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DewDiligence

06/22/11 5:54 PM

#122125 RE: pcrutch #122123

Eliquis (apixaban) highlights from today’s PR:

ARISTOTLE is the second of two phase-3 studies for Eliquis (apixaban) in AF/stroke prevention. The first phase-3 study in this indication, called AVERROES, showed that Eliquis was statsig superior to aspirin on efficacy and not statisg worse than aspirin on safety (i.e. bleeding) in patients unable to tolerate warfarin (#msg-54576974).

In ARISTOTLE, Eliquis went head-to-head against warfarin and was statsig superior on both efficacy and safety. No HR or p-value was disclosed today; full data will be presented at the ESC conference in August.

BMY and PFE, who are co-developing Eliquis, will submit an NDA and European MAA for the combined AVERROES and ARISTOTLE datasets in 4Q11.