulated so far support the continued investigation of POT-4 for the treatment of both dry and wet age-related macular degeneration (AMD) with larger randomized clinical trials to further define its efficacy profile, the company said.

Cedric Francois, president and CEO of Potentia Pharmaceuticals, said: “These safety data strongly support the further development of POT-4 as a potential treatment for patients with AMD. We believe that the product has significant promise based on these early-stage findings and look forward to further testing of the compound in higher doses as we continue this trial.”

SOUTH PORTLAND, Maine, Nov. 11 /PRNewswire/ — Anthem Blue Cross and Blue Shield in Maine is ranked 16th in the nation out of 250 health insurance plans, according to the current (Nov. 17) issue of U.S. News & World Report/NCQA America’s Best Health Plans 2008. This recognition as one of the nation’s best health plans is the result of outstanding overall performance in clinical care measures, member satisfaction and NCQA accreditation.

“We work hard to make sure our members have access to high quality medical care and programs designed to help them live healthier lives,” said Dan Corcoran, president, Anthem Blue Cross and Blue Shield in Maine. “But we go beyond simply improving the lives of our members. Through partnerships and collaborations with other health care organizations, providers and community groups in Maine, we have developed and implemented programs that have a significant positive impact on the health of the communities we serve.”

The Anthem Blue Cross and Blue Shield Maine plan currently holds Excellent Accreditation for its HMO/POS plan and has earned Quality Plus Distinction in Care Management and Health Improvement.

Anthem scored in the 90th percentile (i.e., the top 10 percentile of health plans in the nation) in several key Health Plan Employer Data and Information Set *(HEDIS(R)) Effectiveness of Care measures, including: preventive screenings for breast, cervical and colorectal cancer; diabetes care, cholesterol management, antidepressant medication management and access to care measures. Anthem works with its members to help improve their health through education, reminders and tools to manage their conditions such as a Heart Health Calendar and a Women’s Health Reminder.

 Anthem Health Plans in Connecticut and New Hampshire also made U.S. News &                World Report/NCQA's Top 20 commercial plans.   

“To be recognized in the top 6 percent of all health plans in the country is a testament to our associates and is something we take real pride in,” said Corcoran.

“America’s Best Health Plans is a practical tool that helps consumers make informed decisions when choosing a health plan,” said NCQA President Margaret E. O’Kane. “It lets consumers know which plans have demonstrated they can deliver the highest levels of care and service.”

The Proof is in the Programs

Anthem Maine’s Quality Hospital Improvement Program — QHIP — works to improve the quality of hospital care our members receive. Hospitals are rewarded for instituting programs and adopting technologies that result in better patient outcomes, reduced errors and higher member satisfaction. This voluntary program currently has sixteen Maine hospitals participating. Anthem Maine’s Primary Care Pay for Performance Program encourages providers to improve the quality of care our members receive. Using a framework similar to the QHIP program, providers are rewarded for implementing illness registries for members with chronic disease and for installing electronic medical records in their offices. Approximately 97% of Maine’s Primary Care Providers are participating in this program

About the National Committee for Quality Assurance

The National Committee for Quality Assurance (NCQA) is a private, non-profit organization dedicated to improving health care quality. NCQA accredits and certifies a wide range of health care organizations. NCQA provides health care quality information free of charge through the Web and the media in order to help consumers, employers and others make more informed health care choices. More information can be found at http://www.ncqa.org/ .

Founded in 1933, the weekly news magazine, U.S. News & World Report, is devoted to investigative journalism and reporting and to analyzing national and international affairs, politics, business, health, science, technology and social trends. Through its annual rankings of America’s Best Colleges, America’s Best Graduate Schools and America’s Best Hospitals, and its News You Can Use Brand, U.S. News has earned a reputation as the leading provider of service news and information that improves the quality of life of its readers. Available online at http://www.usnews.com/ , U.S. News, for the second time in a row, was named the most credible newsweekly by the Pew Biennial News Consumption Survey and the most credible news organization in print. “America’s Best Health Plans” is a trademark of U.S. News & World Report.

About Anthem Blue Cross and Blue Shield

Anthem Blue Cross and Blue Shield is the trade name of Anthem Health Plans of Maine, Inc., and an independent licensee of the Blue Cross and Blue Shield Association. (R)ANTHEM is a registered trademark of Anthem Insurance Companies, Inc. The Blue Cross and Blue Shield names and symbols are registered marks of the Blue Cross and Blue Shield Association. Additional information about Anthem Blue Cross and Blue Shield in Maine is available at http://www.anthem.com/ .

*HEDIS is a registered trademark of NCQA.

Anthem Blue Cross and Blue Shield in Maine

CONTACT: Mark Ishkanian, Anthem, +1-207-822-8454

Web Site: http://www.anthem.com/http://www.ncqa.org/http://www.usnews.com/

MALVERN, Pa., Nov. 11 /PRNewswire/ — Arlington Medical Resources (AMR), a provider of premier market intelligence for the pharmaceutical and diagnostic imaging industries, finds that Lantheus Medical Imaging’s Cardiolite has 15 percent more market share than General Electric’s Myoview for September 2008. Both Cardiolite and Myoview are administered intravenously as part of the Myocardial Perfusion Imaging Stress Test to highlight areas of the heart. The Myocardial Perfusion Imaging Stress Test is given to help diagnose coronary artery disease.

“Compared to data from our September 2007 audit, Cardiolite use has dropped nine percent. Even so, Cardiolite continues to dominate the radiopharmaceutical market,” stated Anna Fisher, analyst at AMR.

The newly released edition of the Myocardial Perfusion Study Monthly Monitor also finds the number of patients who were administered Astellas’s Lexiscan (regadenoson) increased 58.5 percent from August 2008 to September 2008. Lexiscan is the newest pharmacologic stress agent on the market–introduced in June 2008–and it is used in patients unable to undergo exercise stress testing.

Why Pharmaceutical and Medical Device Companies Need this Information

The Myocardial Perfusion Study Monthly Monitor enables pharmaceutical and medical device companies to track the number of nuclear myocardial perfusion tests performed in hospital and non-hospital settings. For each study month, this audit provides projections of myocardial perfusion studies performed with each of the various radiopharmaceutical products. Projections are also provided for the number of studies involving pharmacologic stressing with intravenous adenosine, intravenous dipyridamole, intravenous regadenoson and intravenous dobutamine.

