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.
Short Duration Studies
Rachel McMinn – Bank of America Merrill Lynch: It’s kind of high class problem, but Norbert I am just curious what you do with your short duration studies with LONESTAR and ELECTRON show that (indiscernible) treatment duration is positive with really strong STRs. Obviously, this has an impact on potential pricing decision. So, do you expand into multi-center Phase 3 to really trying out more data or is it just something that kind of sits on the sideline and you just kind of price it as a shorter treatment regimen?
Norbert W. Bischofberger, PhD – EVP, R&D and Chief Scientific Officer: So, it is a high class problem, you’re right. But it’s certainly not going to sit on the sidelines. So, what we are currently and this of course needs to be discussed with regulatory authorities to do a non-inferiority study. So, we will do another Phase 3 type study, non-inferiority of 12 versus 8, potentially versus six weeks depending on the outcome of the Phase 2 studies and we would like get that into label. We feel it’s very important to have that information available for our promotional purposes and maybe Kevin could comment on that as well. So that’s our thinking. Rachel, again, this has been discussed with regulatory authorities yet. We still – we yet have to do that.
Kevin Young – EVP, Commercial Operations: Rachel, our preference always at Gilead is to have these things in the label. Not only does that enable our field forces, sales representatives, our medical scientists, but it’s obviously key for the payer. And we would definitely want it for that subject to not being in an appropriate profile for 7977 plus 5885.
Rachel McMinn – Bank of America Merrill Lynch: Just squeezing it up from a timeline perspective , would that delay your combination dose regimen filing or you think you can get all the stuff done in time?
Norbert W. Bischofberger, PhD – EVP, R&D and Chief Scientific Officer: Yeah. Rachel, we think we can get all of it done time. The rate limiting step right seems to be ION-1, so the study that started first, even as you know, we stopped enrolment at the first 200 patients and the other 600 will be enrolled following an interim analysis sometime in the second quarter. so that will be the rate limiting study. Another thing I would might to add Rachel is that the same (provides) for non-inferiority studies is fairly reasonable. You don’t need the large number of patients. The further away you are from 50%, the easier it is to show non-inferiority.