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

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News provided by

Merck

24 Jun, 2017, 17:17 GMT

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DARMSTADT, Germany, June 24, 2017 /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™ (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™ (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™. 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.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

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 € 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.

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