About the Myocardial Perfusion Study Monthly Monitor AMR’s Myocardial Perfusion Study Monthly Monitor is a syndicated audit designed to track the number of nuclear myocardial perfusion tests performed in hospital and non-hospital settings. The audit is available once a month.

About AMR

AMR (http://www.amr-data.com/) serves the market intelligence needs of the pharmaceutical and diagnostic imaging industries. Research includes clinical inpatient databases that directly link anti-infective drug with indication/procedure, formulary and stocking status tracking studies, drug purchasing audits and diagnostic imaging procedure volume/contrast media usage audits. AMR is a Decision Resources, Inc. company.

About Decision Resources, Inc.

Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at http://www.decisionresourcesinc.com/.

All company, brand or product names contained in this document may be trademarks or registered trademarks of their respective holders.

   For more information, contact:    Natalia Morales                           Elizabeth Marshall   Decision Resources                        Decision Resources, Inc.   781-296-2691                              781-296-2563   [email protected]                   [email protected]  

Arlington Medical Resources

CONTACT: Natalia Morales of Decision Resources, +1-781-296-2691,[email protected]; or Elizabeth Marshall of Decision Resources, Inc.,+1-781-296-2563, [email protected]

Web Site: http://www.amr-data.com/

Critical Pharmaceuticals, a specialty pharmaceutical company, has closed a third round of investment totaling GBP650,000.

Based on the company’s success in developing its unique CriticalMix delivery technology and matching pipeline of candidate drugs, the funding was fully supported by existing shareholders.

The company has now raised in excess of GBP2 million in investment and grants since its formation in 2004 as a spin-out from Nottingham University. It also follows the recent announcement of preclinical results for a sustained release somatropin formulation, which demonstrated considerable advantages over existing once-daily products.

Lisbeth Illum, CEO of Critical Pharmaceuticals, said: “The new funds will be used to advance the development of our pipeline of candidate drugs and drug delivery technologies, secure and develop our intellectual property portfolio and invest in our business development capability to secure partnerships with pharmaceutical and biotechnology companies.”

Affymetrix, Inc. (Nasdaq:AFFX) today announced the DMET(TM) Plus Premier Pack, the most comprehensive method for standardizing drug metabolism studies. The DMET (Drug Metabolism Enzymes and Transporters) Plus Panel features the most biologically relevant content identified by key opinion leaders from industry and academia in a cost-effective format. The DMET Plus Panel contains markers in all FDA-validated genes(1) and covers more than 90 percent of the current ADME Core markers as defined by the PharmaADME group. It offers 1,936 high-value drug metabolism and transporter markers.

Researchers in the pharmacology of cancer therapies are already using the DMET Panel to better understand the toxicity of and response to chemotherapeutic agents. The comprehensive DMET Panel enabled John Deeken, M.D., from the Lombardi Comprehensive Cancer Center at Georgetown University, to find numerous genes potentially involved in cancer treatment decisions, in collaboration with Affymetrix.

“The DMET Panel allowed us to characterize the pharmacogenetics of the chemotherapeutic agents docetaxel and thalidomide in patients treated for prostate cancer in a Phase II clinical trial, demonstrating that the DMET Panel can be readily incorporated into cancer clinical trials,” said Dr. Deeken. “The breadth and depth of the DMET Panel provides a unique approach to determining genetic variations’ relevance across a drug’s metabolic pathway.”

“Affymetrix is the first company to deliver a comprehensive drug metabolism solution,” said Kevin King, president of Affymetrix. “In the U.S. alone, adverse drug reactions are the fourth most common cause of death, costing $100 billion.(2) With the DMET Plus Premier Pack, we are enabling industry, academic, and government researchers to identify the high-quality biomarkers that will enable them to ask broader questions and make better go-no-go clinical trial decisions.”

A recent study using the drug warfarin demonstrated the value of the unique DMET content. Warfarin is one of the top 10 drugs known to cause severe adverse events, including drug-related death. Researchers at the Marshfield Clinic discovered a new variant in CYP4F2 which explained 8 percent of dosing variability in select patient populations.(3) This biomarker is now being tested in a Phase III prospective trial.

The DMET Plus Premier Pack also offers software which enables customers to look only at the markers they want to genotype, or those that are allowed by patient consent. Data is automatically interpreted into the commonly used star allele format which can be easily integrated into clinical trial workflows. Using a translation table cuts the time needed for analysis from days to minutes.

For more information on the DMET Plus Premier Pack, please visit: www.affymetrix.com/dmet

(1)Frueh, F.W., et al. Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use. Pharmacotherapy 28(8):992-998

(2) Pharmacogenomics Public Healthcare 2008 (market research report)

(3) Caldwell, M. D., et al. CYP4F2 genetic variant alters required warfarin dose. Blood 111(8):4106-12 (2008)

About Affymetrix

Affymetrix GeneChip(R) microarray technology is the industry-standard tool for analyzing complex genetic information. After inventing microarray technology in the late 1980s, Affymetrix scientists have been dedicated to developing innovative products that provide researchers with a more complete view of the genome. These products continue to accelerate genetic research and enable scientists to develop diagnostics and tailor treatments for individual patients by identifying and measuring the genetic information associated with complex diseases.

Today, Affymetrix technology is used by the world’s top pharmaceutical, diagnostic and biotechnology companies, as well as leading academic, government and not-for-profit research institutes. More than 1,800 systems have been shipped around the world and more than 14,000 peer-reviewed papers have been published using the technology.

Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing facilities in Sacramento, Calif., Cleveland, Ohio, and Singapore. The company has about 1,100 employees worldwide and maintains sales and distribution operations across Europe and Asia. For more information about Affymetrix, please visit the company’s website at www.affymetrix.com.

