Pharmasset Inc. (fka VRUS)

[oc631]

Would Pharmasset consider signing a GT2/GT3 agreement for PSI-7977/SOC (exclusive of other genotypes) if early approval is in fact attainable?

I doubt it considering they want an experienced/well funded partner moving 7977/SOC into Phase 3 with the other genotypes. The possibility of an early filing increases the value of their asset substantially along with their leverage in doing a deal.

The situation with VRUS has changed since I started this thread and with it some ideas I have about how they will move forward. The big news from VRUS is them adding a PSI-7977 monotherapy arm in their phase 2b study. PSI-7977 monotherapy would move much more quickly through late stage testing than the dual nuke combination. PSI-938 hasn't had the chance to prove itself in phase 2 the way 7977 has so more extensive late stage testing can be expected with this combo.

So how else has the story changed?

My idea that VRUS wouldn't seek a partner exclusively for the rollout of PSI-7977/SOC* in GT2/GT3 patients no longer holds water for the simple fact that we may never see PSI-7977/SOC late stage testing in all genotypes. Late stage testing of PSI-7977 very well may be all oral consisting of PSI-7977 monotherapy and the PSI-7977/938 combo. PSI-7977 testing in combination with SOC in GT2/GT3 could also end at phase 2 if the FDA is open minded and allows an early NDA filing.


*It should be noted that the standard of care (SOC) which I refer to here is Pegylated interferon/Ribavirin when if fact the current SOC in HCV treatment is Peg/Riba in combination with a protease inhibitor.