Sanofi and Transgene announce innovative long-term collaboration

Sanofi (EURONEXT: SAN and NYSE: SNY) and Transgene SA (NYSE-Euronext: TNG) announced today 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 – Gerland area for an investment amount of 10 million euro 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 (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 Chief Executive Officer 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, and I am extremely pleased to announce this collaboration with Transgene, representing a total investment of 10 million euro on Genzyme Polyclonals site in the Lyon Gerland area,” said Olivier Charmeil, President and CEO of Sanofi Pasteur. “Merial, Sanofi Pasteur and Genzyme will share locally their expertise to successfully implement this state-of-the-art platform and build a center of excellence available for Transgene and potentially other customers.”

“The agreement between Transgene and Sanofi is symbolic at more than one level”, said Alain Mérieux, Chairman of Institut Mérieux. “It brings into play operational synergies between the pharmaceutical and biotechnology industries in a place of historical importance for Institut Mérieux. The agreement also reinforces the ecosystem in Lyon, where we and other industry players have learned to work together within the context of the local cluster (Lyon Biopole) and of the newly created Research Technology Institute (Bioaster).”

Genzyme Polyclonals site in Lyon – Gerland area – is already manufacturing polyclonal antibodies for the worldwide markets. It has all the necessary capabilities to support the registration of immunotherapy products for the EU and US markets.

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 BLA2 in 2016.

References

1. Modified Vaccinia Ankara. MVA virus is one the vaccinia viruses re-engineered used as vectors for production of recombinant proteins. It is widely considered as the vaccinia virus strain of choice for clinical investigation because of its high safety profile.
2. Biological Licence Application, or filing of registrational dossier.