SERVIER announces Joint Development and Commercialization with XOMA on Novel Therapeutics for Orphan Disease

06/01/2011

Suresnes, France, January 4, 2011 - Servier and XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, today announced the signing of an 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. Servier will fund the first $50 million of XOMA 052 development expenses and 50% of further expenses for the Behcet’s uveitis indication. 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 2011, Servier and XOMA expect to hold discussions with multiple regulatory agencies to initiate Phase 3 studies of XOMA 052 in Behçet’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 Behçet’s disease from regulators in the European Union and in the USA. 

“XOMA 052 gives us a later-stage asset to develop for diabetes and cardiovascular diseases, which are both areas of strength for us, as well as for rare diseases,” said Emmanuel Canet, M.D., Ph.D., Servier’s President, Research and Development. “With this therapeutic antibody designed to inhibit interleukin-1 beta we are reinforcing our strategy in the field of biologics and developing novel approaches aimed at treating severe diseases. We are especially eager to shepherd the development of XOMA 052 for the treatment of patients with Behçet’s uveitis, a population that has very few options and may face eventual blindness.”

About Behçet’s Disease

Behçet’s disease causes chronic inflammation of the blood vessels, or vasculitis, among other complications. Uveitis is a vasculitis of the blood vessels in the eye which can be vision-threatening. Behcet’s uveitis is one of the most severe forms of uveitis which can lead to blindness and affects approximately 60% of Behcet’s disease patients.

There are at least 250,000 patients diagnosed with Behcet’s disease worldwide. Onset of the disease occurs most commonly in adults in their twenties, thirties and forties, and is typically more severe in men.

Without immediate treatment, major exacerbations of Behçet’s uveitis may lead to retinal detachment, macular edema, vitreous hemorrhage, glaucoma and eventual blindness. The effects of these exacerbations on vision are cumulative. Patients often experience multiple exacerbations per year, requiring treatment to control the frequency and severity of attacks of this chronic disease.