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New Efficacy and Safety Data on MS Portfolio to Be Presented at ECTRIMS 2018
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PR Newswire
DARMSTADT, Germany, Oct. 8, 2018
DARMSTADT, Germany, Oct. 8, 2018 /PRNewswire/ --
- Late-breaking Phase II primary endpoint data for investigational therapy evobrutinib, the first oral BTK inhibitor to show clinical proof-of-concept in RMS
- Up to 10 years of patient experience provides further insight into the benefit-risk profile of investigational cladribine tablets
- Late-breaking data from multi-sponsored European IFNβPregnancy registry highlight Rebif safety outcomes during pregnancy
- A total of 23 abstracts for cladribine tablets, Rebif and evobrutinib will be presented at ECTRIMS 2018
Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that it will present data from approved and investigational multiple sclerosis (MS) treatments from its neurology and immunology portfolio at the 34th Congress of the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS), taking place from 10–12 October 2018, in Berlin, Germany. Merck KGaA, Darmstadt, Germany will present 23 abstracts, including new safety and efficacy data on investigational cladribine tablets, Rebif® (interferon beta-1a) and investigational therapy evobrutinib, a highly-specific, oral Bruton's Tyrosine Kinase (BTK) inhibitor.
Key cladribine tablets data will include:
- An updated integrated safety analysis of patients from the CLARITY, CLARITY Extension and ORACLE-MS trials, including two additional years of data from the long-term PREMIERE Registry (up to 10-years of follow-up).
- An overview of the first six months of real-world evidence safety data on cladribine tablets.
- Results from a post hoc analysis of the CLARITY study will characterize relapse severity and frequency in relapsing-remitting MS (RRMS) patients in cladribine tablets versus placebo.
- New data from post hoc analyses to support the duration of effect of cladribine tablets across patient subgroups of different ages and with different disease activity status (in Years 3 and 4 post-treatment) will be presented.
Key late-breaking data presentations include:
- Results of primary 24-week MRI endpoint analysis, along with a description of interim key secondary and safety analysis from a Phase II study of investigational BTK-inhibitor evobrutinib in patients with relapsing MS. The late-breaking oral presentation will highlight the first evidence of clinical activity of a BTK-inhibitor in a non-oncology indication.
- Presentation highlighting pregnancy and infant outcomes with multiple IFNβ therapies, including Rebif®, from the European IFNβ pregnancy registry and Nordic health registers.
"We are proud to be presenting new data across our Neurology and Immunology franchise at Merck KGaA, Darmstadt, Germany during ECTRIMS 2018," said Luciano Rossetti, Head of Global R&D for the biopharma business of Merck KGaA, Darmstadt, Germany. "As we continue to enhance our understanding of the benefit-risk profile of cladribine tablets and the use of Rebif, we are also excited by the presentation of the first clinical data for a BTK inhibitor (evobrutinib) in an MS patient population."
Additional Merck KGaA, Darmstadt, Germany activities at ECTRIMS 2018:
- Results of the Merck KGaA, Darmstadt, Germany-sponsored 'MS in the 21st Century International Unmet Needs Survey' will show that MS patients have substantially different perceptions of the current unmet needs in MS compared with healthcare professionals (HCPs).
- Following on from the #MSInsideOut campaign launch on World MS Day earlier in the year, Merck KGaA, Darmstadt, Germany will be premiering the MS Inside Out Documentary film executively produced by Shift.ms during an event on October 11. At the event, Merck KGaA, Darmstadt, Germany will shine a light on the untold stories of MS, as well as revealing the findings and key results from a new global MS carers survey conducted in collaboration between leading international carer organizations IACO (International Alliance of Carer Organization) and Eurocarers. The data presented at ECTRIMS will further demonstrate the need for a deeper understanding of those affected by MS and their carer.
- Merck KGaA, Darmstadt, Germany will also be announcing the annual Grant for Multiple Sclerosis Innovation (GMSI) Award winners in Berlin. First launched at ECTRIMS 2012, the GMSI Award supports the advancement of science and medical research in the field of MS and provides a grant of up to €1,000,000 per year to one or more selected research projects.
- The company will be holding a press event on Wednesday, 10 October 2018, 15:00–16:25 (CET) at CityCube Conference Center (Room: London 1), Berlin, Germany.
