EMD Serono Completes Enrollment of Evobrutinib Phase III Clinical Trials Ahead of ECTRIMS 2021

Investigational evobrutinib is the first Bruton’s tyrosine kinase (BTK) inhibitor to complete Phase III clinical trial enrollment in relapsing multiple sclerosis (RMS) Data from oral presentations at ECTRIMS show evobrutinib has a positive impact on important biomarkers of disease progression New independent data being presented found that patients treated with MAVENCLAD® (cladribine) tablets had increased antibody IgG titer levels similar to that of the general population after a complete course of an mRNA COVID-19 vaccine ROCKLAND, Mass, October 4, 2021 – EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced enrollment has been completed in the Phase III EVOLUTION RMS clinical trial program, which is evaluating the efficacy and safety of investigational Bruton’s tyrosine kinase (BTK) inhibitor evobrutinib in patients with relapsing multiple sclerosis (RMS). This milestone comes just ahead of the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place virtually from October 13-15, 2021, where 39 abstracts from the Company’s multiple sclerosis (MS) portfolio will be presented. Data will include two oral presentations and a late-breaking ePoster on evobrutinib as well as late-breaking ePosters on MAVENCLAD® (cladribine) tablets including new interim data on patient-reported improvements in quality of life (QoL) and new independent data on MAVENCLAD patients who have received a complete course of an mRNA COVID-19 vaccine. “The breadth of our data at ECTRIMS, paired with the rapid enrollment in our evobrutinib Phase III EVOLUTION RMS clinical trial program, further exemplifies a commitment to continue breaking boundaries in the science of MS,” said Danny Bar-Zohar, Global Head of Development for the Healthcare business of Merck KGaA, Darmstadt, Germany. “By generating new data on MAVENCLAD to demonstrate the positive real-life impact it can have for people with RMS, and also on progressing evobrutinib with its dual mode of action targeting both B-cells and innate immune cells in the central nervous system and periphery, we are hoping to address the needs of people with RMS now and in the future.” Key MAVENCLAD® (cladribine) tablets data include: Updated post-approval safety data of MAVENCLAD demonstrating consistency of real-world experience with the profile reported in the Phase III and ongoing Phase IV trials, and providing evidence that patients receiving MAVENCLAD do not appear at increased risk of severe COVID-19 outcomes In an independent open label study, patients treated with MAVENCLAD were found to increase antibody immunoglobulin G (IgG) titer levels similar to healthy controls after a complete course of an mRNA COVID-19 vaccine. In the U.S., the MAVENCLAD label states that all immunizations should be administered according to immunization guidelines prior to starting MAVENCLAD A new interim analysis from the Phase IV CLARIFY-MS study demonstrating that patients living with RMS reported an improvement in physical and mental health at one year of MAVENCLAD treatment Real-world MAVENCLAD data from the MSBase Registry demonstrating adherence to MAVENCLAD and an annualized relapse rate similar to clinical trial data Late-breaking data including: Long-term Efficacy for Patients Receiving Cladribine Tablets in CLARITY/CLARITY Extension: Primary Results from 9–15 Years of Follow-up in the CLASSIC-MS Study Cladribine tablets after treatment with natalizumab (CLADRINA) trial - Interim analyses Key evobrutinib data include: Data from a post-hoc analysis in the Phase II trial with evobrutinib demonstrated a reduction in volume of slowly expanding lesions (SELs), an in-vivo magnetic resonance imaging (MRI) correlate of chronic active inflammation and axonal loss within the central nervous system (CNS), which may be predictive of subsequent clinical disease progression in MS Results from the same trial showed that increased levels of blood neurofilament light chain (NfL), a marker of neuronal damage, at baseline were predictive of increased relapse and MRI lesion activity in the study and evobrutinib significantly reduced MRI and relapse outcomes Extensive safety profile characterization of evobrutinib in over 1000 patients from Phase II clinical trials in MS, rheumatoid arthritis and systemic lupus erythematosus demonstrating that overall evobrutinib treatment (all doses) was generally well tolerated across indications and elevations in liver enzymes were asymptomatic