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EMD Serono Receives Complete Response Letter From FDA on Cladribine Tablets New Drug Application
Date:3/2/2011

dies are expected by the end of 2011. Top-line results from the ONWARD(3) study are expected in the first half of 2012.

Cladribine Tablets are approved and available under the trade name Movectro® in Australia and Russia as a treatment of relapsing-remitting MS and are under regulatory review in other countries.(1) CLARITY: CLAdRIbine Tablets treating MS orallY(2) ORACLE MS: ORAl CLadribine in Early MS(3) ONWARD: Oral Cladribine added oN to interferon beta-1a in patients With Active Relapsing DiseaseAbout Cladribine TabletsEMD Serono's oral formulation of cladribine (Cladribine Tablets) is an investigational treatment for patients with relapsing forms of multiple sclerosis (MS). Cladribine is a small molecule that may interfere with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS. Cladribine Tablets were approved in Russia in July 2010 and in Australia in September 2010 as a treatment of relapsing-remitting MS and are under regulatory review in other countries.

The clinical development program for Cladribine Tablets includes:

- The CLARITY (CLAdRIbine Tablets treating MS orallY) study and its extension: a two-year Phase III placebo-controlled trial designed to evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in patients with relapsing-remitting MS and the CLARITY EXTENSION two-year Phase III study designed to provide data on the long-term safety and efficacy of extended administration of Cladribine Tablets for up to four years.

- The ORACLE MS (ORAl CLadribine in Early MS) study: a two-year Phase III placebo-controlled trial designed to evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS). This trial was announced in September 2008.

- The ONWARD (Oral Cladribine added o
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SOURCE EMD Serono, Inc.
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