Sanofi and Transgene Announce Innovative Long-Term Collaboration for the Production of Immunotherapy Treatments
Regulatory News:
Sanofi (EURONEXT: SAN and NYSE: SNY) and Transgene SA (Paris:TNG) (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 MVA therapeutic vaccines. Transgene will be a preferred customer of the commercial manufacturing platform for 15 years.
“” said Philippe Archinard, Chairman and Chief Executive Officer of Transgene. “”
“ said Olivier Charmeil, President and CEO of Sanofi Pasteur. “
" said Alain Mérieux, Chairman of Institut Mérieux. ”
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 BLA in 2016.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Transgene (NYSE-Euronext: TNG), a member of the Institut Mérieux Group, is a biopharmaceutical company. It creates, develops and manufactures targeted immunotherapeutics for the treatment of cancers and infectious diseases. Transgene’s products are major technological breakthroughs. They use well tolerated viruses to indirectly or directly kill infected or cancerous cells. Its four most advanced products have generated proof of concept data in randomized clinical studies: in lung cancer (TG4010), liver cancer (Pexa-Vec), hepatitis C (TG4040) and HPV-related cervical lesions (TG4001). Transgene has concluded strategic agreements for the development of three of these products: an option agreement with Novartis for the development of TG4010, an in-licensing agreement with US-based Jennerex, Inc. to develop and market Pexa-Vec and a strategic collaboration with EORTC to develop TG4001 in cancer of the oropharynx. With 280 employees, it is based in Strasbourg, France, and has operations in Lyon, China and the USA. Additional information about Transgene is available at .