Savient Pharmaceuticals, Inc. Q4 2007 Earning Call Transcript

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2008-03-12 14:55:11.0

Tags: Savient Pharmaceuticals Inc.

Question-and-Answer Session

Operator

(Operator Instructions). Your first question will come from the line of Leland Gershell with Cowen & Company.

Leland Gershell

Good morning. Thanks for the update and for taking my questions. I was wondering, first question you had mentioned previously the intention to conduct re-treatment trail of tier case, just one of you can get an update on your plans and timelines there?

Zeb Horowitz

Right, this is Zeb, Leland. Yeah it is still our intention to do so. We have sent a protocol and appropriate documents out to the field. We are looking at foresight that participated in the early development as well as Phase III up to, but probably not more than 20 patients. We expect to have all the patients started probably by May and they are only intending as required under FDA (RIG) to submit safety data during the 120 days safety update. So that all the patients would have finished about 4 or 5 or 6 doses in every 2 week schedule by the time of 120 days safety update. So that is still planned and we expect that to go pretty well.

Leland Gershell

Okay. So we expect to see re-treatment data then in the second half?

Zeb Horowitz

No. I wouldn’t expect you to see re-treatment data. We will take a cut of data for the FDA, but until that study is finished, we have a locked database, et cetera. I wouldn’t be expecting to report that public. And then that would probably be reported in scientific abstracts the next year.

Leland Gershell

Okay. And one more question if I may, in the open label extensions. Could you give us break down of the patients who have been in the ones every two verus once every four week cohort?

Zeb Horowitz

Yeah, I can tell you how they originally enrolled the changing numbers, because they – how we did allow switching originally the patients enrolled pretty evenly about 62 to 68 in the Q4 and Q2 arm. I think that’s approximately right. And I think actually that’s not that was current enrollment as of the end of September. I don’t have the exact numbers as they enrolled over the course of the study, but it was about I think 80 versus 60 in the Q2 and Q4. And I think only two people originally enrolled in the observation arm something like that.

Leland Gershell

 

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