MAVENCLAD® (cladribine tablets) is available through public drug plans for the majority of eligible Canadians with Relapsing-Remitting Multiple Sclerosis

Eligible patients can access ^PrMAVENCLAD® through public drug plans in seven provinces and two federal programs

MISSISSAUGA, ON, Oct. 27, 2020 /CNW/ - EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, is pleased to announce that eligible patients have access to ^PrMAVENCLAD® (cladribine tablets) through seven provincial public drug plans including the Régie de l'assurance maladie du Québec (RAMQ) and the Ontario Drug Benefit Exceptional Access Program. This is an important step to ensure broader, equitable and timely access to MAVENCLAD for eligible patients across Canada.

Eligible patients in Alberta, Manitoba, New Brunswick, Nova Scotia, Ontario, Quebec and Saskatchewan living with relapsing-remitting multiple sclerosis (RRMS) can now access MAVENCLAD through their public drug programs. MAVENCLAD is also currently reimbursed by the Non-Insured Health Benefits (NIHB) Program, Veteran's Affairs Canada (VAC) and most private drug insurance plans across the country.

"Patients living with MS can face significant daily and long-term challenges on their journey. Access to new and innovative medications to ease that burden should not pose an obstacle to MS patients," said Dr. Alexandre Prat, Neurologist and Researcher at CRCHUM, Canada Research Chair in Multiple Sclerosis Professor of Neuroscience and Associate Vice-Dean for Clinical Research, Faculty of Medicine, University of Montreal. "The addition of MAVENCLAD, a short course oral treatment, to provincial benefit plans provides a welcomed option for patients and physicians."

MAVENCLAD is available through the majority of the public drug plans following the positive reimbursement recommendations from the Institut national d'excellence en santé et en services sociaux (INESSS) in February 2020 and the CADTH Canadian Drug Expert Committee (CDEC) in October 2018.  Negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) were completed in late 2019.

"On average, 11 Canadians are diagnosed with MS every day. Ensuring Canadians have access to all Health Canada approved treatments for MS is vital to help manage their disease and live well," said Pamela Valentine, President and CEO of the MS Society of Canada.

Canada has one of the highest rates of MS in the world, with an estimated 1 in 385 people living with the disease.ⁱ EMD Serono, Canada, is committed to supporting those living with the disease and strives to lead innovation in the field of MS.

"We are delighted that the majority of eligible patients with RRMS can access MAVENCLAD through public drug plans," said Robert Woolstencroft, Head of Patient Access & Government Affairs of EMD Serono, Canada. "We continue to work with other participating jurisdictions so eligible patients with RRMS across Canada have timely and equitable access to MAVENCLAD through their public drug plans."

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.ⁱⁱ 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 80 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.ⁱⁱⁱ It is estimated that approximately 2.3 million people have MS worldwide.^iv Canada has one of the highest rates of MS in the world with one in 385 people living with the disease.^v 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.^vi The relapsing forms of MS are the most common type at the time of diagnosis.^vii

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 57,000 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 2019, Merck KGaA, Darmstadt, Germany, generated sales of € 16.2 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 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.

^iMS Society of Canada. About MS. Accessed May 5, 2020. Available at: https://mssociety.ca/about-ms/what-is-ms

^ii EMD Serono. MAVENCLAD (Cladribine) Product Monograph. November 2017. https://pdf.hres.ca/dpd_pm/00042413.PDF

^iii MS Society of Canada. What is MS. Accessed November 27, 2019. Available at https://mssociety.ca/about-ms/what-is-ms

^iv 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/.

^v MS Society of Canada. About MS. What is MS. Accessed November 27, 2019. Available at https://mssociety.ca/about-ms/what-is-ms

^viIbid

^vii 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: Smita Devane-Bhan, Director of Communications, EMD Serono Canada, 905.483.3860, [email protected]; Hibaq Ali, Weber Shandwick Canada, 416.455.8326, [email protected]