Biotech Values

[DewDiligence]

FDA approves JNJ’s Edurant (TMC278) in treatment-naïve HIV:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256087.htm

What makes this approval especially consequential is that TMC278 is a component of GILD’s ‘Btripa’ combination pill that will provide an alternative to the hugely successful Atripla with better economics for GILD (#msg-39660789, #msg-62382001). The PDUFA date for Btripla is 8/11/11.

Today’s Edurant approval is for the first-line setting only, but there is no reason to think that Btripla and standalone Edurant won’t be approved for the second-line setting also.

BMY, the maker of Sustiva, is the loser in all this.