Vivus and Sanofi Chimie have entered into a commercial supply agreement to manufacture and supply the API for avanafil. The pact is on an exclusive basis in the U.S. and other territories and on a semi-exclusive basis in the EU and Latin America. Avanafil is a treatment for erectile dysfunction sold under the name Stendra.

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

Vivus and Sanofi 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. Once the transfer is complete, Vivus will submit amendments to avanafil’s approved 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 approval is expected to be completed no later than June 30, 2015. Until then, Vivus will continue to source avanafil API from Mitsubishi Tanabe Pharma, the company that licensed the drug to Vivus.