The €10m ($12.9m) new platform, the cost of which will be split between the two companies equally, will be developed at Genzyme’s site in Lyon, France. Genzyme is a fully owned subsidiary of Sanofi since 2011 when it was acquired for $20.1bn by the French pharma giant.
Frederic Lemonde-San, a spokesman for Sanofi, told Outsourcing-Pharma.com that “Sanofi and Genzyme will act as Transgene’s CMO” for the manufacture of immunotherapy products in both clinical and commercial batches.
Once built, he continued, “the Platform will remain Sanofi’s exclusive property and will be available for Transgene” who, under terms of the venture, will be a preferred customer for the next 15 years. Furthermore, Lemonde-San added: Sanofi will “have an industrial platform available if we have a project coming from our R&D portfolio, another client or via acquisition.”
When asked, Lemonde-San refused to speculate on any other potential manufacturing contracts that this platform may lead Sanofi to undertake.
Genzyme’s site in Lyon is already manufacturing polyclonal antibodies but this deal will focus to start with on the production of french biotech Transgene’s Modified Vaccinia Ankara (MVA) therapeutic vaccines.
MVA is a robust vector made from re-engineered vaccinia viruses used to produce recombinant proteins for the treatment of cancers and infectious diseases. According to Lemonde-San, the vaccinia virus is the “strain of choice for clinical investigation because of its high safety profile” and Sanofi and its subsidiaries intend “to produce a new class of viral vectors” at the site.
Construction, qualification and validation of the manufacturing suite will commence later this year and should be completed by the first quarter of 2015, when production of commercial grade batches is expected to begin.
The venture will not see an increase in headcount at the Lyon facility until 2017. In the meantime, resources will be shared from the Sanofi Group’s companies including Genzyme, Sanofi and Sanofi Pasteur.