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Merck Completes Enrolment of Evobrutinib Phase III Clinical Trials Ahead of ECTRIMS 2021

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Merck Completes Enrolment of Evobrutinib Phase III Clinical Trials Ahead of ECTRIMS 2021

Business Wire India
Investigational evobrutinib is the first Bruton’s tyrosine kinase (BTK) inhibitor to complete Phase III clinical trial enrolment in relapsing multiple sclerosis (RMS)
Data from oral presentations at ECTRIMS show evobrutinib has a positive impact on important biomarkers of disease progression
New independent data also presented found that patients treated with MAVENCLAD® (cladribine tablets) had increased antibody IgG titer levels similar to that of the general population after a complete course of an mRNA COVID-19 vaccine

Not intended for UK and U.S. based media
 

Merck, a leading science and technology company, today announced enrolment has been completed in the Phase III EVOLUTION RMS clinical trial programme, which is evaluating the efficacy and safety of investigational Bruton’s tyrosine kinase (BTK) inhibitor evobrutinib in patients with relapsing multiple sclerosis (RMS). This milestone comes just ahead of the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place virtually from 13-15 October 2021, where 39 abstracts from the Company’s multiple sclerosis (MS) portfolio will be presented. Data will include two oral presentations and a late-breaking ePoster on evobrutinib as well as late-breaking ePosters on MAVENCLAD® (cladribine tablets), including new interim data on patient-reported improvements in quality of life (QoL) and new independent data on MAVENCLAD patients who have received a complete course of an mRNA COVID-19 vaccine.

 

“The breadth of our data at ECTRIMS, paired with the rapid enrolment in our evobrutinib Phase III EVOLUTION RMS clinical trial programme, further exemplifies a commitment to continue breaking boundaries in the science of MS,” said Danny Bar-Zohar, Global Head of Development for the Healthcare business of Merck. “By generating new data on MAVENCLAD to demonstrate the positive real-life impact it can have for people with RMS, and also on progressing evobrutinib with its dual mode of action targeting both B-cells and innate immune cells in the central nervous system and periphery, we are hoping to address the needs of people with RMS now and in the future.”

 

Key MAVENCLAD® (cladribine tablets) data include:

 

Updated post-approval safety of MAVENCLAD demonstrating consistency of real-world experience with the profile reported in the Phase III and ongoing Phase IV trials, and providing evidence that patients receiving MAVENCLAD do not appear at increased risk of severe COVID-19 outcomes
In an independent open label study, patients treated with MAVENCLAD were found to increase antibody immunoglobulin G (IgG) titer levels similar to healthy controls after a complete course of an mRNA COVID-19 vaccine
A new interim analysis from the Phase IV CLARIFY-MS study demonstrating that patients living with RMS reported an improvement in physical and mental health at one year of MAVENCLAD treatment
Real-world MAVENCLAD data from the MSBase Registry demonstrating adherence to MAVENCLAD and an annualised relapse rate similar to clinical trial data
Late-breaking data including:

Long-term Efficacy for Patients Receiving Cladribine Tablets in CLARITY/CLARITY Extension: Primary Results from 9–15 Years of Follow-up in the CLASSIC-MS Study
Cladribine tablets after treatment with natalizumab (CLADRINA) trial – Interim analyses

 

Key evobrutinib data include:

 

Data from a post-hoc analysis in the Phase II trial with evobrutinib demonstrated a reduction in volume of slowly expanding lesions (SELs), an in-vivo magnetic resonance imaging (MRI) correlate of chronic active inflammation and axonal loss within the central nervous system (CNS), which may be predictive of subsequent clinical disease progression in MS
Results from the same trial showed that increased levels of blood neurofilament light chain (NfL), a marker of neuronal damage, at baseline were predictive of increased relapse and MRI lesion activity in the study and evobrutinib significantly reduced MRI and relapse outcomes
Safety profile characterisation of evobrutinib in over 1000 patients from Phase II clinical trials in MS, rheumatoid arthritis and systemic lupus erythematosus demonstrating that overall evobrutinib treatment (all doses) was generally well tolerated across indications and elevations in liver enzymes were asymptomatic and reversible

 

Additional Company activities at ECTRIMS 2021:

