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03.09.2020 – 14:00

Merck KGaA

Merck to Showcase New Data at ACTRIMS-ECTRIMS MSVirtual2020 Meeting, Furthering Innovation in Multiple Sclerosis

Darmstadt, Germany (ots/PRNewswire)

Not intended for UK and US based media

- Company to present 54 abstracts across its MS portfolio - MAVENCLAD® (cladribine tablets), Rebif® (interferon beta-1a) and investigational evobrutinib

- New long-term data and real-world evidence further characterise efficacy and safety of MAVENCLAD®

- New MAVENCLAD® and Rebif® safety data to be shared demonstrating no increased risk of respiratory viral infections

Merck, a leading science and technology company, today announced it will present data on its approved and investigational multiple sclerosis (MS) treatments at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting. Merck will present 54 abstracts at the meeting, taking place virtually from 11-13 September 2020, including new efficacy and real-world safety data on MAVENCLAD® (cladribine tablets) and new safety data for Rebif® (interferon beta-1a).

In addition, data will be presented demonstrating investigational evobrutinib is the first and only Bruton's Tyrosine Kinase inhibitor (BTKi) to demonstrate high and sustained efficacy through 108 weeks in clinical studies. Preclinical data will also be presented providing insights into evobrutinib`s potential impact on progression in MS.

"The broad range of research revealed through these data demonstrate our strategic approach to advancing the MS treatment landscape through new medicines and patient-focused research initiatives," said Luciano Rossetti, Head of Global Research & Development for the biopharma business of Merck. "Much of our data provide insights on how MAVENCLAD® and Rebif® affect the risk of respiratory viral infections and COVID-19 outcomes in MS patients. These insights will help support clinicians as they make treatment decisions for their patients living with MS."

Key MAVENCLAD®(cladribine tablets) data include:

- Early onset of action: Efficacy results from the Phase IV MAGNIFY-MS study, demonstrating an early onset of action from end of month one through a reduction in mean combined unique active (CUA) lesion count in the first six months of MAVENCLAD® treatment for highly active relapsing multiple sclerosis (RMS) 
- Sustained efficacy: - New data evaluating cumulative relapse incidence over five years in patients enrolled in the CLARITY and CLARITY Extension trials, showing the sustained efficacy of MAVENCLAD® - Late-breaking interim data from the CLASSIC-MS study on the long-term efficacy and real-world treatment patterns for patients receiving MAVENCLAD®, with eight to 14 years of follow up, will be available as part of the late-breaker sessions from 25 September 2020 
- Disability improvement: Results from a post hoc analysis from the CLARITY Extension, showing patients receiving early treatment with MAVENCLAD® had a greater prevalence of disability improvement over five years, as measured by the Expanded Disability Status Scale (EDSS) 
- COVID-19 patient cases: Results from the MAGNIFY and CLARIFY studies, demonstrating clinical outcomes in patients with COVID-19 infection during these Phase IV studies of MAVENCLAD® for the treatment of MS will be available as part of the late-breaker sessions from 25 September 2020   
- Updated post-approval safety data of MAVENCLAD® in the treatment of MS showing that respiratory viral infections were typically non-serious, and consistent with that from the clinical development program 

Key Rebif®(interferon beta-1a) data include:

- Post-approval results on the safety of Rebif® in the treatment of MS, showing no new safety signals, including no increased risk for respiratory viral infections 

Key evobrutinib data include:

- Results of the Phase II open-label extension (OLE) in patients treated with evobrutinib 75 mg BID (twice a day), showing the efficacy at Week 48 was maintained at 108 weeks (ARR, 0.11) and the maximum efficacy observed with BID dosing correlated with optimal BTK occupancy achieved with BID dosing 
- Safety results from the >=60 week Phase II OLE showing no new safety signals identified, consistent with data seen in more than 1,200 patients who have received evobrutinib to date, across MS and other conditions 
- Preclinical data demonstrating evobrutinib's potential to reduce CNS compartmentalized inflammation thought to drive the progression of disability seen in MS 

Additional Merck activities at MSVirtual2020:

