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

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

DARMSTADT,Germany,Sept. 3,2020 -- 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 54abstracts 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 dataevaluating 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,showingno 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 ID

Presentation Details

Reduced Grey Matter Atrophy in Patients With Relapsing Multiple Sclerosis Treated With Cladribine Tablets

Battaglini M,Sormani M P,

Luchetti L,Gentile G,Cortese R,

Alexandri N,De Stefano N

P0231

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:Marco Battaglini

Reduction in CUA MRI Lesions in the First

6 Months of Cladribine Tablets Treatment

for Highly Active Relapsing Multiple Sclerosis:

MAGNIFY-MS Study

De Stefano N,Barkhof F,

Montalban X,Achiron A,

Derfuss T,Chan A,Hodgkinson S,

Prat A,Leocani L. Schmierer K,

Sellebjerg F,Vermersch P,Wiendl H,

Keller B,Roy S

P0382

Session:ePoster

Date: 11-13 September 2020

Time: Available from 9am EDT on 11 September 2020

Presenter:Nicola De Stefano

Durable Efficacy of Cladribine Tablets:

Cumulative Relapse Incidence Over

5 years in CLARITY and CLARITY Extension

Giovannoni G,Rammohan K,

Leist T,Coyle P K,Keller B,

Jack D,Alexandri N

P0202

Session:ePoster

Date: 11-13 September 2020

Time: Available from 9am EDT on 11 September 2020

Presenter:Gavin Giovannoni

Disability Improvement in Relapsing-remitting

Multiple Sclerosis Patients Receiving Cladribine

Tablets,Evaluated by Expanded Disability

Status Scale

Sormani M P,Signori A Giovannoni G,

Alexandri N

P0201

Session:ePoster

Date: 11-13 September 2020

Time: Available from 9am EDT on 11 September 2020

Presenter:Maria Pia Sormani

Updated Post-Approval Safety of Cladribine

Tablets in the Treatment of Multiple Sclerosis,

With Particular Reference to Respiratory

Viral Infections

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

P0415

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Gavin Giovannoni

Clinical Outcomes in Patients With COVID-19

Infection During Phase IV Studies of Cladribine

Tablets for Treatment of Multiple Sclerosis

Karan R,Roy S,Alexandri N

LB1151

Session:Latebreaker ePoster

Date: 25-26 September 2020

Time:Available from 9am EDT on 25 September 2020

Presenter: Radmila Karan

Treatment Satisfaction in Patients With

Highly-active Relapsing Multiple Sclerosis

Treated With Cladribine Tablets: CLARIFY-MS

Study Interim Analysis

Brochet B,Hupperts R,Langdon D,

Solari A,Piehl F,Lechner-Scott J,Selmaj K,Valis M,

Rejdak K,Havrdova EK,Patti F,Keller B

P1066

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Bruno Brochet

Initial Findings From a Dynamic Cohort Study

of Patients With Multiple Sclerosis: A Proactive

Approach for Safety and Comparative

Effectiveness

Sabidó,M,Batech M,Foch C,

Boutmy E,Verpillat P

P0470

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Meritxell Sabidó

Characteristics of Relapsing Multiple

Sclerosis Patients Treated With Cladribine

Tablets in Five European Countries: Multi-year

Chart Review

Zeng F,Harty G,Wong SL,

Maslova E,Schade R,Row B

P0846

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Feng Zeng

Characterization of Relapsing Multiple

Sclerosis Patients Treated With Cladribine

Tablets in Germany Since Marketing

Authorization

Zeng F,Uebler S,Row B,

Ellenberger D,Stahmann A

P0847

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Feng Zeng

CLASSIC-MS: Long-term Efficacy and

Real-World Treatment Patterns for Patients

Receiving Cladribine Tablets - Interim Data

with 8–14 Years Follow-up

Giovannoni G,Aydemir A,

Verdun Di Cantogno E,on behalf of

the CLASSIC-MS Steering Committee

LB1229

Session:Latebreaker ePoster

Date: 25-26 September 2020

Time:Available from 9am EDT on 25 September 2020

Presenter:Thomas Leist

Age-related Efficacy of Cladribine Tablets

in Patients With Relapsing-remitting MS in the

CLARITY Extension Study

Freedman M,Pardo G,De Stefano N,

Aldridge J,Hyvert Y,Lemieux C

P0284