 

Satellite symposium: “Supporting patient needs in MS every step of the way” co-chaired by Prof. Gavin Giovannoni, Chair of Neurology, Barts and The London School of Medicine and Dentistry and Prof. Barbara Kornek, Department of Neurology at the University of Vienna (13 October 2021, 15:00–16:00 CEST)
Medical education symposium “MS innovation in practice: the continuing search for novel therapeutic targets” co-chaired by Prof. Patrick Vermersch, Vice President for research in biology and health at the University of Lille, and Dr. Xavier Montalban, Chairman & Director Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall d’Hebron University Hospital, Barcelona, Spain (13 October 2021, 17:45-18:45 CEST). Medical and healthcare journalists interested in attending can register at merckneurology.com/newsroom

 

To keep up-to-date with our activities at ECTRIMS, along with future data and information, visit merckneurology.com/newsroom or follow us on Twitter @MerckHealthcare and LinkedIn: Healthcare Business of Merck #ECTRIMS2021 #MSInsideOut

 

Below is the full list of Merck-related abstracts accepted for presentation at ECTRIMS 2021:

 

Oral Presentations:

Abstract Name

Authors

Presentation ID

Presentation Details

Effects of evobrutinib, a Bruton’s tyrosine kinase inhibitor, on slowly expanding lesions: an emerging imaging marker of chronic tissue loss in multiple sclerosis

D.L. Arnold, C. Elliott, X. Montalban, E. Martin, Y. Hyvert, D. Tomic

115

Session: Free Communications 2 – Treatment trials – Immunomodulation
Date: 14 October 2021
Time: 16:57-17:04 CEST
Presenter: Douglas L. Arnold

Evobrutinib significantly reduces relapses and magnetic resonance imaging outcomes in patients with multiple sclerosis: association with baseline neurofilament light chain levels

J. Kuhle, L. Kappos, X. Montalban, Y. Li, K. Thangavelu, Y. Hyvert, D. Tomic

116

Session: Free Communications 2 – Treatment trials – Immunomodulation
Date: 14 October 2021
Time: 17:04-17:11 CEST
Presenter: Jens Kuhle

Single cell analysis of cerebrospinal fluid leukocytes in treated multiple sclerosis patients

M. Heming, I. Lu, N. Schwab, D. Schafflick, C.C. Gross, H. Wiendl, G.M. zu Horste

134

Session: Free Communication 3: Pathology
Date: 15 October 2021
Time: 12:33-12:40 CEST
Presenter: Gerd Meyer zu Hörste

Activated Tfh1 cells infiltrate the cerebrospinal fluid in early multiple sclerosis

J.Morille, M. Mandon, S.Rodriguez, A.Garcia, S.Wiertlewski, L.Berthelot, K.Tarte, C.Delaloy, P.Amé, D-A.Laplaud, L.Michel

025

Session: Scientific Session 2: Blood-Brain Barrier
Date: 15 October 2021
Time: 14:04-14:11 CEST
Presenter: Marion Mandon

MAVENCLAD® (cladribine tablets) ePoster Presentations:

Long-term Efficacy for Patients Receiving Cladribine Tablets in CLARITY/CLARITY Extension: Primary Results from 9–15 Years of Follow-up in the CLASSIC-MS Study

G. Giovannoni, T. Leist, A. Aydemir, E. Verdun Di Cantogno, on behalf of the CLASSIC-MS Steering Committee

P975

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Gavin Giovannoni

Cladribine Tablets after treatment with natalizumab (CLADRINA) trial – Interim analyses

P. Sguigna, A. Okai, J. Kaplan, K. Blackburn, L. Tardo, B. Hayward, U. Boschert, L. Lebson, N. Manouchehri, R. Hussain, O. Stuve

P987

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Peter Sguigna

Improvements in QoL at 1 Year in Patients Treated With Cladribine Tablets for Highly Active Relapsing MS: An Interim Analysis of CLARIFY-MS

A. Solari, X. Montalban, J. Lechner-Scott, F. Piehl, B. Brochet, D. Langdon, R. Hupperts, K. Selmaj, E.K. Havrdova, F. Patti, Brieva L, Maida EM, N. Alexandri, P. Kamudoni, A. Nolting, B. Keller

