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Merck KGaA, DE0006599905

Darmstadt, Germany - Not intended for UK and US based media - Company to present 54 abstracts across its MS portfolio - MAVENCLAD?

03.09.2020 - 16:07:17

Merck to Showcase New Data at ACTRIMS-ECTRIMS MSVirtual2020 Meeting, Furthering Innovation in Multiple Sclerosis. (cladribine tablets), Rebif?

Darmstadt, Germany - 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 Sabid?, 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 Sabid?

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 ?, G?recka September 2020 Time: Therapies in Achieving M, W?jcik 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, Mat?as-Guiu J, Ares A, Mart?nez-Gin?s ML, Ara JR, Llaneza M, Castillo-Trivino T, Romero L, Perez-Sempere A, Gonz?lez-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, K?gstr?m 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, Sundstr?m 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 Na?ve 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 Sabid? 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 Sabid?

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 Sabid? 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 H?usler D, Date: 11-13 Inhibitor, Prevents Grenningloh R, September 2020 Time: Antigen-activation of B Boschert U, Br?ck 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, P?loquin 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


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 ? 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.

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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.

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