Interferon beta-1a(Rentschler)

Retrospective analyses from the Phase 3 DAYBREAK open-label extension study showed more than 90% of participants who received Zeposia mounted a serologic response to COVID-19 vaccination All adverse events related to COVID-19 in vaccinated study participants were nonserious Data are among 13 abstracts being presented at ECTRIMS 2022 that further reinforce the safety and efficacy pro Zeposia and Bristol Myers Squibb’s commitment to the multiple sclerosis community PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced new retrospective analyses on serologic responses and clinical outcomes with COVID-19 vaccination in participants treated with Zeposia (ozanimod) from the ongoing Phase 3 DAYBREAK open-label extension (OLE) study in relapsing multiple sclerosis (MS). More than 92% (137/148) of all study participants in these analyses mounted a serological response following vaccination. In addition, among participants with prior COVID-19 exposure, seroconversion was observed in 100% (39/39) of individuals following full COVID-19 mRNA or non-mRNA vaccination. COVID-19-related adverse events were reported in 10% (15/148) of vaccinated participants (12/148 confirmed; 3/148 suspected), all of which were nonserious. The new analyses (Presentation #P1199) will be featured in the late-breaking research session on October 27, 2022, at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place in Amsterdam, the Netherlands. “These data are of clinical importance for physicians treating multiple sclerosis, because they provide a greater understanding of how COVID-19 infections and vaccinations interplay with Zeposia treatment,” said Bruce Cree, MD, PhD, MAS, study investigator and professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and Clinical Research Director, UCSF MS Center. “Regardless of prior COVID-19 exposure, most participants mounted an immune response following COVID-19 vaccination without experiencing adverse events, in contrast to some reports of other S1P modulators that described no response, adding insight to the treatment decision making process.” Additional key Bristol Myers Squibb data presentations at ECTRIMS 2022 include: Interim analyses of the ongoing Phase 3 DAYBREAK OLE study showed that 68% of participants were relapse-free and demonstrated an adjusted annualized relapse rate (ARR) of 0.099 at up to 74 months of treatment. Findings also showed long-term efficacy was sustained on MRI measures after 60 months of treatment, with a mean number of new and enlarging T2 lesions per scan of 0.98, and on disability progression in up to 74 months of treatment, with a 6-month confirmed disability progression of 14%. Treatment emergent adverse events (TEAEs) were reported in 88% of participants, with 14% of participants reporting serious TEAEs; 3.6% of participants discontinued treatment due to TEAEs. (Presentation #P334; Author: Krzysztof Selmaj) Post hoc analyses of the Phase 3 SUNBEAM, RADIANCE and DAYBREAK OLE studies demonstrated that a greater proportion of patients treated with Zeposia versus interferon beta-1a had a lower annualized rate of brain volume loss (SUNBEAM study, Month 12: 50.9% versus 37.5%, respectively; RADIANCE study, Month 24: 63.1% versus 50%, respectively). In patients continuously treated with Zeposia, those with low annualized rate of brain volume loss (ARBVL) showed higher cognitive processing speed as measured by the mean symbol digits modalities test compared with those with high ARBVL (SUNBEAM study into OLE study, Month 60: 52.7 versus 45.4; RADIANCE study into OLE study, Month 72: 50.5 versus 40.5, respectively). (Author: Bruno Brochet; e-Poster #EP1082) “We remain dedicated to pursuing pathbreaking science and collaborating with the scientific and patient communities to deepen our understanding on the use of our medicines and to help individuals with multiple sclerosis live healthier, more fulfilling lives,” said Jonathan Sadeh, MD, MSc, senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb. “Our COVID-19 and disability progression findings, as well as our presentations demonstrating an association between Zeposia use and reduced brain volume loss along with improved cognitive processing speed, reinforce the importance of early intervention in the treatment of multiple sclerosis and Zeposia’s pro the treatment armamentarium.” Bristol Myers Squibb-sponsored abstracts featured at the ECTRIMS 2022 Congress: Serologic response and clinical outcomes of SARS-CoV-2 infection and vaccination in ozanimod-treated participants with relapsing multiple sclerosis Author: Bruce Cree Presentation number: P1199 Session: Poster Session 2 COVID-19 infections and vaccinations among patients receiving ozanimod in the DAYBREAK open-label extension trial Author: Bruce Cree Presentation number: P387 Session: Poster Session 1 Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Interim analysis of the DAYBREAK open-label extension study Author: Krzysztof Selmaj Presentation number: P334 Session: Poster Session 1 Correlations between early MRI parameters and long-term clinical outcomes in Phase 3 and open-label extension studies of ozanimod in relapsing multiple sclerosis Author: Douglas Arnold Presentation number: P358 Session: Poster Session 1 Proportion of relapsing MS patients with low vs high annualised whole brain volume atrophy rates after 5‒6 years of ozanimod and relationship to cognitive processing speed Author: Bruno Brochet e-Poster number: EP1082 Session: e-Poster Session Impact of ozanimod on absolute lymphocyte count and recovery in patients with relapsing multiple sclerosis Author: Krzysztof Selmaj e-Poster number: EP1071 Session: e-Poster Session Relationship between infections and absolute lymphocyte count during Phase 3 and open-label extension trials of ozanimod in patients with