VIVUS In Deal To Reacquire STENDRA Commercial Rights From Sanofi - Quick Facts

(RTTNews) - VIVUS, Inc. ( VVUS) announced Monday that it reached an agreement with French drug major Sanofi (SNY) to return the commercial rights for STENDRA in Africa, the Middle East, Turkey and the Commonwealth of Independent States, including Russia, to VIVUS.

In pre-market activity on Nasdaq, VIVUS shares were gaining around 5.5 percent to $1.16.

Avanafil is licensed from Mitsubishi Tanabe Pharma Corp. VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian-Pacific Rim countries.

VIVUS said it is in discussions with other parties for the commercialization rights to its remaining territories.

As part of the agreement, Sanofi will provide transition services to avoid adverse impacts to the regulatory approval applications in process, specifically in Russia and certain Middle East countries.

STENDRA (avanafil) is approved in the U.S. by the FDA for the treatment of erectile dysfunction. Metuchen Pharmaceuticals LLC has exclusive marketing rights to STENDRA in the U.S., Canada, South America and India.

STENDRA is available through retail and mail order pharmacies.

The company noted that SPEDRA, the trade name for avanafil in the EU, is approved by the EMA for the treatment of erectile dysfunction in the EU. VIVUS has granted an exclusive license to the Menarini Group through its subsidiary Berlin-Chemie AG to commercialize and promote SPEDRA for the treatment of erectile dysfunction in over 40 European countries plus Australia and New Zealand.

Seth Fischer, VIVUS Chief Executive Officer, said, "The return of STENDRA from Sanofi provides us with the opportunity to find a commercial partner in the former Sanofi territories and continue our efforts to build long-term stockholder value. We have begun the process of finding a commercial partner to take advantage of Sanofi's efforts to obtain regulatory approvals in Russia and the Middle East. We look forward to continuing our relationship with Sanofi as the manufacturer of STENDRA."