XOMA Corp. and partner Les Laboratoires Servier (Servier) have entered into an agreement with Boehringer Ingelheim to transfer XOMA's technology and process for the commercial manufacture of gevokizumab, XOMA's interleukin 1-beta (IL-1β) allosteric modulating antibody.
Gevokizumab is in Phase III trials for patients with non-infectious uveitis (NIU). Servier will also conduct a Phase III trial in patients with Behcet's uveitis. Upon completion of the transfer and the establishment of biological comparability, Boehringer will produce gevokizumab at its facility in Biberach, Germany, for XOMA's commercial use. XOMA and Servier retain rights to the development and commercialization of gevokizumab. Financial terms 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. "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, we will have that capability."
Simon Sturge, corporate senior vice president of Biopharmaceuticals at Boehringer Ingelheim, said, "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."