Merck's Mavenclad (Cladribine Tablets) Approved for Relapsing-Remitting Multiple Sclerosis in Canada

Darmstadt, Germany, December 4, 2017/PRNewswire-FirstCall/ - Merck, a leading science and technology company, today announced that Health Canada has approved MAVENCLAD™ (Cladribine Tablets) as monotherapy for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and delay the progression of disability. MAVENCLAD™ is generally recommended in multiple sclerosis (MS) patients who have had an inadequate response to, or are unable to tolerate, one or more therapies for multiple sclerosis (2). MAVENCLAD™ is the first and only oral short-course treatment to provide efficacy across key measures of disease activity in patients with RRMS, including disability progression, annualized relapse rate and magnetic resonance imaging (MRI) activity.

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"Mavenclad is a unique new treatment for our patients that offers potent efficacy with only 20 days of oral treatment over two years", said Dr. Mark S. Freedman, Director, Multiple Sclerosis Research Unit at the Ottawa Hospital, Senior Scientist at The Ottawa Hospital Research Institute and investigator for the CLARITY study.

"Health Canada's approval of Mavenclad represents a significant milestone", said Rehan Verjee, EVP, Chief Marketing and Strategy Officer at the biopharma business of Merck. "We are exceptionally proud of our long-standing partnership with the MS community in Canada and would like to thank the many Canadian patients and investigators who have supported the development of Mavenclad".

MAVENCLAD™ is a selective immune reconstitution therapy (3) (4) which simplifies treatment administration, by giving patients just two short annual courses of tablets with a maximum of 20 days of treatment over two years. MAVENCLAD™ works by selectively targeting B & T lymphocytes followed by a distinct pattern of lymphocyte reconstitution, without continuous suppression of the immune system (2).

The Health Canada Notice of Compliance follows the European Commission (EC) marketing authorization received in August 2017. Product availability in Canada is expected in early January, 2018. Merck plans additional filings for regulatory approval in other countries, including the United States.

MAVENCLAD

MAVENCLAD (cladribine tablets) is approved in the European Union for the treatment of highly active relapsing multiple sclerosis (RMS) and Canada for the treatment of relapsing-remitting multiple sclerosis (RRMS). MAVENCLAD is a short-course oral therapy that selectively targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for cladribine tablets for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland.

The clinical development program for MAVENCLAD (cladribine tablets) includes:

- The CLARITY (cladribine tablets Treating MS Orally) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients with RRMS;

- The CLARITY extension study: a two-year Phase III placebo-controlled study following on from the CLARITY study, designed to evaluate the safety and efficacy of cladribine tablets over an extended administration for four years;

- The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III placebo-controlled study 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);

- The ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study 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;

- PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Studies) study: interim long-term follow-up data from the prospective registry, PREMIERE, to evaluate the safety and efficacy of cladribine tablets This includes more than 10,000 patient years of data with over 2,700 patients included in the clinical trial program, and more than 10 years of observation in some patients.

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 2.3 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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Merck

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of € 15.0 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

1. MS Society of Canada. What is MS. Accessed April 24, 2017. Available at: https://mssociety.ca/about-ms/what-is-ms

2. MAVENCLAD™ Product Monograph. November 2017

3. Giovannoni G. Personalized medicine in multiple sclerosis. 2017 Neurodegenerative Disease Management; 7 (6s) 13-17

4. Giovannoni G. Cladribine to Treat Relapsing Forms of Multiple Sclerosis. Neurotherapeutics. November 2017; DOI 10.1007/s13311-017-0573-4

Source: Merck

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