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24.06.2019 – 14:00

Merck KGaA

Merck to Showcase New Data Across MS Portfolio at EAN 2019

Darmstadt, Germany (ots/PRNewswire)

Not intended for UK or U.S. based media

- Company to present 16 abstracts on MAVENCLAD® (cladribine tablets),
  Rebif® (interferon beta-1a) and investigational evobrutinib at the 
  5th Congress of the European Academy of Neurology 
- Presentations include new data on the long-term efficacy and safety
  of MAVENCLAD®, new safety data for Rebif® and the 48-week analysis 
  from the Phase 2 clinical study with evobrutinib 
- Merck-initiative MS in the 21st Century to present findings from 
  Patient Perceptions Initiative  

Merck, a leading science and technology company, today announced that data from across its multiple sclerosis (MS) portfolio will be presented at the 5th Congress of the European Academy of Neurology (EAN), 29 June - 2 July 2019 in Oslo, Norway. Merck will present a total of 16 abstracts (12 posters and 4 presentations) on MAVENCLAD® (cladribine tablets), Rebif® (interferon beta-1a) and the investigational therapy evobrutinib (an oral, highly selective Bruton's Tyrosine Kinase [BTK] inhibitor). The company will also present findings from the Patient Perceptions Initiative by MS in the 21st Century.

"The wealth of new data that we are presenting at EAN 2019, from both our approved medicines and our pipeline in MS, highlight our commitment to making further advances for people living with this chronic disease," said Luciano Rossetti, Head of Global Research & Development for the Biopharma business of Merck.

Key MAVENCLAD® data will include:

- Post-hoc analysis of the CLARITY Extension study to examine the 
  long-term efficacy in high-disease activity patients treated with 
  cladribine tablets 3.5 mg/kg 
- Updated safety analysis of cladribine tablets 3.5 mg/kg in patients
  with relapsing multiple sclerosis (RMS) 

Key Rebif® data will include:

- Results from the Nordic registry regarding the risk of spontaneous 
  abortion and ectopic pregnancy in patients using interferons 
- Results from the UK Multiple Sclerosis Risk Sharing Scheme on 
  treatment with subcutaneous interferon beta-1a  

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 

In addition, Merck will be presenting results from a global mapping study supported by the MS in the 21st Century initiative. The results will outline the availability of educational resources in MS across several themes including 'MS stages and progression'. The initiative, led by a steering group of international MS specialists, aims to gain insight into patient opinions on unmet needs in MS management.

