New MAVENCLAD® Data at ACTRIMS-ECTRIMS MSVirtual2020 Meeting Highlight Rapid Onset of Action and Compelling Post-Approval Safety

Darmstadt, Germany (ots/PRNewswire) - In MAGNIFY-MS, patients experienced a rapid onset of action from end of Month 1 that was significant in all study periods versus baseline

Post-approval safety analysis showed no increased risk of viral respiratory infections and lower rates of malignancy than in the clinical trial program

Data from MAVENCLAD-treated patients with confirmed or suspected COVID-19 suggest no increased risk of severe outcomes

Merck, a leading science and technology company, today announced the presentation of new efficacy data from the Phase IV MAGNIFY-MS study on MAVENCLAD® (cladribine tablets) in patients with relapsing multiple sclerosis (RMS) which showed a rapid onset of action from end of Month 1 supported by changes in combined unique active (CUA) magnetic resonance imaging (MRI) lesions. The data also showed a significant reduction in mean T1 gadolinium-enhancing (Gd+) lesion counts.

"The MAGNIFY-MS results presented at ACTRIMS-ECTRIMS 2020 further substantiate the ability of MAVENCLAD to deliver early efficacy in patients with RMS," said Prof. Nicola De Stefano, PhD, Professor of Neurology, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy. "Knowing we can provide patients with a treatment option we feel confident can start working quickly and maintain efficacy over a longer period of time without the need for additional treatment or frequent monitoring is very exciting for the MS community."

In the MAGNIFY-MS study, MRI lesions at baseline were compared over three time periods - Months 1-6, 2-6 and 3-6 of treatment. Data showed a rapid onset of action from end of Month 1, with CUA lesion counts significantly reduced in all study periods versus baseline (61% reduction for Months 1-6; 77% reduction for Months 2-6; 87% reduction for Months 3-6). Further, mean T1 Gd+ lesion counts, in particular, were significantly decreased from Month 2 onwards compared to baseline.

Additionally, updated post-approval safety data was presented based on an analysis of the first 18,463 patients who received MAVENCLAD post-approval, as of July 2020. The safety database analysis also provided a look at findings from 46 cases of confirmed or suspected COVID-19 in MAVENCLAD-treated patients (18 and 28, respectively), suggesting that patients treated with MAVENCLAD who acquire COVID-19 are not at an increased risk of severe outcomes. Data specifically showed the majority of patients had mild-to-moderate respiratory symptoms. Four patients were hospitalized and there were no deaths. Additional data on clinical outcomes in patients with COVID-19 infection will be available as part of the late-breaking and COVID-19 sessions from 25 September.

"The data presented exemplify our passion to dig deeper into MS research, continuing to learn more about how our existing treatments can impact those living with the disease, especially as they navigate MS management in the midst of a pandemic," said Luciano Rossetti, Head of Global Research & Development for the biopharma business of Merck. "We now have evidence showing an early onset of action and real-world data supporting the clinical trial findings that MAVENCLAD does not increase the risk of viral respiratory infections."

Based on the analysis presented at the congress, rates of viral respiratory infections were low and typically non-serious; the pattern was consistent with that from the clinical development program. Crude incidences were: influenza, 0.68%; viral infection, 0.27%; and viral upper respiratory tract infection, 0.04%. The crude incidence rate of malignancy was much lower than that observed in the clinical trial program.

About MAVENCLAD®

MAVENCLAD® is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD® for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD® has since then been approved in 79 countries, including Canada, Australia and the U.S. Refer to the respective prescribing information for further details.

The clinical development programme 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 Phase III placebo-controlled study following on from the CLARITY study, which evaluated the safety and exploratory efficacy of cladribine tablets over two additional years beyond the two-year CLARITY study, according to the treatment assignment scheme for years 3 and 4. - 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) study: a long-term observational follow-up safety registry of MS patients who participated in cladribine tablets clinical studies.

In the two-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with cladribine tablets was lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). 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. Adverse Events reported in other clinical studies were similar.

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 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 Neurology and Immunology

Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company`s current MS 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.

The company's robust immunology pipeline focuses on discovering new therapies that have the potential to modulate key pathogenic mechanisms in chronic diseases such as MS, systemic lupus erythematosus and psoriasis.

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About Merck

Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices - the company is everywhere. In 2019, Merck generated sales of EUR 16.2 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.

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