Gilead Sciences Earnings Call Nuggets: Genotype 3 Market and Short Duration Studies
Gilead Sciences Inc (NASDAQ:GILD) recently reported its fourth quarter earnings and discussed the following topics in its earnings conference call.
Genotype 3 Market
Geoffrey Meacham – JPMorgan: A couple related clinical questions. Can you help us with you are thinking about the genotype 3 market based on the data so for. Is the 5886, 5816, 7977, the combo you’re looking for and what are the gating factors there to start the Phase 2? Then, finally on Study 104 in HIV, is 48 weeks enough do you think to see an impact on bone and other points of differentiation with respect to (indiscernible)?
Norbert W. Bischofberger, PhD – EVP, R&D and Chief Scientific Officer: Geoff, it’s Norbert. So regarding genotype 3, I would say immediately we are doing two things. we could think of longer treatment durations to get the response rates up and that’s ongoing in FUSION and we can also think about or we are initiating a study to look at the NEUTRINO regimens or PEGylated interferon, ribavirin and sofosbuvir for genotype 3. That will be a very attractive option, I think, and I’m assuming the response rate with that regimen would mimic what we have seen in NEUTRINO genotype 1456. Newer intermediate term we were actually looking in ELECTRON in two cohorts with our fixed-dose combination of sofosbuvir and 5885 for genotype 2 and 3. I have to tell you my expectation is that that regimen should not be excellent because simply the antiviral activity of 5885 against certain polymerase in genotype 3A is suboptimal. Then lastly, as you pointed out, we’re certainly looking at 5816. I think that compound in combination with sofosbuvir has (indiscernible) opportunity to make this whole issue disappear. And we’re looking at that. Hopefully, we can initiate the Phase 2 study sometime in the middle of this year. Studies in genotype 2 and 3 are currently ongoing, and as soon as those are finished and as we have some inkling about the dose we’ll initiate Phase 2. Then you asked about Study 104. You correctly – so, the 48-week is the primary regulatory end point at which we would analyze the study and submit it for application – for Marketing Authorization Application. But as you know, we always carry these studies out to longer duration in a (blinded) fashion, and this study currently is planning to go for 96 weeks. But we are confident that we can now see differences in BMD at week 48. I want to remind you, we have seen those same differences with a much smaller sample size in the Phase 2 at week 24. So, I’m convinced we are going to see the same thing in the Phase 3 study.
Kevin Young – EVP, Commercial Operations: Geoff, I’d just like to chip in and say that GT-3 market size in the U.S. is 7% of the population. It’s different in Europe and it’s different in the rest of the world. But it’s only 7%. So, market here is very GT-1 and GT-2 and I’d also like to point out that those 11% of patients from (indiscernible) who had to discontinue and that’s in a clinical trial setting. So, clearly, the current standard of peg/riba is difficult to take even of the 24-week period. So, we can do better. We want to do better for GT-3 patient, but the current standard is certainly less and not optimal.