Biopharmaceutical company VIVUS, Inc. 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 US 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.
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 US VIVUS, through collaboration arrangements with third parties, intends to market and sell Stendra in the US and under the trade name Spedra in the EU and other territories outside the US. 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 is currently in discussions with potential partners to commercialize Stendra in the US and its other territories throughout the world.
VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health. For more information about the company, please visit www.vivus.com.