P238

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Alessandra Solari

Post-Approval Safety of Cladribine Tablets With Particular Reference to COVID-19 Outcomes: An Update

G. Giovannoni, J. Berger, T. Leist, D. Jack, A. Galazka, A. Nolting, D. Damian

P766

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Gavin Giovannoni

High Adherence to Treatment With Cladribine Tablets for Multiple Sclerosis: Value-Added Benefit of a Nurse/Pharmacy-led Patient Support Programme During the COVID-19 Pandemic

J. Oh, M.S. Freedman, K. Vernon, M. Ayer, C. Lemieux, K. Morgan, T. Quinn, T. Vella, A. Allignol, M. Stein, E. Verdun di Cantogno, M. Sabidó

P741

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Jiwon Oh

Incidence of Infections and Severe Lymphopenia in Patients Newly Initiating Cladribine Tablets or Fingolimod for Treatment of Multiple Sclerosis: CLARION Study

J. Hillert, H. Butzkueven, M. Soilu-Hänninen, T. Ziemssen, J. Kuhle, J.R. Berger, A. Aydemir, J. Sõnajalg, I. Bezemer, M. Sabidó

P767

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Jan Hillert

Disease-Modifying Treatment Patterns of Patients With Multiple Sclerosis and Newly Treated With Cladribine Tablets or Fingolimod: An Interim Analysis of the CLARION Study

H. Butzkueven, J. Hillert, J. Sõnajalg, M. Soilu-Hänninen, A. Aydemir, T. Ziemssen, J. Kuhle, M. Magyari, S. Wergeland, I. Bezemer, M. Sabidó

P742

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Helmut Butzkueven

Risk of Cancer with Disease-Modifying Drugs in Multiple Sclerosis: A New-User Cohort Design in the French Nationwide Claims Database

P. Bosco-Lévy, M. Sabidó, E. Guiard, P. Diez, C. Foch, C. Favary, J. Jové, E. Boutmy, P. Blin

P756

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Meritxell Sabidó

A Multi-Country Cohort Database Study to Assess Pregnancy and Infant Outcomes in Women Exposed to Cladribine Tablets: CLEAR Study

K. Hellwig, M. Magyari, T. McDonald, K. Gembert, S. Wergeland, M.k. Leinonen, A. Aydemir, M. Sabidó, A. Kawai, A. Arana

 

 

P185

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Kerstin Hellwig

MASTER-2 trial: Cladribine tablets in patients with relapsing-remitting multiple sclerosis and active secondary multiple sclerosis after suboptimal response to prior infusion/oral disease-modifying therapy (interim baseline results)

E.J. Fox, A.D. Bass, J. Aldridge, L.A. Lebson, D. Robertson

P851

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Edward Fox

Evaluation of therapy satisfaction with cladribine tablets in RMS patients – Final results of the non-interventional study CLEVER

C. Grothe, L. Cepek, G. Reifschneider, T. Ziemssen, J. Richter, T. Wagner

P859

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Joachim Richter

Finnish cladribine tablets registry study 2 year data

S. Atula, E. Jarvinen, H. Kuusisto, I. Rauma, M. Ryytty, J. Sipilä,

 

M. Soilu-Hänninen, M. Viitala

P691

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Ilkka Rauma

 

Outcomes after late Cladribine re-dosing in the Australian MSBase cohort

H. Butzkueven, T. Spelman, S. Hodgkinson, A. Van der Walt, K. Buzzard, O. Skibina, T. Kalincik, J. Lechner-Scott, R. Macdonell, E. Verdun di Cantogno

P865

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Helmut Butzkueven

 

Real-world experience with cladribine in the MSBase Registry

H. Butzkueven, T. Spelman, MSBase Investigators (TBC), E. Verdun di Cantogno

P825

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Helmut Butzkueven

Molecular biomarker signature associated with cladribine treatment

N. Fissolo, L. Calvo-Barreiro, H. Eixarch, U. Boschert, C. Espejo, X. Montalban, M. Comabella

P584

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Nicolás Fissolo

Effect of cladribine on differentiation of human neural precursor cells

H. Eixarch, L. Calvo-Barreiro, N. Fissolo, U. Boschert, M. Comabella, X. Montalban, C. Espejo

P899

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Herena Eixarch

Economic Analysis for Introduction of Cladribine Tablets as a Treatment for Relapsing-Remitting and High Disease Activity Multiple Sclerosis in Kuwait

