EMD Serono Receives Positive Recommendation for MAVENCLAD® (cladribine tablets) for the treatment of Relapsing-Remitting Multiple Sclerosis from the Institut national d'excellence en santé et en services sociaux (INESSS)

This decision brings ^PrMAVENCLAD® (cladribine tablets) closer to broader access for eligible patients living with Relapsing-Remitting Multiple Sclerosis in the province of Quebec

MISSISSAUGA, ON, Feb. 6, 2020 /CNW/ - EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that it received a positive recommendation from the Institut national d'excellence en santé et en services sociaux (INESSS) for MAVENCLAD (cladribine tablets). MAVENCLAD was approved by Health Canada in November 2017 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.ⁱ

With the positive assessment of the therapeutic value of MAVENCLAD from INESSS to Quebec's Minister of Health and Social Services, EMD Serono will now work with the Ministère de la Santé et des Services sociaux to include MAVENCLAD on the Régie de l'assurance maladie du Québec (RAMQ) List of Medications.  Once included on the RAMQ List of Medications, eligible patients living in the province of Quebec will have equitable access to MAVENCLAD as a treatment option for RRMS, which is currently reimbursed by most private drug insurance plans. 

"We are delighted with the positive recommendation from INESSS, which recognizes the therapeutic value of MAVENCLAD and the need for this treatment option for eligible patients who live with RRMS," said Gaby Murphy, President & Managing Director, EMD Serono, Canada. "We welcome this as an important step to ensure broader and equitable access to MAVENCLAD in the province of Quebec."

"Some 20,000 people in Quebec alone are living with MS, and the INESSS recommendation for MAVENCLAD is great news for patients," said Louis Adam, Executive Director of the Quebec and Atlantic Division of the MS Society of Canada. "Having access to new and innovative treatment options is important for people living with MS in the province of Quebec, and we are delighted by this positive step forward."

Canada has one of the highest rates of MS in the world, with one in 385 people living with the disease.ⁱⁱ EMD Serono, Canada is deeply committed to people living with MS, and to leading innovation within the MS space.

About MAVENCLAD
MAVENCLAD (cladribine tablets) is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS.ⁱⁱⁱ In November 2017, Health Canada approved MAVENCLAD (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 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.

MAVENCLAD has been approved in over 70 countries including the United States, European Union (EU), Australia and Switzerland, for various relapsing MS indications.

The clinical development program of MAVENCLAD 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
Multiple Sclerosis (MS) is a degenerative autoimmune disease in which the myelin sheath around the nerves in the brain and spinal cord are inflamed and often damaged.^iv It is estimated that approximately 2.3 million people have MS worldwide.^v Canada has one of the highest rates of MS in the world with one in 385 people living with the disease.^vi While symptoms vary, the most common symptoms of MS include extreme fatigue, lack of coordination, weakness, tingling, impaired sensation, vision problems, bladder problems, cognitive impairment and mood changes.^vii The relapsing forms of MS are the most common type at the time of diagnosis.^viii

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, a leading science and technology company, operates across healthcare, life science and performance materials. Around 56,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2018, Merck KGaA, Darmstadt, Germany, generated sales of € 14.8 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

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i	EMD Serono. Mavenclad (Cladribine) Product Monograph. November 2017. https://pdf.hres.ca/dpd_pm/00042413.PDF
ii	MS Society of Canada. About MS. What is MS. Accessed November 27, 2019. Available at https://mssociety.ca/about-ms/what-is-ms
iii	EMD Serono. Mavenclad (Cladribine) Product Monograph. November 2017. https://pdf.hres.ca/dpd_pm/00042413.PDF
iv	MS Society of Canada. What is MS. Accessed November 27, 2019. Available at https://mssociety.ca/about-ms/what-is-ms
v	MS International Federation. Atlas of MS. Accessed November 27, 2019. Available at https://www.msif.org/about-us/who-we-are-and-what-we-do/advocacy/atlas/.
vi	MS Society of Canada. About MS. What is MS. Accessed November 27, 2019. Available at https://mssociety.ca/about-ms/what-is-ms
vii	Ibid
viii	MS Society of Canada. About MS. Types. Accessed March 27, 2019. Available at https://mssociety.ca/about-ms/types

SOURCE EMD Serono, Canada

or to arrange an interview, please contact: Hibaq Ali, Weber Shandwick Canada, 416.642.7915, [email protected]; Smita Devane-Bhan, Associate Director of Communications, EMD Serono Canada, 905.483.3860, [email protected]