Biotech Values

[DewDiligence]

FDA issues CRL for 800mg dose of Prezista:

http://finance.yahoo.com/news/fda-issues-complete-response-letter-130000820.html

This one is a head-scratcher insofar as the normal adult dose of Prezista in the existing FDA label is 800mg qD in the form of two 400mg tablets.* The only change being sought by JNJ is to offer the 800mg in a single pill.

Prezista has been a decent-selling drug for JNJ, and its sales could increase further if the JNJ-GILD collaboration to develop a Prezista-based all-in-one HIV pill pans out. The unnamed all-in-one pill would include Prezista, Emtriva (one of the components of Truvada), Cobicistat (the PK booster in Quad), and GS-7340, a prodrug of tenofovir that is similar to Viread (#msg-69031745).

*The FDA label specifies 600mg BID for patients who have developed partial resistance to Prezista.