Merck Serono Resubmits U.S. Application for Cladribine Tablets as a Potential MS Therapy

GENEVA, June 8, 2010 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Cladribine Tablets as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS). The company received a refuse to file letter from the FDA for the Cladribine Tablets NDA in November 2009.

Regulatory filings for Cladribine Tablets are currently under review in a number of other locations including the European Union.

About Cladribine Tablets

Merck Serono's proprietary 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.

    
    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 its two-year  
      extension 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 ON To Interferon beta-1a
      in Patients With Active Relapsing Disease) study: a Phase II
      placebo-controlled trial designed primarily to evaluate the safety and
      tolerability of adding Cladribine Tablets treatment to patients with
      relapsing forms of MS, who have experienced breakthrough disease while 
      on established interferon-beta therapy. This trial was announced in 
      January 2007.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that more than two million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately incorporated affiliates.

Merck Serono has leading brands serving patients with cancer (Erbitux(R), cetuximab), multiple sclerosis (Rebif(R), interferon beta-1a), infertility (Gonal-f(R), follitropin alfa), endocrine and metabolic disorders (Saizen(R) and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride) as well as cardiometabolic diseases (Glucophage(R), metformin), (Concor(R), bisoprolol), (Euthyrox(R), levothyroxine). Not all products are available in all markets.

With an annual R&D expenditure of more than EUR 1 billion, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.7 billion in 2009, a history that began in 1668, and a future shaped by approximately 33,600 employees in 64 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit http://www.merckserono.com or http://www.merck.de

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