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Eli Lilly Hit With Another FDA Delay

Shares of the drugmaker decline after-hours on another expected regulatory delay for blood thinner prasugrel.

Eli Lilly

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said late Friday that investors will have to wait longer still to find out whether blood thinner prasugrel wins regulatory approval in the U.S.

The company and partner

Daiichi Sankyo

revealed after market close that the Food and Drug Administration did not complete its review of prasugrel by its already-delayed goal date of Sept. 26.

"This is a very large, complex submission, and it should not be surprising that delays occur," said Jennifer Stotka, vice president for global regulatory affairs at Lilly.

The companies are seeking approval for prasugrel to treat patients with acute coronary syndromes being managed with an artery-opening procedure that's known as percutaneous coronary intervention (PCI).

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If approved, prasurgel will be marketed under the name Effient in the U.S. and has the potential to compete with blockbuster Plavix, which is marketed by


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Bristol-Myers Squibb

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Deutsche Bank analyst Barbara Ryan predicts Prasugrel could top $1 billion in worldwide sales by 2012. It stands to provide an important revenue stream as Lilly faces patent expirations that will affect products including anti-psychotic Zyprexa, its highest-earning drug.

Shares of Lilly were falling $1.91, or 4.1%, to $44.91 in recent after-hours trading Friday.