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VIVUS Reports 2010 Fourth Quarter and Full-Year Financial Results
Date:2/28/2011

MOUNTAIN VIEW, Calif., Feb. 28, 2011 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today reported its highlights and financial results for the fourth quarter and year ended December 31, 2010.

2010 Highlights

  • In the QNEXA investigational drug development program, we successfully completed the two-year SEQUEL study, an extension study in 675 patients from the CONQUER study.  Results were announced in September and showed sustained weight loss of greater than 10% for both doses of QNEXA over two years.

  • In December, we filed the Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, in the European Union for QNEXA as a treatment for obesity. Obesity is a global epidemic, with approximately 150 million European adults affected and the prevalence is rising rapidly.

  • In the avanafil investigational drug development program, we completed the two remaining phase 3 studies: in diabetics with erectile dysfunction and the long-term open label safety study.  Both studies met all primary efficacy endpoints. The NDA filing for avanafil is scheduled for Q2 2011.

  • We divested MUSE and the related assets to Meda AB for $22 million and are eligible to receive a $1.5 million milestone based upon future sales of MUSE.  The transaction closed on November 5, 2010. In connection with the sale, all of our loans and long-term notes payable were repaid and our MUSE-related royalty obligations were terminated.

  • Lastly, we ended the year with $139.2 million in cash, cash equivalents and available for sale securities.

  • QNEXA Regulatory Update  On October 28, 2010, we received a Complete Response Letter, or CRL, from the FDA regarding the QNEXA NDA.  The FD
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    Related medicine technology :

    1. Results From Phase 3 EQUATE Trial of VIVUS Qnexa Highlighted at European Congress on Obesity
    2. VIVUS Initiates Open Label Safety Study of Avanafil for Erectile Dysfunction
    3. Data on VIVUS Qnexa to be Featured at European Association for the Study of Diabetes Annual Meeting
    4. VIVUS Announces Promotion of Peter Tam to President
    5. VIVUS to Present at Lazard Capital Markets Healthcare Conference
    6. VIVUS Submits Qnexa(R) New Drug Application to the FDA for the Treatment of Obesity
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    9. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
    10. VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results
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