Replies to post #193101 on Biotech Values

[DewDiligence]

GILD—I wonder why they chose to use the priority-review voucher for R/F/TAF (improved Complera) vs. E/C/F/TAF (improved Stribild)?

The reason may be that Complera-TAF’s being the last of the three* NDA submissions for TAF-based regimens under GILD’s control makes it the one that determines when GILD will be able to launch a full-fledged marketing campaign that promotes all three products.

Moreover, GILD purchased the priority-review voucher on 11/19/14 (#msg-108618217)—thirteen days after the NDA submission of F/TAF on 11/6/14 (#msg-107899029). I’m not sure whether a sponsor can apply a priority-review voucher after an NDA/BLA submission has been made.

*Stribild-TAF (E/C/F/TAF), Truvada-TAF (F/TAF), and Complera-TAF (R/F/TAF); JNJ has the commercial rights to “Prezista-TAF” (#msg-109435833).

[DewDiligence]

GILD reports phase-3 data from “TAF-Stribild”* switching study (in which patients switched from Viread-based regimens to Stribild-TAF):

http://finance.yahoo.com/news/gilead-announces-phase-3-results-180600348.html

Gilead Sciences, Inc. today announced detailed 48-week data from an open-label Phase 3 study (Study 109) evaluating its investigational once-daily single tablet regimen (STR) of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (E/C/F/TAF) among 1,436 virologically suppressed adult patients switching from tenofovir disoproxil fumarate (TDF)-containing regimens.

The study met its primary endpoint by demonstrating non-inferiority of E/C/F/TAF to the TDF-based regimens at Week 48. The study also demonstrated statistical superiority among patients with HIV-1 RNA levels less than 50 copies/mL at Week 48 and statistically significant improvements in bone and renal laboratory parameters.

The PDUFA date for Stribild-TAF is 11/5/15. Since the above study is designated a phase-3 rather than phase-3b, it will presumably be considered by the FDA in the current review.

*a/k/a E/C/F/TAF.