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Below are a selection of abstracts that have been accepted for presentation at ECTRIMS 2018:
| Cladribine Tablets Presentations | |||
| Title | Authors | Abstract No. | Presentation Date/Time/Session |
| An exploratory analysis of the efficacy of Cladribine Tablets 3.5mg/kg in patients with relapsing multiple sclerosis stratified according to age above and below 45 years in the CLARITY study | Giovannoni G, Rammohan K, Cook S, Soelberg-Sorensen P, Vermersch P, Keller B, Verdun di Cantogno E | A-0950-0028-00859 | Session Title: Poster Session 3 |
| Sustained efficacy in relapsing remitting multiple sclerosis following switch to placebo treatment from Cladribine Tablets in patients with high disease activity at baseline | Vermersch P, Giovannoni G, Soelberg-Sorensen P, Keller B, Jack D | A-0950-0028-00886 | Session Title: Poster Session 1 |
| CLARITY: An analysis of severity and frequency of relapses in patients with relapsing-remitting multiple sclerosis treated with Cladribine Tablets or placebo | Schippling S, Sormani M P, De Stefano N, Giovannoni G, Galazka A, Keller B, Alexandri N | A-0950-0028-01315 | Session Title: Poster Session 1 |
| Lymphopenia rates in CLARITY/CLARITY Extension are unrelated to disease activity at baseline | Cook S, Giovannoni G, Vermersch P, Soelberg-Sorensen P, Keller B, Jack D | A-0950-0028-00836 | Session Title: Poster Session 2 |
| Updated safety analysis of Cladribine Tablets in the treatment of patients with multiple sclerosis | Cook S, Giovannoni G, Leist T, Syed S, Nolting A, Schick R | A-0950-0028-00889 | Session Title: Poster Session 2 |
| Durability of NEDA-3 status in patients with relapsing multiple sclerosis receiving Cladribine Tablets: CLARITY Extension | Giovannoni G, Keller B, Jack D | A-0950-0028-01763 | Session Title: Poster Session 2 |
| ADA genetic variants influence central inflammation and clinical characteristics in MS: implications for cladribine treatment | Stampanoni Bassi M, Buttari F, Simonelli I, Sica F, Furlan R, Marfia G A, Salvetti M, Uccelli A, Matarese G, Visconti A, Centonze D | A-0950-0028-01895 | Poster Session 1 10 October 2018 Presenting Time: 17:00-19:00 h |
| Neuroblastoma cell line and lymphocytes talk for cladribine influenced apoptosis and inflammation pathways in Multiple Sclerosis (MS): an "in vitro" study | Ruggieri M, Mastrapasqua M, Gargano C D, Palazzo C, Frigeri A, Paolicelli D, Visconti A, Trojano M on behalf of MSRUN group. | A-0950-0028-01704 | ePoster |
| Dissection of the distinct susceptibility of hematopoietic precursors and immune cells to cladribine | Carlini F, Ivaldi F, Kerlero de Rosbo N, Boschert U , Visconti A, Uccelli A | A-0950-0028-01855 | ePoster |
| Gene expression profiles of proteins involved in Cladribine metabolism and their possible correlation with Epstein-Barr virus variants | Mechelli R, Manfrè G, Pellicciari G, Reniè R, Romano C, Ristori G, Visconti A, Salvetti M on behalf of MSRUN group | A-0950-0032-01730 | Poster Session 3 12 October 2018 Presenting Time: 12:15-14:15 h |
| A Systematic Review of Real-world Adherence and Persistence of Daily Oral Disease-Modifying Drugs (Dimethyl Fumarate, Fingolimod, and Teriflunomide) in Multiple Sclerosis | Edwards NC, Edwards RA, Dellarole A, Grosso M, Phillips A | TBC | Poster Session 3 12 October 2018 Presenting Time: 12:15-14:15 h |
| Rebif® (interferon beta-1a) Presentations | |||
| Subcutaneous Interferon beta-1a, 10-Year Results from the United Kingdom Multiple Sclerosis Risk Sharing Scheme | Harty G, Wong S L, Gillett A, Davies A | A-0950-0030-00894 | Session Title: Poster Session 2 Session Date: 11.10.2018 Presenting Time: 17:15-19:15 h. |
| Rapid reduction of lesion accumulation in specific white matter tracts as assessed by lesion mapping in RR-MS patients treated with IFN beta-1a | De Stefano N, Giorgio A, Gentile G, Stromillo M L, Visconti A, Battaglini M | A-0950-0023-02002 | ePoster |
| Dynamics of pseudo-atrophy in RRMS patients treated with Interferon beta-1a as assessed by monthly brain MRI | De Stefano N, Giorgio A, Gentile G, Stromillo M L, Visconti A, Sormani M P, Battaglini M | A-0950-0023-02027 | Session Title: Poster Session 2 |
| A Real-World Comparison of Infections and Lymphocyte Counts among Relapsing-Remitting Multiple Sclerosis Patients 50 years or older treated with Subcutaneous Interferon-Beta 1a or Dimethyl Fumarate | Hayward B, Cardoso S, Grosso M, Ansari S, Napoli S | A-0950-0031-02072 | Session Title: Poster Session 1 |
| Value of the MoCA test to detect cognitive impairment in MS patients without subjective cognitive complaints | K. Charest, A. Tremblay, R. Langlois, É. Roger, P. Duquette, I. Rouleau | A-0950-0009-01537 | ePoster |
| Rebif® (interferon beta-1a) Late-breaker Presentation | |||
| Pregnancy and Infant Outcomes with Interferon Beta: Data from the European Interferon Beta Pregnancy Registry and Population Based Registries in Finland and Sweden | Hellwig K, Geissbuehler Y, Sabidó M, Popescu C, Adamo A, Klinger J, Huppke P, Ornoy A, Korhonen P, Myhr K-M, Montgomery S , Burkill S on behalf of the European Interferon Beta Pregnancy Study Group | A-0950-0000-02658 | Session Title: Poster Session 3 Session Date: Friday, 12 October 2018 Presenting Time: 12.15 – 14.15 h |
| Evobrutinib (Bruton's Tyrosine Kinase Inhibitor) Presentations | |||
| Safety, Tolerability, Pharmacokinetics and Concentration-QT Analysis of the Novel BTK Inhibitor Evobrutinib (M2951) in Healthy Volunteers | Becker A, Martin E, Ona V, Mitchell DY, Willmer J, Johne A | A-0950-0028-01166 Werbung Mehr Nachrichten zur Merck KGaA Aktie kostenlos abonnieren
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