Question-and-Answer Session
Operator
(Operator instructions) Your first question will come from the line of Corey Davis representing Natixis. Please Proceed.
Corey Davis – Natixis Bleichroeder
Thanks very much. A Geodon ZODIAC study is now out and been presented a couple times and Pfizer has done very little to promote the fact that the study showed no difference in cardiac outcomes between Geodon and Zyprexa. So I guess the question is how relevant is this study to iloperidone in kind of putting to rest the idea of QTc affect clinically and any other thoughts you might have about some of the details of the study?
Mihael Polymeropoulos
Thank you, Corey. We think that the study is quite significant because it confirms what physicians already know and they are telling us. And that is that they do not believe that QTc-prolonging effects of drugs in this class of atypical antipsychotics has any clinical significance in cardiac outcomes. And just to remind everyone on the call, (inaudible) several years back. One of the commitments they have is to run an outcome Phase IV study comparing Geodon and Zyprexa and measuring cardiac outcomes and specifically mortality. And the ZODIAC study that was recently presented – concluded and presented actually confirms the fact that despite the QTc-prolonging effects of Geodon, there are no clinically significant differences on cardiac mortality between this drug and Zyprexa, the (inaudible) compound that is not known to have a QTc-prolongation.
And in terms of Fanapta, this is important because it confirms our assertion from all along that while Fanapta does prolong the QTc in a fashion similar to Geodon, it is not expected to translate to any cardiac events and has not translated to any cardiac events in the course of the Phase III program.
Corey Davis – Natixis Bleichroeder
Great. And then next question would be I know you can't give the intimate details of your FDA interaction, but have you asked about the potential for an advisory panel and what do you think the chances are that you will have one getting – or getting much closer to the PDUFA date?
Mihael Polymeropoulos
Yes, thank you. Yes, we have. And the answer is what you expect it to be. An advisory panel has not been scheduled at this time. I know this is not very informative. Maybe I can say what we believe advisory panels are scheduled for are for issues that the FDA would like to have additional advice from external experts. We have no indication of course today that an advisory panel will be convened or not convened. However, times suggested that the next few weeks will clarify this question because of the fact that there is usually a six- to eight-week notice to the sponsor of an advisory committee panel coming and the advisory committee panel has to convene a few weeks before the action date. If you calculate all this backwards you will arrive at the conclusion that we should have a definitive answer in the next few weeks.
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