Biotech Values

[DewDiligence]

VX-950 notes from VRTX CC:

Note: please reread #msg-11635070 and #msg-11248731 as a prerequisite for reading this message!


PROVE-1/PROVE-2 timeline

PROVE-1:
--160 patients (of planned 260) already screened
--3Q06: enrollment complete
--4Q06: initial data from 12-week arms
--1Q07: 3-mo post-treatment data from 12-week arms
--2Q07: 3-mo post-treatment data from 24-week arms and 6-mo (SVR) post-treatment data from 12-week arms

PROVE-2:
--Each milestone will trail the corresponding one for PROVE-1 (above) by approximately one quarter


PROVE-3 phase-2b study in treatment-refractory patients

--Design has not yet been fully specified but (unlike PROVE-1/PROVE-2) it will definitely include some treatment arms that receive 24 weeks of VX-950
--Launch in 4Q06 upon completion and analysis of 6-mo tox studies in two species that started in March


Manufacturing

--First registration lot will be produced by end 2006
--1-yr stability data on required three lots ready in time for 2008 NDA submission


Phase-3 and NDA submission

--Start phase-3 in mid 2007; if based on phase-3, NDA submission will be in 2008 (no change from prior guidance)
--Obviously, VRTX hopes to submit an NDA based on data from phase-2b, but they cannot make this their official guidance


Competition

--Confirmed rumor that BMY PI program has been canned (#msg-12052181)
--SGP PI program has hit a setback with dosing; patients who were receiving less than the 800mg dose have been upped to 800mg


Dosing frequency and pricing

--There are no plans to make BID dosing part of the initial indication
--If it turns out that VX-950 can be dosed BID because of boosting by ritonavir (or another compound), VRTX will price accordingly even though BID dosing will not initially be in the label


News flow

--AASLD in Oct will not have any data from the PROVE trials, but it will have final data from phase-1b


Dew