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.

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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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Additional content: http://presseportal.de/pm/6873/4696932
OTS: Merck KGaA
ISIN: DE0006599905