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VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results
Date:11/8/2010

at September 30, 2010, as compared to $206.8 million at December 31, 2009.  The decrease in cash, cash equivalents and available-for-sale securities of $48.6 million is primarily due to cash used in operations and other net cash uses offset by proceeds of $2.4 million from the exercise of common stock options and ESPP purchases.

Qnexa Regulatory UpdateOn October 28, 2010, we received a Complete Response Letter (CRL) from the FDA regarding the Qnexa NDA.  The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.  At the present time, we are preparing a written response to the FDA's requests for information in the CRL.

"As demonstrated by the results of the two-year SEQUEL study, Qnexa patients continue to see weight loss greater than 10%.  We received the Qnexa CRL on October 28, 2010.  In response to the FDA's requests, we are working to submit the final study report from SEQUEL and address their requests in a written response to the CRL," stated Leland Wilson, chief executive officer of VIVUS. "In addition to the release of the SEQUEL data, in the third quarter of 2010 we announced the sale of MUSE to Meda.  This transaction closed on November 5, 2010.  The MUSE transaction marks the end of an era and I wish to thank the hundreds of employees that have been involved in the MUSE business since its inception and approval in 1996. The balance sheet remains strong and through the remainder of 2010 we are focused on the written response to the CRL for Qnexa, the filing for approval of Qnexa in the European Union and additional phase 3 trial results from avanafil."

About VIVUS VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead product in clinical development, Qnexa(R), completed phase 3 clinical trials for the treatment of obesity and an NDA was filed and accepted by the F
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SOURCE VIVUS, Inc.
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Related medicine technology :

1. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
2. VIVUS Announces Sale of MUSE Assets to Meda
3. VIVUS Submits Qnexa(R) New Drug Application to the FDA for the Treatment of Obesity
4. VIVUS to Host Conference Call and Webcast Discussion of Avanafil Phase 3 Results
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7. Data on VIVUS Qnexa to be Featured at European Association for the Study of Diabetes Annual Meeting
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