Investigation Overview
An investor in VIVUS filed a lawsuit on behalf of those who purchased common stock of VIVUS, Inc. (VVUS) between September 9, 2009 and July 15, 2010 against VIVUS, Inc. over alleged violations of Federal Securities Laws in connection with its New Drug Application with the Food and Drug Administration for VIVUS product Qnexa as an obesity drug. Meanwhile an investigation on behalf of current long term investors in VIVUS, Inc. (NASDAQ:VVUS) shares over possible breaches of fiduciary duty by certain directors and officers VIVUS, Inc. was announced.
Mountain View, California based VIVUS, Inc. is a biopharmaceutical company focused on the development and commercialization of therapeutic products for underserved markets. VIVUS, Inc. 12month Total Revenue went from $102.23million in 2008 to $50.04million in 2009. VIVUS Net Loss went from $9.94million in 2008 to $54.29million in 2009. For the first two quarters in 2010 VIVUS reported total revenue of $1.73million, respectively $3.90million with a Net Loss of $18.82million, respectively $22.76million.One of VIVUS products is Qnexa, which is an experimental drug hat has completed Phase III clinical trials for the treatment of obesity. The investigation by a law firm on behalf of current long term investors in stock of VIVUS, Inc. (NASDAQ:VVUS) concerns whether certain current and/or former officers and members of VIVUSs board of directors and executive officers can be held liable in connection with the alleged Securities Laws violations in the lawsuit by investors who purchased VVUS stock between between September 9, 2009 and July 15, 2010. According to VIVUS Qnexa is an investigational, once a day, proprietary, oral, controlled-release formulation of low dose phentermine and topiramate, which is believed to address both appetite and satiety - the two main mechanisms that impact eating behavior. 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.
According to the complaint filed in the United States District Court for the Northern District the plaintiff alleges on behalf of purchasers of the common stock of VIVUS, Inc. (NASDAQ:VVUS) between September 9, 2009 and July 15, 2010, that VIVUS, Inc and certain of its officers and executives violated the Securities Exchange Act of 1934 by issuing between September 9, 2009 and July 15, 2010 false and misleading statements about the Company's weight loss drug Qnexa. On July 15, 2010, the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA held a hearing to review Qnexa and VIVUS announced that it voted against recommending Qnexa.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted in the negative on the question of whether the overall risk-benefit assessment of Qnexa is favorable to support its approval for the treatment of obesity. When news of the vote was publicly announced on July 15, 2010, the market price of Vivus common stock declined, falling $6.70 per share, or 55%, to $5.41 per share. Shares of VIVUS, Inc. continued declined to $5.07 per share on August 11 but then increased over the next months to over $8 on October 29, 2010. Even though the vote from the Endocrinologic and Metabolic Drugs Advisory Committee was only recommendation on October 28, 2010 VIVUS, Inc had to announce after the market closed that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for QNEXA and that the FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form. VVUS shares declined since then to $7.12 on Friday November 5, 2010.