Replies to post #156678 on Biotech Values

[oc631]

Those are all valid points but instead of enrolling all HCV patients in NEUTRINO GILD made a conscious decision to exclude GT2 and GT3.



-Did GILD think they would achieve 100% SVR rates in these genotypes during Phase-3 testing?

-100% SVR rates in the real world?

-100% oral SVR rates in existing treatment failures waiting for a better option?



There was no competitive threat in GT2/GT3 so these patients were excluded from NEUTRINO.



-What if ABBV had a GT2/GT3 combo in the same stage of development as Sofo/Riba (meaning treatment-failures could be lost to competition). Do you think GILD would have hedged their bets in GT2/GT3 by testing a interferon-based combo?



GILD delaying market entry of Sofo/PegRiba boosts the case for their oral combo which would be the only drug to hit the market for the first time in 20+ years. Patients will be anxious to try a new option regardless if it's sub-optimal in their genotype. Which could lead to failures and retreatment.

[oc631]

It was later when data from POSITRON phase III in GT2/3 showed a low SVR of 61% in GT3 patients. Perhaps the question is why not start another trial (adding an arm is too late now) and my guess is they wait for the last phase III results and will go to the FDA and in case the FDA insists on better SVR for GT3 they will start a new trial with another agent.

Nobody expected such horrid GT3 data in POSITRON and the results have gone downhill from there. I should have picked up on (and made a issue of) the GT2/GT3 exclusion in the NEUTRINO study sooner, but like most others I was focused on oral development, so in that respect I too was blindsided and speak now in hindsight. I thought an oral therapy solution would be available for most patients (including treatment-failures) but it's still a work in progress for GT3. It's safe to expect the FUSION SVR rates will be 50% or less in treatment-experienced patients. GILD may be delaying the inevitable.




The bind now is very few classes of HCV drugs work in GT3 outside of nukes. The greatest progress looks to be in the NS5A class with work to be done. GILD mentioned they are working on a second pre-clinical nuke and IDIX is talking about future dual-nuke therapy.