Data Provide Further Insight into the Consistent Efficacy Benefits of MAVENCLADtm in Relapsing MS

• Post-hoc analysis of CLARITY study suggests consistent clinical and Magnetic Resonance Imaging efficacy in subgroups of both younger and older adults treated with MAVENCLADtm (cladribine tablets)
• Using an EMA-recommended methodology to compare benefit-risk profiles of MS treatments, MAVENCLADtm had the highest overall weighted preference value in patients with highly active MS

MISSISAUGA, ON, June 18, 2018 /CNW/ - Merck KGaA, Darmstadt, Germany, a leading science and technology company, operating as EMD Serono in North America, today announced the presentation of new efficacy and benefit-risk assessment data for MAVENCLADtm (Cladribine Tablets) at the 4^th Congress of the European Association of Neurology (EAN), in Lisbon, Portugal. Results of a retrospective analysis of the Phase III CLARITY study showed benefits in patients with relapsing remitting MS (RRMS) aged ?50 and >50 years and treated with MAVENCLADtm, with improvements observed in both relapse rate and Magnetic Resonance Imaging (MRI) outcomes when compared with placebo.

The aim of the post-hoc analysis of the Phase III CLARITY study was to investigate whether the beneficial clinical and MRI effects of MAVENCLADtm are consistent in both older and younger adult patients. The results highlight the improvements observed in annualized relapse rate (ARR) and MRI outcomes versus placebo in both subgroups of RRMS patients, ?50 and >50 years; MAVENCLADtm reduced relapse risk compared to placebo by 59 per cent and 52 per cent, respectively. In placebo treated patients, there were higher mean numbers of new T1 Gd+ and active T2 lesions for those aged ?50 years compared to patients aged >50. Despite this, MAVENCLADtm treatment demonstrated significant effects on MRI measures in both age groups (P<0.0001). These data have the potential to differentiate the efficacy of MAVENCLADtm from that of other high efficacy disease-modifying drugs (DMDs) in the treatment of older patients with MS.

"These data have provided further evidence, which confirms MAVENCLADtm as an effective treatment for younger and older adults," said Prof. Gavin Giovannoni, a lead investigator in the CLARITY studies and Chair of Neurology, Barts and The London School of Medicine and Dentistry, UK. "This is something that we have not seen consistently across all clinical endpoints with some of the newer high-efficacy RRMS treatments and so provides a valuable insight into the treatment options available."

Additional data presented at EAN 2018 provide the results of the first application of the EMA-recommended Multi-Criteria Decision Analysis (MCDA) methodology to assess the benefit-risk profile of MAVENCLADtm versus other recently approved DMDs[*] in MS patients with high disease activity.

Results of this systematic application of MCDA methodology indicate either comparable or more favourable benefit-risk profile for MAVENCLADtm in patients with high disease activity when compared to that of other DMDs. Specifically, in patients with high disease activity, MAVENCLADtm had the highest overall weighted preference value compared to the other DMDs evaluated, followed by alemtuzumab and natalizumab. In the overall RRMS population MAVENCLADtm was very close to dimethyl fumarate in being ranked as having the best benefit-risk balance, with an overall weighted preference value of 62 versus 63, respectively.

"The presentation of these data highlight our ongoing commitment to understanding the full benefit-risk profile of MAVENCLADtm in a broad range of patients. Post hoc data from the CLARITY study, coupled with results from a Multi-Criteria Decision Analysis, which are based on expert physician assessment and practice-relevant treatment considerations, form a potentially useful tool for physicians considering therapy options for patients with high disease activity," said Luciano Rossetti, Head of Global R&D for the Biopharma business of Merck KGaA, Darmstadt, Germany. "The MCDA methodology is one that is recommended by EMA, and we are pleased that MAVENCLADtm performed well using this approach, compared with other disease-modifying therapies."

About MAVENCLADtm
MAVENCLADtm (cladribine tablets) is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of multiple sclerosis (MS). In November 2017, Health Canada approved MAVENCLADtm (cladribine tablets) 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. MAVENCLADtm 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.1 MAVENCLADtm is now available in over 10 countries in Europe, plus Australia, Argentina and the United Arab Emirates. MAVENCLADtm is not yet approved for any use in the United States.

The clinical development program of MAVENCLADtm in MS comprises more than 10,000 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 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. Canada has one of the highest rates of MS in the world with one in 340 people living with the disease. 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, 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.

Merck KGaA, Darmstadt, Germany in Multiple Sclerosis
Merck KGaA, Darmstadt, Germany has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). Merck KGaA, Darmstadt, Germany's current portfolio includes two products for the treatment of relapsing MS, with a robust pipeline focusing on discovering new therapies that have the potential to modulate key pathogenic mechanisms in MS. Merck KGaA, Darmstadt, Germany aims to improve the lives of those living with MS, by addressing areas of unmet medical needs.

About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany is a leading science and technology company in healthcare, life science and performance materials. More than 53,000 employees work to further develop technologies that improve and enhance life ? from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2017, Merck KGaA, Darmstadt, Germany generated sales of ? 15.3 billion in 66 countries.

Founded in 1668, Merck KGaA, Darmstadt, Germany is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials. 

SOURCE EMD Serono, Canada