Forward-looking Statements

All statements in this press release that are not historical are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act as amended, including statements regarding Affymetrix’ “expectations,””beliefs,””hopes,””intentions,””strategies” or the like. Such statements are subject to risks and uncertainties that could cause actual results to differ materially for Affymetrix from those projected, including, but not limited to: risks and uncertainties relating to commercial success of the DMET Plus Premier Pack discussed in this press release; risks of the company’s ability to achieve and sustain higher levels of revenue, higher gross margins and reduced operating expenses; uncertainties related to technological approaches, manufacturing and product development; personnel retention; uncertainties related to cost and pricing of Affymetrix products; dependence on collaborative partners; uncertainties related to sole-source suppliers; risks associated with past and future acquisitions; uncertainties relating to FDA and other regulatory approvals; competition; risks relating to intellectual property of others and the uncertainties of patent protection and litigation. These and other risk factors are discussed in Affymetrix’ Form 10-K for the year ended December 31, 2007, and other SEC reports, including its Quarterly Reports on Form 10-Q for subsequent quarterly periods. Affymetrix expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Affymetrix’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

NOTE: Affymetrix, the Affymetrix logo and GeneChip(R) are registered trademarks owned or used by Affymetrix Inc.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception, and male hypogonadism, commented today on a new publication reporting on the efficacy of testosterone in the treatment of Female Sexual Dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD) in menopausal women. In a paper titled, “Testosterone for Low Libido in Postmenopausal Women Not Taking Estrogen,” the authors state that testosterone therapy provides modest but meaningful benefit in the treatment of HSDD in postmenopausal women and that as reported in previous blinded studies, 85 percent of those women reporting a benefit wish to continue treatment. The authors also state that, “Additional data are needed to assess the long-term safety of testosterone in women with estrogen depletion.” The paper appeared in the November 6, 2008, issue of the New England Journal of Medicine.

BioSante currently has two Phase III clinical trials in progress covered by an SPA (Special Protocol Assessment) with the FDA, to demonstrate the safety and efficacy of LibiGel (testosterone gel), in the treatment of HSDD. In addition to the two LibiGel Phase III safety and efficacy trials, BioSante is enrolling women in a Phase III cardiovascular and breast cancer safety study of LibiGel. Pursuant to a written agreement with the FDA, this one safety study will serve as the basis of safety for both surgically and naturally menopausal women. The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for twelve months. At the end of the twelve months, BioSante intends to submit a LibiGel New Drug Application (NDA) for review and possible approval by the FDA. BioSante will continue to follow the women enrolled in the safety study for an additional four years after the NDA submission and possible approval of LibiGel.

BioSante holds two SPAs for LibiGel for the treatment of FSD; one for “surgically” and one for “naturally” menopausal women. “BioSante’s SPAs confirm the FDA’s position that FSD and HSDD are true diagnosable conditions that women experience, with measurable endpoints that can be evaluated and which deserve therapeutic options. Regarding LibiGel specifically, we are pleased that the SPAs affirm that our clinical trial design, endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval,” said Stephen M. Simes, BioSante’s president & CEO. “We have a clearly defined, reasonable and feasible LibiGel development path that can lead to the approval of LibiGel to provide potential benefit for a broad population of menopausal women.”

“No pharmaceutical product is approved for the treatment of FSD or HSDD in the U.S. LibiGel, if approved by the FDA, will address a truly unserved medical need. BioSante today is the only company actively in development of a product for the treatment of FSD in menopausal women and is the only company that has initiated a long-term safety study to determine the safety of testosterone in this indication. BioSante is committed to the development of LibiGel, which ultimately could be the first prescription pharmaceutical product approved by the FDA for this treatment in the U.S.” Although Procter & Gamble has conducted several clinical trials of its Intrinsa testosterone patch, P & G has not initiated a long-term safety study which is a critical FDA requirement for possible approval of a testosterone product for the treatment of FSD.

As previously announced by BioSante, treatment with LibiGel in a Phase II clinical trial significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline (p less than 0.0001); this increase also was significant versus placebo (p less than 0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.

About LibiGel(R)

LibiGel is a gel formulation of testosterone designed to be quickly absorbed through the skin after application of a pea-sized dose of gel on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity.

According to a study published in the Journal of the American Medical Association, 43 percent of American women (about 40 million) experience some degree of impaired sexual function. Among the more than 1,400 women surveyed, 32 percent lacked interest in sex and 26 percent could not experience orgasm. According to IMS data, 2.0 million testosterone prescriptions were written off-label for women by U.S. physicians in 2007. The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical.

About BioSante Pharmaceuticals, Inc.

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. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The company also is developing its calcium phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic medicine (BioLook(TM)). Additional information is available online at: www.biosantepharma.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding BioSante contained in this news release that are not historical in nature, particularly those that utilize terminology such as “will,””potential”, “could,””can,””intends,””continue,””plans,””expects” or comparable terminology, are forward-looking statements. Examples of forward-looking statements in this news release include statements regarding the expected timing of the initiation of clinical trials and the submission of regulatory applications. Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to BioSante that could cause actual results to differ materially from those expressed in such forward-looking statements include the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, the success of clinical testing, and other factors identified and discussed from time to time in BioSante’s filings with the Securities and Exchange Commission, including those factors discussed in BioSante’s most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q, which discussions also are incorporated herein by reference. All forward-looking statements speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

 

Crucell achieves profitability in Q3 2008. Crucell announces third quarter 2008 results with net income of EUR 12.3 million. Total revenue and other operating income increased by 31% to EUR 82.1 million compared to the same quarter last year. Gross margin in the third quarter mproved to 50% (from 36% last year). 2008 full year guidance for total revenue and other operating income growth increased to 25-30% in constant currencies (from 20%).

Leiden, The Netherlands (November 11, 2008) – Dutch biopharma company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced its financial results for the third quarter of 2008, based on International Financial Reporting Standards (IFRS). These financial results are unaudited.

