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Sanofi Chimie will supply the API avanafil for VIVUS.
The biopharmaceutical VIVUS has formed a commercial supply agreement with Sanofi Chimie, a wholly owned subsidiary of Sanofi, to manufacture and supply avanafil, the API in Vivus’ erectle dystfunction drug Stendra/Spedra, 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 FDA and the European Medicines Agency 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. The drug is marketed in the EU as Spedra and in the US as Stendra.
Avanafil is licensed from Mitsubishi Tanabe Pharma. VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian-Pacific Rim countries.