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| | | ![]() Phase III Trial Of Controlled-Release Aciclovir For Genital Herpes Begins LYON, France, Jan. 30, 1997 -- Flamel Technologies S.A. (Nasdaq: FLMLY) today announced the start of a phase III clinical trial in France in patients with acute incidences of genital herpes to compare the effectiveness of Viropump, its twice-daily controlled-release formulation of aciclovir, the leading antiviral drug, with Glaxo-Wellcome's five times daily Zovirax(R), an exiting formulation of aciclovir. In the study, one-half of the patient population will receive Viropump twice daily, while the other half will be administered Zovirax((R) five times daily. The study, which will involve several different medical centers in France, is expected to last approximately twelve months and is being managed by Parexel, the clinical research organization. Viropump utilizes Flamel's proprietary Micropump(TM) technology, a microparticle-based drug-delivery system designed to extend the time of absorption of drugs in the small intestine. The technology has already been applied to Asacard, a controlled-release formulation of aspirin for treatment of cardiovascular diseases, a product which is currently under registration in France and in the U.K. Flamel Technologies is engaged in the development of advanced polymer technologies for unique drug delivery and biomaterial applications. The Company is building on its principal technology platforms -- through programs including Micropump and Medusa in drug-delivery, ColCys in biomaterial-based medical devices, and new materials for ophthalmic lens products -- to meet important unmet medical needs and develop other commercially valuable products. NOTE: This press release contains statements which constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties, including but not limited to the risk that this transaction will not be consummated, the risk associated with the Company's limited history of operations and historic and future losses, and the risk that products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market acceptance of products in development, the impact of competitive products and pricing, reliance on outside parties and the risks associated with key strategic alliances, and other risks detailed in the Company's filings with the Securities and Exchange Commission.
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