Sanofi to produce avanafil for Vivus

(Euronext: SAN) subsidiary Sanofi Chimie to manufacture and supply the active pharmaceutical ingredient (API) for avanafil – the active ingredient of Vivus’ erectile dysfunction drug Spedra - on an exclusive basis in the USA 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 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.

"Sanofi was the logical choice for avanafil API manufacturing," stated Theodore Broman, vice president, chemistry manufacturing and control, Vivus, adding: "Their world-class manufacturing capabilities and facilities are well-suited to undertake the worldwide production of avanafil."