Merck Earnings Call Nuggets: Outcome of IMPROVE-IT and Filing Odanacatib
Outcome of IMPROVE-IT
Tim Anderson – Sanford Bernstein: Couple of questions on odanacatib. You’ve talked about safety obviously in the past and today you said the filing will slip. Without telling us what that safety issue is exactly, can you at least tell us whether that safety concern is a theoretical one, whether there’s actually any signal of some sort that you’ve seen in the data that you have in hand? And then on ZETIA atorvastatin, I look at that as normally a lower risk application, but given the controversies with ZETIA in the past, I would have to imagine FDA doesn’t take any final action until they have results from IMPROVE-IT. So the fact that you are saying FDA should complete its review by midyear might suggest that IMPROVE-IT could wrap up at this next interim look in March. So, I’m wondering if I am thinking about this correctly in terms of IMPROVE-IT potentially stopping at the interim look. And can you just reiterate your level of confidence in the outcome of IMPROVE-IT whenever it starts?
Kenneth C. Frazier – Chairman, President and CEO: Thank Tim for that question. I’d like to turn it over to Peter, but just to reiterate, we continue to believe in the future benefit that’s possibly associated with coming forward with both of those drugs. So, let me turn it over to Peter.
Peter S. Kim, Ph.D. – EVP and President, Merck Research Laboratories: Tim, as you know, in July, we announced that the Data Monitoring Committee; the DMC, for the study completed its first planned interim analysis and they recommended that the study be closed early due to robust efficacy and a favorable benefit risk profile. And as a result of that, we made the decision to begin to take steps to close the pivotal trial. And as you know, we also said that the DMC noted that safety issues remain in certain select areas and they made recommendations with respect to following up on them. At that point, we reiterated the fact that our previously announced plan to conduct a blinded extension trial would allow us to further monitor these issues as well as to continue to measure efficacy. And really, at this point in time, that’s all we can say. We are going to be conducting as I say that extension trial in a double-blinded manner and we anticipate filing in 2014.
With regard to ATOZET, the combination of ZETIA with atorvastatin, what I would say there is that that file has now gone in. It is a re-filing as we have now conducted the clinical efficacy study to show that we’re clinically – with regard to clinical efficacy we have bioequivalence to the individual components alone. And, of course, the individual combination of ZETIA with atorvastatin is something that isn’t the label; it is currently being used. And so what we’re talking about is a combination of convenience. With regard to IMPROVE-IT, you’re correct the data monitoring committee for IMPROVE-IT, as you know, requesting there be another interim analysis. That interim analysis is currently scheduled for March, and we’ll see what happens there. With regard to confidence, I’ll just reiterate as I have before that we are very confident that lowering LDL cholesterol is a good thing to do for cardiovascular health.