DBV Technologies announced that it entered into a strategic manufacturing agreement with Sanofi to produce Viaskin’s Active Pharmaceutical Ingredients (API), such as the peanut protein extract.
Per the agreement, Sanofi will act as DBV’s Contract Manufacturing Organization (CMO). In this context, Sanofi will scale-up and validate the production process of Viaskin®’s API and full supply at commercial scale.
DBV will benefit from Sanofi’s strong expertise in biologics development and manufacturing in the field of plant extraction and purification of therapeutic proteins to further develop Viaskin. In addition, the manufacturing site at Aramon (France), which manufactures produces DBV’s APIs, is FDA-approved and has all the necessary capabilities to support the registration of Viaskin® for both the EU and US markets.
Dr. Pierre-Henri Benhamou, Chairman and CEO of DBV Technologies, said: “The strategic manufacturing agreement with Sanofi is an important step for DBV in the light of Viaskin’s late-stage development and potentially fast-coming commercialization. We believe that the extraction and protein expertise of Sanofi, notably at the Aramon site, will highly benefit DBV, thereby securing our API procurement in the years to come. We were very impressed by the quality and reactiveness of the Sanofi teams, which match perfectly with DBV’s culture and look forward to working closely with them in the months to come.”