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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: epicure who wrote (4870)	7/15/1998 9:29:00 AM
From: Diamondcutter	Respond to of 7041

Wednesday July 15, 8:30 am Eastern Time Company Press Release Zonagen Files NDA for Vasomax THE WOODLANDS, Texas--(BW HealthWire)--July 15, 1998--Zonagen Inc. (NASDAQ:ZONA - news; Pacific:ZNG) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product, Vasomax(R). The indication to be pursued is for the treatment of male erectile dysfunction (MED). Zonagen and Schering-Plough Corporation (NYSE:SGP - news) signed a worldwide marketing agreement in November 1997 for Vasomax(R) in this indication. ''We are very pleased to have submitted our NDA for Vasomax(R),'' said Joseph Podolski, president and chief executive officer of Zonagen. ''This event marks a major milestone for Zonagen and we look forward to working with the FDA during the regulatory review process to make our product available to patients in a timely manner.'' Vasomax is a rapidly-disintegrating oral formulation of phentolamine mesylate that produces an alpha-adrenergic block of short duration leading to vasodilation of the vascular smooth muscles that enhances blood flow to the penis. Utilizing data derived from the Massachusetts Male Aging Study, published in 1994, an estimated 48 million men between the ages of 40 to 70 in the United States, Canada and Europe could suffer from erectile dysfunction. Of these, approximately a third have mild dysfunction, almost half have moderate dysfunction and about 20 percent have severe dysfunction. Zonagen Inc. specializes in products and services for management of reproductive health. Its technologies focus on the areas of urology, female health and contraception. Through its wholly owned subsidiary, Fertility Technologies Inc. (FTI), Zonagen sells devices, instruments and supplies to the fertility specialist and the OB/GYN. Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including but not limited to those relating to the Company's early stage of development, clinical trial results and FDA approval, substantial dependence on one product, history of operating losses, future capital needs and additional funding, ability to protect patents and proprietary technology, litigation, governmental regulation, limited sales and marketing experience and dependence on collaborators, limited manufacturing capabilities and reliance on third-party manufacturers, competition and technological change, product liability and insurance, and other risks identified in the Company's Annual Report on Form 10-K for the year ended December 31, 1997, as filed with the Securities and Exchange Commission. ------------------------------------------------------------------------ Contact: Zonagen Inc., The Woodlands Jean Anne Mire, 281/367-5892