The erectile dysfunction (ED) drug Spedra, licensed from Mitsubishi Tanabe Pharma Corporation (MTPC) by Vivus, received European marketing authorization application (MAA) approval in June. Last week the firm announced it had selected the contract manufacturing division of Sanofi – Sanofi Chimie – on a semi-exclusive basis.
So far, Timothy Morris CEO of Vivus told Outsourcing-Pharma.com, “MTPC, the original licensor of avanafil, has made the clinical supplies and commercial supplies” and “will continue to do so until June of 2015” when amendments submitted to the EMA and FDA to include Sanofi as a qualified supplier are expected to be approved.
However, he continued, “Sanofi has better capacity than MTPC and will be able to supply product at a better price,” and therefore production is being transferred to a facility within the EU from where Sanofi will supply the US and EU markets.
The two companies have been working together since earlier this year when they entered into a tech transfer deal for the manufacture of Spedra’s active pharmaceutical ingredient (API), avanafil. Sanofi is also expected to be named as bulk tablet manufacturer for avanafil.
Vivus holds the worldwide rights for Spedra (known as Stendra in the US) to be used as a treatment for erectile dysfunction in all markets except certain Asia-Pacific countries.
Sanofi Choses Gallus
In other news, Sanofi’s biotech subsidiary Genzyme has selected contract manufacturing organization (CMO) Gallus Biopharmaceuticals to make its acid sphingomyelinase therapy targeting the rare disease, Niemann-Pick type B.
Gallus will provide process and method development, scale-up, clinical supply and preparation for commercial manufacturing of the drug as part of a multiyear agreement, of which financial details have not been divulged.