Friday, October 29, 2010
As paradoxical as this sounds, Vivus Pharmaceuticals received good news by dint of a rejection letter from the FDA. Indeed, after four months of wondering just how bad the FDA would pummel it, the company can see that the road to approval for its fat drug, Qnexa, is doable. After the Advisory gave the combinations drug, phentermine + topirimate, a thumbs down in July, pessimism roiled the the hopes of this small company. The share price plummeted from the $13's to the $4's.
In its 8-K filing the Company sets out its plan.
Form 8-K for VIVUS INC
Item 8.01 - Other Events.
On October 28, 2010, VIVUS, Inc. announced that it received a Complete Response Letter, or CRL, from the U.S. Food and Drug Administration, or FDA, regarding its New Drug Application, or NDA, for the investigational new drug QNEXA� (phentermine/topiramate) Controlled-Release Capsules. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form. The application seeks the approval to market QNEXA as an oral, once-a-day formulation for the treatment of obesity, including 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.
The CRL included the following areas: clinical, labeling, REMS, safety update, and drug scheduling.
In the clinical section of the CRL, the FDA requested a comprehensive assessment of topiramate's and phentermine/topiramate's teratogenic potential. This will include 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. In addition, the FDA 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.
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.
As part of the written response, VIVUS plans to compile analyses integrating existing nonclinical and clinical data to provide a comprehensive assessment of the teratogenic potential of topiramate. In addition, VIVUS plans to provide several new analyses to demonstrate QNEXA does not increase the risk for major cardiovascular events, which would include data from VIVUS' OB-305 and OB-204 studies. In the CRL, no new clinical studies were requested; however, in the event that any of the FDA concerns are not alleviated, additional clinical studies may be required.
VIVUS intends to continue working with the FDA towards the approval of QNEXA for the treatment of obesity and is preparing a comprehensive response to the CRL for submission to the FDA in approximately six weeks.
VIVUS will hold a conference call to discuss this update on Friday, October 29, 2010, beginning at 8:30 a.m. Eastern Time. Those interested can listen to this call by dialing toll-
free 877-359-2916 or 224-357-2386. A 30-day archive of the call can be accessed at http://ir.vivus.com/. To access the webcast of this event, please visit VIVUS' Investors site at http://ir.vivus.com/events.cfm. A replay will also be available on demand from the website at the conclusion of the program.
Certain statements in this Form 8-K are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing and substance of VIVUS' response to the FDA's complete response letter; the FDA's interpretation of the data VIVUS submits relating to teratogenicity and cardiovascular safety; the FDA's interpretation of the data from VIVUS' SEQUEL study (OB-305); that VIVUS may be required to conduct additional clinical trials; substantial competition; uncertainties of patent protection and litigation; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that VIVUS' response to the FDA's complete response letter will be sufficient to satisfy the FDA's safety concerns, that the FDA will not require VIVUS to conduct additional clinical studies or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2009 and periodic reports filed with the Securities and Exchange Commission.
In the before the before equity activity, the share price is paradoxically UP. The closing value last evening (before the CRL was released) was in the low $6.13. Right now the price is $8.08! It appears that the obesity market cognescenti already anticipate a down the road approval for Qnesta.
The conference call is at 8:30 eastern. If missed, Vivus will offer it on their web site for 30 days. The obesity and diabesity crowd still have hope that their medical problems will have a pharmaceutical option. Sadly, the entire disease spectrum of obesity is bereft of much help, except a glib and mostly ineffective diet and exercise
pap speech by mostly non fat people. Those, who are overweight, know how poorly the D&E works. Worse yet D&E set the safety bar for any drug alternative. And a high bar that is!
So, the saga continues. The next chapter in the fat drug story is the Advisory Committee meeting for Orexigen's Contrave. Set in early December, OREX will have the advantage of studying the trials of both VVUS and ARNA before being put on the barbie.
And so it goes...