Highlights:

   * Crucell achieves its first ever quarterly profit; a net income of     EUR 12.3 million, compared to a net loss of EUR 4.5 million in the same     period of 2007. This amounted to EUR 0.19 net profit per share in     the third quarter, compared to a net loss per share of EUR 0.07 in     the third quarter of 2007.   * Crucell received additional contracts of $140 million for     supplies of Quinvaxem(R) and Hepavax-Gene(R) for the period 2008 -     2009, bringing the total for the period 2007 - 2009 to $0.5     billion.   * Crucell presented positive preliminary results of the Phase II     clinical study of its rabies monoclonal antibody combination in     the United States. This advance triggered another milestone     payment from collaboration partner sanofi pasteur in the third     quarter of 2008.   * Crucell also received a milestone payment from sanofi pasteur for     the advancement of the seasonal influenza vaccine (FluCell)     developed by sanofi pasteur, using Crucell's PER.C6(R) technology.   * Crucell and Aeras, the Global TB Vaccine Foundation, announced     two important advances in its collaborative tuberculosis (TB)     vaccine program. The jointly developed TB vaccine candidate     AERAS-402/Crucell Ad35 has entered a new Phase I clinical trial     in Kenya as well as a first Phase II safety study, conducted in     Cape Town, South Africa.   * Crucell received additional funding from the National Institute     of Allergy and Infectious Diseases (NIAID), part of the U.S.     National Institutes of Health (NIH), aimed at the development of     vaccines targeting both Ebola and Marburg viruses. The contract     provides funding of up to $30 million, with additional options     worth a further $40 million.   * Crucell signed several new license agreements including an     exclusive, commercial license agreement with Talecris     Biotherapeutics for an undisclosed and specific protein to be     produced using the PER.C6(R) cell line.   * DSM and Crucell announced another key achievement for PER.C6(R)     technology with a scale up of high-titer fed-batch process to 250     Liters.   * Crucell and Lonza entered into a co-exclusive manufacturing,     sales and distribution agreement related to the PERMEXCIS(TM)     cell culture medium developed by Crucell for PER.C6(R) cells. 

Financial Highlights:

   * Combined total revenue and other operating income for the quarter     of EUR 82.1 million compared to EUR 62.6 in the same quarter of 2007.     The increase of 31% (38% in constant currencies) was largely     driven by strong sales of paediatric vaccines as well as license     income.   * Increase of license revenues mainly driven by milestone payments     for the results of the Phase II clinical study of Crucell's     rabies monoclonal antibody combination and for sanofi pasteur's     seasonal influenza vaccine FluCell.   * Gross margins of 50% compared to 36% in the third quarter of     2007. Gross margins in the third quarter of this year are     positively influenced by a significant increase in license     revenue, sales of our flu product     (Inflexal(R) V) and better production yields, as well as improved     plant utilization due to higher volumes.   * Net income in the third quarter of 2008 of EUR 12.3 million versus a     net loss of EUR 4.5 million in the same quarter of 2007.   * Cash and cash equivalents at the end of the third quarter     amounted to EUR 103.9 million versus EUR 163.2 million at year-end     2007. Deterioration of cash flow and working capital in the first     three quarters of 2008 was expected and is due to the seasonality     of our business.   * Net cash used in operating activities in the third quarter of     2008 was EUR 9.9 million, caused by a EUR 26 million net increase in     working capital, compared to net cash used in operating     activities of EUR 5.5 million in the same quarter of 2007.   * In anticipation of the expected further growth of Quinvaxem(R) in     2009, we will continue to build stock of Quinvaxem(R) in the fourth     quarter of 2008. 

 Key Figures Q3 2008: (EUR  million, except net result per share)      Third Quarter                                 Nine months ended                                             Sept 30 2008      2007   Change                                 2007   Change                                             2008                            Total revenues                                 and                           other operating 82.1    62.6     31%          income        189.6       137.2  38% 12.3   (4.5)     -          Net result      (4.6)       (41.2) -                           Net result per                                share 0.19  (0.07)     -           (basic)        (0.07)      (0.63) -                         Cash & cash equiv.:                           - Sept 30, 2008         103.9                           - Dec 31, 2007          163.2 

Crucell’s Chief Executive Officer Ronald Brus said:

“These results showing profitability represent a great achievement in the history of Crucell.

Our financial strength as well as the sustainable business we operate in, enables us to pursue our ambition to increase the number of people we can protect from infectious diseases. I am very pleased to be able to raise our revenue forecast for 2008 on the back of these strong results.”

Product and Business Update

Product Update:

Product sales for the third quarter of 2008 amounted to EUR 65.6 million and represent sales of paediatric vaccines (44%), travel and endemic vaccines (16%), respiratory vaccines (30%) and other products (10%).

Paediatric

In the third quarter of 2008 we saw strong growth of our paediatric vaccines, mainly driven by Quinvaxem(R).

   * Quinvaxem(R): Fully liquid pentavalent vaccine against five     important childhood diseases.   * Hepavax-Gene(R): Recombinant vaccine against hepatitis B.   * Epaxal(R) Junior: Paediatric dose (0.25mL) of Epaxal(R) - the only     aluminum-free vaccine for children against hepatitis A. The     product is currently under registration in selected countries     worldwide. Sales in South America are progressing well and a     European launch is being planned.   * MoRu-Viraten(R): Vaccine for protection against measles and rubella     (for all age groups). 

Travel and Endemic

The third quarter of 2008 showed solid growth of our travel and endemic portfolio. We continue to see significant untapped demand and potential for geographical expansion of our travel portfolio.

   * Epaxal(R): The only aluminium-free vaccine against hepatitis A.   * Vivotif(R): The only oral vaccine against typhoid fever.   * Dukoral(R): The only oral vaccine against diarrhea caused by     cholera and ETEC (enterotoxigenic E.coli). 

Respiratory

The third quarter of 2008 showed solid growth, compared to the same quarter of 2007 of our flu vaccine Inflexal(R) V.

   * Inflexal(R) V: A virosomal adjuvanted vaccine against influenza     (for all age groups). Due to the seasonality of the product, we     build inventory in the first half of the year to sell the flu     products in the second half of the year. 

Pipeline Update:

   * Flavimun(R) - Live Attenuated Yellow Fever Vaccine: Crucell's     management expects the registration submission of the Yellow     Fever vaccine in Switzerland and Germany in the first quarter of     2009. 

   * Influenza - Seasonal Flu Vaccine (FluCell collaboration with     sanofi pasteur): The seasonal influenza vaccine developed by     Crucell's partner sanofi pasteur, using PER.C6(R) technology. Phase     II testing of the cell based influenza vaccine was initiated in     the U.S. in November 2007. In the third quarter 2008, Crucell     received a milestone payment from sanofi pasteur for the progress     of the Phase II trials involving healthy adult volunteers in the     U.S. The trials focus on the safety profile and immunogenicity of     the cell-based vaccine. 

