Will produce inflammatory disease drug at its Biberach facility
Boehringer Ingelheim has agreed a deal with Servier and its development partner Xoma to manufacture its inflammatory disease monoclonal antibody candidate gevokizumab.
The agreement will see Boehringer produce the drug, which is in phase III clinical development in patients with infectious uveitis (NIU), at its facility in Biberach, Germany once it has established biological comparability.
While financial terms were not disclosed, Servier and Xoma will retain all development and commercialisation rights to the drug.
John Varian, CEO of XOMA said Boehringer was chosen as the German company was able to produce drugs in both Europe and the US and was “recognised globally as a leader in manufacturing monoclonal antibodies at a commercial scale”.
He continued: "They have a well-established track record of successful technology transfers, which gave us confidence in their ability to transfer the gevokizumab production process from our Berkeley facility to their Biberach facility and to be fully prepared with documentation to support regulatory filings in US and other countries.”
Christian Sauveur, industrial general director at Servier, was similarly enthusiastic about Boehringer's ability to manufacture the drug, which is a novel interleukin 1 (IL-1) beta allosteric modulating antibody.
"Gevokizumab is Servier's first molecule in clinical development produced by a bioprocess. Considering the expertise and the long experience of Boehringer Ingelheim in this area, we have found them as an ideal partner for the production of both clinical supplies and later commercial units of this very promising new molecule.”
The drug is developed to work by inhibiting the activation of the IL-1 receptor, which can lead to inflammation when defective, and in phase II studies it demonstrated an ability to reduce inflammation.
Xoma holds rights to the drug in the US and Japan for non-cardiovascular indications, including uveitis and Behçet's disease, while Servier holds all other rights.