Date: 2013-03-25
Type of information: Production agreement
Compound: immunotherapy products
Company: Sanofi (France) Transgene (France)
Therapeutic area: Cancer - Oncology - Infectious diseases
Type agreement: collaboration
production
manufacturing
Action mechanism:
Disease:
Details: Sanofi and Transgene have announced 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 that is already manufacturing polyclonal antibodies for the worldwide markets. This site has all the necessary capabilities to support the registration of immunotherapy products for the EU and US markets. The investment amount of 10 million euro will be 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.
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.
Financial terms:
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