Autoimmune and Inflammatory Diseases Audited

Sales of our psoriasis treatment Raptiva® (efalizumab) rose by 22% to € 93 million. Raptiva® is approved in more than 60 countries around the world. Owing to sharply lower sales expectations, product technology assets were written off in full, leading to an expense of € 195 million. In the United States, Raptiva® is marketed by Genentech.

Raptiva® is approved for the treatment of adult patients with moderate to severe chronic plaque psoriasis. In some countries, this indication is further restricted to patients who have failed to respond to, or who have a contraindication to, or are intolerant to certain other systemic therapies. Since its approval, approximately 46,000 patients have been treated with Raptiva® worldwide.

However, since October 2008, Merck Serono has been notified of a reported side effect, namely a limited number of confirmed cases of progressive multifocal leukoencephalopathy (PML), a usually fatal viral infection of the central nervous system. The Merck Serono division and the regulatory agencies are reviewing the situation carefully and taking the necessary measures.