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24.06.2019 – 14:00

Merck KGaA

Merck to Showcase New Data Across MS Portfolio at EAN 2019

Not intended for UK or U.S. based media

Darmstadt, Germany (ots/PRNewswire)

- 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:

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     
                                            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     
                                            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     
                                            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 
Sclerosis ( Above (                         June 2019    
and Below 45 Years; (                         Time: 12:30  
CLARITY and CLARITY (                         to 13:15     
Extension (                                   Location:    
                                            Screen B12   
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 
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 
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     
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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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 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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