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Results From IMPROVE Study Show Therapeutic Effect of New Formulation of Rebif(R) at 16 Weeks in Patients With Multiple Sclerosis
Date:9/21/2008

-- Study meets primary endpoint by demonstrating significant effect of new formulation of Rebif(R) on disease activity as measured by MRI after 16

weeks of treatment

-- Data presented at late-breaking session of the World Congress on

Treatment and Research in Multiple Sclerosis in Montreal, Canada

GENEVA, Sept. 22 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the ongoing IMPROVE (Investigating MRI Parameters with Rebif imprOVEd formulation) study met its primary endpoint. The primary objective of the study was to evaluate the efficacy of the new formulation of Rebif(R), compared to placebo, in patients with relapsing-remitting multiple sclerosis (RRMS) and active disease by means of magnetic resonance imaging (MRI) at the end of 16 weeks of treatment. The 16- week study results show that the mean number of combined unique active brain MRI lesions per patient was reduced by 69% in patients treated with the new formulation of Rebif(R) compared with those receiving placebo, a statistically significant result (p<0.001). These data were presented at the late-breaking session of the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada.

"Patients who received Rebif(R) experienced far fewer new active brain MRI lesions than the placebo group after 16 weeks of treatment," said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa, Director of the MS Research Clinic at the Ottawa Hospital, and an investigator of the IMPROVE trial. "These data demonstrate a significant effect of the new formulation of Rebif(R) on disease activity and provide further evidence of its benefit in treating patients with relapsing-remitting multiple sclerosis."

The IMPROVE study is a two-arm, randomized, double-blind, controlled, multicenter, international Phase IIIb study to evaluate the efficacy, safety and tolerability of the new
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SOURCE Merck Serono
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