Adeona Executes wellZin(TM) Manufacturing and Supply Agreement
-- Contract Provides Commercial-Scale Manufacturing Capabilities for Company's Zinc Acetate Lozenge Cold Remedy -- -- Company on Track to Make wellZin Commercially Available for this Year's Cold Season --
ANN ARBOR, Mich., Nov. 7, 2011 /PRNewswire via COMTEX/ -- Adeona Pharmaceuticals, Inc. AEN -3.69% , announced today that it has executed an agreement with F&F Foods of Chicago, Illinois, to provide commercial-scale manufacturing of wellZin(TM), the Company's oral zinc lozenge to reduce the duration and symptoms of the common cold. Adeona is planning to commercialize wellZin, a lozenge that contains 13.3 mg of zinc acetate, based on formulations clinically tested by Ananda S. Prasad, M.D., Ph.D., a Distinguished Professor of Internal Medicine at Wayne State University School of Medicine and an Adeona Scientific Advisory Board member. wellZin is intended to be a natural, safe and effective homeopathic over-the-counter (OTC) medicine for the common cold.
In July 2011, Adeona obtained exclusive access to statistically significant clinical data from two separate studies conducted by Dr. Prasad that evaluated the effectiveness of zinc acetate lozenges on the reduction of the duration and the symptoms of the common cold. Based upon findings from Dr. Prasad's two clinical studies[i],[ii] 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 zinc treatment for the common cold. In a February 15, 2011, New York Times article that referred to the recently published Cochrane Review of zinc for the common cold, Dr. Prasad was quoted as saying, "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."
"I am so excited to make wellZin commercially available for adults suffering from the symptoms of the common cold. When I notice cold symptoms coming on, it is the worst feeling and wellZin has the potential to cut the duration and the severity of symptoms of the common cold in half if you start taking it right away," stated James S. Kuo, M.D., M.B.A., Adeona's Chief Executive Officer. "That is why executing this agreement with F&F Foods for the manufacturing of wellZin is so important - it brings us one step for closer to commercialization."
Adeona's proprietary wellZin lozenge is intended to reduce the duration and symptoms of the common cold when taken within 24 hours of symptom onset. wellZin contains 13.3 mg of zinc acetate based on Dr. Prasad's statistically significant clinical findings in two clinical trials[i],[ii], and is intended to be commercialized as a homeopathic OTC medicine. Plans for manufacturing, packaging and marketing of wellZin are currently underway.
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 zinc family brand of products under development by Adeona.
About Adeona Pharmaceuticals, Inc.
Adeona is a pharmaceutical company focused on developing innovative medicines for the treatment of serious central nervous system diseases. The Company's 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 over-the-counter medicine for reducing the duration and symptoms of the common cold. Adeona also operates Adeona Clinical Laboratory, a wholly owned clinical reference laboratory that provides a broad array of chemistry and microbiology diagnostic tests. For more information, please visit Adeona's website at www.adeonapharma.com .
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," "could," "potential," "positions," "continue," "expects," "anticipates," "intends," "plans," "believe," "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 use of zinc to reduce the duration and symptoms of the common cold and our intent to further commercialize development 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, our failure to successfully commercialize our product candidates, including wellZin, the failure of wellZin to reduce the duration and symptoms of the common cold, the failure of future clinical trials studying our product candidates, including wellZin, to have favorable results, 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.
SOURCE Adeona Pharmaceuticals, Inc.