Eli Lilly & Co. said late Wednesday it is suspending two trials of its prasugrel blood-thinner, which had been hoped to be the company's next blockbuster drug, to examine whether certain dosages may need to be changed. The small, Phase II studies are evaluating how well prasugrel works compared to Plavix, which is produced by Bristol-Myers Squibb and sanofi aventis, in stopping clotting in patients with coronary artery disease. "These amendments are strictly protocol-related and do not provide a basis for inferring overall outcomes of other prasugrel trials," Lilly said, noting that patient enrollment would resume once the protocols are amended and approved by institutional review boards. Late-stage clinical trial results are expected to be presented at the American Heart Association meeting November 4. Analysts, however, have speculated the results may be negative; earlier this week Cowen & Co. downgraded Lilly, predicting that prasugrel would be associated with statistically more bleeding than Plavix. Lilly is co-developing prasugrel with its Japanese inventor Daiichi Sankyo Co. and still plans to submit the drug for FDA approval by year-end, with an expected market debut as early as 2008. Analysts say Lilly shares could fall 10% if prasugrel doesn't beat Plavix. "The worst case is the failure to show superiority," said Natixis Bleichroeder analyst Jon LeCroy. "If it's a complete blow-up, we expect Lilly to drop to $50." Lilly shares fell 1.2% to $55.49 AH on the news, following a 1.7% drop in the regular trading session.
Commentary: Big Drugmakers Need To Improve Their Act Already • Sanofi-Aventis and Bristol-Myers Squibb Victorious Over Apotex in Plavix Case
Stocks to watch: LLY. Competitors: BMY, SNY, PFE, GSK. ETFs: PPH, XLV, IYH
Earnings call transcript: Eli Lilly Q3 2007
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