Replies to post #151550 on Biotech Values

[DewDiligence]

Hard to see if and how GILD will be able to show TAF and its new combo pill is different from Viread's combo - Stribild and will a possible difference in efficacy and or safety would be enough when Viread goes generic?

Even when Viread and Emtriva become generic, Elvitegravir and Cobicstat will still be patent-protected; hence, it may be difficult or impossible for users to configure a 3-pill regimen (branded Elvitegravir + branded Cobicstat + generic Truvada) that is cheaper than Quad Prime, the planned single pill composed of TAF + Truvada + Cobicstat.

[DewDiligence]

GILD’s ‘Quad Prime’ advances to phase-3:

http://finance.yahoo.com/news/gilead-initiates-phase-3-clinical-133000795.html

Gilead Sciences, Inc. today announced the initiation of the first of two Phase 3 clinical trials (Study 104) evaluating a single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults. TAF is a novel prodrug of tenofovir, the active agent in Viread® (tenofovir disoproxil fumarate). The Phase 3 studies will examine a once-daily single tablet regimen of TAF 10 mg/elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg compared to Gilead’s Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) among patients new to HIV therapy. The second Phase 3 study (Study 111) will be initiated later this quarter.

The above is the regimen I call Quad Prime; it dioffers from Stribild (formerly called Quad) by substituting TAF for Viread.

(Although genisi disagrees), TAF is a crucially important compound for GILD insofar as it effectively extends the patent life of the Truvada franchise.