Biotech Values

[DewDiligence]

BMY 2Q10 CC notes re Ipilimumab, Apixaban:


Ipilimumab

• The BLA in second-line metastatic melanoma was submitted in Jun 2010—FDA decision on priority review Aug 2010; European MAA in same indication was submitted and has been accepted by EMA for review.

• There is no update re the phase-3 ‘024’ trial testing DTIC±Ipi in first-line melanoma (data still expected 2H10).

• BMY has decided to advance to phase-3 in NSCLC; no details yet on trial design.


Apixaban

• Results of the successful phase-3 study called AVERROES will be presented at the European Society of Cardiology (ESC) in Stockholm on 8/31/10. AVERROES is the study in AF/stroke prevention for patients unable to take warfarin that was stopped early due to overwhelming efficacy (#msg-51176226).

• No new news on the planned EMA submission or potential FDA submission in VTE prevention.