- Live presentation "Exploring the role of real-world data in multiple sclerosis" chaired by Prof. Gavin Giovannoni, Chair of Neurology, Barts and The London School of Medicine and Dentistry (12 September 2020, 14:30-15:30 EDT / 20:30-21:30 CEST; recording available after the event) 
- Two product theatres on demand throughout the congress starting from 11 September 2020, 11:45 EDT / 17:45 CEST - "Multiple sclerosis patient management: update from the UK" by Dr. Wallace Brownlee, MS Specialist Neurologist, National Hospital for Neurology and Neurosurgery, and MS researcher at Queen Square MS Centre, University College London Institute of Neurology- "Real-world multiple sclerosis management: what can we learn from MSBase?" by Dr. Suzanne Hodgkinson, Associate Professor, University of New South Wales, and a senior consultant neurologist at Liverpool Hospital, New South Wales, Australia  

Today, Merck has launched a newsroom for journalists interested in the company`s latest developments and news - merckneurology.com/newsroom - where, among other information, background information on Merck MS treatments, and video presentations from the below will be available:

- Merck's commitment to MS: Andrew Paterson, Senior Vice President, Head of Global and US Multiple Sclerosis Franchise, Merck 
- An overview of MAVENCLAD® MAGNIFY data: Prof. Nicola De Stefano, PhD, Professor of Neurology, Department of Medicine, Surgery & Neuroscience, University of Siena, Italy 
- Evobrutinib clinical trial update: Robert Henderson, Vice President, Global Program Leadership, Neurology & Immunology, Merck 

Following the conclusion of MSVirtual2020, Merck will be hosting "Mastering the Neuroscience of Unconscious Bias," the inaugural virtual event for Merck's I'M IN initiative, a diversity, equity and inclusion effort started in February 2019. I'M IN is an initiative started by Merck`s Neurology & Immunology franchise, which aims to explore solutions together with healthcare providers to improve equity within the healthcare ecosystem.

Below is the full list of Merck abstracts accepted for presentation at ACTRIMS-ECTRIMS 2020:

 MAVENCLAD® (cladribine tablets) Presentations

 Title                   Authors              Presentation Presentation Details
                                              ID

 Reduced Grey Matter     Battaglini M,        P0231        Session: ePoster
 Atrophy in Patients     Sormani M P,                      Date: 11-13
 With Relapsing Multiple Luchetti L, Gentile               September 2020 Time:
 Sclerosis Treated With  G, Cortese R,                     Available from 9am
 Cladribine Tablets      Alexandri N, De                   EDT on 11 September
                         Stefano N                         2020 Presenter:
                                                           Marco Battaglini

 Reduction in CUA MRI    De Stefano N,        P0382        Session: ePoster
 Lesions in the First 6  Barkhof F, Montalban              Date: 11-13
 Months of Cladribine    X, Achiron A,                     September 2020 Time:
 Tablets Treatment for   Derfuss T, Chan A,                Available from 9am
 Highly Active Relapsing Hodgkinson S, Prat                EDT on 11 September
 Multiple Sclerosis:     A, Leocani L.                     2020 Presenter:
 MAGNIFY-MS Study        Schmierer K,                      Nicola De Stefano
                         Sellebjerg F,
                         Vermersch P, Wiendl
                         H, Keller B, Roy S

 Durable Efficacy of     Giovannoni G,        P0202        Session: ePoster
 Cladribine Tablets:     Rammohan K, Leist T,              Date: 11-13
 Cumulative Relapse      Coyle P K, Keller B,              September 2020 Time:
 Incidence Over 5 years  Jack D, Alexandri N               Available from 9am
 in CLARITY and CLARITY                                    EDT on 11 September
 Extension                                                 2020 Presenter:
                                                           Gavin Giovannoni

 Disability Improvement  Sormani M P, Signori P0201        Session: ePoster
 in Relapsing-remitting  A Giovannoni G,                   Date: 11-13
 Multiple Sclerosis      Alexandri N                       September 2020 Time:
 Patients Receiving                                        Available from 9am
 Cladribine Tablets,                                       EDT on 11 September
 Evaluated by Expanded                                     2020 Presenter:
 Disability Status Scale                                   Maria Pia Sormani

