CV Therapeutics, Inc. Q2 2008 Earnings Call Transcript

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2008-07-31 17:05:27.0

Tags: CV Therapeutics Inc.

Question-and-Answer Session

Operator

(Operator Instruction). Your first question comes from the line of Jim Birchenough with Lehman Brothers.

Jim Birchenough - Lehman Brothers.

Guys, congratulations on the quarter.

Louis Lange

Thanks, Jim.

Jim Birchenough - Lehman Brothers.

So, just a question on the process with FDA right now around the Ranexa label, you mentioned that you should get a draft label within the next few weeks. Is this really the first draft label you are getting from FDA, does that begin a process, or is this a final label that you are expecting within the next few weeks? And maybe if you just gave us a few more details on this process?

Louis Lange

Jim, this will be the first look that we have had at the label on how far away it is from the final label, we do not know, but it begins a process of labeled discussion, but we are very pleased to be getting a label and it shows that we are making a fair amount of progress.

Jim Birchenough - Lehman Brothers.

And so, just to clarify, at this point you are not too certain on what the final timelines will be for final label?

Louis Lange

No, we do not have any clarity right now. The point of the fact is, the label's coming and so they are getting there.

Jim Birchenough - Lehman Brothers.

And then, just following up on that, you have got a number of strategic questions in front of you, including the partnership you alluded to for ex-US Ranexa. What happens if the final label gets delayed in the US? How do you think about the choice between a global partnership and an ex-US partnership if you don't have the final label to use to make that decision with?

Louis Lange

Well, I don't think the label is necessarily the driver of partnership discussions. It is important, but partners are very sophisticated at looking at data and where the future may lie. That having been said, we need to partner Europe whether it is approved, it is a great label, there is revenue lying there. We are on a timeframe to conclude a partnership in time to launch it in Europe in the first part of next year. Whether it involves broader rights than that is a question that depends on how opportunistic we can be. But this is not a tab low; this is something that can evolve overtime. We are very happy with current sales and current sales growing the way they are has only increased any potential deal that we might consider doing in the US.

 

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