EMA recommends orphan medicinal product designation for XOMA 052 in treatment of Behcet's disease

Jul 29 2010

XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced that the Committee for Orphan Medical Products of the European Medicines Agency (EMA) has adopted a positive opinion and recommends the granting of orphan medicinal product designation for XOMA 052, an antibody to interleukin-1 beta, for the treatment of Behcet's disease. Positive opinions are submitted to the European Commission for decision and are generally adopted within 30 days of receipt.

The EMA's orphan drug program is designed to promote the development of drugs to treat life-threatening or chronically debilitating conditions with a prevalence of up to five in 10,000 persons in the European Union (EU). The designation provides EU market exclusivity for up to ten years following approval for the given indication. Other potential benefits include protocol assistance, direct access to centralized marketing authorization procedures and financial incentives.

In June 2010, XOMA announced positive results from an open-label pilot study of XOMA 052 in Behcet's disease patients who were suffering from vision-threatening disease exacerbations, known as uveitis, despite maximal doses of immunosuppressive medicines. All seven patients who enrolled in the trial displayed rapid reduction of intraocular inflammation and improvement in visual acuity or other ophthalmic measures following a single treatment with XOMA 052. Five patients received a second infusion to blunt a developing exacerbation, and all responded to the second infusion. The drug appeared to be safe, and no drug-related adverse events were reported. Preliminary results were presented at the Annual Congress of the European League Against Rheumatism (EULAR) in Rome, Italy and at the International Congress on Behcet's Disease in London earlier this month.