Biotech Values

[DewDiligence]

“A serious internal disagreement has developed
over whether to approve the drug as it stands.”

I’m talking about Prasugrel from LLY, not Provenge :- )

http://blogs.wsj.com/health/2008/10/17/sanofi-zooms-on-reported-delay-for-lilly-blood-thinner

›Sanofi Zooms on Reported Delay for Lilly Blood Thinner

October 17, 2008
by Jacob Goldstein

The prescription blood-thinner market is largely a zero-sum game. That explains why shares of Sanofi-Aventis — which sells the popular blood-thinner Plavix — are up more than 7% today in European trading, after reports late yesterday of a delay for a would-be rival.

The rival is prasugrel, which is being developed by Eli Lilly and Daiichi Sankyo. The In Vivo blog, part of a widely read family of biomed biz publications, reported yesterday that the application to sell the drug — which the FDA was supposed to decide on earlier this year — likely won’t get a final decision from the FDA until March of next year “at the earliest.”

That’s good news for Sanofi as well as Bristol-Myers Squibb, which co-markets Plavix.

Citing unnamed sources, In Vivo says a “serious internal disagreement has developed over whether to approve the drug as it stands.” And the blog suggests the drug is likely to be in line for a public hearing before an advisory committee, which isn’t likely until February.

All the murmuring was enough to prompt Lilly and Daiichi Sankyo to put out a statement. But the wording of the statement may not do much to quiet the murmurs.

The companies “continue to have discussions with the FDA regarding the review of this application,” the statement said. “The companies have not been notified of any regulatory action for the new drug application (NDA) or of any decision to have an advisory committee to review prasugrel.”‹