R. Alroughani, M.A. Al-Melh, S. Farouk, A. Abokoura, E. Alsultan, A Boshra, R. Alcharif, R. Ojeil, S. Basu, A. Verma

P280

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Raed Alroughani

Effect of cladribine on COVID-19 serology responses following 2 doses of the BNT162b2 mRNA vaccine in patients with multiple sclerosis

A. Vaknin-Dembinsky

P780

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Ariel Rechtman

Effect of cladribine tablets in highly active MS monitored by global and regional brain atrophy status

A. Raji, G. Winkler

P709

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Alaleh Raji

Clinical Effectiveness and Safety of Cladribine Tablets for Patients Treated at least 12 Months in the Swedish post-market surveillance study “Immunomodulation and Multiple Sclerosis Epidemiology 10” (IMSE-10)

V. Rosengren, E. Ekström, L. Forsberg, S. Kågström, J. Hillert, P. Nilsson, C. Dahle, A. Svenningsson, J. Lycke, A-M. Landtblom, J. Burman, C. Martin, P. Sundström, M. Gunnarsson, F. Piehl, T. Olsson

P743

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Victoria Rosengren

Real-world patient profile of cladribine tablets in multiple sclerosis patients from Argentina

Rojas JI, Alonso R, Luetic G, Pappolla A, Miguez J, Patrucco L, Cohen L, Garcea O, Casas M, Silva B, Deri N, Liwacki S, Silva E, Piedrabuena R et al.

P853

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Juan Ignacio Rojas

Seroconversion following vaccination against SARS-CoV-2 in people with MS: impact of disease modifying therapy

N. Vickaryous, A.N. Asardag, J. Bestwick, S.N. Shah, K. George, K. Schmierer, G. Giovannoni, D. Baker, A. Kang, R. Dobson

P950

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Nikki Vickaryous

Rebif® (interferon beta-1a) subcutaneous injection ePoster Presentations:

Development and Interrelation of Whole-Brain Atrophy and Lesion Volume During 5 Years’ Treatment With Subcutaneous Interferon Beta-1a in Patients With a First Clinical Demyelinating Event in the REFLEX/ION Study

R.M. Mattiesing, G. Gentile, I. Brouwer, D. Jack, A. Seitzinger, F. Barkhof, N. De Stefano, B.M.J. Uitdehaag, J.W.R. Twisk, M. Battaglini, H. Vrenken

P430

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Rozemarijn Mattiesing

Development and Interrelation of Spatiotemporal Patterns of Brain Atrophy and Lesions During 5 Years’ Treatment With Subcutaneous Interferon Beta-1a in Patients With a First Clinical Demyelinating Event in the REFLEX/ION Study

G. Gentile, R.M. Mattiesing, I. Brouwer, D. Jack, A. Seitzinger, F. Barkhof, N. De Stefano, B.M.J. Uitdehaag, H. Vrenken, M. Battaglini

P458

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Giordano Gentile

Exploratory Analysis of Serum GDF-15 Levels in Patients Receiving Subcutaneous Interferon Beta-1a in the REFLEX Trial

M. Coray, A. Seitzinger, S. Roy, M.S. Freedman, F. Barkhof, G. Comi, N. De Stefano, L. Kappos, J. Kuhle, M. Mehling

P674

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Mali Coray

INFORM – Interferon-Beta Exposure in the 2nd and 3rd Trimester of Pregnancy – a Register-Based Drug Utilisation Study in Finland and Sweden

M. Sabidó, K. Suzart-Woischnik, N. Grimes, L.M. Prach, L. Zhao, K.M. Hakkarainen

P794

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Meritxell Sabido

Evobrutinib ePoster Presentations:

Safety profile characterization of evobrutinib in over 1000 patients from phase II clinical trials in multiple sclerosis, rheumatoid arthritis and systemic lupus erythematosus