   * Rabies Human Monoclonal Antibody Combination: Crucell's rabies     monoclonal antibody combination, developed in close collaboration     with sanofi pasteur using Crucell's PER.C6(R) manufacturing     technology. In 2008 Crucell initiated two Phase II studies in the     U.S. and in the Philippines. Promising Phase I data in 2007     showed no serious adverse effects and demonstrated the expected     rabies neutralizing activity upon administration. The rabies     human monoclonal antibody combination was granted a Fast Track     designation by the FDA Department of Health and Human Services.     In the collaboration with sanofi pasteur Crucell will be     responsible for the manufacturing of the final product and has     retained exclusive distribution rights in Europe, co-exclusive     distribution rights in China and the rights to sell to     supranational organizations such as UNICEF, while sanofi pasteur     will have exclusive distribution rights for all other territories     and co-exclusive distribution rights in China.     Positive preliminary  results of  our Phase  II U.S.  study  were     presented at the 19th annual  RITA meeting in Atlanta on  October     1, 2008.  There  was no  serious  adverse event  reported.  These     results triggered another milestone payment from sanofi  pasteur,     at the end of September, as part of the total eligible amount  of     EUR 66.5 million.  This  antibody  combination  is  to  be  used  in     combination with a rabies  vaccine for post-exposure  prophylaxis     (PEP) against this fatal disease. 

   * Tuberculosis Vaccine based on AdVac(R)/PER.C6(R) Technologies:  The     development of the candidate vaccine AERAS-402/Ad35 is being     carried out in collaboration with the Aeras Global TB Vaccine     Foundation.     Phase I:   * U.S. Phase I trial in healthy adults not previously immunized     with Bacille Calmette-Guerin (BCG), the traditional TB vaccine,     has been completed and has demonstrated that AERAS-402/Ad35 is     safe in this population.   * Preliminary results of a second study in South Africa showed     encouraging results, notably CD8-cell immune responses that are     much higher than those seen in humans in any previous TB vaccine     study.   * A third phase I study in healthy adults in St. Louis, U.S.     focuses on the immunogenicity and safety of two AERAS-402/Ad35     boost doses administered at three to six month intervals after     BCG priming in healthy adults.   * In October, a Phase I clinical trial of the jointly developed TB     vaccine was started in Kenya. The study will be conducted by the     Walter Reed Project-Kenya at Kombewa, near Kisumu, Western     Kenya. Its main objective will be to test the safety of the     candidate vaccine in healthy adults, all of whom have been     previously vaccinated with the BCG vaccine and a subset of whom     show evidence of exposure to TB.     Phase II:   * In October enrollment for the first Phase II study of     AERAS-402/Ad35 in Cape Town, South Africa was started. The study     is being conducted by the University of Cape Town Lung Institute     in conjunction with the South African Tuberculosis Vaccine     Institute. The candidate will be tested in 82 adults who have had     active TB. 

   * Malaria Vaccine based on AdVac(R)/PER.C6(R) Technologies: Crucell and     its partner, the National Institute of Allergy and Infectious     Diseases (NIAID), part of the National Institutes of Health     (NIH), are conducting a Phase I trial in the U.S. The study is     being carried out on two sites, VanderBilt and Stanford     University. The first three cohorts have been enrolled and     ongoing safety monitoring has revealed no significant safety     concerns to date, but formal analysis awaits unblinding of the     data. Enrollment for the fourth and final group of volunteers is     still ongoing and initial findings of this Phase I trial are     expected in the first quarter of 2009. 

   * Multivalent Filovirus Vaccine (Ebola & Marburg) based on     AdVac(R)/PER.C6(R) Technologies: In October Crucell announced that it     has secured a NIAID/NIH contract aimed at advancing the     development of Ebola and Marburg vaccines, ultimately leading to     a multivalent filovirus vaccine. The contract provides funding of     up to $30 million, with additional options that may be triggered     at the discretion of the NIH worth a further $40 million. The     Phase I study of an Ad5 based Ebola vaccine, being developed in     partnership with the Vaccine Research Center (VRC) of the     NIAID/NIH, showed safety and immunogenicity at the doses     evaluated. Based on these results a second Phase I study of an     Ebola and/or Marburg vaccine is anticipated. This will use     alternative adenovirus vectors which are able to by-pass     pre-existing immunity against Ad5. 

   * HIV Vaccine based on AdVac(R)/PER.C6(R) Technologies: The     Investigational New Drug Application (IND) for Phase I of the     trial with Harvard Medical School (supported by the NIH) was     approved by the FDA in January 2008. In April, Crucell announced     the start of a Phase I clinical study of the novel recombinant     HIV vaccine, using adenovirus serotype 26 (rAd26) as vector, that     Crucell is jointly developing with the Beth Israel Deaconess     Medical Center. The rAd26 vector is specifically designed to     avoid the pre-existing immunity to the more commonly used     adenovirus serotype 5 (Ad5). The phase I clinical study is being     conducted at the Brigham and Women's Hospital in Boston, U.S. and     is focused on assessing the safety and immunogenicity of the     vaccine. Enrollment is ongoing and involves 48 healthy     volunteers. 

   * This Week Nature Published a Study which Demonstrates the Value     of Crucell's Alternative Adenovirus Serotype Technologies: Using     Crucell's AdVac(R) vaccine- and PER.C6(R) manufacturing technology,     scientists engineered the rare adenovirus serotypes Ad26 and Ad35     to express a protein of SIV, the non human primate equivalent of     HIV. Rare serotype adenoviral vectors - such as rAd26 and rAd35     vectors - have been developed by Crucell to provide more potent     prime-boost vaccine regimes. The study, which investigated the     immunogenicity and protective efficacy of different vaccination     regimes using rAd26, rAd35 or rAd5 as a prime, followed by a     boost with rAd5, showed that in particular the rAd26/rAd5     combination elicits a strong T-cell immune response and provides     protection against the HIV-like virus in non human primate     models. Crucell has several vaccines in development using     alternative rAd26 and rAd35 vectors, including vaccines against     malaria and tuberculosis.   * H5N1 - Human Monoclonal Antibodies against Flu: Crucell's     scientists discovered a set of human monoclonal antibodies that     provides immediate protection and neutralizes the broadest range     of H5N1 strains in preclinical models. When tested in     pre-clinical models for prophylactic or therapy of a potentially     lethal H5N1 infection, this antibody was shown to prevent death     and cure the disease. Currently a study to demonstrate the     effectiveness of this antibody compared to Oseltamivir is being     carried out.   * Blood Coagulation Factor VL/C: Preclinical work on this program     continues but conclusive proof of concept is not expected in the     near future. 

