Eli Lilly shares fall on blood-thinner concerns

The stock fell $1.56, or 3.3 percent, to $45.26 in midday trading. Shares have traded between $43.81 and $59.82 over the past year.

On Friday, Indianapolis-based Eli Lilly said the FDA needs more time to review its application for the blood thinner, which Wall Street sees as a potential blockbuster. This is the second time the regulatory agency has asked for more time, though Eli Lilly has attributed the longer-than-expected review to a complex submission.

Prasugrel is designed to treat patients with acute heart problems such as heart attacks or unstable angina who are at risk of developing blood clots. If approved, it would compete with Sanofi-Aventis SA and Bristol-Myers Squibb Co.'s Plavix, which loses patent protection in 2011. That drug had sales of about $7.3 billion last year, according to pharmaceutical data provider IMS Health.

While a head-to-head study of the drug last year showed fewer prasugrel patients developed blood clots in stents or suffered heart attacks, there was more bleeding associated with the drug.

Despite the multiple delays, Cowen and Co. analyst Steve Scala still expects an FDA decision by the end of 2008.

"We take comfort that FDA did not issue a complete response," he said in a note to investors. "FDA has had several opportunities and sufficient time to issue such a decision. Therefore the delayed decision suggests that there is little reason to believe a negative decision is forthcoming."

He reaffirmed an "Outperform" rating and said the approval Monday of the cancer drug Alimta gives the company a boost.

The FDA approved Alimta as an initial treatment for advanced and metastasized non-small cell lung cancer, the most common form of lung cancer. It was already approved as a secondary treatment for the condition.

"Our consultants are enthusiastic about Alimta in this setting and the market opportunity is double the second-line setting," Scala said.