XOMA Announces Manufacturing Agreement With Les Laboratoires Servier and Boehringer Ingelheim
BERKELEY, Calif., Aug. 3, 2012 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA) announced today its partner Les Laboratoires Servier (Servier) and the Company have entered into an agreement with Boehringer Ingelheim to transfer XOMA's (XOMA) technology and process for the commercial manufacture of gevokizumab, XOMA's novel interleukin 1-beta (IL-1²) 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. "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 (XOMA 052) is a potent monoclonal antibody with unique allosteric modulating properties and the potential to treat patients with a wide variety of inflammatory diseases and other diseases. Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine that has been shown to be involved in Behçet's and other forms of non-infectious uveitis, cardiovascular disease, and other auto-inflammatory diseases. In binding to IL-1 beta, gevokizumab inhibits the activation of the IL-1 receptor, thereby modulating the cellular signaling events that produce inflammation.
Servier is XOMA's development and commercialization partner for gevokizumab. XOMA holds rights to gevokizumab in the U.S. and Japan for non-cardiometabolic indications, including non-infectious uveitis, acne, and erosive osteoarthritis of the hand for which clinical studies are ongoing. Information on all gevokizumab clinical studies can be found at www.clinicaltrials.gov .
About Non-infectious Uveitis
The term uveitis broadly refers to the inflammatory diseases that affect the portion of the eye known as the uvea, which is the middle of three layers that surround the eye. People with uveitis may experience decreased vision, pain, light sensitivity, and floaters. Uveitis may be caused by an infection that is commonly treated with an antimicrobial agent, or by an unknown pathogen triggering inflammation, called non-infectious uveitis.
The most common form of uveitis affects the front of the uvea and is known as anterior uveitis. Other forms include intermediate uveitis, posterior uveitis, and pan uveitis. These types differ in that they all include involvement of the back portions of the uvea. Posterior uveitis refers to inflammation in the retina and the choroid, and it may result from a different immune response trigger. Pan-uveitis refers to inflammation of all three major parts of the eye. Behçet's uveitis is a well-known form of pan-uveitis. Due to the swelling of tissues critical to vision, intermediate, posterior, and pan-uveitis (which collectively make up NIU) can lead to blindness if not treated.
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.
More information is available at: www.servier.com
About XOMA Corporation
XOMA combines a portfolio of innovative therapeutic antibodies, both in late-stage clinical development and in preclinical research, with its recently launched commercial operations. XOMA focuses its antibody research and development on allosteric modulation, which offers opportunities for new classes of therapeutic antibodies to treat a wide range of human diseases. XOMA is developing its lead product gevokizumab (IL-1 beta modulating antibody) with Les Laboratoires Servier (Servier) through a global Phase 3 program in non-infectious uveitis and ongoing proof-of-concept studies in other IL-1-mediated diseases. XOMA's scientific research also produced the XMet program, which consists of three classes of preclinical antibodies, including Selective Insulin Receptor Modulators (SIRMs) that could have a major effect on the treatment of diabetes. In order to retain significant value from its scientific discoveries, XOMA initiated commercial operations in January 2012 through the licensing of U.S. commercial rights to Servier's ACEON® (perindopril erbumine) and a patent-protected portfolio of product candidates.
More detailed information can be found at www.xoma.com .
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Certain statements contained herein concerning the successful completion of the technology and production process transfer, establishment of biological comparability and successful manufacture of gevokizumab, or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. These and other risks, including those scale-up, manufacturing and marketing capabilities, are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects as these statements are based on assumptions that may not prove accurate.
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