PARIS & STRASBOURG, France--(BUSINESS WIRE)--Regulatory News:
Sanofi (EURONEXT: SAN and NYSE: SNY) and Transgene SA (Paris:TNG) (NYSE-Euronext: TNG) announced today that they have launched the construction phase of the manufacturing platform dedicated to the production of viral vectors, such as Transgene’s MUC1 targeted cancer immunotherapy, TG4010. In March 2013, the companies announced a long-term collaboration agreement to build the unit, which is to be constructed on the Genzyme Polyclonals site in Lyon, an important French biopharmaceutical cluster.
Philippe Luscan, Executive VP Industrial affairs Sanofi, said: “We are very pleased to partner with Transgene, an innovative French Biopharmaceutical company developing new drugs which might be a breakthrough in the treatment of life threatening diseases. This state-of-the art industrial platform will be dedicated to production of viral vectors through a broad range of technologies including mammalian cell culture up to 1m3 using single use bioreactors, combining the excellence of Genzyme, Sanofi-pasteur, and Transgene in Lyon area. Sanofi will bring to Transgene its know-how in bioproduction and experience to launch biologics. It reflects the core elements required in improving global health, innovation & partnership.”
Philippe Archinard, Chairman and Chief Executive Officer of Transgene, said: “We are very pleased to be moving forward with the construction phase of this important new commercial production unit. Our decision to invest now reflects the increasing confidence in our programs, including our cancer immunotherapy candidate, TG4010, for which we recently announced topline preliminary data from a clinical study in non-small cell lung cancer. We are building a strong future for Transgene and are taking the steps needed to ensure sufficient future commercial supply.” Mr. Archinard continued: “Sanofi is an ideal partner with extensive experience in effectively managing large production projects and manufacturing novel therapies in commercial quantities.”
The companies together will invest approximately € 10 million in the production unit over an expected two-year timeframe, of which Transgene's share will be approximately € 5 million.
SANOFI, through its Genzyme Polyclonals site for the manufacturing and the CEPIA organization (Commercial & External Partnership Industrial Affairs) for all commercial aspects, will act as Transgene’s Contract Manufacturing Organization (CMO) and Transgene will be considered as a preferred customer of the platform through 2028.
This dedicated platform will be Sanofi’s exclusive property and will enable to produce a new breakthrough class of APIs (Viral vectors).
Sanofi, an integrated global 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 publicly traded French biopharmaceutical company focused on discovering, developing and manufacturing targeted immunotherapies for the treatment of oncology and infectious diseases. Transgene’s programs utilize well-tolerated viruses with the goal of indirectly or directly killing infected or cancerous cells. The Company’s four clinical-stage programs are: TG4010 for non-small cell lung cancer; Pexa-Vec for liver cancer; TG4001 for oropharyngeal cancer (under a collaboration agreement with the EORTC) and TG4040 for chronic Hepatitis C. Transgene has concluded corporate strategic agreements for the development of two of its immunotherapy products: an exclusive option agreement with Novartis for the development and commercialization of TG4010 and an in-licensing agreement with U.S.-based Jennerex, Inc. for the development and commercialization of Pexa-Vec in certain territories. The Company also has several programs in research and pre-clinical development that are based on its core viral vector technology. Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as satellite offices in China and the U.S. 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 about costs and timing of a facility for the commercial production of Transgene’s immunotherapy products. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. There can be no guarantee that the production unit will be built without delays and/or cost overruns nor that the any of the Company’s programs will be approved for marketing and commercially produced. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results and development. The Company’s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Document de Référence, which is available on the AMF website (http://www.amf-france.org) or on Transgene’s website (www.transgene.fr).
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