VIVUS Loss Looks Like A Win (VVUS)
VIVUS, Inc. (NASDAQ: VVUS) is doomed. That is what you would think if you just saw the FDA denial to approve Qnexa for weight loss. Most of the headlines on financial aggregation sites are full of negative headlines…. FDA Nixes VIVUS’ Qnexa, FDA Rejects VIVIS ObesityDrug, VIVUS Fails to Win U.S. Approval; US rejects Highly-Anticipated Diet Drug… and on and on. While the FDA did not approve Qnexa and has asked for more data, the underlying belief now appears to be that despite the headlines Qnexa WILL ultimately be able able to secure FDA approval.
VIVIS received a Complete Response Letter from the FDA on its New Drug Application for the investigational new drug QNEXA Controlled-Release Capsules, with the communication that the NDA cannot be approved in its present form. QNEXA is VIVUS’ big hope and is a once-a-day formulation for the treatment of obesity.
The indication includes weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.
In the clinical section of the CRL, the FDA requested a comprehensive assessment of topiramate’s and phentermine/topiramate’s teratogenic potential, including a detailed plan and strategy to evaluate and mitigate the potential teratogenic risks in women of childbearing potential taking the drug for the treatment of obesity. The FDA also asked VIVUS to provide evidence that the elevation in heart rate associated with phentermine/topiramate does not increase the risk for major adverse cardiovascular events. Apparently, the investment community and VIVUS believe this can be overcome.
The FDA requested that VIVUS formally submit the results from the already completed SEQUEL study (OB-305), a 52-week extension study for a subset of 675 patients who completed the previously reported 56-week CONQUER study. Top-line results from the two-year SEQUEL study were announced by VIVUS on September 21, 2010 and a final study report is being prepared for submission to the NDA.
The FDA reserved the right to comment further on proposed labeling. On REMS, the FDA requested that a discussion of an already submitted REMS plan be continued after the written response from VIVUS has been submitted. The agency also requested a safety update of any new adverse events be submitted to the NDA. Finally, the FDA stated that if approved, phentermine/topiramate would be a Schedule IV drug due to the phentermine component. Again, the belief here appears to be that this can be overcome.
VIVUS said that it plans to compile analyses integrating existing nonclinical and clinical data to provide a comprehensive assessment of the teratogenic potential of topiramate. The company also plans to provide several new analyses to demonstrate QNEXA does not increase the risk for major cardiovascular events, which would include data from our OB-305 and OB-204 studies.
More importantly, VIVUS noted that the CRL does not indicate that new clinical studies were requested. The company did still hedge a bit by noting that if any of the FDA concerns are not alleviated, additional clinical studies may be required.
Investors are hanging on the company’s comments as well. The response release noted, “We remain confident in the efficacy and safety profile of QNEXA demonstrated in the clinical development program and look forward to continue working with the FDA towards the approval for the treatment of obesity,” said Leland Wilson, chief executive officer of VIVUS. “We are preparing a comprehensive response to the CRL for submission to the FDA in approximately six weeks.”
If this is only six weeks, then there is hope. If there are no additional trials that need to be conducted, then there is hope. VIVUS shares are up 32% at $8.11 this morning right before the open and the average volume has been hit even without the market yet open. There have been 3.6 million shares traded and the average volume is only about 3.1 million shares. VIVUS has a 52-week range of $4.69 to $13.68.
The FDA has not exactly been receptive to weight loss drugs from many companies. So far hope is prevailing over caution. Stay tuned!
JON C. OGG
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2 Responses to “VIVUS Loss Looks Like A Win (VVUS)”
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nice write-up. There are a lot of ‘what ifs’ with this product. There is a distinct possibility that the CV issues that the FDA raised – may not in fact be answered with the current trial data. And if the results are significant could result in a rejection due to the fact that the indication sought will be for patients that already suffer from CV issues. You did raise two other issues that are significant. The REMS requirement. This does not stop after approval and is the equivalent to a black box warning. Secondly that the product may be labeled (if it gets one) as a schedule IV – making it rather difficult to get at the pharmacy not to mention the image this portrays. I would look for other better opportunities in the pharma market. Celgene, Savient, Alexion, to name a few. IMHO
hi there