Merck KGaA: Enrollment Completed for ORACLE MS Study of Cladribine Tablets in Patients at Risk of Developing MS

Darmstadt, Germany, November 17, 2010 – Merck KGaA announced today the completion of patient enrollment in the ORACLE MS 1 clinical study. This randomized, double blind, placebo-controlled, international Phase III trial is designed to evaluate the therapeutic effects of Cladribine Tablets on the time to conversion to multiple sclerosis (MS) in people with a first clinical event suggestive of the disease. A total of 617 patients considered at high risk of developing MS due to a recently experienced isolated demyelinating event and having magnetic resonance imaging (MRI) brain scans consistent with early signs of MS were randomized in the study.

The clinical development program of Cladribine Tablets is designed to characterize the potential therapeutic effects of Cladribine Tablets therapy at the various stages of multiple sclerosis, said Dr. Bruno Musch, Merck Serono’s Head of Global Clinical Development Neurodegenerative Diseases. The completion of patient enrollment in the ORACLE MS study is a significant milestone as this study will provide insight on the impact of Cladribine Tablets therapy on the course of multiple sclerosis when administered early in the disease process.

Besides the ORACLE MS study, the Phase III program of Cladribine Tablets includes the completed CLARITY 2 study and the ongoing CLARITY EXTENSION study in patients with relapsing-remitting MS. Cladribine Tablets were recently approved in Australia and Russia as a treatment of relapsing-remitting MS, under the brand name Movectro®, and are under regulatory review in other countries. Registration applications for Cladribine Tablets as a treatment for relapsing-remitting MS are supported by the results from the CLARITY study.

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