X. Montalban, D. Wallace, M.C. Genovese, D. Tomic, D. Parsons-Rich, C. Le Bolay, A. Kao, H. Guehring

P727

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Xavier Montalban

The role of human and mouse BTK in myeloid cells

C. Bassani, M. Molinari, V. Martinelli, R. Grenningloh, U. Boschert, G. Comi, G. Martino, L. Muzio, C. Farina

P656

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Cinthia Farina

Targeting BTK in chronic CNS autoimmunity inhibits activation of microglia

A. Geldaris, S. Torke, R. Grenningloh, U. Boschert, W. Brück, M.S. Weber

P971

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Anastasia Geladaris

Non-Product Specific ePoster Presentations:

DISCOntinuation of disease-modifying therapies in MS (DISCOMS) Extension – Study Design and Baseline Demographics

E. Engebretson, G. Cutter, R. Fox, I. Kister, A. Miller, C. Morgan, R. Seale, J.R. Corboy

P751

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: John Corboy

Genome-wide mapping of patient’s autoantibody targets to understand and predict Multiple Sclerosis pathogenesis and patient responses to Interferon β-1a therapy

E.B. DiCillo, E. Kountikov, M. Zhu, W. Zhang, B. Hayward, D.E. Harlow, S. Lanker, J.L. Bennet, T.F. Tedder

P361

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Europe B DiCillo

Towards a new resource for the MS brain: a cross-brain bank proteomic atlas of non-lesional neocortex

P. Bouman, D. Pitt, D. Reich, J. Schneider, D. Bennett, R. Nagra, R. Reynolds, J. Geurts, J. Corboy, P. De Jager

P317

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Philip De Jager

Multiplexed imaging of the multiple sclerosis meninges using mass cytometry

V. Ramaglia, M. Zuo, N. Fransen, S. Zandee, A. Prat, I. Huitinga, A. Bar-Or, J.L. Gommerman

P319

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Valeria Ramaglia

Interprofessional collaboration and patient-provider communication challenges in MS care: A mixed-methods needs assessment

S. Péloquin, K. Schmierer, J. Oh, T. Leist, S. Murray, P. Lazur

P903

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Sophie Peloquin

Neuropsychological measures associated with disease severity in pediatric onset multiple sclerosis

N. Gur, E. Ganelin Cohen, T. Pilowsky Peleg

P990

Date: 13 October 2021
Time: 16:45-18:45 CEST
Presenter: Noa Gur

About MAVENCLAD®

 

MAVENCLAD® is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD® for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD® has since then been approved in over 80 countries, including Canada, Australia and the U.S. Refer to the respective prescribing information for further details.

 

The clinical development programme 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 Phase III placebo-controlled study following on from the CLARITY study, which evaluated the safety and exploratory efficacy of cladribine tablets over two additional years beyond the two-year CLARITY study, according to the treatment assignment scheme for years 3 and 4.
The 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).
The 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) study: a long-term observational follow-up safety registry of MS patients who participated in cladribine tablets clinical studies.

 

In the two-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with cladribine tablets was lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators. Adverse Events reported in other clinical studies were similar.

 

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 administered 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.

 

About Evobrutinib

 

Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS). It is an oral, highly selective inhibitor of Bruton’s tyrosine kinase (BTK) which is important in the development and functioning of various immune cells including B lymphocytes and macrophages. Evobrutinib is designed to inhibit primary B cell responses such as proliferation and antibody and cytokine release, without directly affecting T cells. Evobrutinib is currently under clinical investigation and not approved for any use anywhere in the world.

 

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 2.8 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 Neurology and Immunology

 

Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company`s current MS portfolio includes two products for the treatment of relapsing MS – Rebif® (interferon beta-1a) and MAVENCLAD® (cladribine tablets). Merck aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to Merck`s commitment to MS, the company also has a pipeline focusing on discovering new therapies that have the potential in other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE).

 

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

 

About Merck

 

Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck generated sales of € 17.5 billion in 66 countries.

 

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science and EMD Electronics.