The Crucell Ambition:

In the last few months The Crucell Ambition program has been rolled out throughout the whole organization and the executive board has met with more than 50% of Crucell’s employees from different parts of the organization. The Crucell Ambition program encompasses coordinated efforts in four priority areas, which have been carefully defined after a thorough review of Crucell’s operations, objectives and potential. These are:

1. ORGANIZATION & PEOPLE. Development of our organization and our people is the foundation for achieving our ambition as a company. Multiple measures are being implemented to achieve this.

2. FOCUS. Crucell is clearly focused on its mission to protect lives from infectious diseases by bringing innovation to global health. We are building on our strengths by prioritizing those programs that are in line with this ambition and that contribute to our strategic and financial objectives.

3. OPERATIONAL EXCELLENCE. Crucell launched its ‘Healthy Ambition’ operational excellence program at the start of 2008 and is now implementing the validated plans drawn up in the first half of the year. By streamlining and optimizing our business processes, the program is expected to generate cost reductions of EUR 30 million by the end of 2009.

4. DELIVER ON PROMISES. Crucell has set its sights high and is firmly committed to delivering on its ambitious promises. Evidence-based target setting and a company-wide emphasis on organization and people, focus and operational excellence will enable us to do so.

PER.C6(R) technology platform:

   * DSM Biologics and Crucell announced that the high-titer fed-batch     process developed at the PERCIVIA PER.C6(R) Development Center,     their joint venture in Cambridge, U.S. was recently scaled up to     250 Liters by DSM Biologics scientists at their GMP facility in     Groningen, The Netherlands. They successfully achieved 8 grams     per liter for an IgG expressed by PER.C6(R) cells using chemically     defined cell culture medium in a SUB (single-use bioreactor).     This result  is  further  confirmation that  PER.C6(R)  cell  lines     provide  a   reliable,   versatile  and   commercially   feasible     production  platform  for   manufacturing  large  quantities   of     therapeutic proteins easily  and affordably.  This latest  result     also demonstrates the  reliable performance of  the PER.C6(R)  cell     line under  conventional fed-batch  production conditions,  which     are widely  used  in  the industry.  Earlier  this  year  Crucell     reported record-breaking protein yields of  27 grams per liter  -     biomass corrected - using DSM's innovative XD(TM) technology. 

Manufacturing & Licensing Agreements:

   * Lonza and Crucell entered into a co-exclusive manufacturing,     sales and distribution agreement related to the PERMEXCIS(TM)     cell culture medium developed by Crucell for PER.C6(R) cells. Under     this agreement, Lonza will manufacture the medium, and in     addition will market and sell it on a global basis. Financial     details of the agreement were not disclosed. [September 2008]     The PERMEXCIS(TM)  medium is  a chemically  defined cell  culture     medium that does not contain human- or animal-derived components.     PERMEXCIS(TM) medium was developed for the cultivation of PER.C6(R)     cells  and  has  been  designed   for  use  in  the   large-scale     manufacture of  biopharmaceutical products,  including  vaccines.     This novel medium has proven, in a comparison study performed  by     Crucell, to  provide  higher  viral  vaccine  product  yields  in     PER.C6(R) based manufacturing  processes than some  of the  current     available media for PER.C6(R) cells on the market.   * Crucell announced that it has signed an exclusive, commercial     license agreement with North Carolina-based Talecris     Biotherapeutics for an undisclosed and specific protein to be     produced using a PER.C6(R) cell line. Crucell received an upfront     payment of $2.5 million following the execution of the agreement     and will be eligible for milestone payments of approximately $30     million across multiple indications. Further financial details of     the agreement were not disclosed. [September 2008]   * Crucell announced a non-exclusive PER.C6(R) research license     agreement with Birmingham-based Vaxin Inc. for their research and     development of a vaccine for the prevention/treatment of     Alzheimer's disease for humans as well as for an additional     undisclosed field. Financial details of the agreement were not     disclosed. [September 2008] 

Patents:

In Q3 2008 Crucell received a total of 50 granted patents, including patents for:

   * Methods for obtaining STAR(R) elements, in Israel   * Stable adenoviral AdVac(R) vectors, in Europe   * Improved methods for the production of viruses using PER.C6(R)     cells, in India   * Adenoviral vector based malaria vaccines, in New Zealand   * Technology for the production of antibody mixtures using PER.C6(R)     cells, in the U.S. and New Zealand   * Improvements in PER.C6(R) expression technology, in China   * Improved methods for quantifying influenza antigens, in Europe   * Technology for producing measles virus vectors, in the U.S. 

Post Balance Sheet Events:

   * Crucell announced that an agreement was reached to relocate     Crucell's Korean production facility from the Shingal site in     Yongin City, Korea to the Incheon Free Economic Zone. All parties     involved have agreed on the time line and conditions of this     relocation, enabling a smooth transition to the new production     facility. With engineering well underway, construction activities     at the new site are starting. The new facility will enable the     further growth and efficient production of Quinvaxem(R) and     Hepavax-Gene(R). No further details were provided. [October 2008]   * Crucell announced a non-exclusive PER.C6(R) research license     agreement with the Australian-based company Arana Therapeutics,     Ltd for the production of monoclonal antibodies. Financial     details of the agreement were not disclosed. [October 2008]   * Crucell announced a non-exclusive PER.C6(R) research license     agreement with the Australian-based company Abraxis Bioscience,     Inc., for the production of proteins. Financial details of the     agreement were not disclosed. [October 2008]   * Crucell announced the sale of its fully-owned subsidiary Etna     Biotech Srl (Catania, Italy) to Zydus Cadila (Ahmedabad, India).     The sale results in net proceeds for Crucell of several hundred     thousand Euros. This transaction is in line with Crucell's     increased focus on the strengths of its core business. [November     2008]   * Crucell announced a non-exclusive manufacturing, sales and     distribution agreement with Cambridge-based Biochrom AG related     to the PERMEXCIS(TM) cell culture medium developed by Crucell for     PER.C6(R) cells.     Biochrom is one of the leading European manufacturers of tissue     culture media, animal sera, and buffers for the pharmaceutical     industry. Established in 1981, the company manufactures and     distributes the full range of products related to mammalian cell     culturing technologies. Biochrom will manufacture the medium, and     in addition will market and sell it in the European Union,     Switzerland, Turkey, Russia and Israel. Financial details of the     agreement were not disclosed. [November 2008] 

Financial Review

Total Revenue and Other Operating Income

Total revenue and other operating income was EUR 82.1 million for the third quarter of 2008, an increase of 31% compared to the same quarter of 2007 (38% in constant currencies). The increase was driven by continued strong sales of paediatric and respiratory vaccines as well as higher license fees.