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

MAVENCLAD®         
(cladribine        
tablets)           
Title               Lead       Poster       Presentation 
                    Author                  / Session    
NEDA-3 durability   Giovannoni EPO1244      Session: "MS 
in CLARITY          G                       and related  
Extension in                                disorders 3" 
patients with                               Date:        
relapsing multiple                          Saturday, 29 
sclerosis receiving                         June 2019    
Cladribine Tablets                          Time: 12:30  
                                            to 13:15     
                                            Location:    
                                            Screen B12   
Variations of uric  Moccia M   EPO2218      Session: "MS 
acid levels and                             and related  
their clinical                              disorders 5" 
correlates during                           Date: Sunday 
cladribine                                  30 June 2019 
treatment                                   Time: 12:30  
                                            to 13:15     
                                            Location:    
                                            Screen B11   
CLARITY Extension:  Vermersch  EPO3211      Session: "MS 
Sustained efficacy  P                       and related  
in relapsing                                disorders 8" 
remitting multiple                          Date: Monday,
sclerosis following                         01 July 2019 
switch from                                 Time: 12:30  
Cladribine Tablets                          to 13:15     
to placebo in                               Location:    
patients with high                          Screen B11   
disease activity at                                      
baseline                                                 
Rationale, design   Boyko A    POD026       Session:     
and feasibility                             "Poster on   
assessment of the                           Display      
phase IV CLASSIC-MS                         Date:        
study evaluating                            Saturday 29  
long-term efficacy                          June-Monday 1
outcomes for                                July         
patients with                                            
multiple sclerosis                                       
treated with                                             
Cladribine Tablets                                       
Incidence and risk  Kuiper J   EPO2202      Session: "MS 
of any malignancies                         and Related  
in multiple                                 Disorders 4" 
sclerosis (MS) from                         Date: Sunday 
the Netherlands                             30 June 2019 
(NL) and Denmark                            Time: 12:30  
(DK)                                        to 13:15     
                                            Location:    
                                            Screen B10   
Incidence and risk  Nørgaard M EPO2226      Session: "MS 
of malignancies by                          and related  
type, in multiple                           disorders 6" 
sclerosis (MS)                              Date: Sunday,
patients, compared                          30 June 2019 
from the                                    Time: 12:30  
Netherlands (NL)                            -13:15       
and Denmark (DK)                            Location:    
                                            Screen B12   
Severity and        Schippling EPO3196      Session: "MS 
frequency of        S                       and related  
relapses in                                 disorders 7" 
patients with                               Date: Monday,
relapsing-remitting                         01 July 2019 
MS treated with                             Time: 12:30  
Cladribine Tablets                          to 13:15     
in CLARITY and                              Location:    
placebo in CLARITY                          Screen B10   
Extension                                                
CLARITY/CLARITY     Cook S     POD049       Poster on    
Extension:                                  Display      
Lymphopenia rates                           Date:        
are consistent in                           Saturday 29  
patients with and                           June-Monday 1
without high                                July         
disease activity at                                      
baseline                                                 
Treatment of        Cook S     POD050       Poster on    
patients with                               Display      
Multiple Sclerosis:                         Date:        
An updated safety                           Saturday 29  
analysis of                                 June-Monday 1
Cladribine Tablets                          July         
Efficacy of         Giovannoni EPO1243      Session: "MS 
Cladribine Tablets  G                       and related  
3.5 mg/kg in                                disorders 3" 
Patients with                               Date:        
Relapsing Multiple                          Saturday, 29 
SclerosisAged Above                         June 2019    
and Below 45 Years;                         Time: 12:30  
CLARITY and CLARITY                         to 13:15     
Extension                                   Location:    
                                            Screen B12   
Evobrutinib        
Bruton's Tyrosine   Montalban  Oral         Session: "MS 
Kinase Inhibitor    X          presentation and related  
Evobrutinib (M2951)            - O1205      disorders"   
in Patients with                            Date:        
Relapsing Multiple                          Saturday, 29 
Sclerosis: a                                June 2019    
Randomised,                                 Time: 17:30  
Placebo-Controlled,                                      
Phase 2 Study                                            
Rebif® (interferon 
beta-1a)           
No increased risk   Juuti R    EPR2074      Session:     
of spontaneous                              ePresentation
abortion and                                Date: Sunday,
ectopic pregnancy                           June 30Time: 
after exposure to                           13:30 to     
interferon-beta                             14:15Screen  
prior to or during                          A6           
pregnancy: Results                                       
from register-based                                      
Nordic study among                                       
women with MS                                            
Subcutaneous        Harty G    EPR1089      Session:     
Interferon ?-1a: 10                         ePresentation
years of the UK                             Date:        
Multiple Sclerosis                          Saturday 29  
Risk Sharing Scheme                         JuneTime:    
                                            13:30 to     
                                            14:15 Screen 
                                            A7           
A systematic review Sabidó M   EPO3194      Session:     
of relapse rates in                         ePosterDate: 
patients with                               Monday 1 July
relapsing multiple                          Time: 12:30  
sclerosis during                            to           
pregnancy and                               13:15Screen  
breastfeeding                               B10          
Rapid reduction of  De Stefano EPR1086      Session:     
lesion accumulation N                       ePresentation
in specific white                           Date:        
matter tracts as                            Saturday 29  
assessed by lesion                          JuneTime:    
mapping in RR-MS                            13:30 to     
patients treated                            14:15 Screen 
with IFN beta-1a                            A7           
Dynamics of         De Stefano EPO1234      Session:     
Pseudo-Atrophy in   N                       ePosterDate: 
RRMS Patients                               Saturday 29  
Treated with                                JuneTime:    
Interferon beta-1a                          12:30 to     
as Assessed by                              13:15Screen  
Monthly Brain MRI                           B11          
MS in the 21st     
Century            
A sub-analysis of   Vermersch  EPO1148      Session:     
global mapping data P                       ePosterDate: 
on the availability                         Saturday, 29 
of online                                   June 2019    
educational                                 Time: 12:30  
resources for                               to           
multiple sclerosis                          13:15Screen  
patients                                    A5            

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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 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 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 selective 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 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 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 (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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