and reversible Additional Company activities at ECTRIMS 2021: Satellite symposium: “Supporting patient needs in MS every step of the way” co-chaired by Prof. Gavin Giovannoni, Chair of Neurology, Barts and The London School of Medicine and Dentistry and Prof. Barbara Kornek, Department of Neurology at the University of Vienna (October 13, 2021, 9:00-10:00 EDT) Medical education symposium “MS innovation in practice: the continuing search for novel therapeutic targets” co-chaired by Prof. Patrick Vermersch, Vice President for research in biology and health at the University of Lille, and Dr. Xavier Montalban, Chairman & Director Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall d'Hebron University Hospital, Barcelona, Spain (October 13, 2021, 11:45-12:45 EDT). To keep up-to-date with our activities at ECTRIMS, along with future data and information, follow us on Twitter @EMDSerono and LinkedIn: EMD Serono, Inc. #ECTRIMS2021 #MSInsideOut Below is the full list of EMD Serono-related abstracts accepted for presentation at ECTRIMS 2021: Oral Presentations: Abstract Name Authors Presentation ID Presentation Details Effects of evobrutinib, a Bruton’s tyrosine kinase inhibitor, on slowly expanding lesions: an emerging imaging marker of chronic tissue loss in multiple sclerosis D.L. Arnold, C. Elliott, X. Montalban, E. Martin, Y. Hyvert, D. Tomic 115Session: Free Communications 2 - Treatment trials - Immunomodulation Date: October 14, 2021 Time: 10:57-11:04 EDT Presenter: Douglas L. Arnold Evobrutinib significantly reduces relapses and magnetic resonance imaging outcomes in patients with multiple sclerosis: association with baseline neurofilament light chain levels J. Kuhle, L. Kappos, X. Montalban, Y. Li, K. Thangavelu, Y. Hyvert, D. Tomic 116 Session: Free Communications 2 - Treatment trials - Immunomodulation Date: October 14, 2021 Time: 11:04-11:11 EDT Presenter: Jens Kuhle Single cell analysis of cerebrospinal fluid leukocytes in treated multiple sclerosis patients M. Heming, I. Lu, N. Schwab, D. Schafflick, C.C. Gross, H. Wiendl, G.M. zu Horste 134 Session: Free Communication 3: Pathology Date: October 15, 2021 Time: 6:33-6:40 EDT Presenter: Gerd Meyer zu Hörste Activated Tfh1 cells infiltrate the cerebrospinal fluid in early multiple sclerosis J.Morille, M. Mandon, S.Rodriguez, A.Garcia, S.Wiertlewski, L.Berthelot, K.Tarte, C.Delaloy, P.Amé, D-A.Laplaud, L.Michel 025Session: Scientific Session 2: Blood-Brain Barrier Date: October 15, 2021 Time: 8:04-8:11 EDT Presenter: Marion Mandon MAVENCLAD® (cladribine) tablets ePoster Presentations: Abstract Name Authors Presentation ID Presentation Details Long-term Efficacy for Patients Receiving Cladribine Tablets in CLARITY/CLARITY Extension: Primary Results from 9–15 Years of Follow-up in the CLASSIC-MS Study G. Giovannoni, T. Leist, A. Aydemir, E. Verdun Di Cantogno, on behalf of the CLASSIC-MS Steering Committee P975Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Gavin Giovannoni Cladribine Tablets after treatment with natalizumab (CLADRINA) trial – Interim analyses P. Sguigna, A. Okai, J. Kaplan, K. Blackburn, L. Tardo, B. Hayward, U. Boschert, L. Lebson, N. Manouchehri, R. Hussain, O. Stuve P987Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Peter Sguigna Improvements in QoL at 1 Year in Patients Treated With Cladribine Tablets for Highly Active Relapsing MS: An Interim Analysis of CLARIFY-MS A. Solari, X. Montalban, J. Lechner-Scott, F. Piehl, B. Brochet, D. Langdon, R. Hupperts, K. Selmaj, E.K. Havrdova, F. Patti, Brieva L, Maida EM, N. Alexandri, P. Kamudoni, A. Nolting, B. Keller P238 Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Alessandra Solari Post-Approval Safety of Cladribine Tablets With Particular Reference to COVID-19 Outcomes: An Update G. Giovannoni, J. Berger, T. Leist, D. Jack, A. Galazka, A. Nolting, D. Damian P766Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Gavin Giovannoni High Adherence to Treatment With Cladribine Tablets for Multiple Sclerosis: Value-Added Benefit of a Nurse/Pharmacy-led Patient Support Programme During the COVID-19 Pandemic J. Oh, M.S. Freedman, K. Vernon, M. Ayer, C. Lemieux, K. Morgan, T. Quinn, T. Vella, A. Allignol, M. Stein, E. Verdun di Cantogno, M. SabidóP741Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Jiwon Oh Incidence of Infections and Severe Lymphopenia in Patients Newly Initiating Cladribine Tablets or Fingolimod for Treatment of Multiple Sclerosis: CLARION