Hemispherx Submits New Drug Application to European Union
Wednesday December 2, 9:03 am Eastern Time
Company Press Release
SOURCE: Hemispherx Biopharma, Inc.
PHILADELPHIA, Dec. 2 /PRNewswire/ -- Hemispherx Biopharma (Amex: HEB - news) said that today it had submitted a final marketing application and associated filings to the European Medical Evaluation Agency (EMEA) for the approval for commercial use throughout the European Union of its lead drug Ampligen® in the treatment of Chronic Fatigue Syndrome (CFS), also known as Myalgic Encephalomyelitis (ME).
Hemispherx Biopharma Europe utilized new EMEA guidelines to accelerate regulatory review of potential treatments for severely debilitating or life-threatening diseases, such as CFS/ME, for which there is no other treatment yet available.
The company said that its submission included the mandatory ''expert reports,'' which are a comprehensive review of the clinical data conducted by leading independent European medical experts in the CFS/ME field. These medical experts evaluated the medical benefits of the anticipated therapy.
In the U.S., Ampligen is currently being evaluated in Phase III clinical programs and is also available under a cost-recovery program for especially ill patients authorized by the FDA and administered in conjunction with Olsten Healthcare (NYSE: OLS - news). At this time, there is no fully approved treatment specifically for CFS/ME in the U.S. or Europe. To the company's knowledge, Ampligen® is the only drug authorized for Phase III clinical testing in CFS/ME in the U.S., and the only drug for CFS/ME now awaiting full commercial approval in a major health-care market.
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risks of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Accordingly, actual results may differ materially from those in any forward-looking statements.
SOURCE: Hemispherx Biopharma, Inc.
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