It's not enough for Eli Lilly & Co.'s anti-clotting drug prasugrel to be approved by U.S. regulators. Unless the medicine works better than Bristol-Myers Squibb Co. and Sanofi-Aventis SA's Plavix, it's a failure.
Doctors are awaiting study results that will determine if Lilly's experimental drug is safer and more effective than Plavix, the best-selling treatment for preventing blood clots that cause heart attacks and strokes. The findings from the 13,000-patient study, to be released Nov. 4, will establish whether prasugrel can grab a share of a $6 billion annual market.
Investors already are losing confidence in the drug.
Indianapolis-based Lilly dropped 4.5 percent after the close of trading in New York yesterday after saying it was temporarily halting two smaller trials to adjust dosing. Seventeen of 25 analysts surveyed by Bloomberg rate Lilly a hold or sell because of the prospects for prasugrel. Analysts say Lilly shares will drop 10 percent if prasugrel doesn't beat Plavix.
``The worst case is the failure to show superiority,'' said Jon LeCroy, an analyst with Natixis Bleichroeder in New York. ``If it's a complete blow-up, we expect Lilly to drop to $50.''
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