Incyte Q1 2009 Earnings Call Transcript

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2009-05-08 12:18:15.0

Tags: Seeking Alpha, Incyte Corp.

Question-and-Answer Session

Operator

Thank you. We will now be conducting the question-and-answer session (Operator Instructions). Our first question comes from Mona Ashaya with JPMorgan. Please state your question.

Mona Ashaya - JPMorgan

Hi good morning. I'm here for Cory. A couple of questions. One on the acceptance of 13739 data for ADA. Is it safe to assume that you wouldn't have pushed this if you weren't excited about the findings from the interim analysis?

Paul Friedman, M.D.

I think that is a safe assumption. But that interim analysis was done on about 35% of the patients who ultimately enrolled in the study. So I think it would be prudent to not make assumptions until we get the final data set very early in June.

Mona Ashaya - JPMorgan

Okay. And then my second question is, so it sounds like in the SPA, the second iteration is ramping up and I wonder if you could speak to how much the trial design might have changed to what you had originally envisioned. Is it similar to what you had spoken about earlier?

Paul Friedman, M.D.

Well, I don't want to get into that until we get agreement from the FDA.

Mona Ashaya - JPMorgan

Okay.

Paul Friedman, M.D.

I think if they agree with our resubmitted SPA we'll able to start pivotal and I think at that point in time we will provide you with a very clear description of what we're doing. Suffice it to say we are still anticipating completing the study and filing the NDA in late 2010 or early 2011.

Mona Ashaya - JPMorgan

Okay.

Paul Friedman, M.D.

But I just think it's not prudent to be talking about things that the FDA is reviewing. I'd rather wait until we get the feedback from them.

Mona Ashaya - JPMorgan

Okay. Fair enough. And then my last question is, you've spoken about potentially partnering your early stage oncology assets. And I wonder if you could just provide an update and maybe speak about how much of a priority that is at this point?

Paul Friedman, M.D.

You mean c-MET and sheddase?

Mona Ashaya - JPMorgan

Yes.

Paul Friedman, M.D.

Yes. Well, I think for c-MET if we could find an appropriate partner that... we think we have the best molecule of the c-MET inhibitors. There has been a fair amount of interest and it is a reasonably high priority for us. But if you think about the other things that we talked about partnering and our balance sheet issues, it doesn't move the needle as a pre-clinical entity in a way that an inflam deal or an MPD deal could do because such programs are significantly farther along.

 

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