Sanofi has formed an innovative collaboration with fellow French company Transgene that will see it act at the biotech’s contract manufacturing organisation (CMO).
The two companies will each invest €5m to update the polyclonals facility run by Sanofi’s Genzyme unit in the Gerland area of Lyon, adding a “state-of-the-art industrial platform”.
The platform, which will be dedicated to the production of immunotherapy products, including Transgene’s therapies, will remain the exclusive property of Sanofi.
But in return for its investment Transgene will be its preferred customer for 15 years once it is up and running.
Olivier Charmeil, president and CEO of Sanofi Pasteur, said: “[Sanofi companies] Merial, Sanofi Pasteur and Genzyme will share locally their expertise to successfully implement this state-of-the-art platform and build a centre of excellence available for Transgene and potentially other customers.”
The deal will see Sanofi and Genzyme act as Transgene’s CMO to manufacture clinical and commercial batches of drug substance of Transgene’s immunotherapy products, including its therapeutic vaccines.
Philippe Archinard, chairman and CEO of Transgene, said: “Transgene is extremely pleased to announce this agreement with the Sanofi Group, as it combines the strong expertise of recognised experts and pioneers in the fields of gene therapy and vaccines.
“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.”
Construction, qualification and validation of the manufacturing suite will start later this year in the third quarter and Sanofi said it should be completed by the first quarter of 2015.
This should put it on track to product its first batches of commercial grade products in 2015, ahead of Transgene’s plans to file its first biologics licence application (BLA) in 2016.
The biotech’s most advanced candidates are TG4010, a therapeutic vaccine for non-small cell lung cancer it is developing with Novartis, and JX594 for hepatocarcinoma and other solid tumours, for which it has partnered with Jennerex Biotherapeutics. Both products are currently in phase IIb trials.