From October 2008 to February 2009, Merck Serono reported to the European Medicines Agency (EMA) three virologically confirmed fatal cases of progressive multifocal leukoencephalopathy (PML). They were observed as adverse events in patients treated with Raptiva®, our drug for the treatment of moderate-to-severe psoriasis. In February, the EMA recommended the suspension of the marketing authorization for Raptiva®. Subsequent to the EMA recommendation, we worked closely with the drug regulatory agencies not only in Europe, but also in all our other markets to terminate the supply of Raptiva® and withdraw the product from the market around the world.
As a result of the sales termination and product recalls, sales of Raptiva® dropped from € 93 million in 2008 to € 4.7 million. We recorded an exceptional item of € 40 million for all costs associated with the suspension of the marketing authorization. Merck Serono intends to continue to focus on Autoimmune and Inflammatory Diseases, a commitment that is underscored by the development projects in our pipeline in conditions as diverse as systemic lupus erythematosus and osteoarthritis.
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