Biotech Values

[DewDiligence]

BMY has begun a rolling submission for Apixaban based on the AVERROES (non-warfarin) study and expects to complete the submission in 1Q11. It appears that we were wrong when we presumed that BMY would wait for the results of the ARISTOTLE study before filing an NDA.

BMY’s plan to submit a “freestanding” NDA based on AVERROES makes a lot of sense, actually. Management thinks the non-warfarin part of the AF market is where Apixaban can be strongly differentiated from Pradaxa and Xarelto insofar as those drugs will not have data from head-to-head trials vs aspirin. (Source: BMY’s 3Q10 CC)