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20211004005317/en/

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Press Release

Bitdeer Group’s Customer Obsession Approach Brings It to the World Top Player

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Bitdeer Group’s Customer Obsession Approach Brings It to the World Top Player

Business Wire India

Bitdeer Group, the world’s leading digital asset mining service provider, earlier announced its plans to list on the NASDAQ through a merger with the publicly traded special purpose acquisition company Blue Safari Group Acquisition Corp. The transaction values Bitdeer at an implied enterprise value of approximately $4 billion. It marks Bitdeer Group’s latest achievement on the group level and the success of its business lines that support the group’s thriving growth, which could not have been achieved without Bitdeer’s obsession with its customers that leads to the customer-centric approach throughout the years.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211126005355/en/

 

Bitdeer Group’s Customer Obsession Approach Brings It to the World Top Player (Graphic: Business Wire)

The Iceberg of Success

 

What Bitdeer Group has achieved today is only the visible part of the tip of the iceberg. Over the past years, the group has made a number of strategically decisive moves that helped sharpen its competitive edge and consolidate its leading position in this fiercely competitive market. All of this originates from and is guided by a core concept: customer obsession – the philosophy that any innovations must be driven by what truly matters to customers. For Bitdeer Group, this revolves around three key areas: 1) value-adding service offerings and user-friendly functions, 2) a stable operating entity that abides by laws and mitigates risks, and 3) data privacy and security. To better meet these needs, the group has taken an agile approach in establishing and developing its business lines.

 

Joint-effort and Achievement from Multiple Business Lines

 

As one of the business lines under Bitdeer Group and a highly trusted sharing service platform for digital assets mining, Bitdeer was first launched in December 2018. Bitdeer provided exactly what customers were desperately seeking – a simpler and more accessible approach and channel to acquire cryptocurrencies – at a time when the barrier to entry for crypto mining was a major deterring factor for individual crypto miners and enthusiasts. Alongside the evolving market trends, Bitdeer has diversified its portfolio of offerings by adding state-of-the-art cryptocurrencies and altcoins. Different service modes (Classic and Accelerator) have also been created in response to users’ varying needs. The platform is also localized in 9 languages to provide greater convenience and access to the global community.

 

Mining Datacenter, another major business line under Bitdeer Group, has recently celebrated its achievement in adopting clean and renewable energy, which is a result of its determination to grow responsibly and awareness of environmental impacts arising from the mining operation. This is a pioneering breakthrough in the industry to develop professional and standardized mining facilities, which are capable of operating at optimal levels under various climate conditions and linking up with a range of power supplies supported by the group’s proprietary innovations. It has significantly improved stability and lowered risks associated with electricity supply, so as to provide users with reliability and stability.

 

The boom of the industry on a global scale brings with it both challenges and opportunities. The Outlook of Bitdeer Group remains promising given its customer-centric approach which drives constant innovation and optimization of its products and services. No matter how Bitdeer Group evolves in the future, the mindset of ‘customer obsession’ will always come first and be at its core.

 

About Bitdeer Group

 

Bitdeer Group is the world’s leading digital asset mining service provider. It was founded by Jihan Wu, Co-Founder of Bitmain and Matrixport, with venture investment from Sequoia Capital, IDG, and other well-known investment groups in the blockchain space. Headquartered in Singapore, Bitdeer Group currently operates in the United States and Europe. The Group has three business lines — Bitdeer, Mining Datacenter, and Minerplus — demonstrating the dedication and expertise in becoming the world’s most reliable digital asset mining service provider.

 

For more information, please get in touch with Bitdeer Group:

 

Website: www.bitdeer.com
LinkedIn: www.linkedin.com/company/bitdeer-group
Sales Consultation: sales@bitdeer.com
Business Cooperation: contact@bitdeer.com
Mining Datacenter Partnership: miningcenter@bitdeer.com

 

*Information provided in this article is for general information and reference only and does not constitute nor is intended to be construed as any advertisement, professional advice, offer, solicitation, or recommendation to deal in any product. No guarantee, representation, warranty or undertaking, express or implied, is made as to the fairness, accuracy, timeliness, completeness or correctness of any information, or the future returns, performance or outcome of any product. Bitdeer expressly excludes any and all liability (to the extent permitted by applicable law) in respect of the information provided in this article, and in no event shall Bitdeer be liable to any person for any losses incurred or damages suffered as a result of any reliance on any information in this article.

