Pharmasset Inc. (fka VRUS)

[oc631]

PSI-7977 on the market by 2012?



Since I wasn't cut to threads with this overly ambitious post on the Biotech Values MB I thought I would add it here.


I feel there's a strong case for an early NDA filing and priority review of PSI-7977 plus SOC in GT2/GT3 patients at the beginning of 2012 for the following reasons.


1- Data on 450 patients treated with PSI-7977/SOC (genotypes 1-6) will be released this Fall. Exceptional efficacy and safety in all groups so far.

2- Near 100% efficacy in the GT2/GT3 cohort. 24 of 25 reaching SVR12 with one drop out, after taking one pill, at the beginning of the study.

3- Over 700,000 patients in the U.S. with GT2/GT3. Latest approvals will bring increased attention by the public and the FDA to those in need of better treatment.

There are two other drugs in phase 2 GT2/GT3 testing worth mentioning. RG7128/SOC can't match PSI-7977 on any metric though it has a slight lead in development. It's not clear how BMS-790052/SOC will read out in GT2/GT3. There are unanswered questions on resistance to viral breakthrough in BMS' DAA study using 790052 which hasn't been seen so far in VRUS' two drug nuke/nuke study sans SOC.

If PSI-7977/SOC in GT2/GT3 reaches SVR24 without any safety issues it could be on the market by this time next year.