July 28, 2011
Adeona Plans to Commercialize wellZin(TM) to Reduce Symptoms of the Common Cold
ANN ARBOR, Mich., July 28, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), announced today that it has acquired exclusive access to two sets of clinical data demonstrating, with statistical significance, the safety and efficacy of a particular oral zinc formulation in reducing the duration and severity of symptoms associated with the common cold. The common cold is one of the most widespread illnesses and is a leading cause of visits to the doctor and absenteeism from school and work. Based on the reduction of common cold symptoms demonstrated by the 13.3 mg zinc acetate formulation, Adeona intends to commercialize an oral zinc lozenge as a homeopathic over-the-counter (OTC) drug under the brand name wellZin((TM)).
Pursuant to the agreement with Ananda S. Prasad, M.D., Ph.D., a Distinguished Professor of Internal Medicine at Wayne State University School of Medicine, an Adeona Scientific Advisory Board member and the Principal Investigator of two separate clinical studies that evaluated a particular zinc lozenge for symptoms of the common cold, Adeona has obtained exclusive access to statistically significant clinical data, including the following:
- A randomized, double-blind, placebo-controlled study of 50 participants demonstrated that compared to the placebo group, the zinc lozenge group (13.3 mg of zinc acetate) had a mean overall reduction of the following(i):
- Duration of the cold (4.0 versus 7.1 days; P-value < 0.0001)
- Cough (2.1 versus 5.0 days; P-value < 0.0001)
- Nasal discharge (3.0 versus 4.5 days; P-value < 0.02)
- A randomized, double-blind, placebo-controlled study of 48 participants demonstrated that compared to the placebo group, the zinc lozenge group (12.8 mg of zinc acetate) had a mean overall reduction of the following(ii):
- Duration of the cold (4.5 versus 8.1 days; P-value < 0.01)
- Cough (3.1 versus 6.3 days; P-value < 0.001)
- Nasal discharge (4.1 versus 5.8 days; P-value < 0.025)
Both of the clinical studies demonstrated that these zinc lozenges were well-tolerated by the treatment participants and that the zinc and placebo groups did not differ significantly in the incidences of adverse effects.
Clinical data from Dr. Prasad's two studies are included in the "Zinc for the Common Cold Review" ("Cochrane Review") prepared by The Cochrane CollaborationÃ® and published in 2011(iii). In the Cochrane Review, the authors included 15 studies that enrolled a combined 1,360 participants and concluded that zinc administered within 24 hours of onset of symptoms reduces the duration and severity of the common cold in healthy people.
Based upon findings from Dr. Prasad's clinical studies and his expertise as a pioneer in the field of zinc, he believes that many of the zinc preparations currently available on the market include a sub-optimal formulation and/or dose of zinc, and also include flavors and binders that diminish the effectiveness of the treatment for the common cold. In a February 15, 2011 New York Times article regarding the Cochrane Review of zinc for the common cold, Dr. Prasad said, "The public is confused because people have used the wrong dose, they have used the wrong sort of zinc or they have not started the treatment within 24 hours of onset."
Upon executing the agreement with Adeona, Dr. Prasad stated, "After evaluating slightly different dosages of zinc in two separate clinical trials, I believe that the 13.3 mg zinc acetate lozenge, which is intended to be commercialized as wellZin, is optimal for reducing the duration and severity of the common cold, while also being safe and tolerable."
"Some people are not aware of the significant morbidity and large economic consequences caused by the common cold, and thus do not believe there is a need for a treatment that reduces the symptoms. The common cold is the source of 75 to 100 million physician visits each year in the U.S., and conservatively, about $7.7 billion in costs. We believe a therapy like wellZin, that is the same or similar zinc dose used in two independent clinical studies that demonstrated a significant reduction in duration, cough and runny nose of the common cold, should be made commercially available," stated James S. Kuo, M.D., M.B.A., Adeona's Chairman and CEO. "We are very pleased that Dr. Prasad has agreed to further our efforts by sharing his significant clinical data and expertise with us."
The trademarked name, wellZin, is derived from the combination of "well", as the product seeks to help people suffering from symptoms of the common cold, and "Zin", the root used to distinguish the family brand of zinc products under development by Adeona. Plans for manufacturing, packaging and marketing of wellZin are currently underway. Adeona's proprietary wellZin lozenge will be a homeopathic OTC drug that contains 13.3 mg of zinc acetate based on Dr. Prasad's clinical findings. wellZin is intended to be marketed for adults in the United States.
