Boehringer Ingelheim has announced an agreement with Servier and its partner XOMA Corporation (Nasdaq: XOMA) 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). 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 Servier’s commercial use. Servier and XOMA 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. "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."
"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" said Christian Sauveur, Industrial General Director at Servier.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine. In 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro.
Boehringer Ingelheim Biopharma Contract Manufacturing is now represented by its new brand Boehringer Ingelheim BioXcellence™. As a leading biopharmaceutical contract manufacturer with more than 35 years of experience - the company has brought 19 biopharmaceutical products to market. Boehringer Ingelheim BioXcellence™ offers tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to fill and finish under one roof at its facilities in Biberach (Germany), Vienna (Austria) and Fremont (USA).
Boehringer Ingelheim BioXcellence™ can secure product supply throughout the entire product lifecycle - transferring customer projects at any stage, delivering to almost any scale and thereby makes outsourcing easy.
About Servier
Servier is a privately-run French research-based pharmaceutical company. Current therapeutic domains for Servier medicines are cardiovascular, metabolic, neurological, psychiatric and bone and joint diseases, as well as oncology. Servier is established in 140 countries worldwide with over 20,000 employees and a 2011 turnover of €3.9 billion. Servier invests 25% of its turnover in R&D.