 Updated Post-Approval   Giovannoni G, Berger P0415        Session: ePoster
 Safety of Cladribine    J, Leist T, Jack D,               Date: 11-13
 Tablets in the          Galazka A, Nolting                September 2020 Time:
 Treatment of Multiple   A, Damian D                       Available from 9am
 Sclerosis, With                                           EDT on 11 September
 Particular Reference to                                   2020 Presenter:
 Respiratory Viral                                         Gavin Giovannoni
 Infections

 Clinical Outcomes in    Karan R, Roy S,      LB1151       Session: Latebreaker
 Patients With COVID-19  Alexandri N                       ePoster Date: 25-26
 Infection During Phase                                    September 2020 Time:
 IV Studies of                                             Available from 9am
 Cladribine Tablets for                                    EDT on 25 September
 Treatment of Multiple                                     2020 Presenter:
 Sclerosis                                                 Radmila Karan

 Treatment Satisfaction  Brochet B, Hupperts  P1066        Session: ePoster
 in Patients With        R, Langdon D, Solari              Date: 11-13
 Highly-active Relapsing A, Piehl F,                       September 2020 Time:
 Multiple Sclerosis      Lechner-Scott J,                  Available from 9am
 Treated With Cladribine Montalban X, Selmaj               EDT on 11 September
 Tablets: CLARIFY-MS     K, Valis M, Rejdak                2020 Presenter:
 Study Interim Analysis  K, Havrdova EK,                   Bruno Brochet
                         Patti F, Alexandri
                         N, Nolting A, Keller
                         B

 Initial Findings From a Sabidó, M, Batech M, P0470        Session: ePoster
 Dynamic Cohort Study of Foch C, Boutmy E,                 Date: 11-13
 Patients With Multiple  Verpillat P                       September 2020 Time:
 Sclerosis: A Proactive                                    Available from 9am
 Approach for Safety and                                   EDT on 11 September
 Comparative                                               2020 Presenter:
 Effectiveness                                             Meritxell Sabidó

 Characteristics of      Zeng F, Harty G,     P0846        Session: ePoster
 Relapsing Multiple      Wong SL, Maslova E,               Date: 11-13
 Sclerosis Patients      Schade R, Row B                   September 2020 Time:
 Treated With Cladribine                                   Available from 9am
 Tablets in Five                                           EDT on 11 September
 European Countries:                                       2020 Presenter: Feng
 Multi-year Chart Review                                   Zeng

 Characterization of     Zeng F, Harty G,     P0847        Session: ePoster
 Relapsing Multiple      Wong SL, Uebler S,                Date: 11-13
 Sclerosis Patients      Maslova E, Schade R,              September 2020 Time:
 Treated With Cladribine Row B, Ellenberger                Available from 9am
 Tablets in Germany      D, Stahmann A                     EDT on 11 September
 Since Marketing                                           2020 Presenter: Feng
 Authorization                                             Zeng

 CLASSIC-MS: Long-term   Giovannoni G, Leist  LB1229       Session: Latebreaker
 Efficacy and Real-World T, Aydemir A, Verdun              ePoster Date: 25-26
 Treatment Patterns for  Di Cantogno E, on                 September 2020 Time:
 Patients Receiving      behalf of the                     Available from 9am
 Cladribine Tablets -    CLASSIC-MS Steering               EDT on 25 September
 Interim Data with 8-14  Committee                         2020 Presenter:
 Years Follow-up                                           Thomas Leist

 Age-related Efficacy of Freedman M, Pardo G, P0284        Session: ePoster
 Cladribine Tablets in   De Stefano N,                     Date: 11-13
 Patients With           Aldridge J, Hyvert                September 2020 Time:
 Relapsing-remitting MS  Y, Galazka A,                     Available from 9am
 in the CLARITY          Lemieux C                         EDT on 11 September
 Extension Study                                           2020 Presenter: Mark
                                                           Freedman

 Cladribine Tablets in   Miravelle A, Katz J, P0310        Session: ePoster
 Patients with RRMS and  Robertson D, Hayward              Date: 11-13
 Active SPMS After       B, Walsh JS, Harlow               September 2020 Time:
 Suboptimal Response to  DE, Lebson LA,                    Available from 9am
 Prior DMD (MASTER-2 and Sloane JA, Bass AD,               EDT on 11 September
 CLICK-MS): Initial      Fox EJ                            2020 Presenter:
 Baseline Demographics                                     Augusto Miravelle

