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WKN: 659990 ISIN: DE0006599905 Ticker-Symbol: MRK 
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21.04.2017 | 15:46
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PR Newswire·Mehr Nachrichten von PR Newswire

DARMSTADT, Germany, April 21, 2017 /PRNewswire/ --

  • Breadth of data and activities underscore company's long-standing commitment to enhancing care for people with MS

Merck, a leading science and technology company, will present data at the American Academy of Neurology (AAN) 69th Annual Meeting, taking place from April 22-28, 2017, in Boston, Mass. Merck will present 15 abstracts on multiple sclerosis (MS), including studies evaluating Rebif® (interferon beta-1a) and investigational Cladribine Tablets, as well as analyses of complications and MS relapse rates during pregnancy and real-world data related to the impact of treatment adherence and patient costs.

(Logo: http://mma.prnewswire.com/media/492737/Merck_Logo.jpg )

"Rebif has a well-established safety profile supported by more than 20 years of accrued clinical trial and patient experience, and the information from the studies and analyses we are presenting at AAN deepens our understanding of this important RRMS therapy," said Dr. Kathleen Hawker, Vice President, Neurology and Immunology US, EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany.

The company will also present efficacy and safety data for Cladribine Tablets, an investigational short-course oral therapy that is thought to selectively and periodically target lymphocytes which may 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 or elsewhere. In July 2016, the European Medicines Agency (EMA) accepted for review the Marketing Authorisation Application (MAA) of Cladribine Tablets for the treatment of adult patients with RRMS.

"We have an unwavering focus on delivering innovation to patients in need, and our presentations this week at AAN, a leading neurology conference, further validate the promise of Cladribine Tablets as a potential RRMS treatment option," said Luciano Rossetti, Head of Global R&D for the biopharma business of Merck.

Attendees can learn more about our programs, pipeline and activities in neurology by visiting our medical booth #473. Booth activities include a $25,000 charitable donation presentation to Can DO MS on April 25 at 3 p.m., as well as "I'm Facing MS" simulation stations that will translate users' experiences with different MS impairments into artwork.

AAN Brain Health Fair

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada will have an exhibition at the AAN Brain Health Fair on April 21 from 10 a.m. - 4 p.m. ET, where attendees can gain first-hand experience about what it's like to have MS through virtual reality and other activities.

The following abstracts were accepted for presentation at theAAN 2017 Annual Meeting:

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

    Cholecalciferol              W. Camu         004          April 27, 2017, 4:06 p.m.
    Supplementation in                                        Oral Presentation
    Relapsing Multiple                                        Session S44: MS Risk
    Sclerosis Patients Treated                                Factors and Modifications
    with Subcutaneous
    Interferon Beta-1a: A                                     
    Randomized Controlled
    Trial      
                                                              
    High Dose Cholecalciferol    R. Hupperts     005          April 27, 2017, 4:18 p.m.
    (Vitamin D3) Oil as Add-on                                Oral Presentation
    Therapy in Subjects with                                  Session S44: MS Risk
    Relapsing-Remitting
    Multiple Sclerosis
    Receiving Subcutaneous
    Interferon ss-1a
    (scIFNbeta-1a)

    Treatment with Interferon    M. Battaglini   340          April 28, 2017, 4:00 - 
    Reduces the Appearance of                                 5:30 p.m.
    Lesions in Clinically                                     Poster Session P6
    Relevant White Matter (WM)
    Tracts in Patients with
    Clinically Isolated
    Syndrome (CIS)                             
                                                              
    Effect of Early Versus       M. Freedman     358          April 28, 2017, 4:00 -
    Delayed Treatment (DT)                                    5:30 p.m.                       
    with Subcutaneous IFN                                     Poster Session P6
    ss-1a (scIFNss-1a) on
    Radiological Activity Free
    (RAF) or Clinical Activity                                
    Free (CAF) Status in                                      
    Patients with Clinically
    Isolated Syndrome (CIS): A
    Post-hoc Analysis of
    REFLEXION                                              
                              
