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 1 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 BLA 2 in 2016.About Sanofi 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). About Transgene 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 www.transgene.fr. Sanofi Forward Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Transgene Forward Looking Statements This press release contains forward-looking statements notably referring to an anticipated future BLA filing date by Transgene. Such anticipated future BLA filing date is based on the current plan of product development and testing. This plan may change in the future and, as such, Transgene could be in a position not to meet the currently anticipated development milestones, including such BLA filing. For further information on the risks and uncertainties involved in the testing and development of Transgene’s product candidates, see Trangene’s Document de Référence on file with the French Autorité des marchés financiers on its website at http://www.amffrance.org and on Transgene’s website at www.transgene.fr . 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.