A panel of the European Medicines Agency recommended the approval of prasugrel, Eli Lilly’s new blood thinner, and such recommendations are usually followed by the agency within a couple of months, Reuters reports. The news is a significant win in Lilly’s long campaign to get this drug to market. It also means that Lilly CEO John Lechleiter’s gamble in the acquisition of ImClone is now more likely to pay off.
The ImClone buy and the fate of prasugrel are not linked, but BNET readers will remember that Lilly’s expensive move to gain ImClone came at a time when prasugrel — an expected blockbuster — was experiencing delays at the FDA, and in fact will not be approved until March 2009 at the earliest.
Further bad news piled up on prasugrel in November, when a prominent doctor pronounced that serious bleeding in high-risk patients was not properly controlled for in studies, and that therefore it was not possible to know which patients should be excluded from prasugrel use.
Thus the ImClone acquisition — $6.5 billion — looked more and more like a hedge against the idea that prasugrel would not be approved. ImClone would give Lilly a new pipeline in prasugrel’s absence.
If prasugrel is indeed ultimately approved in both the U.S. and Europe, then the best-case scenario emerges for Lilly and Lechleiter looks like a genius. We’ll see in March …
