ROCKLAND - EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, announced today it will present data on its approved and investigational multiple sclerosis (MS) treatments at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting.

The Company will present 54 abstracts at the meeting, taking place virtually from September 11-13, 2020, including new efficacy and real-world safety data on MAVENCLAD (cladribine) tablets and new safety data for Rebif (interferon beta-1a).

In addition, data will be presented on the efficacy profile of evobrutinib, an investigational, oral, highly selective Bruton's Tyrosine Kinase inhibitor (BTKi), through 108 weeks of treatment in the Phase II open-label extension (OLE) in adult patients with relapsing multiple sclerosis (RMS). Preclinical data will also be presented providing insights into evobrutinib's potential impact on progression in MS.

'The broad range of research revealed through these data demonstrate our strategic approach to advancing the MS treatment landscape through new medicines and patient-focused research initiatives,' said Luciano Rossetti, Global Head of Research & Development for EMD Serono. 'Much of our data provide insights on how MAVENCLAD and Rebif affect the risk of respiratory viral infections and COVID-19 outcomes in MS patients. These insights will help support clinicians as they make treatment decisions for their patients living with MS.'

Key MAVENCLAD (cladribine) tablets data include: Efficacy results from the Phase IV MAGNIFY-MS study and its impact on a reduction in mean combined unique active (CUA) lesion count in the first six months of MAVENCLAD treatment for highly active RMS

New data evaluating cumulative relapse incidence over five years in patients enrolled in the MAVENCLAD CLARITY and CLARITY Extension trials

Late-breaking interim data from the CLASSIC-MS study on the long-term efficacy and real-world treatment patterns for patients receiving MAVENCLAD, with eight to 14 years of follow up, will be available as part of the late-breaker sessions from September 25, 2020

Results from a post hoc analysis from the CLARITY Extension and the impact of MAVENCLAD on the prevalence of disability improvement over five years, as measured by the Expanded Disability Status Scale (EDSS)

Results from the MAGNIFY and CLARIFY studies regarding clinical outcomes in patients with COVID-19 infection during these Phase IV studies of MAVENCLAD for the treatment of MS will be available as part of the late-breaker sessions from September 25, 2020

Updated post-approval safety data of MAVENCLAD in the treatment of MS, including respiratory viral infections and findings that the safety profile was consistent with that from the clinical development program

Key Rebif (interferon beta-1a) data include: Post-approval results on the safety of Rebif in the treatment of MS, showing no new safety signals

Key evobrutinib data include: Efficacy results of the Phase II OLE in patients treated with evobrutinib 75 mg BID (twice a day) as measured by annualized relapse rate from Week 48 to Week 108

Safety results from the 60 week Phase II OLE

Preclinical data demonstrating evobrutinib's potential to reduce CNS compartmentalized inflammation thought to drive the progression of disability seen in MS

Additional EMD Serono activities at MSVirtual2020: Live presentation 'Exploring the role of real-world data in multiple sclerosis' chaired by Prof. Gavin Giovannoni, Chair of Neurology, Barts and The London School of Medicine and Dentistry (September 12, 2020, 14:30-15:30 EDT; recording available after the event)

Two product theatres on demand throughout the congress starting from September 11, 2020, 11:45 EDT

'Multiple sclerosis patient management: update from the UK' by Dr. Wallace Brownlee, MS Specialist Neurologist, National Hospital for Neurology and Neurosurgery, and MS researcher at Queen Square MS Centre, University College London Institute of Neurology

'Real-world multiple sclerosis management: what can we learn from MSBase' by Dr. Suzanne Hodgkinson, Associate Professor, University of New South Wales, and a senior consultant neurologist at Liverpool Hospital, New South Wales, Australia

Following the conclusion of MSVirtual2020, EMD Serono will be hosting 'Mastering the Neuroscience of Unconscious Bias,' the inaugural virtual event for the company's I'M IN initiative, a diversity, equity and inclusion effort started in February 2019. I'M IN is a US-based initiative started by the Neurology & Immunology franchise, which aims to explore solutions together with healthcare providers to improve equity within the healthcare ecosystem.

About MAVENCLAD

MAVENCLAD, approved by the U.S. Food and Drug Administration (FDA) on March 29, 2019, is the first and only short-course oral therapy for the treatment of adults with relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of multiple sclerosis (MS), and MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS). Patients should follow healthcare provider instructions including cancer screening, contraception and blood tests. The approved dose of MAVENCLAD is 3.5 mg per kg body weight over two years, administered as one treatment course of 1.75 mg per kg per year, each consisting of two treatment weeks. The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes. MAVENCLAD causes a dose-dependent reduction in lymphocyte counts followed by recovery.

About Rebif (interferon beta-1a)

Rebif (interferon beta-1a) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is used to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS.

About Evobrutinib

Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS). It is an oral, highly selective inhibitor of Bruton's tyrosine kinase (BTK) which is important in the development and functioning of various immune cells including B lymphocytes and macrophages. Evobrutinib is designed to inhibit primary B cell responses such as proliferation and antibody and cytokine release, without directly affecting T cells. BTK inhibition is thought to suppress autoantibody-producing cells, which preclinical research suggests may be therapeutically useful in certain autoimmune diseases. Evobrutinib is currently under clinical investigation and not approved for any use anywhere in the world.

About Multiple Sclerosis

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. 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.

EMD Serono, Inc. and Multiple Sclerosis

For more than 20 years, EMD Serono has been relentlessly focused on understanding the journey people living with MS face in order to create a meaningful, positive experience for them and the broader MS community. However, there is still much that is unknown about this complex and unpredictable disease. EMD Serono is digging deeper to advance the science.

About EMD Serono, Inc.

EMD Serono the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. www.emdserono.com.

Contact:

Tel: 1-781-206-1951

Email: emma.silva@emdserono.com

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