Will the second time prove the charm for Vivus? Some investors were betting that way this morning, driving up the biotech's share value by 14% on the news that it had come to terms with the FDA on an early resubmission of the obesity drug Qnexa.
Last fall, of course, Vivus ($VVUS) shares were blighted by the FDA's rejection of Qnexa based on regulators' fear of the cardio risks presented by the weight drug, which has demonstrated an ability to spur marginal weight loss among people. Vivus had been vying with Orexigen and Arena to become the first company in a decade to gain an approval, and all of them ran into regulatory roadblocks.
Arena had expected to wait until it completed a new study on the drug. But with new safety data already in hand Vivus is making an early strike at changing the FDA's mind on its application. Its next regulatory hurdle comes in the first quarter of 2012 with a second presentation to an FDA advisory committee. The second PDUFA date will fall in the second quarter.
"Topiramate teratogencity data published and presented since our last meeting with the FDA in April 2011 includes two case-control studies....In addition, a birth defect study from Denmark on newer generation antiepileptic drugs including topiramate was published in JAMA. In all of these studies, the authors concluded that topiramate was not a major teratogen," commented Wesley Day, vice-president clinical development. "The conclusions reached in all of these studies were instrumental in the development of the Qnexa NDA resubmission plan."
- check out Vivus' release
- here's the story from Reuters