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Re: DewDiligence post# 160427

Monday, 04/14/2014 4:56:20 PM

Monday, April 14, 2014 4:56:20 PM

Post# of 257265
BMY submits NDA for Reyataz + GILD’s Cobicstat in single pill:

http://finance.yahoo.com/news/bristol-myers-squibb-submits-drug-120000381.html

Bristol-Myers Squibb Company announced today the submission of a new drug application on April 4, 2014 to the U.S. Food and Drug Administration for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective.

Reyataz, the leading HIV protease inhibitor in worldwide sales, is almost always taken with 100mg ritonavir to boost the PK and enable qD dosing at a lower dose than would otherwise be possible. Combining Reyataz with Cobicstat instead of ritonavir may have fewer drug-drug interactions.

p.s. It’s a little misleading for the above PR to call Cobicstat investigational, even though it hasn’t been approved by the FDA as a standalone drug, because it’s a component of GILD’s Stribild.

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