Merck KGaA ’s Cladribine Tablets for MS Approved in Russia

  • First approval of an oral, disease-modifying therapy for multiple sclerosis
  • Cladribine Tablets will be marketed in Russia under the trade name Movectro
  • Russian launch expected early 2011

Darmstadt, Germany, July 12, 2010 - Merck KGaA announced today that the Russian Federal Service on Surveillance in Healthcare and Social Development has become the first government agency to grant marketing approval to Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS). Cladribine Tablets will be available in Russia under the trade name Movectro®.

“This approval for Cladribine Tablets means that people with multiple sclerosis in Russia will benefit soon from this effective oral treatment,” said Elmar Schnee, Member of the Board of Merck KGaA and head of the Merck Serono division. “This is an important milestone reinforcing Merck Serono’s leadership position and ongoing commitment to fight against the devastating disease of multiple sclerosis. We expect other regulatory approvals in the near future.”
Merck initiated its global filings in mid-2009 and, to date has submitted regulatory applications for Cladribine Tablets in about 40 countries.

“The availability of Cladribine Tablets in Russia will represent a key milestone for people with multiple sclerosis as this is the first approval of an orally-administered disease-modifying therapy for multiple sclerosis”, said Professor Alexey Boyko, Department of Neurology and Neurosurgery at the Russian State Medical University, Moscow. “This approval is an important step toward optimizing medical care in multiple sclerosis.”

“The approval of Cladribine Tablets will transform the way Russian patients with relapsing-remitting multiple sclerosis and physicians approach therapy options,” said Professor Gavin Giovannoni, Blizard Institute of Cell and Molecular Science, Barts and The London School of Medicine and Dentistry, London, United Kingdom, and principal investigator of the CLARITY study. “I hope that this new therapeutic option will also be available soon for people living with multiple sclerosis in other countries.”

Merck will now apply for the listing of Cladribine Tablets within the Russian State Federal drug reimbursement program. The company expects to launch Movectro in Russia in early 2011.

Russian registration was supported by the results from the CLARITY1 study, the largest placebo-controlled Phase III clinical trial in relapsing-remitting MS completed to date. A total of 1,326 patients with relapsing-remitting MS were randomized at 155 centers in 32 countries, including 23 centers in Russia. The CLARITY study results, recently published in The New England Journal of Medicine2, show that short-course treatment with Cladribine Tablets significantly reduced relapse rates (the primary endpoint), the risk of disability progression (a key secondary endpoint), and MRI measures of disease activity (other key secondary endpoints) at 96 weeks. Adverse events that were more frequent in the Cladribine Tablets groups included lymphopenia and herpes zoster.

1 CLARITY: CLAdRIbine Tablets Treating MS OrallY
2 Giovannoni G et al. A placebo-Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis; available on www.nejm.org; will also be published in the February 4, 2010 printed issue of The New England Journal of Medicine


CLARITY study design
The CLARITY study was a two-year (96-week), randomized, double-blind, placebo-controlled, international trial. It randomized 1,326 patients with relapsing-remitting MS according to the revised McDonald criteria. Study participants were randomized to one of three different treatment groups consisting of two different dose regimens of Cladribine Tablets or matching placebo tablets (1:1:1 ratio). Cladribine Tablets were given in two (3.5 mg/kg total dose) or four (5.25 mg/kg total dose) treatment courses in the first year, with each course consisting of once daily administration for four to five consecutive days (depending on patient weight), which means study patients took Cladribine Tablets for 8 to 20 days during the year. In the second year, two treatment courses were administered to all patient groups, meaning that patients took Cladribine Tablets for 8 to 10 days during the year.
The primary endpoint of the CLARITY study was the relapse rate over 96 weeks. Secondary endpoints included MRI endpoints, proportion of subjects relapse-free and disability progression at 96 weeks.


About Cladribine Tablets
Merck Serono’s oral formulation of cladribine (Cladribine Tablets) is an investigational treatment for patients with relapsing-remitting 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. Merck Serono has applied for marketing approval of Cladribine Tablets in the European Union, the United States and other locations.
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 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 approximately 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.
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