relapsing multiple sclerosis Author: Hans-Peter Hartung Presentation number: P707 Session: Poster Session 2 Safety patterns with ozanimod during Phase 3 and open-label extension trials in patients with relapsing multiple sclerosis Author: Krzysztof Selmaj Presentation number: P732 Session: Poster Session 2 NfL as a predictor of GdE lesions in patients with relapsing multiple sclerosis treated with ozanimod in the Phase 2 RADIANCE trial Author: Krzysztof Selmaj e-Poster number: EP1020 Session: e-Poster Session Post hoc analysis of cognitive processing speed at time of first confirmed relapse in patients with relapsing multiple sclerosis treated with ozanimod vs interferon β-1A in the Phase 3 SUNBEAM trial ​Author: John DeLuca e-Poster number: EP1116 Session: e-Poster Session Effect of disease modifying therapy on T2-flair-based neurodegenerative MRI outcomes: A longitudinal, real-world, US-based, multi-center multiple sclerosis study Author: Bruce Cree e-Poster number: EP1121 Session: e-Poster Session The impact of cognitive impairment on disease burden in Chinese patients with multiple sclerosis: A model simulation study Author: Qian Jiang e-Poster number: EP0870 Session: e-Poster Session Uncovering challenges in achieving health equity in multiple sclerosis care: A deep-dive into the experiences and perspectives of patients and their care teams in general neurology and MS specialty clinics Author: Mitzi Williams Presentation number: P110 Session: Poster Session 1 Bristol Myers Squibb thanks the patients and investigators who are participating in our Zeposia clinical trials. About DAYBREAK DAYBREAK is a Phase 3, multi-center, long-term open-label extension (OLE), randomized, double-blind, double-dummy, active-controlled, parallel group study to evaluate the safety and efficacy of Zeposia (ozanimod) administered orally to patients with relapsing forms of multiple sclerosis (MS). Eligible patients from the RADIANCE, SUNBEAM and RPC01-1001 trials diagnosed with relapsing forms of MS are enrolled to receive treatment until the end of the DAYBREAK trial or until the development program is discontinued. Patients in the trial are receiving Zeposia 0.92 mg (equivalent to ozanimod HCl 1 mg). About RADIANCE RADIANCE Part B was a pivotal, Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of oral Zeposia (0.92 mg, equivalent to 1 mg) against weekly intramuscular AVONEX® (interferon beta-1a) over a 24-month treatment period. The study included 1,320 people living with relapsing forms of MS across 150 sites in 21 countries. The primary endpoint of the trial was ARR over 24 months. The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 24 months. About SUNBEAM SUNBEAM was a pivotal, Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral Zeposia (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCl, respectively) against weekly intramuscular AVONEX® (interferon beta-1a) for at least a 12-month treatment period. The study included 1,346 people living with relapsing forms of MS across 152 sites in 20 countries. The primary endpoint of the trial was annualized relapse rates during the treatment period. The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 12 months, number of gadolinium-enhanced brain MRI lesions at Month 12 and percent change from baseline in whole brain volume at Month 12. Cortical grey and thalamic volume changes were also prospectively assessed versus active comparator. About Multiple Sclerosis Multiple sclerosis (MS) is a disabling, unpredictable disease in which the immune system attacks the protective myelin sheath that covers the nerves. The myelin damage disrupts communication between the brain and the rest of the body. Ultimately, the nerves themselves may deteriorate—a process that's currently irreversible. MS affects 700,000 people in Europe and approximately 2.5 million people worldwide. Relapsing forms of MS, including clinically isolated syndrome, relapsing remitting disease and active secondary progressive disease, is characterized by clearly defined attacks of worsening neurologic function. These attacks—often called relapses, flare-ups or exacerbations—are followed by partial or complete recovery periods. During these recovery periods, also called remissions, symptoms improve partially or completely with no apparent progression of disease. Since MS relapses are unpredictable, patients can feel frustrated, stressed, or scared when they occur. Relapsing forms of MS are the most common disease course at the time of diagnosis. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared with 10-15% with progressive forms of the disease. About Zeposia (ozanimod) Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which Zeposia exerts therapeutic effects in multiple sclerosis (MS) is unknown but may involve the reduction of lymphocyte migration into the central nervous system. The U.S. Food and Drug Administration approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis in March 2020 and adults with moderately to severely active UC in May 2021. The European Commission approved Zeposia for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease as defined by clinical or imaging features in May 2020 and for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent in November 2021. U.S. FDA APPROVED INDICATIONS ZEPOSIA® (ozanimod) is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Moderately to severely active ulcerative colitis (UC) in adults. IMPORTANT SAFETY INFORMATION Contraindications: Patients who in the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III/IV heart failure or have a presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker Patients with severe untreated sleep apnea Patients taking a monoamine oxidase (MAO) inhibitor Infections: ZEPOSIA may increase the susceptibility to infections. Life-threatening and rare fatal infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months or after discontinuation of prior MS or UC therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with an active infection until the infection is resolved. Consider interruption of treatment with ZEPOSIA if a patient develops a serious infection. Continue monitoring for infections up to 3 months after discontinuing ZEPOSIA. Herpes zoster was reported as an adverse reaction in ZEPOSIA-treated patients. Herpes simplex encephalitis and varicella zoster meningitis have been reported with sphingosine 1-phosphate (S1P) receptor modulators. Patients without a healthcare professional-confirmed history of varicella (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus (VZV), should be tested for antibodies to VZV before initiating ZEPOSIA. