SOURCE: Bernstein Liebhard LLP

November 19, 2010 11:05 ET

Bernstein Liebhard LLP Announces Action Filed on Behalf of Investors in Vivus, Inc.

NEW YORK, NY--(Marketwire - November 19, 2010) - Bernstein Liebhard LLP today announced that an action has been filed in the United States District Court for the Northern District of California on behalf of purchasers (the "Class") of Vivus, Inc. ("Vivus" or the "Company") (NASDAQ: VVUS) common stock during the period September 9, 2009 and July 15, 2010, inclusive (the "Class Period").

Vivus' lead product in clinical development is Qnexa® ("Qnexa") 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 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.

Plaintiff seeks to recover damages on behalf of all Class members who purchased or otherwise acquired shares of Vivus during the Class Period. If you purchased or otherwise acquired Vivus shares during the Class Period, and either lost money on the transaction or still hold the shares, you may wish to join in this action to serve as lead plaintiff. In order to do so, you must meet certain requirements set forth in the applicable law and file appropriate papers no later than January 3, 2011.

A "lead plaintiff" is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Under certain circumstances, one or more class members may together serve as lead plaintiff. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. You may retain Bernstein Liebhard LLP, or other counsel of your choice, to serve as your counsel in this action.

If you are interested in discussing your rights as a Vivus shareholder and/or have information relating to the matter, please contact Joseph R. Seidman, Jr. at (877) 779-1414 or

Bernstein Liebhard has pursued hundreds of securities, consumer and shareholder rights cases and recovered almost $3 billion for its clients. It has been named to The National Law Journal's "Plaintiffs' Hot List" in each of the last eight years.

You can obtain a copy of the complaint from the clerk of the court for the United States District Court for the Northern District of California.

Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
(877) 779-1414

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