About the Common Cold
According to the Cochrane Review, the common cold is one of the most widespread illnesses, with adults having two to four episodes annually. Children may have 6 to 10 colds a year (and up to 12 colds a year for school children). In the United States, the common cold leads to 75 to 100 million physician visits annually at a conservative cost estimate of US $7.7 billion per year. Americans spend $2.9 billion on over-the-counter drugs and another $400 million on prescription medicines for symptomatic relief. More than one-third of patients who saw a doctor received an antibiotic prescription, which has implications for antibiotic resistance from overuse of such drugs. An estimated 22 to 189 million school days are missed annually due to a cold. As a result, parents missed 126 million workdays to stay home to care for their children. When added to the 150 million work days missed by employees suffering from a cold, the total economic impact of cold-related work loss exceeds $20 billion per year. This accounts for 40% of time lost from work. The complications of the common cold include otitis media, sinusitis and exacerbations of reactive airway diseases. Rhinoviruses are the most frequent cause and may account for nearly 80% of common colds during autumn.
About Ananda S. Prasad, M.D., Ph.D.
Ananda S. Prasad, M.D., Ph.D., a Distinguished Professor of Internal Medicine at Wayne State University School of Medicine and renowned zinc expert, recently received the 2010 Mahidol Award in the Field of Public Health for his groundbreaking research. Among his many achievements, he is credited with identifying zinc deficiency as the underlying cause of growth retardation and hypogonadism that has afflicted millions of children in the developing world. Dr. Prasad estimates that over 2 billion people worldwide currently suffer from zinc deficiency. For over five decades, he has been a vocal advocate of zinc supplementation for diseases characterized by zinc deficiency. Dr. Prasad is the 2007 recipient of the American College of Physicians Award for Outstanding Work in Science as Related to Medicine and has over 200 peer-reviewed publications.
About Adeona Pharmaceuticals, Inc.
Adeona is a pharmaceutical company largely focused on developing innovative medicines for the treatment of serious central nervous system diseases. The Company's primary strategy is to license product candidates that have demonstrated a certain level of clinical efficacy and develop them to a stage that results in a significant commercial collaboration. Adeona is developing, or has partnered the development of, drug product candidates to treat multiple sclerosis, fibromyalgia, amyotrophic lateral sclerosis (ALS) and Alzheimer's disease. The Company is currently preparing to make the following products commercially available: reaZin((TM)), a prescription medical food for the dietary management of zinc deficiency associated with Alzheimer's disease, and wellZin((TM)), a homeopathic OTC drug for symptoms of the common cold. Adeona also operates its wholly owned clinical reference laboratory, Adeona Clinical Laboratory. For more information, please visit Adeona's website at www.adeonapharma.com.
The Cochrane CollaborationÃ® is a registered trademark of The Cochrane Collaboration Secretariat.
This release includes forward-looking statements on Adeona's current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the commercialization of wellZin and the effectiveness of wellZin. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Adeona's forward-looking statements include, among others, a failure of wellZin to achieve desired results, a failure by us to successfully commercialize wellZin and other factors described in Adeona's report on Form 10-K for the year ended December 31, 2010 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Adeona undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
(i) Prasad AS, Beck FWJ, Bao B, Snell DC, Fitzgerald JT, Duration and Severity of Symptoms and Levels of Plasma Interleukin-1 Receptor Antagonist, Soluble Tumor Necrosis Factor Receptor, and Adhesion Molecules in Patients with Common Cold Treated with Zinc Acetate, JID, 2008; 197:795-802.
(ii) Prasad AS, Fitzgerald JT, Bao B, Beck FWJ, Chandrasekar PH, Duration of Symptoms and Plasma Cytokine Levels in Patients with the Common Cold Treated with Zinc Acetate, Ann Intern Med, 2000; 133:245-252.
(iii) Singh M, Das RR. Zinc for the common cold. Cochrane Database of Systematic Reviews 2011, Issue 2. Art. No.: CD001364. DOI: 10.1002/14651858.CD001364.pub3.
SOURCE Adeona Pharmaceuticals, Inc.