StudyJ. Hillert, H. Butzkueven, M. Soilu-Hänninen, T. Ziemssen, J. Kuhle, J.R. Berger, A. Aydemir, J. Sõnajalg, I. Bezemer, M. SabidóP767Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Jan Hillert Disease-Modifying Treatment Patterns of Patients With Multiple Sclerosis and Newly Treated With Cladribine Tablets or Fingolimod: An Interim Analysis of the CLARION StudyH. Butzkueven, J. Hillert, J. Sõnajalg, M. Soilu-Hänninen, A. Aydemir, T. Ziemssen, J. Kuhle, M. Magyari, S. Wergeland, I. Bezemer, M. SabidóP742Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Helmut Butzkueven Risk of Cancer with Disease-Modifying Drugs in Multiple Sclerosis: A New-User Cohort Design in the French Nationwide Claims DatabaseP. Bosco-Lévy, M. Sabidó, E. Guiard, P. Diez, C. Foch, C. Favary, J. Jové, E. Boutmy, P. BlinP756Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Meritxell Sabidó A Multi-Country Cohort Database Study to Assess Pregnancy and Infant Outcomes in Women Exposed to Cladribine Tablets: CLEAR StudyK. Hellwig, M. Magyari, T. McDonald, K. Gembert, S. Wergeland, M.k. Leinonen, A. Aydemir, M. Sabidó, A. Kawai, A. AranaP185Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Kerstin Hellwig MASTER-2 trial: Cladribine tablets in patients with relapsing-remitting multiple sclerosis and active secondary multiple sclerosis after suboptimal response to prior infusion/oral disease-modifying therapy (interim baseline results)E.J. Fox, A.D. Bass, J. Aldridge, L.A. Lebson, D. RobertsonP851Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Edward Fox Evaluation of therapy satisfaction with cladribine tablets in RMS patients – Final results of the non-interventional study CLEVERC. Grothe, L. Cepek, G. Reifschneider, T. Ziemssen, J. Richter, T. WagnerP859Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Joachim Richter Finnish cladribine tablets registry study 2 year dataS. Atula, E. Jarvinen, H. Kuusisto, I. Rauma, M. Ryytty, J. Sipilä, M. Soilu-Hänninen, M. ViitalaP691Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Ilkka Rauma Outcomes after late Cladribine re-dosing in the Australian MSBase cohortH. Butzkueven, T. Spelman, S. Hodgkinson, A. Van der Walt, K. Buzzard, O. Skibina, T. Kalincik, J. Lechner-Scott, R. Macdonell, E. Verdun di CantognoP865Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Helmut Butzkueven Real-world experience with cladribine in the MSBase RegistryH. Butzkueven, T. Spelman, MSBase Investigators (TBC), E. Verdun di CantognoP825Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Helmut Butzkueven Molecular biomarker signature associated with cladribine treatmentN. Fissolo, L. Calvo-Barreiro, H. Eixarch, U. Boschert, C. Espejo, X. Montalban, M. ComabellaP584Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Nicolás Fissolo Effect of cladribine on differentiation of human neural precursor cellsH. Eixarch, L. Calvo-Barreiro, N. Fissolo, U. Boschert, M. Comabella, X. Montalban, C. EspejoP899Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Herena Eixarch Economic Analysis for Introduction of Cladribine Tablets as a Treatment for Relapsing-Remitting and High Disease Activity Multiple Sclerosis in KuwaitR. Alroughani, M.A. Al-Melh, S. Farouk, A. Abokoura, E. Alsultan, A Boshra, R. Alcharif, R. Ojeil, S. Basu, A. VermaP280Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Raed Alroughani Effect of cladribine on COVID-19 serology responses following 2 doses of the BNT162b2 mRNA vaccine in patients with multiple sclerosisA. Vaknin-DembinskyP780Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Ariel Rechtman Effect of cladribine tablets in highly active MS monitored by global and regional brain atrophy statusA. Raji, G. WinklerP709Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Alaleh Raji Clinical Effectiveness and Safety of Cladribine Tablets for Patients Treated at least 12 Months in the Swedish post-market surveillance study "Immunomodulation and Multiple Sclerosis Epidemiology 10" (IMSE-10)V. Rosengren, E. Ekström, L. Forsberg, S. Kågström, J. Hillert, P. Nilsson, C. Dahle, A. Svenningsson, J. Lycke, A-M. Landtblom, J. Burman, C. Martin, P. Sundström, M. Gunnarsson, F. Piehl, T. OlssonP743Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Victoria Rosengren Real-world patient profile of cladribine tablets in multiple sclerosis patients from ArgentinaRojas JI, Alonso R, Luetic G, Pappolla A, Miguez J, Patrucco L, Cohen L, Garcea O, Casas M, Silva B, Deri N, Liwacki S, Silva E, Piedrabuena R et al.P853Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Juan Ignacio Rojas Seroconversion following vaccination