VIVUS Inc. Q4 2008 Earnings Call Transcript

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2009-03-09 18:08:31.0

Tags: Physician, Call Transcript, Earnings, Population, Vivus Inc., Federal Government, Government, Seeking Alpha

Question-and-Answer Session

Operator

(Operator Instructions) Your first question comes from Jason Butler - Rodman & Renshaw.

Jason Butler - Rodman & Renshaw

I was just wondering if you could give us some background on the methodology you’re using to assess changes in cognitive function in the EQUIP and CONQUER studies and maybe point us to any historical examples, where the FDA has accepted the use of this methodology in the past?

Peter Tam

Yes Jason, this is Peter. We haven’t disclosed specific instruments that we are using to assess cognitive function, but one thing I do want to remind is we do have those tools in place in our trials.

What we’re going to do is that in addition to the adverse events, we will provide to the FDA the results of these cognitive instruments, but just right now we haven’t disclose the exact tool yet, but one thing I also want to remind you is that the incidence of cognitive events were very low in all the studies that we’ve conducted today, especially because of the low doses of topiramate that we’re using.

So in the grand scheme of things, I just really don’t see how much more we can provide or how much additional information we can provide in terms of cognitive issues that have already not been addressed by the label.

Jason Butler - Rodman & Renshaw

Okay great, and then maybe not specifically a partnership question, but maybe something that goes to the potential pro forma partner. Can you discuss what you guys view as the initial target physician population for Qnexa when assuming the drug’s launched?

Leland Wilson

Yes, well we believe that it will start with specialists; that will be to include diabetologist, endocrinologist and weight loss specialists, but also include cardiologist. They are a very powerful influential group in this treatment of treating metabolic disease if you will on cardiovascular risk and so that will be the start.

Clearly we’ll roll that out to primary care. 60% of the population of United States is over weight or obese and so that’s a very large target population, clearly covered by primarily by primary care physician and so we would very much like to have a very big partner to go reach that very large population.

Operator

Your next question comes from Adam Cutler - Canaccord Adams

Adam Cutler - Canaccord Adams

I’m wondering, can you give us an update on any discussions you’re having with European regulatory authorities about some of the studies you may need to be there in order to enable filing in Europe. I know you’ve mentioned in the past that there maybe some additional studies or some longer term studies that you may want to do to support filing there.

 

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