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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly)

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To: Anthony Wong who wrote (1105)	11/20/1998 7:53:00 PM
From: Anthony Wong	Read Replies (1) of 1722

11/20 17:02 Warner-Lambert to study wider use of diabetes drug By Simon Hirschfeld NEW YORK, Nov 20 (Reuters) - Warner-Lambert Co. <WLA.N> said Friday it will study the ability of its controversial drug Rezulin to treat a precondition of diabetes after receiving the go-ahead from the U.S. Food and Drug Administration (FDA). "It's a very bullish statement on the FDA's level of comfort with the drug," said Mara Goldstein, an analyst with CIBC Oppenheimer, referring to the Agency's willingness to allow Warner-Lambert to proceed with its Rezulin studies. The National Institutes of Health (NIH) in June discontinued its own trial of the drug, when one patient in the study experienced liver failure and later died. The five-year Warner-Lambert study, like the NIH study, will test Rezulin's effect on impaired glucose tolerance, a precursor to adult onset type II diabetes that affects 21 million people, according to a spokeswoman for Warner-Lambert. Use of the drug for healthy, pre-diabetic patients would significantly expand the drug's potential market. Rezulin is now prescribed to about 1.3 million people with type II diabetes who are not sufficiently responsive to insulin, the spokeswoman said. Insulin regulates blood sugar levels in the body. In July the FDA said that despite the Rezulin-related deaths of 14 people from liver failure, and calls to pull the drug from groups such as Ralph Nader's Public Citizen, the drug was worth keeping on the market. The agency determined that in all cases, the deaths were due to the failure to properly monitor use of the drug. "They do enough blood tests now where it can be detected early enough to prevent liver failure," Alex Zisson of Hambrecht & Quist said. Smithkline Beecham Plc <SB.L> and Eli Lilly & Co. <LLY.N> are currently developing similar products that do not appear to be associated with liver toxicity, analysts said. Smithkline intends to submit data on its drug Avandia to the FDA by the end of the year, meaning that the drug could go to market before the end of Warner-Lambert's five-year trial. But CIBC's Goldstein pointed out that Smithkline had the benefit of being able to observe the problems that occurred with Rezulin.

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