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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: Zebra 365 who wrote (9336)	6/8/1998 9:15:00 AM
From: esterina	Read Replies (1) \| Respond to of 23519

Only .62 and something to look at ============================================= CAMBRIDGE, Mass.--(BW HealthWire)--June 8, 1998-- Agreement accelerates DynaGen's new product pipeline and FDA submissions and will conserve cash DynaGen Inc. (NASDAQ:DYGN) (BSE:DYG) today announced that through its generic manufacturing subsidiary, Able Laboratories Inc., it has entered into a joint venture agreement with ClinSites for clinical testing and analytical services that will support DynaGen's generic drug development program. Under the terms of the agreement, ClinSites will provide clinical and analytical services to DynaGen. ClinSites will perform bioequivalence studies comparing DynaGen's generic formulations against the brand name drugs. The results of ClinSites' findings will be utilized to support DynaGen's U.S. Food and Drug Administration (FDA) submissions for approval of the company's newly-developed generic drugs. "This agreement is a major step forward in our goal to rapidly develop and expand our generic drug product line and to accelerate clinical testing and ANDA (Abbreviated New Drug Application) submissions," stated C. Robert Cusick, Chairman of DynaGen Inc. "This should allow us to launch new products quickly and economically. In addition, the spirit of the agreement is that of a joint venture which will conserve DynaGen's cash and benefit both companies." "We recognize the potential of the products DynaGen has slated for development and therefore we have chosen to invest in their future," commented D. Scott Davis, President of ClinSites. "We are extremely pleased with our new agreement with DynaGen and we look forward to a productive collaboration." DynaGen has identified for development a range of products for use in women's health care and gastrointestinal treatment markets. The products include both tablet and suppository formulations which draw upon the company's area of expertise. The agreement with ClinSites initially provides for the testing of at least four specific formulations; but both companies anticipate broadening the agreement to incorporate additional products and formulations. ClinSites, headquartered in Charlotte, North Carolina, is a privately-held company of wholly-owned multi-specialty clinical trial sites dedicated to conducting a broad range of clinical trials including bioavailability and bioequivalency trials for generic formulations. ClinSites investigators are experienced physicians who provide protocol specific patient care. Currently, their investigator team is comprised of more than 400 board-certified physicians in various therapeutic specialties. DynaGen Inc. is a health care company involved in the research, development, manufacture and distribution of brand and generic therapeutic products. DynaGen's subsidiary, Able Laboratories Inc. develops and manufactures the company's generic products in its FDA registered 46,000 square foot facility located in South Plainfield, NJ. The company markets and distributes its products to independent retail chain and institutional pharmacies through its wholly-owned marketing subsidiaries, Superior Pharmaceutical Company and Generic Distributors Inc. The company employs and maintains operations in Massachusetts, New Jersey, Ohio and Louisiana. This press release contains or refers to forward-looking information including products under development or planned for development, potential regulatory registration for approval of new products, future revenues, and income and is based upon current expectations that involve a number of business risks and uncertainties. Among the factors that could cause actual results to differ materially from any forward-looking statement include, but are not limited to, lack of receipt of regulatory approval for newly developed products, technological innovations of competitors, delays in product introductions, changes in health care regulations, litigation claims, product acceptance or changes in government regulation of the company's products, as well as other factors discussed in the company's Securities and Exchange Commission filings. CONTACT: LBI Group Inc. Paul Lovito, 800/913-9767 or DynaGen Inc. C. Robert Cusick, 617/491-2527 KEYWORD: MASSACHUSETTS INDUSTRY KEYWORD: MEDICINE BIOTECHNOLOGY Today's News On The Net - Business Wire's fu