XOMA Announces Manufacturing Agreement with Servier and Boehringer Ingelheim
News Aug 13, 2012
XOMA Corporation has announced that its partner Les Laboratoires Servier (Servier) and the Company have entered into an agreement with Boehringer Ingelheim to transfer XOMA's technology and process for the commercial manufacture of gevokizumab, XOMA's novel interleukin 1-beta (IL-1β) allosteric modulating antibody.
Gevokizumab currently is in Phase 3 clinical development in patients with non-infectious uveitis (NIU) involving the intermediate and/or posterior segment of the eye.
The global development plan includes a Phase 3 trial to be conducted by Servier in patients with Behçet's uveitis.
Upon completion of the transfer and the establishment of biological comparability, Boehringer Ingelheim is expected to produce gevokizumab at its facility in Biberach, Germany, for XOMA's commercial use.
XOMA and Servier retain all rights to the development and commercialization of gevokizumab. Financial terms of the agreement were not disclosed.
"Together with Servier, we selected Boehringer Ingelheim because they are recognized globally as a leader in manufacturing monoclonal antibodies at a commercial scale," said John Varian, Chief Executive Officer of XOMA.
Varian continued, "During our conversations with the team at Boehringer Ingelheim, we concluded they are the right partner for both XOMA and Servier. 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 U.S. and other countries. Ultimately, we wanted a partner who could produce materials in both Europe and the U.S., and with Boehringer Ingelheim, we will have that capability."
Simon Sturge, Corporate Senior Vice President Biopharmaceuticals at Boehringer Ingelheim, commented, "We are delighted to be chosen by Servier and XOMA as their manufacturing partner for gevokizumab, and we look forward to leveraging our more than 35 years expertise in this area to support both companies in further executing their clinical development strategies for gevokizumab."