Boehringer wins contract to make Servier’s gevokizumab
pharmafile | August 7, 2012 | News story | Manufacturing and Production | Boehringer Ingelheim, CMO, Servier, antibody
Boehringer Ingelheim’s contract manufacturing organisation (CMO) division will provide commercial-scale manufacturing of a new monoclonal antibody developed by Servier and Xoma, under the terms of a new agreement between the companies.
The deal covers the production of gevokizumab (Xoma 052), an interleukin 1-beta (IL-1β) allosteric modulating antibody-based drug in Phase III development as a treatment for non-infectious uveitis, an inflammatory disease of the eye.
Germany-based Boehringer and Xoma of the US are working on a technology transfer operation that will allow Xoma’s manufacturing process for gevokizumab at its Berkeley plant to be carried over to the CMO’s flagship bioproduction facility in Biberach.
Boehringer is one of the biggest commercial-scale contract manufacturers of biologic medicines in the world, and Xoma chief executive John Varian said a critical factor in awarding the contract was Boehringer’s ability eventually to manufacture the antibody both in Europe and the US.
The news is momentous for Servier because it is the first biologic molecule it has taken into clinical development. The French company will be the recipient for antibody made by Boehringer at Biberach, with Xoma handling production for the US market in the near-term.
Further down the line Boehringer will take over full production responsibility, as Xoma is in the process of selling off its Berkeley plant to Danish contract manufacturer CMC Biologics as part of a cost-reduction drive that has also seen it axe around a third of its workforce.
Servier forged a development and commercialisation deal for gevokizumab with Xoma in 2011, paying an upfront fee of $55 million with up to $470 million in the offing for milestone payments and royalties.
That deal also provided Xoma with its first commercial product, providing commercialisation rights to Servier’s cardiovascular drug perindopril in the US.
In June, Xoma started enrolment in two trial of gevokizumab, one a Phase III study in non-infectious uveitis and the other a Phase II trial in erosive osteoarthritis of the hand, while another Phase II study in moderate-to-severe inflammatory acne is also ongoing. Meanwhile Servier is gearing up to start a Phase III trial of the antibody in Behcet’s uveitis.
There was disappointment for the partners last year however, when gevokizumab failed a Phase IIb trial in type II diabetes, which had been considered its largest potential market.
Phil Taylor
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