Question-and-Answer Session
Operator
(Operator Instructions) Your first question comes from John Boris with Citigroup.
John Boris - Citigroup
My first question is for Elliott. Yesterday there was an early communication from the FDA on a safety review on clopidagril, most notably on patients that are poor metabolizers and on a drug interaction with proton pump inhibitors. Is this something you are anticipating that could end up in your label before you complete these additional clinical trials, or will the FDA wait until you conduct those clinical trials before there is any change to the label?
Secondly, also related to Plavix, can we just get an update on the current OASIS 7 trial? Enrollment and when we might see final results on that.
Then I have a question for Jean-Marc on working capital. Can you provide a little additional color on how you plan on getting the billion out by 2010 and the timing of how you see that billion coming.
Elliott Sigal M.D., Ph.D
Yes, the FDA made a statement yesterday. We are working very closely with not only the FDA, but the health care authorities around the world, to ensure that our advice continues on Plavix to use this important medicine in a safe and effective way. I can’t comment, at this time, on what labeling changes will occur. We are very interested in adding information that would help both physicians and patients receive appropriate guidance on the use of the drug. We are committed to the safe and effective use of Plavix.
I will say that the variability of response of any drug is certainly a phenomenon that resides with any drug. It has been very complex to examine this for clopidogrel and recent publications have focused our attention on new science with regard to variability of Plavix that may be linked to certain drug interactions like the proton pump inhibitors and also to specific genetic variation. Some of the information has been contradictory and so we are working closely with the FDA and other authorities to review this issue and provide more data. We are looking at ongoing studies, analyses of completed studies, and select new studies to further define the metabolism of the drug and the effect of the interaction with PPIs, the PK and PD is influenced by genetic variation and different dosing regimens.
I think the most important thing that we can state at this time, that has been stated by the FDA, that health care providers should continue to prescribe and patients should continue to take Plavix as directed, because it has demonstrated benefits in preventing blood clots that could lead to heart attacks or strokes and they should reevaluate the need or the continued use for a PPI or alternative medicines. Within a matter of months we hope to have more data with regard to the PKPD establishing whether or not there is an interaction or, more importantly, how to take concomitant medicines with Plavix.
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