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30.04.2019 – 14:05

Merck KGaA

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

Darmstadt, Germany (ots/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      
Title               Lead       Poster       Presentation / 
                    Author                  Session        
Durability of       Giovannoni P3.2-100     11:30 - 18:30  
NEDA-3 status in    G                       ET, Tuesday 7  
patients with                               May P3: MS     
relapsing multiple                          Clinical Trials
sclerosis receiving                         and Therapeutic
cladribine tablets:                         Research       
CLARITY Extension                                          
Cladribine tablets  Scarberry  P3.2-061     11:30 - 18:30  
were associated     S                       ET, Tuesday 7  
with rapid onset of                         May  P3: MS    
improvements in MRI                         Clinical Trials
outcomes in the                             and Therapeutic
ORACLE-MS trial                             Research       
The effect of       Bowen J    P3.2-101     11:30 - 18:30  
cladribine tablets                          ET, Tuesday 7  
on delaying the                             May P3: MS     
time to conversion                          Clinical Trials
to CDMS or McDonald                         and Therapeutic
MS is consistent                            Research       
across subgroups in                                        
the ORACLE-MS study                                        
Untreated Patients  Nørgaard M P4.2-060     11:30 - 18:30  
with Multiple                               ET, Wednesday 8
Sclerosis:                                  May  P4: MS    
Prevalence and                              Epidemiology,  
Characteristics in                          Co-Morbidities,
Denmark and in the                          and Modifiable 
United States                               Risk Factors   
Updated safety      Cook S     P4.2-046     11:30 - 18:30  
analysis of                                 ET, Wednesday 8
cladribine tablets                          May  P4: MS    
in the treatment of                         Therapeutics:  
patients with                               MOA and Safety 
multiple sclerosis                                         
                                                           
Gaps in treatment   Nicholas J P3.2-102     11:30 - 18:30  
and treatment                               ET, Tuesday 7  
discontinuation                             May P3: MS     
among patients with                         Clinical Trials
multiple sclerosis                          and Therapeutic
newly-initiating                            Research       
once- or                                                   
twice-daily oral                                           
disease-modifying                                          
drugs                                                      
Lymphopenia rates   Cook S     P3.2-062     11:30 - 18:30  
in CLARITY/CLARITY                          ET, Tuesday 7  
Extension are                               May P3: MS     
consistent in                               Clinical Trials
patients with or                            and Therapeutic
without high                                Research       
disease activity at                                        
baseline                                                   
                                                           
Meta-analysis of    Nicholas J P3.2-041     11:30 - 18:30  
real-world                                  ET, Tuesday 7  
adherence and                               May P3: MS     
persistence of                              Clinical Trials
maintenance once-                           and Therapeutic
or twice-daily oral                         Research       
disease-modifying                                          
drugs (dimethyl                                            
fumarate,                                                  
fingolimod, and                                            
teriflunomide) in                                          
multiple sclerosis                                         
                                                           
ADA genetic         Stampanoni P4.2-044     11:30 - 18:30  
variants influence  Bassi M                 ET, Wednesday 8
central                                     May  P4: MS    
inflammation and                            Therapeutics:  
clinical                                    MOA and Safety 
characteristics in                                         
MS: implications                                           
for cladribine                                             
treatment                                                  
Dissection of the   Carlini F  P4.2-045     11:30 - 18:30  
distinct                                    ET, Wednesday 8
susceptibility of                           May  P4: MS    
hematopoietic                               Therapeutics:  
precursors and                              MOA and Safety 
immune cells to                                            
cladribine                                                 
                                                           
Neuroblastoma cell  Ruggieri M P2.2-095     11:30 - 18:30  
line and                                    ET, Monday 6   
lymphocytes talk                            May  P2: MS    
for cladribine                              Immunology and 
influenced                                  Basic Science  
apoptosis and                                              
inflammation                                               
pathways in                                                
Multiple Sclerosis                                         
(MS): an "in vitro"                                        
study                                                      
Gene expression     Mechelli R P2.2-096     11:30 - 18:30  
profiles of                                 ET, Monday 6   
proteins involved                           May  P2: MS    
in cladribine                               Immunology and 
metabolism and                              Basic Science  
their possible                                             
correlation with                                           
Epstein-Barr virus                                         
variants                                                   
Evobrutinib data   
Efficacy and Safety Montalban  Oral         13:33 ET,      
of the Bruton's     X          presentation Friday 10 May  
Tyrosine Kinase                             S56: MS Trials 
Inhibitor                                   and Treatment  
Evobrutinib (M2951)                                        
in Patients with                                           
Relapsing Multiple                                         
Sclerosis over 48                                          
Weeks: a                                                   
Randomized,                                                
Placebo-Controlled,                                        
Phase 2 Study                                              
Inhibition of       Alankus YB P2.2-077     11:30 - 18:30  
Bruton's Tyrosine                           ET, Monday 6   
Kinase Prevents                             May  P2: MS    
Inflammatory                                Immunology and 
Macrophage                                  Basic Science  
Differentiation: A                                         
Potential Role in                                          
Multiple Sclerosis                                         
Inhibition of       Torke S    P2.2-063     11:30 - 18:30  
Bruton's Tyrosine                           ET, Monday 6   
Kinase Selectively                          May  P2: MS    
Prevents                                    Immunology and 
Antigen-Activation                          Basic Science  
of B cells and                                             
Ameliorates                                                
B-Cell-Mediated                                            
Experimental                                               
Autoimmune                                                 
Encephalomyelitis                                          
Rebif® (interferon 
beta-1a)           
Pregnancy and       Hellwig K  450          13:44 ET,      
Infant Outcomes                             Thursday 9     
with Interferon                             MayS49: MS     
Beta: Data from the                         Epidemiology   
European Interferon                         and Risk       
Beta Pregnancy                              Stratification 
Registry and MS                                            
Preg study                                                 
conducted in                                               
Finland and Sweden                                         
Dynamics of         De Stefano P5.2-047     11:30 - 18:30  
Pseudo-Atrophy in   N                       ET, Thursday 9 
RRMS Patients                               May  P5: MS    
Treated with                                Neuroimaging   
Interferon beta-1a                                         
as Assessed by                                             
Monthly Brain MRI                                          
                                                           
MS in the 21st     
Century            
Comparing patient   Williams M P4.9-076     11:30 - 18:30  
perceptions on                              ET, Wednesday 8
multiple sclerosis                          May   P4:      
management and care                         Practice,      
- a sub-analysis of                         Policy, and    
geographic                                  Ethics I       
differences                                                 

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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 RebiSlide(TM). 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 EUR 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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