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Mark Freedman

Cladribine Tablets in Patients with RRMS

and Active SPMS After Suboptimal Response

to Prior DMD (MASTER-2 and CLICK-MS): Initial

Baseline Demographics

Miravelle A,Katz J,Robertson D,

Hayward B,Walsh JS,Harlow DE,

Lebson LA,Sloane JA,Bass AD,

Fox EJ

P0310

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Augusto Miravelle

Treatment-emergent Adverse Events

Occurring Early in the Treatment Course

of Cladribine Tablets in two Phase 3 Trials

in Multiple Sclerosis

Oh J,Walker B,Giovannoni G,Dangond F,Lebson L,Leist TP

P0411

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Jiwon Oh

Identification and Characterization of

Adherence Trajectory Subgroups in Patients

With MS Initiating Once- or Twice-daily Oral

Disease-modifying Drugs

Cisternas MG,Rajagopalan D,

Leszko M,Andrade K,Phillips AL

P0967

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Amy Phillips

Real-world Patient-level Costs of

Administering Infusion Disease-modifying

Drugs: A US Retrospective Claims Database

Analysis

Kozma CM,Roberts NL,Phillips AL

P1052

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Chris Kozma

Value-added Benefits of a

Nurse/Pharmacy-led Service for Patients

With Multiple Sclerosis Treated Over 2 Years

With Cladribine Tablets in the UK

Morgan K,Vernon K,Ayer M

P1069

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Kate Morgan

Demonstrating the Value of a Patient

Support Program for Multiple Sclerosis

Patients Prescribed Cladribine Tablets

in Ireland at the end of Year 1

Morgan K,Joseph B,Williams V,

Kelly M

P1015

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Kate Morgan

Low Discontinuation Rate and

Side-effect Burden After Switching

to Cladribine Tablets: Canadian Experience

from the adveva® Patient Support Program

Oh J,Giacomini P,Devonshire V,

Clift F,Lemieux C,Sabido M,

Allignol A,Freedman M

P0880

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Jiwon Oh

Cladribine Tablets Versus Other

Disease-modifying Therapies in Achieving

Disability Improvement in Relapsing-remitting

Multiple Sclerosis Patients – Network

Meta-analysis

Piasecka-Stryczyńska K,Rolka M,

Kaczyński Ł,Górecka M,Wójcik R,

Adamek I,Kaczor MP,Rejdak K

P0040

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:K. Piasecka-Stryczynska

MS Disease-modifying Therapy

Sequencing – Natalizumab to Cladribine

Tablets – Experience in 46 Patients

Ziemssen T,Penner IK,Wagner T,

Huebschen M,Mueller B,Buescher T,

Richter J,Posevitz-Fejfar A

566

Session:ePoster

Date: 11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Tjalf Ziemssen

Switching disease modifying treatment

in relapsing multiple sclerosis: Delphi

consensus of the Demyelinating Group

of the Spanish Society of Neurology

Saiz A,Aguera E,Moral E,Brieva L,

Rodriguez-Antiguedad A,

Casanova-Estruch B,

Jordi R,Meca-Lallana V,

Garcia-Merino JA,

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

P0401

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:Luis Brieva

CLADQoL (CLADribine Tablets – evaluation of Quality of Life) Study: Evaluating QoL 12 Months After Treatment Initiation with Cladribine Tablets

Penner IK,Pul R,Kallmann BA,

Raji A,Richter J,

Buescher T,Posevitz-Fejfar A

P0849

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:Iris-Katharina Penner

Effects of Cladribine on Proliferation,Survival and Cytokine Release of Human Astrocytes

Eixarch H,Calvo-Barreiro L,Fissolo N,

Boschert U,Comabella M,Montalban X,

Espejo C

P0330

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:Herena Eixarch

Real-world Experience With Cladribine in the MSBase Registry

Butzkueven H,Spelman T,

Verdun di Cantogno E,Fabris J,

Zeng F,G Harty

P0907

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:Helmut Butzkueven

2-Chlorodeoxyadenosine (Cladribine) Preferentially Inhibits the Biological Activity of Microglia Cells

Aybar F,Marcora S,Eugenia Samman M,

Perez MJ,Pasquini JM,Correale J

P0270

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:Jorge Correale

Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis (ChariotMS)

