VIVUS Inc. Q2 2008 Earnings Call Transcript

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2008-08-04 16:16:10.0

Tags: Vivus Inc.

Question-and-Answer Session

Operator

(Operator Instructions). Your first question comes from the line of Cory Kasimov from JPMorgan. Please proceed.

Tim Morris

Cory are you there?

Operator

Please unmute your line Mr. Kasimov.

Tim Morris

Operator, we can come back. Cory are you there?

Cory Kasimov - JPMorgan

Yeah, can you hear me?

Tim Morris

Yeah, go ahead Corey.

Leland Wilson

I got you now.

Cory Kasimov - JPMorgan

Hi sorry, I got to put you in on the speaker phone, I am having some problems with the handset here, sorry about that. Thanks for taking the question. First question I have for you, could you just give us your reactions to the recent UK registry study of Topamax. Whether in epileptic patients or whether or not you all surprised by this, given what is in label, and also if could remind us what pregnancy precautions are built into the Phase 3 program for Qnexa?

Leland Wilson

Yeah, Corey, we were not surprised by the UK registry because of the label, what's already mentioned in the Topamax label and we expect that additional registries will provide data probably similar to what was found in the UK registry.

With the regard to the precautions, the pregnancy precautions we have put in place for the Phase 3 program, we are actually requiring two methods of contraception for patients of child-bearing potential to consistently comply with that recommendation, throughout the study.

We are also implementing pregnancy test every month, each time they come in for a study visit. So we are monitoring that very closely.

Cory Kasimov - JPMorgan

Okay, great, thanks. And then with regards to the diabetes program, you guys answered to lot of my questions with your prepared remarks. But I wanted kind of get some of your follow up thoughts, following the promising data at ADA as well, as the FDA panel meeting you discussed.

And realizing that you have your end of Phase 2 meeting coming up in the next couple of months, if all goes well there, can you talk a little bit about potential timing of launching a phase III program and how that may relate to strategic options you have. Whether or not, you would take the same route, or if you are just going to wait for the obesity data, before you partner Qnexa for any indication or I would assume it probably be difficult to disassociate obesity from diabetes with a product like this. So would be a partner for all of it. Can you just discuss the strategic options there?

 

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