 Treatment-emergent      Oh J, Walker B,      P0411        Session: ePoster
 Adverse Events          Giovannoni G, Jack                Date: 11-13
 Occurring Early in the  D, Dangond F,                     September 2020 Time:
 Treatment Course of     Nolting A, Aldridge               Available from 9am
 Cladribine Tablets in   J, Lebson L, Leist                EDT on 11 September
 two Phase 3 Trials in   TP                                2020 Presenter:
 Multiple Sclerosis                                        Jiwon Oh

 Identification and      Cisternas MG,        P0967        Session: ePoster
 Characterization of     Rajagopalan D,                    Date: 11-13
 Adherence Trajectory    Leszko M, Andrade K,              September 2020 Time:
 Subgroups in Patients   Phillips AL                       Available from 9am
 With MS Initiating                                        EDT on 11 September
 Once- or Twice-daily                                      2020 Presenter: Amy
 Oral Disease-modifying                                    Phillips
 Drugs

 Real-world              Kozma CM, Roberts    P1052        Session: ePoster
 Patient-level Costs of  NL, Phillips AL                   Date: 11-13
 Administering Infusion                                    September 2020 Time:
 Disease-modifying                                         Available from 9am
 Drugs: A US                                               EDT on 11 September
 Retrospective Claims                                      2020 Presenter:
 Database Analysis                                         Chris Kozma

 Value-added Benefits of Morgan K, Vernon K,  P1069        Session: ePoster
 a Nurse/Pharmacy-led    Ayer M                            Date: 11-13
 Service for Patients                                      September 2020 Time:
 With Multiple Sclerosis                                   Available from 9am
 Treated Over 2 Years                                      EDT on 11 September
 With Cladribine Tablets                                   2020 Presenter: Kate
 in the UK                                                 Morgan

 Demonstrating the Value Morgan K, Joseph B,  P1015        Session: ePoster
 of a Patient Support    Williams V, Kelly M               Date: 11-13
 Program for Multiple                                      September 2020 Time:
 Sclerosis Patients                                        Available from 9am
 Prescribed Cladribine                                     EDT on 11 September
 Tablets in Ireland at                                     2020 Presenter: Kate
 the end of Year 1                                         Morgan

 Low Discontinuation     Oh J, Giacomini P,   P0880        Session: ePoster
 Rate and Side-effect    Devonshire V, Clift               Date: 11-13
 Burden After Switching  F, Lemieux C, Sabido              September 2020 Time:
 to Cladribine Tablets:  M, Allignol A,                    Available from 9am
 Canadian Experience     Freedman M                        EDT on 11 September
 from the adveva®                                          2020 Presenter:
 Patient Support Program                                   Jiwon Oh

 Cladribine Tablets      Piasecka-Stryczynska P0040        Session: ePoster
 Versus Other            K, Rolka M,                       Date: 11-13
 Disease-modifying       Kaczynski ?, Górecka              September 2020 Time:
 Therapies in Achieving  M, Wójcik R, Adamek               Available from 9am
 Disability Improvement  I, Kaczor MP, Rejdak              EDT on 11 September
 in Relapsing-remitting  K                                 2020 Presenter: K.
 Multiple Sclerosis                                        Piasecka-Stryczynska
 Patients - Network
 Meta-analysis

 MS Disease-modifying    Ziemssen T, Penner   566          Session: ePoster
 Therapy Sequencing -    IK, Wagner T,                     Date: 11-13
 Natalizumab to          Huebschen M, Mueller              September 2020 Time:
 Cladribine Tablets -    B, Buescher T,                    Available from 9am
 Experience in 46        Richter J,                        EDT on 11 September
 Patients                Posevitz-Fejfar A                 2020 Presenter:
                                                           Tjalf Ziemssen

