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To: eric deaver who wrote (29431)	7/22/1998 5:00:00 PM
From: lightfoot	Respond to of 34592

ISIP - First of its kind approval!! Heres an interesting paragraph NEW YORK (July 16) BUSINESS WIRE -July 16, 1998--There are over 350 biotech drugs in FDA clinical trials. About 25% of these drugs are in Phase III. A Phase III FDA trial is the final step in the drug approval process before the FDA reviews the clinical data to make a recommendation as to whether or not the drug has been shown to be safe and effective. These trials usually consist of controlled studies over several years. As many as one thousand patients or more can be enrolled in a phase III trial. "The value of a biotech company and the direction of the stock price is often heavily dependent on the results of these studies and the recommendation of an FDA committee", says Steven Delco, senior biotech analyst at the firm Miller Tabak Hirsch +Co., New York City. "There is little room for the middle ground. Like an Olympic sport an approval can make you an instant star or a disapproval, plunge you into the agony of defeat." There are several biotech companies that await crucial decisions by the FDA for a first-of-its-kind drug. Among these companies include Isis Pharmaceuticals, Inc (ISIP), Immunex Corp.(IMNX) and Aviron(AVIR). If approved, Isis's Vitravene(TM) a HIV related, CMV retinitis antisense therapy will be the first gene based therapy. Vitravene(TM) is expected to be reviewed on July 22 by the FDA. As opposed to the current treatments which merely reduce pain and swelling, Immunex's TNF-receptor drug Enbrel(TM) a treatment for rheumatoid arthritis will become the first arthritis therapy which blocks the inflammation process itself. Aviron's has announced its product license application for FluMist(TM), the first intranasal influenza vaccine. As we move into the 21st century the rich pipeline of biotech drugs in clinical trials should yield several new classes of treatments and first-of-its-kind therapies.