Merck to Present New Data on Mavenclad®, Rebif® and the Investigational Therapy Evobrutinib at the AAN Annual Meeting 2019

Darmstadt (Germany) April 30th 2019 (PROTEXT/PRNewswire)

Not intended for U.S. or U.K. based media

- 20 abstracts will be presented during the AAN Annual Meeting 2019 to demonstrate Merck's commitment and clinical development program in multiple sclerosis

Merck, a leading science and technology company, today announced that data from across its multiple sclerosis (MS) portfolio will be presented at the American Academy of Neurology (AAN) 2019 Annual Meeting, 4-10 May 2019 in Philadelphia, United States. Merck will present a total of 20 abstracts (18 posters and two platform presentations), including data on MAVENCLAD® (cladribine tablets), the investigational therapy evobrutinib (an oral, selective Bruton's Tyrosine Kinase (BTK) inhibitor) and Rebif® (interferon beta-1a), as well as findings from the patient perceptions initiative by MS in the 21st Century.

"The wealth of data to be presented at AAN 2019 highlights our continued progress across our portfolio of marketed products and investigational agents in multiple sclerosis," said Luciano Rossetti, Head of Global Research & Development for the Biopharma business of Merck. "We are very proud of our commitment to further the understanding of multiple sclerosis and enhance our clinical development program to meet the needs of patients."

Key MAVENCLAD® data will include:

- Post-hoc analysis of the CLARITY Extension study to examine the durability of no evidence of disease activity-3 (NEDA-3) in relapsing MS (RMS) patients receiving cladribine tablets

- Integrated analysis of pooled long-term safety data of cladribine tablets in patients with MS collated from the CLARITY, CLARITY Extension, ORACLE-MS studies and the PREMIERE registry

- A new analysis of the speed of onset of the MRI effect is presented. At 3 months the effect on new inflammatory lesions was apparent in the ORACLE-MS study. In the same study consistency in clinical outcomes was observed across different patient subgroups defined by patient and disease characteristics at baseline

- Abstracts from the ORACLE-MS study describe the effect of cladribine tablets on early MS

- Results from studies investigating the biological effects of cladribine tablets, including the effect on lymphocyte proliferation, and endothelial responsiveness to tumour necrosis factor and its effect on hematopoietic precursors and immune cells, to offer further insights on the potential mode of action of cladribine tablets

Key evobrutinib data will include:

- Results of analysis of the efficacy and safety of evobrutinib in patients with RMS over 48 Weeks: a randomized, placebo-controlled, phase 2 study

Key Rebif® data will include:

- Investigation from the European Interferon Beta (IFN?) pregnancy registry and Nordic health study into the prevalence of pregnancy outcomes in IFN?-exposed women

- Results from the IMPROVE study on the dynamics of pseudo-atrophy in RMS patients treated with interferon beta-1a as assessed by monthly brain MRI

In addition, Merck will be publishing new data from the MS in the 21st Century initiative comparing patient perceptions on MS management and care across Europe and North America. The initiative, led by a Steering Group of international MS specialists, aims to gain insight into patient opinions on unmet needs in MS management.

Merck will also be announcing the launch of a new, collaborative MS research network called 'MS-LINK' (Leadership and Innovation Network), an initiative that brings together a community of multiple sclerosis stakeholders to form a scientific foundation for sustainable transformation of MS care, with the shared goal of improving patient outcomes.

Below is a selection of abstracts that have been accepted for presentation at AAN 2019:

MAVENCLAD (cladribine tablets) data
TitleLead AuthorPosterPresentation / Session
Durability of NEDA-3 status in patients with relapsing multiple sclerosis receiving cladribine tablets: CLARITY ExtensionGiovannoni GP3.2-10011:30 - 18:30 ET, Tuesday 7 May P3: MS Clinical Trials and Therapeutic Research
Cladribine tablets were associated with rapid onset of improvements in MRI outcomes in the ORACLE-MS trialScarberry SP3.2-06111:30 - 18:30 ET, Tuesday 7 May P3: MS Clinical Trials and Therapeutic Research
The effect of cladribine tablets on delaying the time to conversion to CDMS or McDonald MS is consistent across subgroups in the ORACLE-MS studyBowen JP3.2-10111:30 - 18:30 ET, Tuesday 7 May P3: MS Clinical Trials and Therapeutic Research
Untreated Patients with Multiple Sclerosis: Prevalence and Characteristics in Denmark and in the United StatesNorgaard MP4.2-06011:30 - 18:30 ET, Wednesday 8 May P4: MS Epidemiology, Co-Morbidities, and Modifiable Risk Factors
Updated safety analysis of cladribine tablets in the treatment of patients with multiple sclerosisCook SP4.2-04611:30 - 18:30 ET, Wednesday 8 May P4: MS Therapeutics: MOA and Safety
Gaps in treatment and treatment discontinuation among patients with multiple sclerosis newly-initiating once- or twice-daily oral disease-modifying drugsNicholas JP3.2-10211:30 - 18:30 ET, Tuesday 7 May P3: MS Clinical Trials and Therapeutic Research
Lymphopenia rates in CLARITY/CLARITY Extension are consistent in patients with or without high disease activity at baselineCook SP3.2-06211:30 - 18:30 ET, Tuesday 7 May P3: MS Clinical Trials and Therapeutic Research
Meta-analysis of real-world adherence and persistence of maintenance once- or twice-daily oral disease-modifying drugs (dimethyl fumarate, fingolimod, and teriflunomide) in multiple sclerosisNicholas JP3.2-04111:30 - 18:30 ET, Tuesday 7 May P3: MS Clinical Trials and Therapeutic Research
ADA genetic variants influence central inflammation and clinical characteristics in MS: implications for cladribine treatmentStampanoni Bassi MP4.2-04411:30 - 18:30 ET, Wednesday 8 May P4: MS Therapeutics: MOA and Safety
Dissection of the distinct susceptibility of hematopoietic precursors and immune cells to cladribineCarlini FP4.2-04511:30 - 18:30 ET, Wednesday 8 May P4: MS Therapeutics: MOA and Safety
Neuroblastoma cell line and lymphocytes talk for cladribine influenced apoptosis and inflammation pathways in Multiple Sclerosis (MS): an "in vitro" studyRuggieri MP2.2-09511:30 - 18:30 ET, Monday 6 May P2: MS Immunology and Basic Science
Gene expression profiles of proteins involved in cladribine metabolism and their possible correlation with Epstein-Barr virus variantsMechelli RP2.2-09611:30 - 18:30 ET, Monday 6 May P2: MS Immunology and Basic Science
Evobrutinib data
Efficacy and Safety of the Bruton's Tyrosine Kinase Inhibitor Evobrutinib (M2951) in Patients with Relapsing Multiple Sclerosis over 48 Weeks: a Randomized, Placebo-Controlled, Phase 2 StudyMontalban XOral presentation13:33 ET, Friday 10 MayS56: MS Trials and Treatment
Inhibition of Bruton's Tyrosine Kinase Prevents Inflammatory Macrophage Differentiation: A Potential Role in Multiple SclerosisAlankus YBP2.2-07711:30 - 18:30 ET, Monday 6 May P2: MS Immunology and Basic Science
Inhibition of Bruton's Tyrosine Kinase Selectively Prevents Antigen-Activation of B cells and Ameliorates B-Cell-Mediated Experimental Autoimmune EncephalomyelitisTorke SP2.2-06311:30 - 18:30 ET, Monday 6 May P2: MS Immunology and Basic Science
Rebif (interferon beta-1a)
Pregnancy and Infant Outcomes with Interferon Beta: Data from the European Interferon Beta Pregnancy Registry and MS Preg study conducted in Finland and SwedenHellwig K45013:44 ET, Thursday 9 MayS49: MS Epidemiology and Risk Stratification
Dynamics of Pseudo-Atrophy in RRMS Patients Treated with Interferon beta-1a as Assessed by Monthly Brain MRIDe Stefano NP5.2-04711:30 - 18:30 ET, Thursday 9 May P5: MS Neuroimaging
MS in the 21 Century
Comparing patient perceptions on multiple sclerosis management and care - a sub-analysis of geographic differencesWilliams MP4.9-07611:30 - 18:30 ET, Wednesday 8 May P4: Practice, Policy, and Ethics I
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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 more than 50 countries, including Canada and Australia and most recently in the U.S. in March 2019.

Visit www.MAVENCLAD.com for more information.

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 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 Evobrutinib

Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). It is an oral, highly specific inhibitor of Bruton's tyrosine kinase (BTK) which is important in the development and functioning of various immune cells including B lymphocytes and macrophages. Evobrutinib is designed to inhibit primary B cell responses such as proliferation and antibody and cytokine release, without directly affecting T cells. BTK inhibition is thought to suppress autoantibody-producing cells, which preclinical research suggests may be therapeutically useful in certain autoimmune diseases. Evobrutinib is currently under clinical investigation and not approved for any use anywhere in the world.

About Rebif®

Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif® in chronic progressive MS has not been established. Interferon ß is thought to help reduce inflammation. The exact mechanism is unknown.

Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide. Rebif® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*.

Rebif® can be administrated with the RebiSmart® electronic auto-injection device (not approved in the US), or with the RebiDose® single-use disposable pen, or the manual multidose injection pen RebiSlideTM. Rebif® can also be administered with the autoinjector Rebiject II® or by manual injection using ready-to-use pre-filled syringes. These injection devices are not approved in all countries.

In January 2012, the European commission approved the extension of the indication of Rebif® in early multiple sclerosis. The extension of the indication of Rebif® has not been submitted in the United States.

Rebif® should be used with caution in patients with a history of depression, liver disease, thyroid abnormalities and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors.

*The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

Rebif® (interferon beta-1a) is approved in the United States for relapsing forms of MS.

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 Immunology

Merck has a long-standing legacy in immunology, with significant R&D and commercial experience in multiple sclerosis. Our 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 (SLE) and forms of arthritis, including rheumatoid arthritis (RA) and osteoarthritis (OA).

About Merck

Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 52,000 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 2018, Merck generated sales of € 14.8 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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