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Biotech / Medical : Biotech Valuation

CRSP 55.15

+2.5%

Jan 5 3:59 PM EST

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From: Doc Bones	12/13/2004 5:20:51 AM
	of 52153

Bristol-Myers Seeks to Sell Pravachol Without Prescription By LEILA ABBOUD and ANNA WILDE MATHEWS Staff Reporters of THE WALL STREET JOURNAL December 13, 2004; Page B3 Bristol-Myers Squibb Co. is seeking permission from regulators to sell its cholesterol-lowering drug Pravachol without a prescription. A move to over-the-counter access would shake up competition in the lucrative and huge drug category of statins. Branded cholesterol-lowering drugs, such as the market leader, Pfizer Inc.'s Lipitor, and AstraZenecaPLC's Crestor, could come under pressure as health insurers push the use of lower-cost over-the-counter versions. No statin currently is available in the U.S. without a prescription. Bristol-Myers's move likely was spurred in large part because it will lose patent protection on Pravachol in April 2006. Sales were $2.8 billion world-wide last year. Spokesman Robert Hutchison said an over-the-counter version would broaden access and "potentially provide an important benefit to millions of consumers." Merck & Co. has applied to sell its older cholesterol-lowering drug Mevacor without a prescription. The FDA is expected to hold a meeting of its outside advisers to weigh in on Merck's application on Jan. 13-14. Britain recently permitted OTC sales of a Merck cholesterol drug. This is the second time Bristol-Myers and Merck have sought over-the-counter status. An outside panel of FDA advisers examined Mevacor and Pravachol in 2000, and voted against both switches. They questioned whether consumers, without a doctor, could make the right decisions about how to treat a potentially serious problem such as high cholesterol. They also asked whether the benefits of the low proposed over-the-counter dosage outweighed risks tied to the drugs. The agency might have reason to rethink its position. New studies and medical guidelines have said more people could benefit from cholesterol-lowering medications. The widely used drugs have years of use and research showing they are broadly effective. Some safety concerns remain. In 2001, Bayer AG withdrew the statin Baycol after 31 patients in the U.S. developed a serious muscle condition and died while taking the drug. A recent study in the Journal of the American Medical Association confirmed that Baycol's risks were higher than other widely used statins. online.wsj.com

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