EMD Serono Announces New Data Strengthening Evidence for Use of MAVENCLAD® During the COVID-19 Pandemic

• New analysis indicates a specific immune repopulation pattern in people treated with ^PrMAVENCLAD®, which may allow the ability to fight infections and develop protective antibodies from vaccine ¹
• Independent study from Israel showed MAVENCLAD-treated patients receiving COVID-19 vaccine were able to mount antibody response similar to that of healthy subjects ²
• Updated safety data show MAVENCLAD-treated patients with confirmed or suspected COVID-19 continue to have a disease course similar to the general population ³

MISSISSAUGA, ON, April 28, 2021 /CNW/ - EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, announced a new analysis from the MAGNIFY-MS sub-study showing a specific immune repopulation pattern in patients with relapsing multiple sclerosis (RMS) treated with MAVENCLAD® (cladribine) tablets, which may allow the ability to fight infections and develop protective antibodies from vaccines.¹ The data were presented at the 2021 American Academy of Neurology (AAN) Annual Meeting that was held virtually April 17 – 22, 2021.

In the MAGNIFY-MS study, reduction of memory B cells occurred as early as one month after MAVENCLAD initiation with lowest levels sustained for up to 12 months, while naïve B cells, which are typically required for the generation of antibody responses following vaccination, began recovering immediately.¹ Previously shared data from MAGNIFY-MS indicated that patients receiving MAVENCLAD are able to mount responses to influenza and varicella zoster vaccines, irrespective of lymphocyte count. ^4,5

"The findings presented at AAN further our understanding of how this treatment impacts the immune system, and how it may exert a therapeutic effect in patients with multiple sclerosis – a particularly important finding at this time," said Caroline Lemieux, PhD, Regional Medical Director of Neurology & Immunology, North America at EMD Serono. "In addition to addressing MS relapses and progression, the data shows that patients may be able to continue with their regular MS management while mounting a vaccine response".

In addition, a recent independent study conducted by Anat Achiron, MD, PhD, FAAN and colleagues, The Multiple Sclerosis Center at Sheba Medical Centre and Sackler School of Medicine Tel Aviv University, Israel, and recently published in Therapeutic Advances in Neurological Disorders, shows that patients who have taken MAVENCLAD were able to generate COVID-19 antibodies following the mRNA vaccine from Pfizer/BioNTech administered as early as 4.4 months after last MAVENCLAD dosing.² The observational analysis showed that all 23 MS patients treated with MAVENCLAD who received the Pfizer/BioNTech mRNA vaccine developed a protective SARS-COV-2 IgG antibody response [antibody titer >1.1 is considered positive; median=7.0], which was similar to the comparison group of MS patients not receiving any immunomodulatory treatments and healthy subjects.² No unexpected safety findings post first and second dose of Pfizer/BioNTech COVID-19 vaccination were identified in MS patients, according to another recent publication in the Multiple Sclerosis Journal.⁶

The ability to mount an adequate immune response is critical as the COVID-19 pandemic impacts patients living with chronic disease around the world. As published in the Multiple Sclerosis and Related Disorders(MSaRD), an updated post-market safety analysis provided a look at outcomes from cases of COVID-19 in MAVENCLAD-treated patients. The safety database analysis included cases of confirmed (n=160) or suspected (n=101) COVID-19 in MAVENCLAD-treated patients. Based on the analysis, the majority of patients had mild to moderate respiratory symptoms, and none required mechanical ventilation. MAVENCLAD-treated patients had a similar disease course with COVID-19 compared with the general population who acquired COVID-19.⁷

"Our aim is for Canadian MS patients to be able to live their lives with as much normalcy as possible during the COVID-19 pandemic," said Manuel Zafra, Managing Director, EMD Serono. "We're pleased that the data shows encouraging initial evidence for patients on this treatment course." 

About MAVENCLAD 
MAVENCLAD (cladribine) is indicated 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.⁸ It is estimated that approximately 2.8 million people have MS worldwide.⁹Canada has one of the highest rates of MS in the world with approximatly, 12 Canadians diagnosed with MS everyday.¹⁰While 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.¹¹ The relapsing forms of MS are the most common type at the time of diagnosis.¹²

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 electronics. Around 58,000 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 2020, Merck KGaA, Darmstadt, Germany generated sales of € 17.5 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 Electronics. 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. 

SOURCE EMD Serono, Canada