    Clinical Efficacy of         F. Nelson       343          April 28, 2017, 4:00 -
    Interferon ss-1a                                          5:30 p.m.
    Subcutaneously Three Times                                Poster Session P6
    Weekly According to
    Baseline Radiological
    Characteristics: Post Hoc                                 
    Analyses of PRISMS Data                                   
                                                  
    Efficacy of Interferon       E. Williamson   329          April 28, 2017, 4:00 -
    ss-1a Subcutaneously Three                                5:30 p.m.
    Times Weekly According to                                 Poster Session P6
    Baseline EDSS/Duration,
    EDSS, and MSSS Sub-groups:
    Post Hoc Analysis of
    PRISMS Data           

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

    Cladribine Tablets in the    S. Cook         394          April 27, 2017, 5:30 -
    Treatment of Patients with                                7:00 p.m.
    Multiple Sclerosis (MS):                                  Poster Session P5
    An Integrated Analysis of
    Safety from the MS
    Clinical Development
    Program
                                  
    Absolute Lymphocyte Count    P.              379          April 27, 2017, 5:30 -
    Recovery in Patients with    Soelberg-                    7:00 p.m.
    Relapsing-Remitting          Sorensen                     Poster Session P5
    Multiple Sclerosis (RRMS)
    Treated with Cladribine
    Tablets 3.5 mg/kg in
    CLARITY and CLARITY                                       
    Extension                                           
                                                            
    Cladribine Tablets in the    G. Comi         349          April 28, 2017, 4:00 -
    ORACLE-MS Study Open-label                                5:30 p.m.
    Maintenance Period:                                       Poster Session P6  
    Analysis of Efficacy in
    Patients after Conversion
    to Clinically Definite
    Multiple Sclerosis (CDMS)                              
                              
    Defining High Disease        G. Giovannoni   351          April 28, 2017, 4:00 -
    Activity (HDA) in Patients                                5:30 p.m.
    with Relapsing Multiple                                   Poster Session P6
    Sclerosis (RMS) Receiving
    Placebo in the CLARITY                                    
    Study                                                     
                                              
    Durable Efficacy of          G. Giovannoni   353          April 28, 2017, 4:00 -
    Cladribine Tablets in                                     5:30 p.m.
    Patients with Multiple                                    Poster Session P6
    Sclerosis: Analysis of
    Relapse Rates and
    Relapse-free Patients in
    the CLARITY and CLARITY
    Extension Studies          
                                                 
    Efficacy of Cladribine       G. Giovannoni   360          April 28, 2017, 4:00 - 
    Tablets 3.5 mg/kg in High                                 5:30 p.m.
    Disease Activity (HDA)                                    Poster Session P6
    Subgroups of Patients with
    Relapsing Multiple
    Sclerosis (RMS) in the                                    
    CLARITY Study           

Additional Company-Sponsored Presentations
                                                 Abstract/    Presentation
    Title                        Lead Author     Poster #     Date/Time/Session

    Multiple Sclerosis Relapse   A. Phillips     361          April 23, 2017, 4:00 -
    Rates, Before, During, and                                5:30 p.m.
    After Pregnancy: A US                                     Poster Session P1
    Retrospective Claims                                      
    Database Analysis                                         

    Pregnancy Complications of   MK. Houtchens   110          April 24, 2017, 8:30  
    Women With and Without                                    a.m. - 7:00 p.m.
    Multiple Sclerosis in a                                   Poster Session P2
    Large US Claims Database                                  

    Does Patients' Experience    J. Smrtka       337          April 25, 2017, 5:30 -                   
    of Care Differ by Level of                                7:00 p.m.
    Adherence in Multiple                                     Poster Session P3
    Sclerosis?                                    

About Cladribine Tablets

Cladribine Tablets is an investigational short-course oral therapy that is thought 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. In July 2016, the European Medicines Agency (EMA) accepted for review the Marketing Authorisation Application (MAA) of Cladribine Tablets for the treatment of relapsing remitting multiple sclerosis.

The clinical development program for Cladribine Tablets includes:

  • 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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