Lieberman D,Mangat H,Allen-Philby K,Baker D,Chandran S,Chapman C,Chataway J,Ford H,Hobart J,Hooper R,Hussain T,Walker N,Macmanus D,Mihaylova B,Pavitt S

P0196

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: David Lieberman

Predicting Long-term Sustained Disability Progression in Multiple Sclerosis: Application in the CLARITY Trial

Sharmin S,Bovis F,Sormani MP,Butzkueven H,Kalincik T and the MSBase study group

P0131

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:S Sharmin

A Clinical Data Summary

for Cladribine Patients Treated

at least 12 Months - A Swedish

Nationwide Study of the

Long-Term Effectiveness

and Safety of Cladribine (IMSE 10)

Forsberg L,Kågström S,Hillert J,Nilsson P,Dahle C,Svenningsson A,Lycke J,Landtblom AM,Burman J,Martin C,Sundström P,Gunnarsson M,Olsson T

P0276

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:L Forsberg

Impact of Cladribine Tablets

on Brain Volume Protection in

Highly Active MS

Raji A,Winkler G

P0586

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:A Raji

Early Real-World Safety,Tolerability,and Efficacy of Cladribine Tablets: A Single Center Experience

Bain J,Jones A,Overholt S,Guenette M,Selchen D,Jiwon Oh

P0319

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:J Bain

Switching From Ocrelizumab to Cladribine: Real-world Data

O'Neill DTD,Sharma M,Gonzales B,Vandenheuvel M,Tse B,Hodgkinson SJ

P0399

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:D O'Neill

The Effect of Cladribine Upon Naïve and Activated CD4+ T Regulatory Cells in MS Patients

Verma ND,Al-Atiyah R,O'Neill D,Tran CT,Hall BM,Hodgkinson SJ

P0406

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:Suzanne Hodgkinson

Rebif® (interferon beta-1a) Presentations

A Systematic Review and Meta-analyses of Pregnancy and Fetal Outcomes in Women with Multiple Sclerosis. IMI2 ConcePTION

Lopez-Leon S,Geissbuehler Y,

Sabidó M,Turkson,Wahlich C,Morris J

P0278

Session:ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Meritxell Sabidó

Post-approval Safety of Subcutaneous Interferon β-1a in the Treatment of Multiple Sclerosis,With Particular Reference to Respiratory Viral Infections

Freedman M S,Guehring H,Murgasova Z,Jack D

P0370

Session:ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Mark Freedman

Effect of Neutralizing Antibodies on Pharmacodynamic Biomarkers of Subcutaneous Interferon β-1a in REFLEX and REFLEXION

Freedman MS,Holmberg KH,Fluck M,Hyvert H,Stinchi S,D'Urso V,Dangond F

P0323

Session:ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Mark Freedman

Baseline Serum Neurofilament Light Chain Levels Predict Conversion to McDonald 2005 MS Within 2 yrs of a First Clinical Demyelinating Event in REFLEX

Kuhle J,Leppert D,Comi G,Kappos L,Freedman MS,Issard D,Roy S

P0032

Session:ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Sanjeev Roy

Effect of age on Effectiveness and Discontinuation of Subcutaneous Interferon beta-1a,and Healthcare Utilization,in Patients With Multiple Sclerosis

Sabidó M,Allignol A Marhardt K,Boutmy EF

P0320

Session:ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Patrick Vermersch

Comparing Infection-related Outcomes in Patients with Multiple Sclerosis and Matched Controls Using Administrative Claims Data

Bove R,Kozma C,Phillips AL,Lobo C

P0451

Session:ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Riley Bove

Assessment of the Effectiveness of a Cognitive Behavioral Program for Fatigue (FACETS +) in 110 French Patients with Relapsing Remitting Multiple Sclerosis (RR MS): A randomized,controlled trial (RCT)

Hemelin F,Marie Claire G,Olivier H,Marie B,Frederic B

P1095

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:Fanny Hamelin

Impact of Interferon-beta Exposure During Early Pregnancy on Relapse Rate

Tokic M,Thiel S,Litvin N,Ciplea A,Gold R,Hellwig K

P1126

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:M Tokic

Evobrutinib Presentations

Clinical Relapse Rates in

Relapsing MS Patients

Treated with the BTK Inhibitor

Evobrutinib: Results of an

Open-Label Extension to

Phase II Study

Montalban X,Arnold D L,Weber MS,Staikov I,Piasecka-Stryczynska K,Martin E C,Mandel M,Ona V,Wolinsky JS

