Replies to post #122642 on Biotech Values

[DewDiligence]

GILD—Would it be enough for GS7340 [+Emtriva] to show better tolerability than Truvada or would it have to show better efficacy?

The former, IMO; I don’t think better efficacy than Truvada is a realistic goal for any dual-nuke backbone.

Another possible threat to Gilead is if nuke-sparing regimens eventually become popular.

Possible, yes, but this is less worrisome to GILD investors, IMO, than the 2017 loss of patent protection on Viread.

[DewDiligence]

FDA approves pediatric doses of Viread:

http://finance.yahoo.com/news/U-S-Food-Drug-Administration-bw-4241059041.html?x=0

The new doses are 150mg, 200mg, and 250mg for children age 6-12, and a powdered formulation for younger children. The standard adult dose of Viread (including embedded use in Atripla and Truvada) is 300mg qD.

[DewDiligence]

GILD starts phase-2 trial of GS-7340, an enhanced version of Viread:

http://finance.yahoo.com/news/Gilead-Initiates-Phase-2-bw-4140142819.html?x=0

The Phase 2 study will evaluate GS-7340 as part of a once-daily, co-formulated single-tablet regimen that will also contain the boosting agent cobicistat, the integrase inhibitor elvitegravir, and Emtriva® (emtricitabine) [i.e. Quad with GS-7340 substituted for Viread]. The GS-7340-containing single-tablet regimen will be compared to Gilead’s Quad single-tablet regimen, which contains Viread and Emtriva (as Truvada®), elvitegravir and cobicistat, and is currently under review for marketing approval by U.S. and European regulatory agencies.

Gilead plans to initiate a second Phase 2 trial for GS-7340 later in 2012 that will assess GS-7340 as part of another single-tablet regimen containing cobicistat, Emtriva and Tibotec Pharmaceuticals’ protease inhibitor Prezista (darunavir). Gilead announced an agreement with Tibotec to develop this single-tablet regimen on November 15, 2011 [#msg-69031745].

Due to the expiration of the Viread (and probably Truvada) US patents in 2017, GILD has a lot riding on the success of GS-7340. See #msg-62301844 for background.