Replies to post #135726 on Biotech Values

[oc631]

I thought that cobicistat is needed because of the elvitegravir component which needs to be taken twice a day if not boosted. If a competitor has an integrase inhibitor such as dolutegravir that can be dosed once-a-day without boosting, then they would not need cobicistat.

Dolutegravir still needs BID dosing in treatment-experienced patients resistant to raltegravir but your point is well taken. Cobicistat can be used in combination with integrase or protease inhibitors so it's a valuable tool for GILD in future HIV drug development.

[DewDiligence]

GILD submits MAA for standalone Cobicistat as a replacement for ritonavir:

http://finance.yahoo.com/news/gilead-files-european-marketing-application-200500656.html

The PR says a similar NDA submission to the FDA is planned in 3Q12.

Note: Cobicstat is a component of the 4-drug HIV regimen called Quad and is also a PK booster for Elvitegravir that enables it to be dosed qD. The PDUFA date for Quad is 8/27/12; the submission date for Elvitegravir is supposed to be in 2Q12.