Merck KGaA temporarily suspends cancer vaccine Stimuvax clinical program due to case of encephalitis

23 March 2010

Merck Serono, a division of German drug major Merck KGaA, and its US affiliate, EMD Serono, have temporarily suspended the clinical program for its cancer vaccine Stimuvax (BLP25 liposome vaccine) in all recruiting studies worldwide as a result of a suspected unexpected serious adverse reaction (SUSAR). This decision was taken in alignment with the US Food and Drug Administration's clinical hold placed on the Investigational New Drug application for Stimuvax.

Shares of Merck dropped as much as 2.8% in early Frankfurt trade, and the company's stock has lost about 8% of its value over the last year. The firm suffered when it failed to get extended use of its blockbuster cancer drug Erbitux (cetuximab) for lung tumors and fading prospects of approval for its multiple sclerosis drug candidate cladribine, after the US FDA issued a 'refuse to file' letter on the firm's New Drug Application for the compound as a therapy for relapsing forms of MS (The Pharma Letter December 1, 2009).

Another setback for the firm

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