MAVENCLAD™ (cladribine tablets) Receives Positive CADTH Canadian Drug Expert Committee (CDEC) Recommendation

Funding recommendation marks an important step to provide access to this innovative new oral treatment for Canadians living with relapsing-remitting multiple sclerosis (RRMS)

MISSISSAUGA, ON, Oct. 29, 2018 /CNW/ - Merck KGaA, Darmstadt, Germany, a leading science and technology company, operating as EMD Serono in the U.S. and Canada, is pleased to announce that the CADTH Canadian Drug Expert Committee (CDEC) has issued a positive recommendation that MAVENCLAD^TM (cladribine tablets) be reimbursed by public drug plans as a treatment for adult patients living with relapsing-remitting multiple sclerosis (RRMS).

The next step in the reimbursement process is to work with the pan-Canadian Pharmaceutical Alliance (pCPA) to negotiate for the funding of MAVENCLAD^TM by provincial and territorial drug plans.  MAVENCLAD^TM is also currently available through the majority of plans from private insurers.

MAVENCLAD^TM "occupies a unique place amongst existing therapies, and as a neurologist caring for people living with MS, I am very happy that the option of Mavenclad is available for my patients," said Dr. Jiwon Oh, MD, PhD, FRCPC. Staff Neurologist, St-Michael's Hospital Scientist, Keenan Research Centre of the Li Ka Shing Knowledge Institute, Assistant Professor, Department of Medicine, University of Toronto. 

The CDEC recommendation in Canada follows the October 2018 selection of MAVENCLAD^TM as a Rapid Uptake Productⁱ in the United Kingdom by the National Institute for Health and Care Excellence (NICE) Accelerated Access Collaborative (AAC). Along with the UK, Canada now joins a number of countries including Australia, Germany, Ireland, the Netherlands and Sweden in their recommendations to reimburse MAVENCLAD.

EMD Serono Canada applauds the decision, noting that the CDEC recommendation reflects the clinical evidence that supports the benefits of MAVENCLAD^TM for use in a well-defined group of RRMS patients.

The CDEC recommendation was based on the results of a double-blind, randomized controlled trial (RCT) of patients with RRMS who had at least one relapse within 12 months before study entry and who had not had two or more previous disease-modifying therapies (CLARITY, N = 1,326),ⁱⁱ Researchers found that MAVENCLAD^TM was superior to placebo for reducing annualized relapse rates (rate ratio of 0.43; 95% confidence interval [CI], 0.34 to 0.54, P < 0.001).ⁱⁱⁱ Furthermore, MAVENCLAD^TM was associated with a decreased risk of confirmed disease progression sustained for three months as compared with placebo (hazard ratio of 0.67; 95% CI, 0.48 to 0.93, P = 0.018).^iv The CDEC noted that MAVENCLAD^TM provides an alternative disease-modifying therapy for patients with RRMS while offering a different safety profile relative to other disease-modifying therapies for RRMS.^v

"Having been part of the Canadian MS Community for over 20 years, our entire company is truly energized and proud to bring an innovative new treatment option like MAVENCLAD^TM to Canadians living with MS," said Gaby Murphy, Country Director, EMD Serono Canada. "We thank CADTH for their thorough review process and the recommendation that MAVENCLAD^TM be reimbursed.  We are thrilled as this decision brings more choice to patients and their clinicians; and we look forward to working with the pCPA to make MAVENCLAD^TM available through public drug plans."

About MAVENCLAD^TM
MAVENCLAD^TM (cladribine tablets) is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of MS. In November 2017, Health Canada approved MAVENCLAD^TM (cladribine tablets) as monotherapy for the treatment of adult patients with RRMS to reduce the frequency of clinical exacerbations and delay the progression of disability. MAVENCLAD^TM is generally recommended in MS patients who have had an inadequate response to, or are unable to tolerate, one or more therapies for multiple sclerosis. As of August 2018, MAVENCLAD^TM has been approved in more than 40 countries since August 2017, including the European Union (EU), Canada, Australia, Israel, Argentina, United Arab Emirates, Chile and Lebanon. It has also been accepted for filing by the U.S. Food and Drug Administration (FDA).  Additional filings in other countries are planned for 2018. It is not yet approved for any use in the United States.

The clinical development program of MAVENCLAD^TM in MS comprises more than 12,000 patient years of data with over 2,700 patients included in the clinical trial program, and up to 10 years of observation in some patients. These clinical trials include the Phase III CLARITY, CLARITY extension and ORACLE MS trials, the Phase II ONWARD trial and the PREMIERE Long-term Safety Registry.

About 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. Canada has one of the highest rates of MS in the world with one in 340 people living with the disease. 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 EMD Serono, Canada
EMD Serono, Canada, is the Canadian biopharmaceutical business of Merck KGaA, Darmstadt, Germany. EMD Serono, Canada has integrated cutting-edge science, innovative products and devices, and industry-leading patient support and access programs. EMD Serono, Canada has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in neurology, oncology, immunology and immuno-oncology. Today, EMD Serono, Canada has more than 100 employees across Canada with headquarters in Mississauga, Ontario.

About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany is a leading science and technology company in healthcare, life science and performance materials. More than 53,000 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 2017, Merck KGaA, Darmstadt, Germany generated sales of € 15.3 billion in 66 countries.

Founded in 1668, Merck KGaA, Darmstadt, Germany is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany 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. 

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ⁱ NICE - Accelerated Access Collaborative. Rapid Uptake Products Announcement. Accessed October 25, 2018. Available at: http://www.ahsnnetwork.com/nhs-test-beds-accelerated-access-collaborative/
ⁱⁱ CADTH. CADTH Canadian Drug Expert Committee Recommendation. Accessed October 25, 2018. On file.
ⁱⁱⁱ Giovannoni G, Comi G, Cook S et al. A Placebo-Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis. 2010 New England Journal of Medicine 362:416-426.
^iv Ibid.
^v CADTH. CADTH Canadian Drug Expert Committee Recommendation. Accessed October 25, 2018. On file.

SOURCE EMD Serono, Canada

For more information, or to arrange an interview, please contact: Samantha Ouimet, EMD Serono Canada, Head of Communications, Canada, 905.919.0296, [email protected]; Hibaq Ali, Weber Shandwick Canada, 416.642.7915, [email protected]