P0197

Session:ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Fernando Dengond

Safety of the Bruton's Tyrosine

Kinase Inhibitor Evobrutinib in

Relapsing Multiple Sclerosis During

an Open-label Extension to a

Phase II Study

Montalban,X Arnold D L,Weber M S,Zima Y,Dengond F,Tomic D,Wolinsky JS

P0235

Session:ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Fernando Dengond

Effect Of Evobrutinib,a BTK

Inhibitor,on Immune Cell and

Immunoglobulin Levels in Relapsing

MS: An Open-Label Extension to

a Phase II Study

Montalban X,Shaw J,Martin EC,Grenningloh R,Ying Li,Weber MS

P0070

Session:ePoster

Time:Available from 9am EDT on 11 September 2020

Presenter: Jamie Shaw

Evobrutinib,a Highly Selective BTK

Inhibitor,Prevents Antigen-activation

of B Cells and Ameliorates B

Cell–mediated Experimental

Autoimmune Encephalomyelitis

Torke S,Pretzsch R,Häusler D,Boschert U,Brück W,Weber MS

P0334

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Sebastian Torke

Expression of Bruton's Tyrosine

Kinase in B Cell-rich Meningeal

Infiltrates in two Models of

Progressive MS

Kebir H,Ceja G,Miller MC,Li C,May MJ,Vite CH,Church ME,Alvarez JI

P0962

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Kebir Hania

T-bet+ B-cell Development in MS:

Association with Bruton's Tyrosine

Kinase Activity and Targeting by

Evobrutinib

Rijvers L,Melief MJ,van Langelaar J,Wierenga-Wolf AF,Marieke van Ham S,Smolders J,van Luijn MM

P0403

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT 11 September 2020

Presenter: Liza Rijvers

The Bruton's Tyrosine Kinase Inhibitor

Evobrutinib Ameliorates Meningeal

Inflammation in Experimental Autoimmune

Encephalomyelitis

Kim S,Boschert U Grenningloh R,Bhargava P

P0404

Session:ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Pavan Bhargava

The Validity and Applicability of

the PROMIS SF v2.1 - Physical Function

(MS) 15a: A new PROMIS® Short Form for

Assessing Physical Function in Relapsing

and Progressive Multiple Sclerosis Types

Kamudoni P,Amtmann D,Johns J,Cook K,Salem R,Salek S,Raab J,Middleton R,Repovic P,Alschuler KN,von Geldern G,Wundes A,Henke C

P1062

Session:ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Paul Kamudoni

The Interpretation and Clinical

Application of the PROMIS® SF

v1.0 - Fatigue (MS) 8b: A PROMIS

Short Form for Assessing Fatigue in

Relapsing and Progressive Multiple

Sclerosis

Kamudoni P,Henke C,Amtmann D

P1061

Session:ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Paul Kamudoni

General MS Franchise

Identifying Gaps in Knowledge,

Skills and Confidence Among MS

Specialists to Facilitate Improved

MS Care

Schmierer K,Peniuta M,Oh J,Lazure P,Péloquin S

P1100

Session:ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Klaus Schmierer

An Investigation Into the Role

and Impact That Carers Play in

Consultations Between Healthcare

Professionals and People With MS

Langdon D,Sumelahti M L,Potra S,Alroughani R,on behalf of the MS in the 21st Century initiative,Verdun Di Cantogno E

P1006

Session:ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter: Dawn Langdon

Characterization of Age-related

Changes in Circulating T cells in

Multiple Sclerosis and Normal

Controls: A Pilot Study

Zuroff LR,Li R,Shinoda K,Rezk A,Bar-Or A

P0952

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:LR Zuroff

Treatment and Care Management,

Clinical Outcomes and Mobility

Impairment in People With or Without

MS Aged ≥50 Years: Observational

6-year Analysis

Freeman L,Lucas A,Zhou J,Hayward B,Livingston T

P0176

Session: ePoster

Date:11-13 September 2020

Time:Available from 9am EDT on 11 September 2020

Presenter:Terrie Livingston

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™. 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/subscribeto register online,change your selection or discontinue this service.

About Merck

Merck,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 € 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