Replies to post #85667 on Biotech Values

[DewDiligence]

VRTX disclosed plans for a phase-3b trial comparing BID Telaprevir to TID Telaprevir. This trial is essentially a larger version of the successful ‘C208’ study, which showed that BID dosing was non-inferior to TID dosing (#msg-43121388).

From today’s PR:

http://finance.yahoo.com/news/Vertex-Pharmaceuticals-bw-3482367852.html?x=0&.v=1

In the fourth quarter of 2010, Vertex and its collaborator Tibotec [JNJ] expect to initiate a Phase 3b clinical trial to evaluate twice-daily dosing of telaprevir (1,125 mg BID) compared to three-times-daily dosing of telaprevir (750 mg; q8h). This trial is expected to enroll approximately 700 treatment-naïve people with genotype 1 hepatitis C in two telaprevir-based treatment arms and will be conducted in the U.S., E.U. and certain other countries. Based on advice from regulatory authorities in the U.S. and E.U., the trial will not include a control arm of pegylated-interferon and ribavirin.

If this phase-3b trial shows non-inferiority of BID dosing as the C208 study did, VRTX and JNJ ought to be able to get BID dosing added to the Telaprevir label.