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GEN News Highlights : Mar 26, 2013

Novel Platform for Immunotherapies Created

Sanofi and Transgene inked a collaboration agreement for the creation of a new industrial platform for the production of immunotherapeutics, including Transgene’s therapeutic products. The platform will be based at Genzyme Polyclonals site in Lyon-Gerland area for an investment amount of $12.9 million dollars, equally financed by Sanofi and Transgene. The platform will remain Sanofi’s exclusive property.

Sanofi and Genzyme will act as Transgene’s contract manufacturing organization to make 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.”

“The Lyon area is a strategic place for Sanofi in the field of immunology,” added Olivier Charmeil, president and CEO of Sanofi Pasteur. “Merial, Sanofi Pasteur, and Genzyme will share locally their expertise to successfully implement this platform and build a center of excellence available for Transgene and potentially other customers.”

Construction, qualification, and validation of the manufacturing suite will start in Q3 2013 and should be completed in Q1 2015. First batches of commercial grade products from the suite are expected in 2015. Transgene expects to file its first BLA in 2016.