EMD Serono to Present Data Highlighting Investigational Cladribine Tablets at ACTRIMS 2018

ROCKLAND, Mass., Feb. 1, 2018 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, today announced that six posters evaluating investigational Cladribine Tablets in multiple sclerosis (MS) will be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum taking place February 1-3 in San Diego, California. The six posters evaluate the safety of Cladribine Tablets and its impact on the immune system via post hoc analyses of the CLARITY, CLARITY Extension, and ORACLE-MS trials, as well as the PREMIERE registry study.^1,2,3,4,5,6

The company recently announced it will file a regulatory submission for Cladribine Tablets with the U.S. Food and Drug Administration in the second quarter of 2018. In August 2017, the European Commission granted marketing authorization for Cladribine Tablets, marketed as MAVENCLAD^®, for the treatment of highly active relapsing forms of multiple sclerosis as defined by clinical or imaging features, in the 28 countries of the EU in addition to Norway, Liechtenstein and Iceland. In December 2017, Health Canada approved MAVENCLAD for the treatment of relapsing forms of MS.

“We are proud to share further clinical trial data during ACTRIMS 2018 evaluating the use of Cladribine Tablets in patients with multiple sclerosis. This adds to the body of research to help best understand the role of Cladribine Tablets as a potential future treatment option for appropriate patients who live with MS,” said John Walsh, M.D., Vice President, Neurology & Immunology, US Medical Affairs at EMD Serono. “Our ongoing research underscores our commitment to developing new therapeutic options for patients with chronic and hard-to-treat conditions like MS.”

The posters report on findings regarding Cladribine Tablets’ selectivity and adaptive and innate immune system function and add further information about the safety profile.^1,2,3,4,5,6

Attendees can learn more about EMD Serono’s programs, pipeline and activities in neurology and immunology by visiting our medical booth #219. Booth activities include “I’m Balancing MS,” an experience to help visitors better understand the balance between healthcare and lifestyle for those facing MS. For each participant EMD Serono will make a $100 donation to the Accelerated Cure Project for Multiple Sclerosis to support their mission to accelerate efforts toward a cure for multiple sclerosis by rapidly advancing research that determines its causes and mechanisms.

The following posters have been accepted for presentation at ACTRIMS 2018 Forum and will be presented on February 1, 6-8 p.m. PST (9-11 p.m. EST) in the Sapphire Ballroom, Hilton San Diego Bayfront:

 Cladribine Tablets Presentations -------------------------------- Poster Title Lead Author Poster Number ------------ ----------- ------------- Effects of cladribine tablets on CD4+ T-cell subsets in the ORACLE-MS study: Results from an analysis of lymphocyte surface markers O. Stuve P059 --------------------------------- -------- ---- Cladribine tablets produce selective and discontinuous reduction of B and T lymphocytes and NK cells in patients with early and relapsing MS O. Stuve P060 --------------------------------- -------- ---- Innate immune cell counts in patients with relapsing-remitting multiple sclerosis treated with cladribine tablets 3.5 mg/kg in CLARITY and CLARITY EXT P. Soelberg-Sorensen P061 ---------------------------------- -------------------- ---- Infections during periods of Grade 3 or 4 lymphopenia in patients taking cladribine tablets 3.5 mg/ kg: data from an integrated safety analysis S. Cook P070 ----------------------------------- ------- ---- Long-term lymphocyte counts in patients with RRMS treated with cladribine tablets 3.5 mg/kg: Total lymphocytes, B-, and T- cell subsets P. Soelberg-Sorensen P084 -------------------------------- -------------------- ---- Rates of lymphopenia in Years 1-4 in patients with relapsing multiple sclerosis treated annually with cladribine tablets 3.5 mg/kg S. Cook P086 --------------------------------- ------- ---- 

About Cladribine Tablets
Cladribine Tablets is an investigational short-course oral therapy that is thought to selectively and periodically target lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). Cladribine Tablets is currently under clinical investigation and not yet approved for the treatment for any use in the United States. In August 2017, the European Commission granted marketing authorization for Cladribine Tablets, marketed as MAVENCLAD^®, for the treatment of highly active relapsing forms of multiple sclerosis as defined by clinical or imaging features, in the 28 countries of the EU in addition to Norway, Liechtenstein and Iceland. 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.

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.

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

¹ Stuve O. ACTRIMS 2018 [Poster No. 060] Cladribine Tablets Produce Selective and Discontinuous Reduction of B and T Lymphocytes and Natural Killer Cells in Patients with Early and Relapsing Multiple Sclerosis (ORACLE-MS, CLARITY and CLARITY Extension).
² Cook S. ACTRIMS 2018 [Poster No. 086] Rates of Lymphopenia Year-by-year in Patients with Relapsing Multiple Sclerosis Treated and Retreated with Cladribine Tablets 3.5mg/kg.
³ Soelberg-Sorensen P. ACTRIMS 2018 [Poster No. 061] Innate Immune Cell Counts in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) Treated with Cladribine Tablets 3.5 mg/kg in CLARITY and CLARITY Extension.
⁴ Stuve O. ACTRIMS 2018 [Poster No. P059] Effects of Cladribine Tablets on CD4+ T Cell Subsets in the ORACLE-MS Study: Results from an Analysis of Lymphocyte Surface Markers.
⁵ Soelberg-Sorensen P. ACTRIMS 2018 [Poster No. 084] Long-Term Lymphocyte Counts in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) Treated with Cladribine Tablets 3.5 mg/kg: Total Lymphocytes, B and T Cell Subsets.
⁶ Cook S. ACTRIMS 2018 [Poster No. 070] Infections During Periods of Grade 3 or 4 Lymphopenia in Patients Taking Cladribine Tablets 3.5 mg/kg: Data from an Integrated Safety Analysis.

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