EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that it completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) and signed a letter of intent (LOI) for PrMAVENCLAD® (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]
This is an important step to ensure broader, equitable and timely access to MAVENCLAD for eligible patients across Canada. The signed LOI allows EMD Serono, Canada to work with participating jurisdictions to implement public funding of MAVENCLAD for eligible RRMS patients, which is currently reimbursed by most private drug insurance plans.
“We’re excited to complete the pCPA negotiations and reach an agreement on the terms of public reimbursement for MAVENCLAD,” said Gaby Murphy, President & Managing Director, EMD Serono, Canada. “We look forward to working with participating jurisdictions to achieve the timely listing of MAVENCLAD by their respective public drug plans, and ensure broader access to this treatment option for Canadians living with MS.”
“Canada has one of the highest rates of MS [multiple sclerosis] in the world,” said Dr. Jiwon Oh, a Neurologist at the St. Michael’s Hospital MS Clinic in Toronto. “We are fortunate to have new and innovative MS drugs approved by Health Canada for optimal MS management. Patients need access to new treatment options, and it is encouraging that MAVENCLAD is now a step closer to being available to Canadian RRMS patients who receive their benefits from public drug plans.”
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.[i] 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 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.[iI] It is estimated that approximately 2.3 million people have MS worldwide.[iii] Canada has one of the highest rates of MS in the world with one in 385 people living with the disease.[iv] 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.[v] The relapsing forms of MS are the most common type at the time of diagnosis.[vi]
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 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.
[i] EMD Serono. Mavenclad (Cladribine) Product Monograph. November 2017. https://pdf.hres.ca/dpd_pm/00042413.PDF
[ii] EMD Serono. Mavenclad (Cladribine) Product Monograph. November 2017. https://pdf.hres.ca/dpd_pm/00042413.PDF
[ii] MS Society of Canada. What is MS. Accessed November 27, 2019. Available at https://mssociety.ca/about-ms/what-is-ms
[iii]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/.
[iv]MS Society of Canada. About MS. What is MS. Accessed November 27, 2019. Available at https://mssociety.ca/about-ms/what-is-ms
[vi]MS Society of Canada. About MS. Types. Accessed March 27, 2019. Available at https://mssociety.ca/about-ms/types