Increase of license revenues was driven by milestone payments triggered by the Phase II clinical study of our Rabies program, the progress on sanofi pasteur’s FluCell program as well as license income from Talecris Biotherapeutics.

Product sales for the third quarter amounted to EUR 65.6 million and represent sales of paediatric vaccines (44%), travel and endemic vaccines (16%), respiratory vaccines (30%) and other products (10%).

License revenues were EUR 10.4 million in the third quarter, an increase of EUR 8.6 million compared to the same quarter of 2007. License revenues consist of initial payments from new contracts as well as milestones and other payments on existing contracts.

Service fees for the quarter were EUR 2.6 million, compared to EUR 3.7 million last year. Service fees represent revenue for product development activities performed under contracts with partners and licensees.

Other operating income was EUR 3.5 million for the quarter, compared to EUR 1.9 million in the third quarter of 2007.

Cost of Goods Sold

Cost of goods sold for the third quarter of 2008 amounted to EUR 39.6 million, EUR 37.5 million of which represents product costs and EUR 2.2 million represents the cost of service and license activities. Gross margins of 50% compared to 36% in the third quarter of 2007. Gross margins in the third quarter of this year are positively influenced by a significant increase in license income, sales of our flu product (Inflexal(R) V) and better production yields, as well as improved plant utilization due to higher volumes. Positive currency effects also contributed approximately 2.5 percentage points to gross margins.

Expenses

Total expenses consist of research and development (R&D) expenses, marketing and sales (M&S) and general and administrative (G&A) expenses. Total expenses for the third quarter were EUR 33.5 million, representing a EUR 6.0 million increase over the same period in 2007 (EUR 27.6 million).

R&D expenses for the third quarter amounted to EUR 17.7 million, which represents a EUR 5.3 million increase versus the third quarter of 2007. The increase can be attributed to the timing of specific R&D expenses during the year. Overall R&D spending for the full year is expected to be around EUR 70 million.

SG&A expenses for the quarter were EUR 15.9 million, which represents a EUR 0.6 million increase versus the third quarter of 2007. This increase was due to higher one-off expenses in the same quarter last year and includes costs related to the ‘Healthy Ambition’ operational excellence program.

Net financial income and divestments in the third quarter of EUR 2.6 million was the result of foreign exchange gains mainly caused by the increase of the U.S. dollar against the Euro and the sale of Kenta for EUR 1.6 million.

Net Result

Net income of EUR 12.3 million was reported in the third quarter of 2008, compared to a net loss of EUR 4.5 million in the same period of 2007. This amounted to EUR 0.19 net result per share, compared to a net loss per share of EUR 0.07 in the third quarter of 2007.

Balance Sheet

Tangible fixed assets amounted to EUR 150.2 million on September 30, 2008. Intangible assets, representing assets through acquisitions, amounted to EUR 80.5 million. This figure includes acquired in-process research and development, developed technology, patents and trademarks, and value of customer and supplier relationships.

Investments in associates and joint ventures amounted to EUR 8.5 million and mainly represent investments in AdImmune and PERCIVIA. Crucell’s investment in Galapagos NV is classified under available-for-sale investments.

Total equity on September 30, 2008 amounted to EUR 424.5 million. A total of 65.7 million ordinary shares were issued and outstanding on September 30, 2008.

Investment in working capital increased significantly, mainly due to build-up of paediatric vaccine inventory, in anticipation of strong 2009 sales.

Cash Flow and Cash Position

Cash and cash equivalents decreased by EUR 3.0 million in the third quarter to EUR 103.9 million. Deterioration of cash flow and working capital in the first three quarters of 2008 was expected and due to the seasonality of our business.

Net cash used in operating activities in the third quarter of 2008 was EUR 9.9 million, driven by a EUR 26 million net increase in working capital. Overall investments in net working capital increased mainly due to inventory build-up of Quinvaxem(R). In anticipation of the expected further growth of Quinvaxem(R) in 2009, we will continue to build stock of Quinvaxem(R) in the fourth quarter of 2008.

Net cash used in investing activities in the third quarter amounted to EUR 4.4 million. Net cash from financing activities in the third quarter amounted to EUR 11.3 million.

Outlook 2008:

Crucell expects combined full year 2008 total revenue and total other operating income to grow by 25-30% in constant currencies[1]. Prior guidance was 20% growth which has been increased due to a particularly strong third quarter.

Furthermore, Crucell reiterates its expectations that margins will be significantly higher compared to 2007 and that, despite significant investments in inventory build-up in anticipation of strong 2009 paediatric vaccine sales, it expects to end the year cash flow positive.

Forward-looking statements

This press release contains forward-looking statements that involve inherent risks and uncertainties. We have identified certain important factors that may cause actual results to differ materially from those contained in such forward-looking statements. For information relating to these factors please refer to our Form 20-F, as filed with the U.S. Securities and Exchange Commission on May 7, 2008, and the section entitled “Risk Factors”. The Company prepares its financial statements under International Financial Reporting Standards (IFRS).

Conference Call and Webcast

At 14:00 Central European Time (CET), Crucell’s management will conduct a conference call, which will also be webcast. To participate in the conference call, please call one of the following telephone numbers 10 minutes prior to the event:

                     +44 203 023 4471 for the UK;                    +1 646 843 4608 for the US; and                  +3120 794 8426 for the Netherlands 

Following a presentation of the results, the lines will be opened for a question and answer session.

