Q: Vivus is among a small group of companies seeking FDA approval of the first prescription weight loss therapy in over a decade. Talk about what this means to your company and to those who await such a treatment.
A: We are fortunate in that we have two late-stage products in development. Clearly, though, the excitement in the stock market is around Qnexa because of the Phase 3 data that we have and because of the lack of effective products in this therapeutic category, which, I think, by everyone’s recognition is underserved.
Q: Can you share with us some highlights of the top-line results for Qnexa?
A: It is never-before-seen weight loss and that would include average weight loss in the neighborhood of up to 15 percent, in some cases held over a two-year period. We also noted the weight loss caused massive changes in risk of major cardiovascular events, which could help prevent early morbidity and mortality due to cardiovascular disease.
Q: Qnexa is also being tested for sleep apnea. Who, among those nighttime sufferers, might stand to benefit from this therapy?
A: It’s a devastating condition that affects breathing – you stop breathing during the night or your breathing is slowed or interfered with so that you don’t get enough oxygen. It’s an area of unmet medical need for patients.
We’ll be doing additional clinical trials in this area once we get approval for Qnexa.
Q: You, like others in the space, received a complete response letter (CRL) recently from the FDA. Any advice for companies working directly with the FDA under similar circumstances, waiting to advance important new therapies?
A: We got the CRL “lite” and fully expect, with minimal work on our part, to have an acceptable new drug application (NDA) submission. We have resubmitted our response to them, and we’ll be holding a meeting with them this month. We’ll resubmit formally, hopefully, soon thereafter. They wanted us to analyze our data in such a way as to give them assurance that this slight increase in heart rate (about 1.6 beats per minute) does not have any long-term sequela as far as long-term morbidity and concerns.
Also, topiramate carries with it a concern for teratogenic potential (birth defects). The issue there was two-fold. One, was to inform by a collection of information around the teratogenic potential of topiramate, and also Qnexa. It is largely a literature search on topiramate.
Q: Its sounds as if you are optimistic about your submission.
A: I am very optimistic.
Q: What else is on the docket for 2011?
A: We’re going to put in a NDA for our second product, avanafil, and we have also filed a European submission for Qnexa.
Avanafil is a PDE5 much in the lineage of Viagra, Cialis, etc. But it has some superior characteristics – more specific for the enzyme we’re tying to target (phosphodiesterase type 5).
We have excellent results in after 15 minutes of taking the oral pill, which is as much as 45 minutes to an hour and 45 minutes faster than the leading compounds in the market.
Q: Is the strategy still to seek a marketing partnership for Qnexa following FDA approval?
A: Yes, clearly Europe is an area where we need a partner. I think we’re going to be in a very good negotiating position to drive a good deal.
Q: Any remaining hurdles as Vivus prepares to launch its weight loss drug pending FDA approval?
A: The biggest area we have issues with is reimbursement. CMS does not cover medical treatments for obesity. The paradox in that is bariatric surgery is covered, but as a medical treatment it is not. On the private side, I would say obesity is largely not covered, however, some employers who are progressively minded do cover it. They pay the extra money to prove that overall it is a better outcome for their employees.
Certainly, in the last year, there’s been a huge rise in the awareness around obesity, specifically the contribution to the growth of diabetes as well as healthcare costs.
We’ve worked diligently on a pharmaeconomics model submitted for publication around cost of obesity and the savings that can be incurred on the public health side with the simple reduction of 5 percent or 10 percent weight loss.
We have brought our clinical data to private payers and to a number of folks in the public health area and they are very impressed with our data. While we may not have an entirely welcoming reimbursement environment the day of our launch, we’re quite confident that, say, a year after our launch it will be a very different picture. I think people will understand what obesity does and how much of a root cause it is of some of these other disease areas.
Q: What keeps you awake at night?
A: Our job here is to get a successful resubmission. The data all looks very, very good. We have to get an A+ on this report we’re filing and it’s a big one – a massive amount of work and data analysis. It is about pulling together and getting this done in a timely fashion.
CHI-Advancing California biomedical research and innovation