sprite-preloader
Anzeige
Mehr »
Dienstag, 21.08.2018 Börsentäglich über 12.000 News von 598 internationalen Medien

Indizes

Kurs

%
News
24 h / 7 T
Aufrufe
7 Tage

Aktien

Kurs

%
News
24 h / 7 T
Aufrufe
7 Tage

Xetra-Orderbuch

Devisen

Kurs

%

Rohstoffe

Kurs

%

Passende Knock-Outs zu Ihrer Suchanfrage (Anzeige)
Erweiterte
Suche
lynx
Ad hoc-Mitteilungen

WKN: 659990 ISIN: DE0006599905 Ticker-Symbol: MRK 
Aktie:
Branche
Pharma
Aktienmarkt
DAX-30
Prime Standard
DAX International 100
1-Jahres-Chart
MERCK KGAA Chart 1 Jahr
1-Woche-Intraday-Chart
MERCK KGAA 1-Woche-Intraday-Chart
RealtimeGeldBriefZeit
92,32
92,34
14:34
92,30
92,32
14:34
14.06.2018 | 15:04
(27 Leser)
Schrift ändern:
(0 Bewertungen)

PR Newswire·Mehr Nachrichten von PR Newswire

DARMSTADT, Germany, June 14, 2018 /PRNewswire/ --

  • 14 abstracts to be presented, further characterizing the complementary profiles of Mavenclad (cladribine tablets)and Rebif (interferon beta-1a)

Merck, a leading science and technology company, will present data from its neurology and immunology portfolio at the 4th Congress of the European Academy of Neurology (EAN), taking place from June 16-19, in Lisbon, Portugal. Merck will present a total of 14 abstracts in the area of relapsing multiple sclerosis (RMS), including a post-hoc analysis of the Phase III CLARITY study, investigating whether the beneficial clinical and magnetic resonance imaging (MRI) effects of MAVENCLAD are consistent in older (>50 years) and younger (=50) adult patients with relapsing remitting MS (RRMS). Data presented at the congress will also provide further insights into the benefit-risk profile of MAVENCLAD in patients with relapsing MS with high disease activity, using Multi-Criteria Decision Analysis, an EMA-recommended methodology used to indirectly compare the benefit-risk profile between treatments. A separate post hoc analysis of patients in the ONWARD study evaluates the efficacy of MAVENCLAD as add-on to interferon beta-1a in patients with secondary progressive MS (SPMS) with relapses, compared to patients with RRMS from the same study.

Additionally, data presentations on Rebif (interferon beta-1a) include analysis of MRI in MS (MAGNIMS) score[1] to predict long-term clinical disease activity (CDA)-free status and disability progression following treatment with Rebif.

In line with Merck's MS Inside Out campaign aiming to better understand patients with MS, results of the Merck-sponsored 'MS in the 21st Century International Unmet Needs Survey' show that MS patients have substantially different perceptions of the current unmet needs in MS compared to healthcare professionals (HCPs). Identification and understanding of these differences could lead to an improved dialogue between HCPs and patients, which is integral to finding appropriate individualised treatment approaches for each patient.

Attendees can learn more about Merck's programs, pipeline and activities in neurology and immunology by visiting the company's medical booth A07

The following abstracts have been accepted for presentation at EAN Congress 2018:

MAVENCLAD(R) (Cladribine Tablets) Presentations
                                                                      Presentation
    Title                       Authors             Abstract No.    Date/Time/Session

                                                                     
    Infections during    
    periods of grade 3 or
    4 lymphopenia in                                        
    patients taking          Cook S, Leist T,                      
    cladribine tablets 3.5   Comi G, Montalban                     
    mg/kg: data from an      X, Sylvester E,                        ePoster
    integrated safety        Hicking C, Dangond                     16-18 Jun 2018
    analysis                 F                        748           Time:12:30-14:15       
                                                                   
    Effects of cladribine
    tablets on CD4+ T cell                                         
    subsets in the           Stuve O,                              
    ORACLE-MS study:         Soelberg-Sorensen
    Results from an          P, Leist T, Hyvert                     ePoster
    analysis of lymphocyte   Y, Damian D,                           16-18 Jun 2018
    surface markers          Boschert U               762           Time:12:30-14:15
  