The live audio webcast can be accessed via the homepage of Crucell’s website at www.crucell.com and will be archived and available for replay following the event.

About Crucell

Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a global biopharma company focused on research, development, production and marketing of vaccines, proteins and antibodies that prevent and treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell’s core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine and the only aluminum-free hepatitis A vaccine on the market. The Company has a broad development pipeline, with several product candidates based on its unique PER.C6(R) production technology. The Company licenses its PER.C6(R) technology and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi-aventis, Novartis, Wyeth and Merck & Co. Crucell is headquartered in Leiden, the Netherlands, with subsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the U.S. The Company employs over a 1000 people. For more information, please visit www.crucell.com.

 Financial Calendar: 17 February 2009       Q4 Results 2008 6 May 2009               Q1 Results 2009 5 June 2009               Annual General Meeting of Shareholders 11 August 2009         Q2 Results 2009 3 November 2009       Q3 Results 2009 9 February 2010        Q4 Results 2009 For further information please contact: Crucell N.V. Oya Yavuz Director Corporate Communications & Investor Relations Tel. +31-(0)71-519 7064 [email protected] www.crucell.com 

[1] Constant currencies = Weighted average EUR/USD rate of 1.38 in 2007.

PDF file including financials: http://hugin.info/132631/R/1268267/280081.pdf

This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.

Copyright Copyright Hugin AS 2008. All rights reserved.

SOURCE: Crucell N.V.

To offset dramatic delays in collection of flight revenues, Angel MedFlight has expanded services to include specialized medical claims processing.

“The economy hasn’t affected the number of flights we’ve performed,” says Cheyenne Lord, Corporate Claims Director at Angel MedFlight, “but we’re seeing a much longer insurance claims process, even for pre-authorized medical flights.”

Healthcare comprises the largest sector of America’s economy, and an industry once thought to be recession-proof is feeling the bite. Insurance carriers are tightening their coffers as medical costs rise and profits and enrollment decrease. The impact on the air ambulance industry is a virtually automatic denial of coverage for air medical flights, and a longer, tougher road to claims payment.

Since 2003, less than three percent of standard health-care appeals filed by consumers with the Arizona Department of Insurance have been approved*. When claims are denied or take months rather than weeks to pay, patients and providers feel it.

“In order to thrive in a near-recession, we’re directing our resources to finding solutions,” says Lord. “Ideally, we want what’s fair for the patient, and we want it in a timely manner.”

Angel MedFlight’s proactive approach to collecting payments from fiduciary parties has garnered much success to date. The claims department at Angel MedFlight cites education, hard work and commitment as primary reasons for their positive outcomes.

“We’re in business to help patients,” reiterates Lord. “A big source of stress for the patient and their family is the cost of the transport. If we can help remedy that, we’re happy to do it.”

About Angel MedFlight:

Angel MedFlight Worldwide Air Ambulance Services is a full service provider of air ambulance, ground ambulance and commercial medical escort for critically ill and injured patients. The One Touch Promise provides safe, quality, cost-conscious medical transport and relieves case managers and patients’ families of the burden of travel logistics. Angel MedFlight has a pristine safety record, with no incidents or accidents.

* The Arizona Republic, Arizona Backs Insurers in Most Claim Disputes, 11/2/08, Ken Alltucker

 Media Contact: Jenna Murray Angel MedFlight Worldwide Air Ambulance Services 8014 East McClain, Suite 120 Scottsdale, Arizona 85260 Phone: 877-ANGEL70 (877-264-3570) www.angelmedflight.comEmail Contact

SOURCE: Angel MedFlight

TUCSON, Ariz., Nov. 10 /PRNewswire/ — Medipacs, Inc., a Tucson based drug delivery device company, announced the appointment of David Swenson, RPh and Agustin Vilches, RPh to the company’s medical Advisory Board. Both Swenson and Vilches have pharmacy backgrounds and together have practiced in Hospital, Hospice and Home care settings.

David Swenson worked for fifteen years at Swedish Hospital Medical Center and the Fred Hutchinson Cancer Research Center in Seattle, WA, before joining the Pyxis management team soon after its founding, where David played a central role in developing the economic value proposition for their Medstation drug dispensing systems. David is a founder of IntelliDOT Corporation and serves as Chief Clinical Officer. IntelliDOT has developed and is marketing point of care patient and workflow systems which reduce medication, laboratory and other errors in hospitals. David is an expert in the area of drug delivery safety and in systems which reduce the rate of serious errors that extend length of stay, a significant cost to hospitals.

Agustin (Tino) Vilches is a registered pharmacist who founded Capitol Home Infusion, Inc. (CHI) in 1994, a business serving patients receiving their medications in alternate site settings. Tino was responsible for operations and reimbursement. Since the sale of CHI to Neighborcare/Omnicare in 2004, he has served as Hospice Account Manager whereby he manages all aspects of Hospice pharmacy services for the Washington DC region. He is an expert in evaluating drug delivery systems and methods in Hospice and Home care settings.

“David’s experience in hospital pharmacy, work flow, economic value analysis and drug delivery safety are central to Medipacs’ plans to deploy devices which reduce medication errors and reduce therapy costs while enhancing patient service quality. David brings an exceptional combination of customer and industry perspective to the Medipacs board of advisors. Complementing David’s Hospital experience, Tino’s Hospice and Home care clinical experience as well as his operations and reimbursement business experience expand our deep understanding of clinical practice from hospital to hospice to home and will inform Medipacs how best to deploy products which facilitate the transition of patients through various care settings. We are very pleased to have David and Tino recognize the value of our technology and join our team. Each has been involved in the delivery of small volume injectable drugs for many years and knows well the problems of current delivery methods. Like other pharmacists and nurses who have seen our devices, they believe Medipacs has a game changing technology,” said Mark McWilliams, CEO of Medipacs.

About Medipacs

Medipacs, Inc. is a Tucson based drug delivery device company with expertise in hydro gel polymers. It is developing advanced infusion technologies and is now focused on its first commercial application, a programmable disposable infusion device called a Mini-Infuser(TM). The company is located at the Arizona Center for Innovation. Please contact: Mark McWilliams 858-227-0569 [email protected]

Medipacs, Inc.

CONTACT: Mark McWilliams of Medipacs, Inc., +1-858-227-0569,[email protected]

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