Replies to post #97508 on Biotech Values

[DewDiligence]

BMY/PFE will present the full Apixaban dataset from the AVERROES study at ESC 8/31/10, as previously promised:

http://finance.yahoo.com/news/BristolMyers-Squibb-and-bw-3220893905.html?x=0&.v=1

Positive top-line data from this study were reported in June (#msg-51176226), which greatly improved the overall commercial prospects for Apixaban. However, the AVERROES study sidestepped the most important segment of the AF market insofar as it compared Apixaban to aspirin in patients unable to tolerate warfarin.

genisi and I predicted that BMY/PFE will defer submitting an NDA for Apixaban in AF until they have the results of the phase-3 study called ARISTOTLE, where Apixaban is compared to warfarin rather than aspirin (#msg-51490977).

[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)

[DewDiligence]

Apixaban—BMY reversed course and said on the 4Q10 CC that the AVERROES and ARISTOTLE studies will be consolidated in the submissions to the FDA and EMA, as we originally expected.