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Biotech / Medical : wla(warner lambert) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (400)	1/15/1999 10:02:00 AM
From: Anthony Wong	Respond to of 942

Warner-Lambert's Rezulin Diabetes Drug to Get U.S. FDA Review for Safety Bloomberg News January 15, 1999, 9:07 a.m. ET Warner-Lambert's Rezulin Drug to Get FDA Review for Safety Washington, Jan. 15 (Bloomberg) -- Warner-Lambert Co. said its Rezulin diabetes pill will be the subject of a safety review at a March 26 advisory committee meeting for the U.S. Food and Drug Administration. The advisory panel will consider the data on Rezulin's safety and efficacy in the nearly two years since it has been available for sale in the U.S., Warner-Lambert said. U.S. regulators have confirmed that 33 people have died after taking Rezulin. The panel will also review the company's application for wider clearance to promote the drug's use in combination with other diabetes drugs. ''Warner-Lambert welcomes the opportunity for a rational review of Rezulin,'' said Anthony Wild, president of the pharmaceutical sector at Warner-Lambert. The company also said it will delay a planned study into the drug's effects in people at high risk of diabetes. Since Rezulin's introduction in March 1997, its label has been strengthened three times. A black box on the label -- considered the Food and Drug Administration's strongest warning measure -- highlights the section on Rezulin's risks. Even with the ''black-box'' warning, doctors have still been prescribing the drug. Rezulin's third-quarter sales rose 32 percent to $181 million. Rezulin and another drug introduced last year, cholesterol- reducing Lipitor, turned Warner-Lambert from one of the least successful U.S. drugmakers into one seen as an industry leader. Warner-Lambert's third-quarter profit rose 49 percent to $296 million, boosted by sales of Lipitor and Rezulin. Rezulin could have 1998 sales of $700 million and Lipitor of more than $2 billion, analysts have estimated. Public Citizen, a watchdog group founded by Ralph Nader, petitioned the FDA in July to ban Rezulin. The group cited the drug as an example of the flaws in the FDA's recent moves to speed drug approvals. Rezulin is the first of the a class known as glitazones approved in the U.S. SmithKline Beecham Plc and Eli Lilly & Co. could have their own versions of glitazone drugs on the U.S. market by 2000. Like Rezulin, these drugs work to help the body make better use of limited insulin supplies. These pills are used to treat the more common form of diabetes, Type 2, where the body fails to produce enough insulin to properly regulate blood sugar. About 15 million people in the U.S. have this form of diabetes. --Kristin Reed in Washington and Kerry Dooley in Princeton,