Merck KGaA

Merck to Present Data on MAVENCLAD(TM) (Cladribine Tablets) and Rebif® (interferon beta-1a) in Patients with Relapsing MS at EAN Congress 2017

Darmstadt, Germany (ots/PRNewswire) -

- New data builds on company's longstanding commitment to MS  

Merck, a leading science and technology company, will present data from its neurology and immunology portfolio at the 3rd Congress of the European Academy of Neurology (EAN), taking place from June 24-27, in Amsterdam, the Netherlands. Merck will present a total of 12 abstracts on multiple sclerosis (MS), including studies evaluating Rebif® (interferon beta-1a) as well as efficacy and safety data on the use of MAVENCLAD(TM) (Cladribine Tablets), Merck's short-course oral therapy recently recommended for marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) in patients with relapsing MS.

(Logo: http://photos.prnewswire.com/prnh/20170421/492737LOGO )

Data being presented at the Congress will provide further insights into the proposed mode of action of Cladribine Tablets, which is thought to selectively target and discontinuously reduce lymphocytes which may be integral to the pathological process of MS.

On 23 June, the Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion on the use of Cladribine Tablets for highly active relapsing MS, and this recommendation has been passed on to the EC to make the final decision on the Marketing Authorization Application (MAA) later this year.

"We are pleased with the recent CHMP positive opinion, which takes Cladribine Tablets a step closer to potentially benefitting patients with this debilitating disease," said Luciano Rossetti, Head of Global R&D for the biopharma business of Merck. "The data presented at EAN provide a detailed characterization of the effect of Cladribine Tablets on B and T lymphocytes in patients followed for up to eight years and provide further support for the use of Cladribine Tablets in patients with relapsing MS."

Attendees can learn more about Merck's programmes, pipeline and activities in neurology by visiting our medical booth B30.

The following abstracts have been accepted for presentation at the EAN Congress 2017:



Rebif (interferon beta-1a) Presentations
Abstract/       
Presentation
Title                      Lead Author     Poster #        
Date/Time/Session


Evaluation of modified Rio M. Freedman     PR2082          MS and
related   
score (MRS) as a                                           
disorders 3
predictive score in                                        Sunday
June 25
clinical trial                                             
13:30-14:15
sub-populations of
multiple sclerosis (MS)
patients treated
with subcutaneous
interferon beta 1-a 

Patient adherence to       G. de Voer      POD506         Poster 
on display
subcutaneous interferon                                   session
beta-1a injections using
the RebiSmart(R) injection                               
device: A retrospective
real-world study among
Dutch and German patients                                 
with multiple sclerosis  

Impact of a patient        V. Salgado      EP3111         MS and 
related
support program (REBICARE)                                
disorders 1
on interferon beta 1a                                     Monday 
June 26
adherence and clinical                                    
12:30-13:15
outcomes in
Relapse-Remitting Multiple
Sclerosis                           



Oxidative stress in        M. Moccia       EP2166          MS and
related
multiple sclerosis: effect                                 
disorders 4
of dietary supplementation                                 Sunday
June 25
with coenzyme Q10                                          
12:30-13:15

Cladribine Tablets Presentations
Abstract/       
Presentation
Title                      Lead Author     Poster #        
Date/Time/Session


Efficacy of cladribine     G. Comi          EP1140         MS and
related
tablets in patients after                                  
disorders 1
conversion to clinically                                   
Saturday June 24
definite multiple                                          
12:30-13:15
sclerosis (CDMS): analysis
of the ORACLE-MS study
open-label maintenance
period                              


Safety of cladribine      S. Cook            EP1141        MS and
related
tablets in the treatment                                   
disorders 1
of patients with multiple                                  
Saturday June 24
sclerosis (MS): an                                         
12:30-13:15
integrated analysis from
the MS clinical
development program           

Effect of cladribine     G. Giovannoni       POD040       Poster 
on display
tablets on relapse rates                                  session
and the proportions
qualified relapse-free in
patients with multiple
sclerosis: analysis of the
CLARITY and CLARITY                                       
Extension studies                   


High Disease Activity    G. Giovannoni       EP1156        MS and
related
(HDA) Definitions in                                       
disorders 2                                  
Patients with Relapsing                                    
Saturday June 24
Multiple Sclerosis (RMS)                                   
12:30-13:15
Receiving Placebo in the
CLARITY Study                       


Cladribine tablets in high   G. Giovannoni    EP1157       MS and
related
disease activity (HDA)                                     
disorders 2
subgroups from the CLARITY                                 
Saturday June 24
study of patients with                                     
12:30-13:15
relapsing multiple
sclerosis (RMS)                     


Absolute lymphocyte counts  P.               EP3120        MS and
related
in patients with            Soelberg-Sorensen              
disorders 6
relapsing-remitting                                        Monday
June 26
multiple sclerosis (RRMS)                                  
12:30-13:15             
treated with cladribine
tablets 3.5 mg/kg in the  
CLARITY and CLARITY       
Extension studies                                 

Selective and               O. Stuve          EP3122       MS and
related                                
discontinuous reduction of                                 
disorders 6
B and T lymphocytes by                                     Monday
June 26
cladribine tablets in                                      
12:30-13:15
patients with early and                                   
relapsing multiple
sclerosis (ORACLE-MS,
CLARITY and CLARITY
Extension)                          


Year-by-year lymphopenia   S. Cook            EP1142       MS and
related
rates in patients with                                     
disorders 1
relapsing multiple                                         
Saturday June 24
sclerosis (RMS) treated                                    
12:30-13:15                       
with cladribine tablets
3.5 mg/kg in CLARITY and
re-treated in CLARITY
Extension                            

About MAVENCLAD(TM) (Cladribine Tablets)

Cladribine Tablets is a short-course oral therapy that is believed to selectively and periodically target lymphocytes thought to be integral to the pathological process of MS. Cladribine Tablets is currently under clinical investigation and not yet approved for the treatment for any use in the United States, Canada and Europe. On 23 June, the Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion on the use of Cladribine Tablets for highly active relapsing MS, and this recommendation has been passed on to the EC to make the final decision on the Marketing Authorization Application (MAA) later this year.

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 four-year Phase III 
  placebo-controlled study following on from the CLARITY study, 
  designed to evaluate the safety and efficacy of Cladribine Tablets 
  over an extended administration for four years.
- CLARITY (CLAdRIbine Tablets Treating MS OrallY) study and its 
  extension: 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 and its two-year extension 
  designed to provide data on the long-term safety and efficacy of 
  extended administration of Cladribine Tablets for up to four years.
- 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).
- 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 Patients Who Have Participated in Cladribine 
  Clinical Studies) study: interim long-term follow-up data from the 
  prospective registry, PREMIERE, to evaluate the safety and efficacy
  of Cladribine Tablets. The follow-up will consist of over 10,000 
  patient years of exposure in total, with follow-up in some patients
  exceeding eight years at completion. 

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. RebiSmart®, an electronic device for self-injection of Rebif®, is also not approved in the United States. Cladribine Tablets is an investigational product and not approved for use in any indication in the United States.

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.

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About Merck

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of EUR 15.0 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

Contact:

Erin-Marie Beals +49-151-1454-2694

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