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Merck Serono's Safinamide Significantly Improved Motor Function in Patients With Advanced Parkinson's Disease in a Phase III Pivotal Trial
Date:2/3/2009

y. The primary efficacy endpoint of the study was the increase in mean daily "ON" time ("ON" time without dyskinesia plus "ON" time with minor dyskinesia) during an 18-hour period as assessed by patients' recordings on diary cards.

Out of the 669 randomized patients, 89% of patients treated with safinamide completed the study (91% in the 50 mg dose group and 87% in the 100 mg dose group) compared to 89% in the placebo group. Over 90% of patients who completed the initial 24 weeks of treatment elected to enter a 78-week, placebo-controlled double-blind extension study, which is ongoing, to specifically assess the effect on dyskinesias as primary endpoint.

Secondary efficacy endpoints of this study were also met, including decrease in daily "OFF" time, decrease in mean "OFF" time following first morning dose of levodopa, mean change from baseline in the Unified Parkinson's Disease Rating Scale (UPDRS)(2) Section III (motor) score during "ON" time and mean change in Clinical Global Impression of severity of disease and change from baseline (CGI)(3). The incidence of dropouts, serious adverse events or clinically notable events among the three groups of the study were comparable.

Full study results after completion of ongoing analyses will be submitted for presentation at upcoming scientific meetings.

Merck Serono has exclusive worldwide rights to develop, manufacture and commercialize safinamide in Parkinson's disease, Alzheimer's disease and other therapeutic applications, as per the agreement signed with Newron in 2006.

About safinamide

Safinamide, an alpha-aminoamide derivative that is orally formulated, is currently being developed by Merck Serono and Newron as an add-on treatment for patients with Parkinson's disease. Safinamide is believed to have a novel dual mechanism of action based on the enhancement of the dopaminergic function (through reversible inhib
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SOURCE Merck Serono
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