    Innate Immune Cell                                             
    Counts in Patients
    with
    Relapsing-Remitting                   
    Multiple Sclerosis                                             
    (RRMS) Treated with      Soelberg-Sorensen
    Cladribine Tablets 3.5   P, Dangond F,                          ePresentation
    mg/kg in CLARITY and     Hicking C,                             16-18 Jun 2018
    CLARITY Extension        Giovannoni G             749           Time:12:30-14:15
  
    Cladribine tablets
    produce selective and
    discontinuous                                                  
    reduction of B and T
    lymphocytes and
    natural killer cells     Stuve O,
    in patients with early   Soelberg-Sorensen                     
    and relapsing multiple   P, Giovannoni G,
    sclerosis (ORACLE-MS,    Leist T, Hyvert Y,                     ePresentation
    CLARITY and CLARITY      Damian D, Boschert                     16-18 Jun 2018
    Extension)               U                        746           Time:12:30-14:15
                                                                   
    An analysis of
    malignancy risk in the
    clinical development
    programme of             Galazka A, Nolting                    
    cladribine tablets in    A, Cook S, Leist T,
    patients with            Comi G, Montalban                      ePoster
    relapsing multiple       X, Hicking C,                          16-18 Jun 2018
    sclerosis (RMS)          Dangond F                757           Time:12:30-14:15
                                                                   
    Pregnancy outcomes
    during the clinical
    development programme
    of cladribine in         Galazka A, Nolting                    
    multiple sclerosis       A, Cook S, Leist T,
    (MS): an integrated      Comi G, Montalban                      ePresentation
    analysis of safety for   X, Hicking C,                          16-18 Jun 2018
    all exposed patients     Dangond F                765           Time:12:30-14:15
 
    A benefit-risk
    assessment of                                                  
    cladribine tablets
    using Multi-Criteria
    Decision Analysis for    Vermersch P,
    patients with            Martinelli V,                        
    relapsing multiple       Pfleger C,
    sclerosis                Rieckmann P,                           ePoster
    demonstrating high       Galazka A, Dangond                     16-18 Jun 2018
    disease activity         F, Phillips L            759           Time:12:30-14:15

    Efficacy of cladribine
    tablets 3.5 mg/kg
    added to
    interferon-beta in                                             
    patients with
    secondary progressive
    multiple sclerosis
    (SPMS) or                                                      
    relapsing-remitting      Montalban X, Cohen
    multiple sclerosis       B, Leist T, Moses                      ePresentation
    (RRMS): a post-hoc       H, Hicking C,                          16-18 Jun 2018
    analysis from ONWARD     Dangond F                766           Time:12:30-14:15

    A pooled analysis of
    the efficacy of                                                
    cladribine tablets 3.5
    mg/kg in patients with
    EDSS greater than or
    equal to3.5 or less                                            
    than or equal to3.0 at   Giovannoni G,
    baseline in the          Montalban X,                           ePresentation
    CLARITY and ONWARD       Hicking C, Dangond                     16-18 Jun 2018
    studies                  F                        747           Time:12:30-14:15
    Efficacy of cladribine                                         
    tablets 3.5 mg/kg in
    patients with highly
    active relapsing
    multiple sclerosis                                             
    (RMS): Pooled analysis
    of the double-blind      Giovannoni G,                          ePresentation
    cohort from CLARITY      Montalban X, Damian                    16-18 Jun 2018
    and ONWARD               D, Dangond F             1345          Time:12:30-14:15

    Efficacy of cladribine                                         
    tablets 3.5 mg/kg in
    patients less than or    Giovannoni G,
    equal to50 and >50       Rammohan K, Cook S,
    years of age with        Comi G, Rieckmann                     
    relapsing-remitting      P,
    multiple sclerosis       Soelberg-Sørensen                      ePresentation
    (RRMS): a post hoc       P, Vermersch P,                        16-18 Jun 2018
    analysis from CLARITY    Dangond F, Damian D      1341          Time:12:30-14:15