 Switching disease       Saiz A, Aguera E,    P0401        Session: ePoster
 modifying treatment in  Moral E, Brieva L,                Date: 11-13
 relapsing multiple      Rodriguez-Antiguedad              September 2020 Time:
 sclerosis: Delphi       A, Casanova-Estruch               Available from 9am
 consensus of the        B, Jordi R,                       EDT on 11 September
 Demyelinating Group of  Meca-Lallana V,                   2020 Presenter: Luis
 the Spanish Society of  Garcia-Merino JA,                 Brieva
 Neurology               Costa-Frossard L,
                         Arnal-Garice C,
                         Landete L,
                         Meca-Lallana J,
                         Blanco Y,
                         Matías-Guiu J, Ares
                         A, Martínez-Ginés
                         ML, Ara JR, Llaneza
                         M, Castillo-Trivino
                         T, Romero L,
                         Perez-Sempere A,
                         González-Platas M,
                         Mendibe-Bilbao M

 CLADQoL (CLADribine     Penner IK, Pul R,    P0849        Session: ePoster
 Tablets - evaluation of Kallmann BA, Raji A,              Date: 11-13
 Quality of Life) Study: Richter J, Wagner T,              September 2020 Time:
 Evaluating QoL 12       Mueller B, Buescher               Available from 9am
 Months After Treatment  T, Posevitz-Fejfar A              EDT on 11 September
 Initiation with                                           2020 Presenter:
 Cladribine Tablets                                        Iris-Katharina
                                                           Penner

 Effects of Cladribine   Eixarch H,           P0330        Session: ePoster
 on Proliferation,       Calvo-Barreiro L,                 Date: 11-13
 Survival and Cytokine   Fissolo N, Boschert               September 2020 Time:
 Release of Human        U, Comabella M,                   Available from 9am
 Astrocytes              Montalban X, Espejo               EDT on 11 September
                         C                                 2020 Presenter:
                                                           Herena Eixarch

 Real-world Experience   Butzkueven H,        P0907        Session: ePoster
 With Cladribine in the  Spelman T, Verdun di              Date: 11-13
 MSBase Registry         Cantogno E, Fabris                September 2020 Time:
                         J, Zeng F, G Harty                Available from 9am
                                                           EDT on 11 September
                                                           2020 Presenter:
                                                           Helmut Butzkueven

 2-Chlorodeoxyadenosine  Aybar F, Marcora S,  P0270        Session: ePoster
 (Cladribine)            Eugenia Samman M,                 Date: 11-13
 Preferentially Inhibits Perez MJ, Pasquini                September 2020 Time:
 the Biological Activity JM, Correale J                    Available from 9am
 of Microglia Cells                                        EDT on 11 September
                                                           2020 Presenter:
                                                           Jorge Correale

 Cladribine to Halt      Lieberman D, Mangat  P0196        Session: ePoster
 Deterioration in People H, Allen-Philby K,                Date: 11-13
 With Advanced Multiple  Baker D, Barkhof F,               September 2020 Time:
 Sclerosis (ChariotMS)   Chandran S, Chapman               Available from 9am
                         C, Chataway J, Ford               EDT on 11 September
                         H, Giovannoni G,                  2020 Presenter:
                         Hobart J, Hooper R,               David Lieberman
                         Hussain T, Walker N,
                         Macmanus D,
                         Mihaylova B, Pavitt
                         S

 Predicting Long-term    Sharmin S, Bovis F,  P0131        Session: ePoster
 Sustained Disability    Sormani MP,                       Date: 11-13
 Progression in Multiple Butzkueven H,                     September 2020 Time:
 Sclerosis: Application  Kalincik T and the                Available from 9am
 in the CLARITY Trial    MSBase study group                EDT on 11 September
                                                           2020 Presenter: S
                                                           Sharmin

 A Clinical Data Summary Forsberg L, Kågström P0276        Session: ePoster
 for Cladribine Patients S, Hillert J,                     Date: 11-13
 Treated at least 12     Nilsson P, Dahle C,               September 2020 Time:
 Months - A Swedish      Svenningsson A,                   Available from 9am
 Nationwide Study of the Lycke J, Landtblom                EDT on 11 September
 Long-Term Effectiveness AM, Burman J, Martin              2020 Presenter: L
 and Safety of           C, Sundström P,                   Forsberg
 Cladribine (IMSE 10)    Gunnarsson M, Piehl
                         F, Olsson T

 Impact of Cladribine    Raji A, Winkler G    P0586        Session: ePoster
 Tablets on Brain Volume                                   Date: 11-13
 Protection in Highly                                      September 2020 Time:
 Active MS                                                 Available from 9am
                                                           EDT on 11 September
                                                           2020 Presenter: A
                                                           Raji

