Global healthcare company Sanofi and biopharmaceutical company Transgene have signed a collaboration agreement for the creation of a new state-of-the-art industrial platform dedicated to the production of immunotherapy products including Transgene's therapeutic products.
The platform will be realized on Genzyme Polyclonals site in Lyon, France, for an investment amount of roughly $13 million equally financed by Sanofi and Transgene. The platform will remain Sanofi's exclusive property.
Sanofi and Genzyme will act as Transgene's CMO to manufacture clinical and commercial batches of drug substance of Transgene's immunotherapy products, including its MVA1 therapeutic vaccines. Transgene will be a preferred customer of the commercial manufacturing platform for 15 years.
"Transgene is extremely pleased to announce this agreement with the Sanofi Group, as it combines the strong expertise of recognized experts and pioneers in the fields of gene therapy and vaccines," said Philippe Archinard, chairman and CEO of Transgene. "This collaboration will secure Transgene's commercial production over the long run, enabling us to focus our resources on development and marketing of our products."
Construction, qualification and validation of the manufacturing suite will start in the third quarter of 2013 and should be completed in 2015. First batches of commercial grade products from the suite are expected in 2015. Transgene expects to file its first BLA2 in 2016.