    Rebif(R) (interferon beta-1a) Presentations

    Disease activity as
    assessed by the                                                
    MAGNIMS score predicts
    long-term clinical
    disease activity free
    status and disability    Sormani MP,                           
    progression in           Freedman MS,
    patients treated with    Aldridge J,                            ePresentation
    subcutaneous             Marhardt K, De                         16-18 Jun 2018
    interferon beta-1a       Stefano N                743           Time:12:30-14:15
                                                                   
    Evolution of new
    lesions and its          Vrenken H, de Vos
    temporal patterns in     ML, Battaglini M,
    patients with            Nagtegaal GJ, de                      
    clinically isolated      Almeida Teixeira
    syndrome treated with    BC, Marhardt K, De                     ePresentation
    subcutaneous             Stefano N, Barkhof                     16-18 Jun 2018
    interferon beta-1a       F                        444           Time:12:30-14:15
 
    Additional Merck-sponsored Presentations

    Patient involvement in
    treatment
    decision-making: a
    sub-analysis of the
    'MS in the 21st
    Century international    Rieckmann P,
    unmet needs survey'      Langdon D on behalf                   
    comparing patient and    of MS in the 21st
    healthcare               Century Steering
    professional             Group, and Contango
    perspectives             EV                       1340          Poster on Display

1. Magnetic Resonance Imaging in MS

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 MAVENCLAD

MAVENCLAD (cladribine tablets) is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of multiple sclerosis (MS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD for the treatment of relapsing forms of MS (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD is now available in over 10 countries in Europe, plus Australia, Argentina and the United Arab Emirates. MAVENCLAD is not yet approved for any use in the United States.

The clinical development program of MAVENCLAD in MS comprises more than 10,000 patient years of data with over 2,700 patients included in the clinical trial program, and up to 10 years of observation in some patients. These clinical trials include the Phase III CLARITY, CLARITY extension and ORACLE MS trials, the Phase II ONWARD trial and the PREMIERE Long-term Safety Registry.

EU Indication

MAVENCLAD (cladribine tablets) is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (RMS) as defined by clinical or imaging features.

Important EU Safety Information

Contraindications:

MAVENCLAD is contraindicated in patients with hypersensitivity to the active substance, human immunodeficiency virus (HIV), active chronic infection (tuberculosis or hepatitis), active malignancy, moderate to severe renal impairment (creatinine clearance <60 mL/min), and those who are pregnant and breast-feeding. MAVENCLAD is also contraindicated in immunocompromised patients, including patients currently receiving immunosuppressive or myelosuppressive therapy.

Special warnings and precautions for use:

The most clinically relevant adverse reactions were lymphopenia and herpes zoster.

Haematology

Decreases in neutrophil count, red blood cell count, haematocrit, haemoglobin or platelet count compared to baseline values have been observed in clinical studies, although these parameters usually remain within normal limits.

Additive haematological adverse reactions may be expected if cladribine is administered prior to or concomitantly with other substances that affect the haematological profile

Lymphocyte counts must be determined

  • before initiating MAVENCLAD in year 1,
  • before initiating MAVENCLAD in year 2,
  • 2 and 6 months after start of treatment in each treatment year. If the lymphocyte count is below 500 cells/mm³, it should be actively monitored until values increase again.

Infections

Cladribine can reduce the body's immune defence and may increase the likelihood of infections. HIV infection, active tuberculosis and active hepatitis must be excluded before initiation of cladribine.

The incidence of herpes zoster was increased in patients on cladribine. If lymphocyte counts drop below 200 cells/mm³, anti-herpes prophylaxis according to local standard practice should be considered during the time of grade 4 lymphopenia. Interruption or delay of MAVENCLAD may be considered until proper resolution of the infection.

Cases of progressive multifocal leukoencephalopathy (PML) have been reported for parenteral cladribine in patients treated for hairy cell leukaemia with a different treatment regimen.

In the clinical study data base of cladribine in MS (1,976 patients, 8,650 patient years) no case of PML has been reported. However, a baseline magnetic resonance imaging (MRI) should be performed before initiating MAVENCLAD (usually within 3 months).

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.

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 Multiple Sclerosis

Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). Merck's current 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.

About Merck

Merck is a leading science and technology company in healthcare, life science and performance materials. More than 53,000 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 2017, Merck generated sales of € 15.3 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.

(Logo: https://mma.prnewswire.com/media/705849/Merck_Logo.jpg )


© 2018 PR Newswire