Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients With Multiple...( - Primary Endpoint met With a Signifi...),Health

- Primary Endpoint met With a Significant Reduction in Relapse Rate

- Secondary Endpoints met Including MRI Measures, Proportion of Patients Relapse-Free and Disability Progression

- Submission for Registration of Cladribine Tablets Planned for mid-2009

SEATTLE and GENEVA, April 30 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, announced today detailed results of the two-year (96-week) placebo-controlled CLARITY(1) Phase III trial using Cladribine Tablets (Merck Serono's proprietary investigational oral formulation of cladribine) to treat patients with relapsing-remitting multiple sclerosis (MS). The results of the pivotal trial show that annual short-course treatment with Cladribine Tablets led to a significant reduction in the rate of clinical relapses, disability progression and brain lesions, as well as a significant increase in the proportion of patients who remained relapse-free. The data were presented today for the first time, as a late-breaking oral presentation at the 61st Annual Meeting of the American Academy of Neurology (AAN) in Seattle, WA.

"All primary and secondary endpoints of the CLARITY study were statistically significant and demonstrate that annual short-course treatment with Cladribine Tablets in this study was effective across multiple important clinical and MRI efficacy measures," said Dr. Gavin Giovannoni, principal investigator of the study, Institute of Cell and Molecular Science, Barts and The London School of Medicine and Dentistry, London, United Kingdom.

"We are very pleased with the successful outcome of the CLARITY study," said Elmar Schnee, President of Merck Serono. "This is an exciting development in multiple sclerosis clinical research, and represents an important step towards delivering an oral therapy to people living with this condition."

The results from both Cladribine Tablets treatment groups in the study d
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