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20211126005355/en/

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Press Release

Mavenir Announces Commercial Availability of 4G Open RAN-based Outdoor Small Cell

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Mavenir Announces Commercial Availability of 4G Open RAN-based Outdoor Small Cell

Business Wire India

Mavenir, the Network Software Provider building the future of networks with cloud-native software that runs on any cloud and transforms the way the world connects, announced today the commercial availability of its 4G Open RAN small cell for outdoor deployments, expanding the MAVair radio and access portfolio of small cells to meet Communications Service Providers’ (CSPs) growing need for enhanced network capacity and coverage. The solution had already been tested and deployed in commercial operation with a Tier 1 European CSP.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211124006039/en/

 

Mavenir’s 4G Open RAN Small Cell for Outdoor deployments. (Photo: Business Wire)

Mavenir’s outdoor small cell (O410) is a customer driven product, that addresses a need for outdoor small cells supporting both distributed and centralized Open RAN architectures. The solution is built on Mavenir’s modular hardware architecture and highly scalable, cloud-native software platforms, the underlying principles which enabled an expedited time-to-market with full architectural and deployment flexibility. Mavenir’s expanded small cells solutions, present a future proof way of building networks that ensures interoperability, vendor competition, element security and reduced operating costs across the RAN. Mavenir’s MAVair Open RAN small cells are market-proven, carrier grade solutions, that are easy to deploy, fully automated, software upgradable, highly scalable and adaptable.

 

The outdoor small cell supports both Split 2 and S1 interfaces and can be configured remotely for full deployment flexibility and upgradability, especially effective in areas where coverage and capacity from the CSPs macro is not available, is not economically viable, or faces zoning issues, etc. Ideal deployments include rural and remote locations, sites which are constrained by size, power, backhaul, and planning restrictions. The solution is plug and play, with zero-touch provisioning and installation, powered with Power over Ethernet (PoE) and offers interfaces with the same Open RAN CU as the macro network, and with common management with macro.

 

“By leveraging our modular hardware architecture and cloud-native scalable software, Mavenir is capable of delivering new products in an agile fashion which integrate and work seamlessly with other network components deployed by CSPs. This 4G outdoor small cell is the precursor for a completely new line of 4G and 5G Open RAN-based small cell products with integrated DU, as well as Multi RAT radio access solutions in general,” said Mavenir’s Aniruddho Basu, SVP and GM of Emerging Business.

 

With the release of the 4G outdoor small cell, Mavenir now has a complete offering of Multi-G (2G/3G/4G/5G), software upgradable, Open RAN-based small cells enabling CSPs to enhance their network capacity and coverage beyond in-building use cases.

 

About Mavenir:

 

Mavenir is building the future of networks and pioneering advanced technology, focusing on the vision of a single, software-based automated network that runs on any cloud. As the industry’s only end-to-end, cloud-native network software provider, Mavenir is focused on transforming the way the world connects, accelerating software network transformation for 250+ Communications Service Providers in over 120 countries, which serve more than 50% of the world’s subscribers. www.mavenir.com

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20211124006039/en/

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Press Release

Payhawk Raises $112 Million in the Second Largest Series B in Central and Eastern Europe

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Payhawk Raises $112 Million in the Second Largest Series B in Central and Eastern Europe

Business Wire India
Only seven months after closing its $20m Series A financing round, Payhawk announces its Series B of $112m all equity round led by US investor Greenoaks, who previously invested in high-growth companies like Checkout.com, Robinhood, Stripe and Brex
 
This is the second largest ever Series B for a B2B company in the CEE region after UiPath, and is the largest and fastest Series B in the spend management space across Europe
 
All existing investors, including QED Investors, Earlybird Digital East and Eleven Ventures are participating in the round
 
Payhawk currently serves companies in 27 countries with its company cards and spend management platform across Europe and will continue its global expansion with aims to open offices in the US, Netherlands, France, Australia and Singapore
 
The fintech will use the new funds to accelerate its product roadmap with the launch of a credit card in Q1 2022, and low-cost cross-border transfers as an alternative to SWIFT payments

 

