News Releases

ROCKLAND, Mass., May 29, 2018 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that six abstracts including two poster presentations on Cladribine Tablets, an investigational treatment for relapsing multiple sclerosis (RMS), will be presented at the 32^nd Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), taking place from May 30 – June 2, 2018, in Nashville, TN.

Poster presentations for Cladribine Tablets include evaluations of no evidence of disease activity (NEDA) and radiological outcomes in RMS patients from the CLARITY trial. Cladribine Tablets, marketed as MAVENCLAD^® outside of the U.S., is an investigational short-course oral therapy that is thought to preferentially target lymphocytes, which may be integral to the pathological process of RMS. Cladribine Tablets is currently under clinical investigation and is not approved in the U.S.

"We look forward to presenting data at CMSC 2018 evaluating the use of Cladribine Tablets in patients with relapsing forms of multiple sclerosis," said John Walsh, Vice President, Neurology & Immunology (N&I), U.S. Medical Affairs for EMD Serono. "This data is a further testament to our commitment to understanding MS in a deeper way and building a better future for the MS community."  

Additional poster presentations include analyses of health economics and outcomes research (HEOR) data on the diagnosis and treatment of infertility and live birth rates in women with or without MS, and the prevalence of comorbidities in patients with or without MS. A mapping study comparing the availability of educational resources for MS patients across different geographical regions will also be shared at the meeting.

Meeting attendees can learn more about EMD Serono and its support of the MS community by participating in the following interactive activities at booth #522:

• "I'm Balancing MS": Individuals can learn about the balance between healthcare and lifestyle for those facing MS through a mobile art activity. For each participant, EMD Serono will make a donation to the MS Foundation.
• "Shine a Light": Individuals can create their own Light Trail art symbolizing what drives their commitment to fighting MS.
• "Sage on the Stage": Subject matter experts will provide brief presentations sharing their insights on emerging issues of importance around MS.

The Company will also sponsor booth #500, which is focused on MS in the 21st Century (MS21), an initiative comprised of an international steering group of healthcare professionals (HCPs) and patient advocates showcasing its newly developed consultation tool, 'My MS Priorities.' This priority planner aims to assist with improving patient engagement, enhancing mutual trust between patients and HCPs, and encouraging a more open dialogue. MS21 will host a series of short workshops at the exhibit throughout Wednesday, May 30 and Thursday, May 31 to introduce this tool to attendees.

Partnering with CMSC
Additionally, EMD Serono is proud to support the June Halper MS Nursing Scholarship, sponsored by The Foundation of the Consortium of Multiple Sclerosis Centers (FCMSC). The program awards nurses who are not certified in MS with a scholarship in order to participate in this year's CMSC Annual Meeting.

EMD Serono is pleased to sustain its support of the CMSC's MS Teamworks online program, an educational web-based series that launched at the CMSC annual meeting in 2017. The 14-18 minute episodes have a wide range of speakers and are designed help the MS community prepare for clinical appointments, gain knowledge when they are between appointments, and ensure accurate and state-of-the-art education to all those affected by MS. The targeted talks feature practical answers and solutions to common questions and concerns surrounding topics such as symptoms, child rearing, where and how to seek care, and self-care leading to wellness. The program is continuing to expand in 2018 with new video content. For more information visit: http://msteamworks.com/.

The following abstracts were accepted for presentation at the CMSC 2018 Annual Meeting:

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 and reconstruct a new understanding of MS, inside and out. We are committed to delivering solutions that improve the lives of all those affected by MS. www.GetCloserToMS.com

About Cladribine Tablets
Cladribine Tablets is an investigational short-course oral therapy that is thought to selectively target lymphocytes which may be integral to the pathological process of relapsing MS (RMS). Cladribine Tablets is currently under clinical investigation and not approved for the treatment for any use in the United States. MAVENCLAD^® has received marketing authorization in 35 countries including European Union member countries, Canada, Australia, Argentina, Israel, and the United Arab Emirates. MAVENCLAD^® is now available in Germany, UK, Canada, Netherlands, Norway, Denmark, Sweden, Israel, and other markets.  In December 2017, Health Canada approved MAVENCLAD^® for the treatment of relapsing forms of MS.

The clinical development program for Cladribine Tablets includes:

• The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in patients with RRMS.
• The CLARITY extension study: a two-year Phase III placebo-controlled study following on from the CLARITY study, designed to evaluate the safety and efficacy of Cladribine Tablets over an extended administration for four years.
• The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS).
• The ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study designed primarily to evaluate the safety and tolerability of adding Cladribine Tablets treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy.
• PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Studies) study: interim long-term follow-up data from the prospective registry, PREMIERE, to evaluate the safety and efficacy of Cladribine Tablets. This includes more than 10,000 patient years of data with over 2,700 patients included in the clinical trial program, and more than 10 years of observation in some patients.

In the two-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with Cladribine Tablets was lymphopenia. The incidence of infections was 48.3% with Cladribine Tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators.

About EMD Serono, Inc.
EMD Serono is the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the business has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas. Today, the business has 1,300 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. www.emdserono.com

SOURCE EMD Serono