against SARS-CoV-2 in people with MS: impact of disease modifying therapyN. Vickaryous, A.N. Asardag, J. Bestwick, S.N. Shah, K. George, K. Schmierer, G. Giovannoni, D. Baker, A. Kang, R. DobsonP950Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Nikki Vickaryous Rebif® (interferon beta-1a) subcutaneous injection ePoster Presentations: Abstract Name Authors Presentation ID Presentation Details Development and Interrelation of Whole-Brain Atrophy and Lesion Volume During 5 Years’ Treatment With Subcutaneous Interferon Beta-1a in Patients With a First Clinical Demyelinating Event in the REFLEX/ION Study R.M. Mattiesing, G. Gentile, I. Brouwer, D. Jack, A. Seitzinger, F. Barkhof, N. De Stefano, B.M.J. Uitdehaag, J.W.R. Twisk, M. Battaglini, H. Vrenken P430Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Rozemarijn Mattiesing Development and Interrelation of Spatiotemporal Patterns of Brain Atrophy and Lesions During 5 Years’ Treatment With Subcutaneous Interferon Beta-1a in Patients With a First Clinical Demyelinating Event in the REFLEX/ION Study G. Gentile, R.M. Mattiesing, I. Brouwer, D. Jack, A. Seitzinger, F. Barkhof, N. De Stefano, B.M.J. Uitdehaag, H. Vrenken, M. Battaglini P458Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Giordano Gentile Exploratory Analysis of Serum GDF-15 Levels in Patients Receiving Subcutaneous Interferon Beta-1a in the REFLEX Trial M. Coray, A. Seitzinger, S. Roy, M.S. Freedman, F. Barkhof, G. Comi, N. De Stefano, L. Kappos, J. Kuhle, M. Mehling P674 Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Mali Coray INFORM – Interferon-Beta Exposure in the 2nd and 3rd Trimester of Pregnancy – a Register-Based Drug Utilisation Study in Finland and Sweden M. Sabidó, K. Suzart-Woischnik, N. Grimes, L.M. Prach, L. Zhao, K.M. Hakkarainen P794Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Meritxell Sabido Evobrutinib ePoster Presentations: Abstract Name Authors Presentation ID Presentation Details Safety profile characterization of evobrutinib in over 1000 patients from phase II clinical trials in multiple sclerosis, rheumatoid arthritis and systemic lupus erythematosus X. Montalban, D. Wallace, M.C. Genovese, D. Tomic, D. Parsons-Rich, C. Le Bolay, A. Kao, H. Guehring P727Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Xavier Montalban The role of human and mouse BTK in myeloid cells C. Bassani, M. Molinari, V. Martinelli, R. Grenningloh, U. Boschert, G. Comi, G. Martino, L. Muzio, C. Farina P656Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Cinthia Farina Targeting BTK in chronic CNS autoimmunity inhibits activation of microglia A. Geldaris, S. Torke, R. Grenningloh, U. Boschert, W. Brück, M.S. Weber P971Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Anastasia Geladaris Non-Product Specific ePoster Presentations: Abstract Name Authors Presentation ID Presentation Details DISCOntinuation of disease-modifying therapies in MS (DISCOMS) Extension – Study Design and Baseline Demographics E. Engebretson, G. Cutter, R. Fox, I. Kister, A. Miller, C. Morgan, R. Seale, J.R. Corboy P751Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: John Corboy Genome-wide mapping of patient’s autoantibody targets to understand and predict Multiple Sclerosis pathogenesis and patient responses to Interferon β-1a therapy E.B. DiCillo, E. Kountikov, M. Zhu, W. Zhang, B. Hayward, D.E. Harlow, S. Lanker, J.L. Bennet, T.F. TedderP361Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Europe B DiCillo Towards a new resource for the MS brain: a cross-brain bank proteomic atlas of non-lesional neocortexP. Bouman, D. Pitt, D. Reich, J. Schneider, D. Bennett, R. Nagra, R. Reynolds, J. Geurts, J. Corboy, P. De JagerP317Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Philip De Jager Multiplexed imaging of the multiple sclerosis meninges using mass cytometryV. Ramaglia, M. Zuo, N. Fransen, S. Zandee, A. Prat, I. Huitinga, A. Bar-Or, J.L. GommermanP319Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Valeria Ramaglia Interprofessional collaboration and patient-provider communication challenges in MS care: A mixed-methods needs assessmentS. Péloquin, K. Schmierer, J. Oh, T. Leist, S. Murray, P. LazurP903Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Sophie Peloquin Neuropsychological measures associated with disease severity in pediatric onset multiple sclerosisN. Gur, E. Ganelin Cohen, T. Pilowsky Peleg P990Date: October 13, 2021 Time: 10:45-12:45 EDT Presenter: Noa Gur

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