Vivus signs commercial supply agreement with Sanofi to produce Avanafil
The deal is on an exclusive basis in the US and other territories
US biopharmaceutical firm Vivus has signed a commercial supply agreement with Sanofi Chimie, a wholly owned subsidiary of Sanofi, to manufacture the active pharmaceutical ingredient (API) for Avanafil, a treatment for erectile dysfunction.
The deal is on an exclusive basis in the US and other territories and on a semi-exclusive basis in the European Union and Latin America.
Vivus’s Vice President, Chemistry Manufacturing and Control, Theodore Broman, said Sanofi’s ‘world-class manufacturing capabilities and facilities are well-suited to undertake the worldwide production of Avanafil’.
The two firms had previously entered into a technology transfer agreement and have been working on the transfer of the Avanafil API manufacturing process. They are also working on the qualification of Sanofi as a bulk tablet manufacturer for Avanafil.
Until the completion of the qualification and subsequent approval, which is expected by 30 June 2015, Vivus and its partners will continue to source Avanafil API from Mitsubishi Tanabe Pharma Corporation.
