| Company: | VIVUS |
| Ticker Symbol: | VVUS |
| Class Period: | Sep-9-09 to Jul-15-10 |
| Date Filed: | Nov-3-10 |
| Lead Plaintiff Deadline: | Jan-2-11 |
| Court: | Northern District of California |
| Allegations: | |
The Company's lead product in clinical development is Qnexa(R) ("Qnexa" or the "drug"), an experimental drug that has completed Phase III clinical trials for the treatment of obesity. In December 2009, Vivus submitted a New Drug Application ("NDA") to the Food and Drug Administration ("FDA") to have Qnexa approved as an obesity drug.
The complaint charges Vivus and certain of its officers and directors with violations of the Securities Exchange Act of 1934. The complaint alleges that during the Class Period, defendants made false and misleading statements about the Company's weight loss drug Qnexa. More specifically, the Company failed to disclose that: (a) the studies conducted by Vivus and submitted to the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA (the "FDA Panel") could not support FDA Panel approval for Qnexa's use to treat obesity as a chronic condition, and, at the very least, longer-term clinical studies would be needed to determine whether Qnexa was safe for its intended use to treat chronic obesity; (b) the trial results showed worrisome adverse effects of the type that scuttled approval for other obesity drugs, including: increased risk of suicide, cardiovascular events, and birth defects; (c) four to seven times as many patients taking the highest dose of Qnexa, compared to patients taking lower doses or placebos, dropped out of the study because of adverse side effects such as anxiety, sleep disorders, or depression; and (d) Qnexa would likely receive a "Pregnancy Category X" label from the FDA due to risks of birth defects (teratogenicity), instead of the proposed "Pregnancy Category C" label, thereby potentially eliminating a huge swath of potential Qnexa customers.
On July 15, 2010, the FDA Panel held a hearing to review Qnexa. Following the lengthy review and discussion, the FDA Panel voted against recommending Qnexa based on concerns regarding adverse effects and the unknown impact of long-term use beyond the 56-week clinical study period. The FDA Panel voted 10-to-6 in the negative on the question of whether the "overall risk-benefit assessment of Qnexa is favorable to support approval." When news of the vote was publicly announced on July 15, 2010, the market price of Vivus common stock plummeted, falling $6.70 per share, or 55%, in one day on unusually high trading volume of over 42.3 million shares. On October 28, 2010, the FDA followed the recommendation of the FDA Panel and rejected Vivus's NDA for Qnexa.
If you acquired the securities of the defendants during the Class Period you may, no later than the Lead Plaintiff Deadline shown above, request that the Court appoint you as lead plaintiff through counsel of your choice. You may also choose to remain an absent class member. A lead plaintiff must meet certain requirements.
