Medarex, Inc. Q4 2008 Earnings Call Transcript

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2009-02-25 21:14:11.0

Tags: Data, J.P. Morgan Chase & Co., Call Transcript, Earnings, Medarex Inc., Seeking Alpha

Question-and-Answer Session

Operator

(Operator Instructions) Your first question comes from the line of Matthew Roden - JPMorgan.

Matthew Roden - JPMorgan

First the question on MDX-1100, could you talk a little about the DSMB interim analysis mid-year, would we expect to hear anything about the specific data there? Would that be top line release or is there any chance of full data at medical conference this year?

Geoffrey Nichol

Yes, Geoffrey Nichol here. The first here is these approved concept studies, one on rheumatoid and one on ulcerative colitis. We structured this so that we would have an interim analysis of a patient who abruptly half the patient in each study, with a couple of options from that. One is to actually expand the studies at the interim data is very promising to dose ranging in which case we would tell you that or to just simply wait the conclusion of the studies which will happen in mid to second half of the year. The third option is that the studies may well need to enroll a few more patients based on an assessment of the conditional power of the interim.

Many of these Phase II-A studies have been problematic because the placebo rate has been misassessed or whatever. So, we have had the DSMB gives us some advice on that. So, the earliest you could hear might be towards mid of the year and certainly by the end of the year.

Howard Pien

Our goal, Geoff, would be to put out as much data as we can in order to announce that perhaps if we reach proof-of-concept and also to preserve the ability to submit data to a scientific conference, but when it is available, we will make it available.

Matthew Roden - JPMorgan

Okay, and then just quick follow up on that. If the data are encouraging in support of further development, should we assume that you would explore strategic options for the asset following the Phase II data or is there any discussion at all of carrying internally for the development?

Howard Pien

I think the answer there is, see, all of the above. Clearly, we will look at the data if there are interested partners, we will clearly discuss with them the opportunities to move forward and then we will also look into clearly doing it ourselves. So, as in every decision we make on the proof-of-concept study they are data dependent, and so receiving positive data will of course there are several partnerships in the program and the maturity of the data and we got that and we will make some decisions on a go-forward basis.

 

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