Date: 2011-01-04
Type of information: Development agreement
Compound: gevokizumab (Xoma 052)
Company: Servier (France) Xoma (USA - CA)
Therapeutic area: Cancer - Oncology - Inflammatory diseases - Rare diseases
Type agreement:
Action mechanism: XOMA 052 is a monoclonal antibody with the potential to improve the treatment of patients with a wide variety of inflammatory diseases and other diseases including cancer. XOMA 052 binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine involved in Behcet\'s uveitis, diabetes, cardiovascular disease, rheumatoid arthritis, gout, and other auto-inflammatory diseases. IL-1 is a well-validated therapeutic target, with three marketed IL-1 inhibitors that have been used by more than 200,000 patients overall. By binding to IL-1 beta, XOMA 052 inhibits the activation of the IL-1 receptor, thereby preventing the cellular signaling events that produce inflammation.
Disease: Behcet\'s uveitis, inflammatory diseases, cancer
Details: * On January 4, 2011, Xoma, a leader in the discovery and development of therapeutic antibodies, and Les Laboratoires Servier (Servier), France\'s largest privately-held pharmaceutical company, announced the signing of a regional agreement to jointly develop and commercialize XOMA 052, XOMA\'s anti-inflammatory drug candidate, in multiple indications. XOMA 052 is designed to inhibit the pro-inflammatory cytokine interleukin-1 beta that is believed to be a primary trigger of pathologic inflammation in multiple diseases. Xoma will receive approximately $35 million upfront, up to approximately $470 million in milestone payments and tiered royalties up to a mid-teens percentage rate. The US company retains development and commercialization rights for Behcet\'s uveitis and other inflammatory and oncology indications in U.S. and Japan. Servier receives similar rights in the rest of the world. XOMA 052 is expected to advance into Phase 3 development in Behcet\'s uveitis in 2011. Servier will fund development for diabetes and cardiovascular disease indications in exchange for worldwide rights. Xoma retains development and commercialization rights for Behcet\'s uveitis and other inflammatory and oncology indications in U.S. and Japan. Servier receives similar rights in the rest of the world. Servier will fund development for diabetes and cardiovascular disease indications in exchange for worldwide rights. Xoma retains an option to reacquire the development and commercialization rights to the diabetes and cardiovascular indications in the U.S. and Japan by paying an option fee and partial reimbursement of incurred development expenses. If Xoma reacquires these rights, it has the ability to license them to one or more third parties. In 2011, Xoma and Servier expect to hold discussions with multiple regulatory agencies to initiate Phase 3 studies of XOMA 052 in Behcet\'s uveitis, a debilitating ophthalmic inflammatory condition that often leads to vision-threatening complications including blindness. XOMA 052 has already received orphan drug designations for Behcet\'s disease from regulators in the U.S. and European Union, which support an expedited path to commercialization. XOMA expects to release results from two ongoing Phase 2 studies in patients with Type 2 diabetes in the first quarter of 2011.
Financial terms: Xoma will receive approximately $35 million in an upfront payment consisting of $15 million and a 15 million euro loan, which does not have to be repaid until 2016. Regarding milestone payments, if XOMA reacquires diabetes and cardiovascular rights in the U.S. and Japan, then the milestone payments could be up to $470 million as mentioned above. If Xoma does not reacquire these rights, then the milestone payments could be up to $800 million. XOMA will be responsible for Xoma 052 manufacturing throughout clinical development and launch and anticipates being a long-term manufacturer. This adds to the company\'s potential profit participation during the life of the commercial product.
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