Two Sanofi companies have entered biomanufacturing deals with Vivus and Gallus Biopharmaceuticals. Sanofi subsidiary Sanofi Chimie has made an agreement with Vivus to manufacture and supply the active pharmaceutical ingredient (API) for erectile dysfunction drug avanafil (known as Stendra™ in the U.S. and Spedra™ in the EU) on an exclusive basis in the U.S. and other territories and on a semi-exclusive basis in the EU and Latin America.
Earlier this year, the companies entered into a tech transfer agreement and say they have been working on the transfer of the avanafil API manufacturing process since then. After the transfer is complete, Vivus will be submitting amendments to the already-approved avanafil regulatory applications to the FDA and 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. Vivus hopes this regulatory approval will be completed no later than June 30, 2015, and will be working with Mitsubishi Tanabe Pharma in the meantime as its source for avanafil API.
"Sanofi was the logical choice for avanafil API manufacturing," said Theodore Broman, vp of chemistry manufacturing and control at Vivus. "Their world-class manufacturing capabilities and facilities are well suited to undertake the worldwide production of avanafil."
Meanwhile, Genzyme, another Sanofi company, entered a multi-year development and manufacturing supply agreement with St. Louis-based CMO Gallus Biopharmaceuticals in which Gallus will provide process and method development, scale-up, clinical supply, and preparation for commercial manufacturing for an infused protein-based therapy targeting the rare disease Niemann-Pick type B.
"We are confident that our deep process development expertise and over ten years of commercial, perfusion-based biomanufacturing for global markets using proprietary, flexible stainless steel bioreactors will result in successful delivery of this therapeutic molecule to advance Genzyme’s clinical program," Mark Bamforth, Gallus’ CEO and president, said of the agreement.