Replies to post #160427 on Biotech Values

[DewDiligence]

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.

[DewDiligence]

GILD—FDA accepts resubmitted NDAs for standalone Elvitegravir and standalone Cobicstat:

http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1920297&highlight

The PDUFA dates are 10/3/14 for Cobicstat and 10/4/14 for Elvitegravir.

Due to a regulatory quirk, both of these drugs are already on the market as components of GILD’s Stribild, but as standalone agents they received a CRL in Apr 2013 (#msg-87357861).

Separately, BMY has an NDA pending for the combination of Reyataz and Cobicstat (#msg-100574469).

In the EU, standalone Elvitegravir is approved under the brand name, Vitekta (#msg-94184330) and standalone Cobicstat is approved under the brand name, Tybost.