Payhawk, the payments and expense solution with offices in London, Sofia, Berlin and Barcelona, has raised $112 million just three years after its inception, valuing the company at $570m. The Series B round is led by the San Francisco-based investor Greenoaks, who has a strong track record of investing in high-growth technology companies such as Gorillas, Robinhood, Stripe and Brex. All existing investors, including QED Investors, Earlybird Digital East and Eleven Ventures are participating in the round.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211122006123/en/

 

Description: Hristo Borisov CEO left, Boyko Karadzhov CTO centre, Konstantin Djengozov CFO. (Photo: Business Wire)

Currently, finance teams are still bound to a high amount of manual work as they are using multiple disconnected tools for cards, payments, invoices and expense management. Payhawk reduces the amount of manual work by combining those key elements in one platform and therefore acting as a one-stop-shop for finance teams.

 

With high-growth companies, in particular, looking to digitise financial processes, Payhawk emerges as the leading platform for large SMEs and enterprise customers, especially those multinationals who have multiple offices worldwide.

 

In 2021, Payhawk introduced 3% cashback on all payments, new enterprise features, free bill payments, and support for Apple Pay and Google Pay in 30 countries. Since its Series A round, transaction volume through the platform has increased by 663% and continues to grow at 45%+ month-on-month in October. Its customer base consists of a mix of scale-ups and corporates in 27 countries across Europe, including A.T.U, Luxair, Flink, Viking Life and Wagestream.

 

In 2022, Payhawk will continue its expansion by aiming to open offices in the U.S., the Netherlands, Australia and Singapore, enabling the company to further expand its product offering by introducing credit cards and allowing smarter and cheaper cross-border transactions on top of its invoice management system.

 

These expansion and product build plans will run in tandem with growing the marketing and sales team in Payhawk’s key markets of the UK, Germany, Spain and Benelux. To further boost its enterprise focus, the company has appointed Paul Albert as SVP Global Sales, who will lead direct sales, partnerships and customer success.

 

Patrick Backhouse, a Partner of Greenoaks, said, “Ask any business owner, and they’ll tell you that managing corporate spend is among the most frustrating parts of running a company. It requires significant manual work that consumes employee time and introduces substantial room for error. Payhawk turns a fragmented process into a seamless one, providing a single place to manage the entire spending lifecycle from company cards to expenses and bill payments to invoices. We’ve been thrilled to see how fast they’ve grown, already serving a truly global customer base that’s attracted by powerful and delightful software. We think that painful expense reports and bill payments should be a thing of the past, and we are excited to partner with Payhawk on the way to getting there.”

 

Hristo Borisov, CEO and Founder at Payhawk, said, “Managing company cards, especially reports, bill payments, and invoices is currently a disconnected experience bridged by finance teams through a lot of manual work. We are building enterprise software running on global payments infrastructure that automates all spend processes. Our strong product background and engineering team allows us to move at break-neck speed. This, in turn, will enable global enterprises and fast-growing technology companies to transform how they manage their company spending, and improve efficiencies while unlocking employee time to be better spent elsewhere”

 

-ends-

 

About Payhawk
Payhawk is a financial platform that combines expense management, payments and invoice management in one solution and therefore works as a one-stop-shop for finance teams. Its customer base consists of a mix of fast-growing and mature multinational companies like LuxAir, Lotto24, Viking Life, Gtmhub, Flink, MacPaw and By Miles. Payhawk is also leading the digital transformation agenda of companies like A.T.U in Germany, where the product has replaced cash with company cards at more than 550 branches. The fintech is headquartered in London and was founded in 2018 by Hristo Borisov, Boyko Karadzhov and Konstantin Dzhengozov and is supported by renowned investors such as Greenoaks, QED Investors, Earlybird Digital East and Eleven Ventures.

 

About Greenoaks

 

Founded in 2012, Greenoaks is a global investment firm that makes concentrated, long-term investments in technology-enabled businesses around the world. At Greenoaks, we believe a small handful of companies define each generation. Our sole mission is to identify these companies early in their life cycles and partner with their founders for decades. We’ve led investments in companies such as Discord, Brex, and Rippling in the US; Deliveroo and Checkout in Europe; Coupang in South Korea; and Kavak in Latin America.

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20211122006123/en/

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