 Early Real-World        Bain J, Jones A,     P0319        Session: ePoster
 Safety, Tolerability,   Overholt S, Guenette              Date: 11-13
 and Efficacy of         M, Selchen D, Jiwon               September 2020 Time:
 Cladribine Tablets: A   Oh                                Available from 9am
 Single Center                                             EDT on 11 September
 Experience                                                2020 Presenter: J
                                                           Bain

 Switching From          O'Neill DTD, Sharma  P0399        Session: ePoster
 Ocrelizumab to          M, Gonzales B,                    Date: 11-13
 Cladribine: Real-world  Vandenheuvel M, Tse               September 2020 Time:
 Data                    B, Hodgkinson SJ                  Available from 9am
                                                           EDT on 11 September
                                                           2020 Presenter: D
                                                           O'Neill

 The Effect of           Verma ND, Al-Atiyah  P0406        Session: ePoster
 Cladribine Upon Naïve   R, O'Neill D, Sharma              Date: 11-13
 and Activated CD4+ T    M, Tran CT, Hall BM,              September 2020 Time:
 Regulatory Cells in MS  Hodgkinson SJ                     Available from 9am
 Patients                                                  EDT on 11 September
                                                           2020 Presenter:
                                                           Suzanne Hodgkinson

 Rebif® (interferon beta-1a) Presentations

 A Systematic Review and Lopez-Leon S,        P0278        Session: ePoster
 Meta-analyses of        Geissbuehler Y,                   Date: 11-13
 Pregnancy and Fetal     Sabidó M, Turkson,                September 2020 Time:
 Outcomes in Women with  M, Wahlich C, Morris              Available from 9am
 Multiple Sclerosis.     J                                 EDT on 11 September
 IMI2 ConcePTION                                           2020 Presenter:
                                                           Meritxell Sabidó

 Post-approval Safety of Freedman M S,        P0370        Session: ePoster
 Subcutaneous Interferon Guehring H,                       Date: 11-13
 ?-1a in the Treatment   Murgasova Z, Jack D               September 2020 Time:
 of Multiple Sclerosis,                                    Available from 9am
 With Particular                                           EDT on 11 September
 Reference to                                              2020 Presenter: Mark
 Respiratory Viral                                         Freedman
 Infections

 Effect of Neutralizing  Freedman MS,         P0323        Session: ePoster
 Antibodies on           Holmberg KH, Fluck                Date: 11-13
 Pharmacodynamic         M, Hyvert H, Stinchi              September 2020 Time:
 Biomarkers of           S, D'Urso V, Dangond              Available from 9am
 Subcutaneous Interferon F                                 EDT on 11 September
 ?-1a in REFLEX and                                        2020 Presenter: Mark
 REFLEXION                                                 Freedman

 Baseline Serum          Kuhle J, Leppert D,  P0032        Session: ePoster
 Neurofilament Light     Comi G, De Stefano                Date: 11-13
 Chain Levels Predict    N, Kappos L,                      September 2020 Time:
 Conversion to McDonald  Freedman MS, Issard               Available from 9am
 2005 MS Within 2 yrs of D, Roy S                          EDT on 11 September
 a First Clinical                                          2020 Presenter:
 Demyelinating Event in                                    Sanjeev Roy
 REFLEX

 Effect of age on        Sabidó M, Allignol A P0320        Session: ePoster
 Effectiveness and       Marhardt K,                       Date: 11-13
 Discontinuation of      Vermersch P, Boutmy               September 2020 Time:
 Subcutaneous Interferon EF                                Available from 9am
 beta-1a, and Healthcare                                   EDT on 11 September
 Utilization, in                                           2020 Presenter:
 Patients With Multiple                                    Patrick Vermersch
 Sclerosis

 Comparing               Bove R, Kozma C,     P0451        Session: ePoster
 Infection-related       Phillips AL, Harlow               Date: 11-13
 Outcomes in Patients    DE, Lobo C                        September 2020 Time:
 with Multiple Sclerosis                                   Available from 9am
 and Matched Controls                                      EDT on 11 September
 Using Administrative                                      2020 Presenter:
 Claims Data                                               Riley Bove

