MOUNTAIN VIEW, Calif., Dec. 12, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced that it has entered into a License and Commercialization Agreement with Sanofi to commercialize avanafil on an exclusive basis in Africa, the Middle East, Turkey, and the Commonwealth of Independent States (CIS) including Russia. Sanofi will be responsible for obtaining regulatory approval in its territories. Sanofi intends to market avanafil under the tradename SPEDRA ™ or STENDRA ™.
Under the terms of the agreement, VIVUS is eligible to receive up to $61 million in upfront payments, regulatory and sales milestones. VIVUS will also receive escalating royalties based on net sales over the life of the agreement.
"Sanofi is an established leader in emerging markets and a valued partner for VIVUS," said Seth H. Z. Fischer, CEO of VIVUS, Inc.In July 2013, VIVUS announced an exclusive license with the Menarini Group to commercialize avanafil in Europe, Australia and New Zealand. In October 2013, VIVUS announced an exclusive license with Auxilium Pharmaceuticals, Inc. to commercialize avanafil in the United States and Canada. Under the Menarini, Auxilium and Sanofi agreements, avanafil is expected to be commercialized in over 100 countries worldwide. "We are pleased with the alliance we have forged with our partners at Sanofi," stated John L. Slebir, vice president, business development and general counsel of VIVUS, Inc. "This agreement is another key accomplishment for VIVUS in the monetization of avanafil." Aquilo Partners, L.P. acted as the exclusive advisor to VIVUS on the transaction. About Avanafil SPEDRA ™, the trade name for avanafil in the EU and certain other territories outside of the U.S., has been approved by the EMA for the treatment of erectile dysfunction in the EU. STENDRA ™, the trade name for avanafil in the U.S. and certain other territories, is approved by the FDA for the treatment of erectile dysfunction in the U.S. Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). 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 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. VIVUS has granted an exclusive license to Auxilium Pharmaceuticals, Inc. to market STENDRA in the United States and Canada. VIVUS has granted an exclusive license to Sanofi to commercialize avanafil in Africa, the Middle East, Turkey, and the Commonwealth of Independent States (CIS) including Russia. VIVUS is currently in discussions with potential partners to commercialize STENDRA in its remaining territories.
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