MOUNTAIN VIEW, Calif., Aug. 1, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced that it has entered into a Commercial Supply Agreement with Sanofi Chimie ("Sanofi"), a wholly owned subsidiary of Sanofi, to manufacture and supply the active pharmaceutical ingredient (API) for avanafil on an exclusive basis in the United States and other territories and on a semi-exclusive basis in the European Union and Latin America. The companies had entered into a technology transfer agreement earlier in the year and have been actively working on the transfer of the avanafil API manufacturing process since that time. Pending completion of the transfer, VIVUS intends to submit amendments to the approved avanafil regulatory applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to include Sanofi as a qualified supplier of avanafil API. The companies are also working on the qualification of Sanofi as a bulk tablet manufacturer for avanafil.
"Sanofi was the logical choice for avanafil API manufacturing," stated Theodore Broman, vice president, chemistry manufacturing and control, VIVUS, Inc. "Their world-class manufacturing capabilities and facilities are well-suited to undertake the worldwide production of avanafil."
The qualification and subsequent approval by regulatory authorities is expected to be completed no later than June 30, 2015. Until such approvals, VIVUS and its partners will continue to source avanafil API from Mitsubishi Tanabe Pharma Corporation.About Avanafil SPEDRA™, the trade name for avanafil in the EU, has just been approved by the EMA for the treatment of erectile dysfunction in the EU. STENDRA is approved by the FDA for the treatment of erectile dysfunction in the U.S. VIVUS, through collaboration arrangements with third parties, intends to market and sell STENDRA in the U.S. and under the trade name SPEDRA in the EU and other territories outside 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.