Vivus Inc. (VVUS) recently announced that it has reached an agreement with the Endocrine and Metabolic Division of the US Food and Drug Administration (FDA) which allows for an early resubmission of the new drug application (NDA) for its obesity candidate, Qnexa.
On the basis of this agreement, Vivus intends to resubmit the NDA by the end of October 2011, prior to the completion of the FORTRESS study. In the resubmitted NDA, Vivus will seek approval of Qnexa for an initial indication that includes obese men and women of non-child bearing potential.
FORTRESS is a retrospective, observational study of fetal outcomes of offspring of women exposed to topiramate. Top-line results from the FORTRESS study are expected in December 2011. Favorable results from this study would allow Vivus to file for the full indication of Qnexa in late 2012.
The FDA plans to have an Advisory Committee meeting for the NDA of Qnexa in the first quarter of 2012, leading to a decision on the candidate in the second quarter of 2012.
Meanwhile, the company filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Qnexa (for obesity) in December 2010. A decision from the European regulatory body is expected in the fourth quarter of 2011.
We note that Vivus is also evaluating Qnexa as a potential treatment for type II diabetes and obstructive sleep apnea.
Neutral on Vivus
We currently have a Neutral recommendation on Vivus. The stock carries a Zacks #3 Rank (Hold rating) in the short-run. We view the agreement with FDA Advisory Committee as a positive for the company, which currently does not have any marketed drug in its portfolio.
Apart from Qnexa, Vivus is seeking approval of avanafil for the treatment of erectile dysfunction (ED). The FDA has set a target date of April 29, 2012 for the drug.
We expect investor focus to remain on avanafil and Qnexa’s approval.
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