 Assessment of the       Hemelin F, Marie     P1095        Session: ePoster
 Effectiveness of a      Claire G, Olivier H,              Date: 11-13
 Cognitive Behavioral    Marie B, Frederic B               September 2020 Time:
 Program for Fatigue                                       Available from 9am
 (FACETS +) in 110                                         EDT on 11 September
 French Patients with                                      2020 Presenter:
 Relapsing Remitting                                       Fanny Hamelin
 Multiple Sclerosis (RR
 MS): A randomized,
 controlled trial (RCT)

 Impact of               Tokic M, Thiel S,    P1126        Session: ePoster
 Interferon-beta         Litvin N, Ciplea A,               Date: 11-13
 Exposure During Early   Gold R, Hellwig K                 September 2020 Time:
 Pregnancy on Relapse                                      Available from 9am
 Rate                                                      EDT on 11 September
                                                           2020 Presenter: M
                                                           Tokic

 Evobrutinib Presentations

 Clinical Relapse Rates  Montalban X, Arnold  P0197        Session: ePoster
 in Relapsing MS         D L, Weber MS,                    Date: 11-13
 Patients Treated with   Staikov I,                        September 2020 Time:
 the BTK Inhibitor       Piasecka-Stryczynska              Available from 9am
 Evobrutinib: Results of K, Martin E C,                    EDT on 11 September
 an Open-Label Extension Mandel M, Ona V,                  2020 Presenter:
 to Phase II Study       Dangond F, Wolinsky               Fernando Dengond
                         JS

 Safety of the Bruton's  Montalban, X Arnold  P0235        Session: ePoster
 Tyrosine Kinase         D L, Weber M S,                   Date: 11-13
 Inhibitor Evobrutinib   Staikov I,                        September 2020 Time:
 in Relapsing Multiple   Piasecka-Stryczynska              Available from 9am
 Sclerosis During an     K, Martin E C,                    EDT on 11 September
 Open-label Extension to Mandel M, Ona V,                  2020 Presenter:
 a Phase II Study        Zima Y, Dengond F,                Fernando Dengond
                         Tomic D, Wolinsky JS

 Effect Of Evobrutinib,  Montalban X, Shaw J, P0070        Session: ePoster
 a BTK Inhibitor, on     Dangond F, Martin                 Time: Available from
 Immune Cell and         EC, Grenningloh R,                9am EDT on 11
 Immunoglobulin Levels   Ying Li, Weber MS                 September 2020
 in Relapsing MS: An                                       Presenter: Jamie
 Open-Label Extension to                                   Shaw
 a Phase II Study

 Evobrutinib, a Highly   Torke S, Pretzsch R, P0334        Session: ePoster
 Selective BTK           Häusler D,                        Date: 11-13
 Inhibitor, Prevents     Grenningloh R,                    September 2020 Time:
 Antigen-activation of B Boschert U, Brück W,              Available from 9am
 Cells and Ameliorates B Weber MS                          EDT on 11 September
 Cell-mediated                                             2020 Presenter:
 Experimental Autoimmune                                   Sebastian Torke
 Encephalomyelitis

 Expression of Bruton's  Kebir H, Ceja G,     P0962        Session: ePoster
 Tyrosine Kinase in B    Miller MC, Li C, May              Date: 11-13
 Cell-rich Meningeal     MJ, Vite CH, Church               September 2020 Time:
 Infiltrates in two      ME, Grenningloh R,                Available from 9am
 Models of Progressive   Boschert U, Alvarez               EDT on 11 September
 MS                      JI                                2020 Presenter:
                                                           Kebir Hania

 T-bet+ B-cell           Rijvers L, Melief    P0403        Session: ePoster
 Development in MS:      MJ, van Langelaar J,              Date: 11-13
 Association with        Wierenga-Wolf AF,                 September 2020 Time:
 Bruton's Tyrosine       Marieke van Ham S,                Available from 9am
 Kinase Activity and     Boschert U,                       EDT 11 September
 Targeting by            Grenningloh R,                    2020 Presenter: Liza
 Evobrutinib             Smolders J, van                   Rijvers
                         Luijn MM

