Date: 2013-08-01
Type of information: Production agreement
Compound: avanafil
Company: Vivus (USA - CA) Sanofi (France)
Therapeutic area: Technology - Services
Type agreement: production manufacturing
Action mechanism:
Disease:
Details: * On August 1, 2013, Vivus has announced that it has entered into a commercial supply agreement with Sanofi Chimie, 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 FDA and the 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.
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™,the trade name for avanafil in the US, has been approved by the FDA for the treatment of erectile dysfunction in the U.S. Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation. 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 U.S. and its other territories throughout the world.
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