Up to 10-years of follow-up data reaffirm safety profile of Mavenclad (cladribine tablets)

Merck, the vibrant science and technology company, today announced the presentation of new data for MAVENCLAD® (cladribine tablets) at the 34th Congress of the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS) in Berlin, Germany. The data presented at ECTRIMS 2018 build on the existing real-world and clinical evidence around the safety and efficacy of cladribine tablets and reaffirm a positive benefit-risk profile of the oral treatment which is taken for a maximum of 20 days over two years.

Based on an integrated analysis of patients from the CLARITY, CLARITY EXT, and ORACLE-MS trials, including two additional years of data from the long-term PREMIERE Registry, the treatment emergent adverse event (TEAE) profile associated with cladribine tablets in patients with relapsing MS (RMS) was confirmed, with no new safety findings. The integrated analysis is based on patients followed for up to 10 years(1) (923 patients received cladribine tablets (3.5 mg/kg); 641 patients received placebo). As part of this analysis, an overview of post-approval safety data to July 2018 also showed no new safety or tolerability signals for cladribine tablets.

"In my opinion, we have entered the MS era of immune reconstitution therapies (IRT), which are administered intermittently but have an effect on the disease that lasts much longer than the period of dosing," said Prof. Gavin Giovannoni, a lead investigator in the CLARITY studies and Chair of Neurology, Barts and The London School of Medicine and Dentistry. "The new data presented at ECTRIMS indicated that cladribine tablets delivers sustained efficacy well beyond the dosing regimen with no new safety signals found in the long-term."

Post hoc analyses of CLARITY EXT following 20 days of treatment with cladribine tablets 3.5 mg/kg in Years 1 and 2 show that annual NEDA-3 status was sustained in patients treated with cladribine tablets 3.5 mg/kg or placebo up to the end of Year 4 (2). There is also an analysis of EDSS, and clinical and MRI outcomes in patients with high disease activity.

A further post hoc analysis of CLARITY data indicated that the relapse and MRI efficacy of cladribine tablets does not appear to be impacted by age, consistent with previous similar analyses(3). Data from this study showed that qualifying relapses were reduced in RMS patients aged below and above 45. With regards to MRI measures, the data showed that the number of cumulative new T1 Gd+ and active T2 lesions at Week 96 was reduced with cladribine tablets compared to placebo in both age groups(3).

"The data presented at ECTRIMS 2018 highlight our commitment to continuing to understand the extended benefit-risk profile of cladribine tablets," said Luciano Rossetti, Head of Global R&D for the Biopharma business of Merck. "With more and more patients able to access cladribine tablets globally, it becomes increasingly important for us to invest in scientific research that further characterizes the therapeutic profile, so patients may optimally benefit."

About MAVENCLAD®

MAVENCLAD® (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 August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD® for the treatment of relapsing forms of MS (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. As of August 2018, MAVENCLAD® has been approved more than 40 countries since August 2017, including the European Union (EU), Canada, Australia, Israel, Argentina, United Arab Emirates, Chile and Lebanon. Additional filings in other countries are planned for 2018. It is not yet approved for any use in the United States.

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 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.

Merck in Multiple Sclerosis

Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). Merck'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 aims to improve the lives of those living with MS, by addressing areas of unmet medical needs.

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