Question-and-Answer Session
Operator
(Operator Instructions) Your first question comes from Cory Kasimov from J.P. Morgan.
Mona Nilsson - J.P. Morgan
This is actually Mona for Cory. My first question is actually on the 120-day safety update. I was wondering if you are in a position to share the data from how many patients in the DURATION studies were actually included in that update?
Dan Bradbury
I am not in a position to share that information. Just to say that the 120-day update was consistent with the FDA regulations around their requirement for 120-days which is all of those patients that would be completed within the period of time according to the regulation which is a number of months prior to that date.
Mona Nilsson - J.P. Morgan
Okay and then I realize the data from the DURATION-4 and 5 studies are going to be available in 2010, but are you in a position to put a refined timing on that?
Dan Bradbury
At this time we are not providing any more specific guidance on DURATION-4 and 5 with the exception of 5 which we are expecting in the first half of 2010.
Mona Nilsson - J.P. Morgan
Okay, thanks very much.
Operator
Your next question comes from Jason Zhang of BMO Capital Markets.
Jason Zhang - BMO Capital Markets
I jumped in a little late and I am wondering how much you have talked about your – you submitted the 120-day safety update and you also announced a cardiovascular trial for exenatide. Do you envision using that as a fulfillment for the cardiovascular requirements? I mean how has that trial played out in this whole process? Do you plan that trial primarily for actually showing the cardiovascular benefit or you might actually use that trial as a fulfillment for the cardiovascular risk mitigation before the potential approval?
Dan Bradbury
That is a great question. The cardiovascular outcome study has been specifically designed to demonstrate superiority relative to other diabetes therapies in showing an improvement in outcomes with respect to cardiovascular events. It is not being designed with a view towards answering the regulatory requirement. We announced previously, earlier this year, the analysis that we had done on the entire exenatide database demonstrating that there was no increase in cardiovascular risk associated with exenatide therapy; that analysis was updated as part of the 120-day update. Consistent with the agency’s request in our 74-day letter to do a combined analysis looking at all exenatide therapy, which is both BYETTA and exenatide once weekly, as part of the assessment of cardiovascular risk.
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