 The Bruton's Tyrosine   Kim S, Boschert U    P0404        Session: ePoster
 Kinase Inhibitor        Grenningloh R,                    Date: 11-13
 Evobrutinib Ameliorates Bhargava P                        September 2020 Time:
 Meningeal Inflammation                                    Available from 9am
 in Experimental                                           EDT on 11 September
 Autoimmune                                                2020 Presenter:
 Encephalomyelitis                                         Pavan Bhargava

 The Validity and        Kamudoni P, Amtmann  P1062        Session: ePoster
 Applicability of the    D, Johns J, Cook K,               Date: 11-13
 PROMIS SF v2.1 -        Salem R, Salek S,                 September 2020 Time:
 Physical Function (MS)  Raab J, Middleton R,              Available from 9am
 15a: A new PROMIS®      Repovic P, Alschuler              EDT on 11 September
 Short Form for          KN, von Geldern G,                2020 Presenter: Paul
 Assessing Physical      Wundes A, Henke C                 Kamudoni
 Function in Relapsing
 and Progressive
 Multiple Sclerosis
 Types

 The Interpretation and  Kamudoni P, Johns J, P1061        Session: ePoster
 Clinical Application of Cook K, Salem R,                  Date: 11-13
 the PROMIS® SF v1.0 -   Henke C, Salek S,                 September 2020 Time:
 Fatigue (MS) 8b: A      Raab J, Middleton R,              Available from 9am
 PROMIS Short Form for   Repovic P, Alschuler              EDT on 11 September
 Assessing Fatigue in    KN, von Geldern                   2020 Presenter: Paul
 Relapsing and           G,Wundes A, Amtmann               Kamudoni
 Progressive Multiple    D
 Sclerosis

 General MS Franchise

 Identifying Gaps in     Schmierer K, Peniuta P1100        Session: ePoster
 Knowledge, Skills and   M, Oh J, Leist T,                 Date: 11-13
 Confidence Among MS     Lazure P, Péloquin S              September 2020 Time:
 Specialists to                                            Available from 9am
 Facilitate Improved MS                                    EDT on 11 September
 Care                                                      2020 Presenter:
                                                           Klaus Schmierer

 An Investigation Into   Langdon D, Sumelahti P1006        Session: ePoster
 the Role and Impact     M L, Potra S,                     Date: 11-13
 That Carers Play in     Alroughani R, on                  September 2020 Time:
 Consultations Between   behalf of the MS in               Available from 9am
 Healthcare              the 21st Century                  EDT on 11 September
 Professionals and       initiative, Verdun                2020 Presenter: Dawn
 People With MS          Di Cantogno E                     Langdon

 Characterization of     Zuroff LR, Li R,     P0952        Session: ePoster
 Age-related Changes in  Shinoda K, Rezk A,                Date: 11-13
 Circulating T cells in  Bar-Or A                          September 2020 Time:
 Multiple Sclerosis and                                    Available from 9am
 Normal Controls: A                                        EDT on 11 September
 Pilot Study                                               2020 Presenter: LR
                                                           Zuroff

 Treatment and Care      Freeman L, Lucas A,  P0176        Session: ePoster
 Management, Clinical    Zhou J, Hayward B,                Date: 11-13
 Outcomes and Mobility   Livingston T                      September 2020 Time:
 Impairment in People                                      Available from 9am
 With or Without MS Aged                                   EDT on 11 September
 >=50 Years:                                               2020 Presenter:
 Observational 6-year                                      Terrie Livingston
 Analysis
 

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 79 countries, including Canada, Australia and the US. 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(TM). 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. BTK inhibition is thought to suppress autoantibody-producing cells, which preclinical research suggests may be therapeutically useful in certain autoimmune diseases. 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 2.3 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 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, 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.

The company`s robust immunology pipeline focuses on discovering new therapies that have the potential to modulate key pathogenic mechanisms in chronic diseases such as MS, systemic lupus erythematosus osteoarthritis and psoriasis.

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 performance materials. Around 57,000 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 2019, Merck generated sales of EUR 16.2 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 Performance Materials.

Contact
tone-brauti.fritzen@merckgroup.com
+49 151 1454 2694 

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Weitere Storys: Merck KGaA
Weitere Storys: Merck KGaA