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with ZEPOSIA. Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another S1P receptor modulator. If CM is suspected, ZEPOSIA should be suspended until cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated. In the MS and UC clinical studies, patients who received ZEPOSIA were not to receive concomitant treatment with antineoplastic, non-corticosteroid immunosuppressive, or immune-modulating therapies used for treatment of MS and UC. Concomitant use of ZEPOSIA with any of these therapies would be expected to increase the risk of immunosuppression. When switching to ZEPOSIA from immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects. Use of live attenuated vaccines should be avoided during and for 3 months after treatment with ZEPOSIA. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA. Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability. PML has been reported in patients treated with S1P receptor modulators, including ZEPOSIA, and other MS and UC therapies and has been associated with some risk factors. If PML is suspected, withhold ZEPOSIA and perform an appropriate diagnostic evaluation. If confirmed, treatment with ZEPOSIA should be discontinued. Bradyarrhythmia and Atrioventricular Conduction Delays: Since initiation of ZEPOSIA may result in a transient decrease in heart rate and atrioventricular conduction delays, dose titration is recommended to help reduce cardiac effects. Initiation of ZEPOSIA without dose escalation may result in greater decreases in heart rate. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought for those individuals: with significant QT prolongation with arrhythmias requiring treatment with Class 1a or III anti-arrhythmic drugs with ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension with a history of Mobitz type II second-degree or higher AV block, sick sinus syndrome, or sino-atrial heart block Liver Injury: Elevations of aminotransferases may occur in patients receiving ZEPOSIA. Obtain liver function tests, if not recently available (i.e., within 6 months), before initiation of ZEPOSIA. Patients who develop symptoms suggestive of hepatic dysfunction should have hepatic enzymes checked and ZEPOSIA should be discontinued if significant liver injury is confirmed. Caution should be exercised when using ZEPOSIA in patients with history of significant liver disease. Fetal Risk: There are no adequate and well-controlled studies in pregnant women. Based on animal studies, ZEPOSIA may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during treatment and for 3 months after stopping ZEPOSIA. Women who become pregnant while taking ZEPOSIA for MS may enroll in the ZEPOSIA pregnancy registry by calling 1-877-301-9314 or visiting . Increased Blood Pressure: Increase in systolic pressure was observed after about 3 months of treatment and persisted throughout treatment. Blood pressure should be monitored during treatment and managed appropriately. Certain foods that may contain very high amounts of tyramine could cause severe hypertension in patients taking ZEPOSIA. Patients should be advised to avoid foods containing a very large amount of tyramine while taking ZEPOSIA. Respiratory Effects: ZEPOSIA may cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy, if clinically indicated. Macular Edema: S1P modulators have been associated with an increased risk of macular edema. Patients with a history of uveitis or diabetes mellitus are at increased risk. Patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation and regular follow-up examinations. An ophthalmic evaluation is recommended in all patients at any time if there is a change in vision. Continued use of ZEPOSIA in patients with macular edema has not been evaluated; potential benefits and risks for the individual patient should be considered if deciding whether ZEPOSIA should be discontinued. Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving a S1P receptor modulator. If a ZEPOSIA-treated patient develops unexpected neurological or psychiatric symptoms or any symptom/sign suggestive of an increase in intracranial pressure, a complete physical and neurological examination should be conducted. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, treatment with ZEPOSIA should be discontinued. Unintended Additive Immunosuppressive Effects From Prior Immunosuppressive or Immune-Modulating Drugs: When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation. Initiating treatment with ZEPOSIA after treatment with alemtuzumab is not recommended. Severe Increase in Multiple Sclerosis (MS) Disability After Stopping ZEPOSIA: In MS, severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ZEPOSIA treatment so patients should be monitored upon discontinuation. Immune System Effects After Stopping ZEPOSIA: After discontinuing ZEPOSIA, the median time for lymphocyte counts to return to the normal range was 30 days with approximately 90% of patients in the normal range within 3 months. Use of immunosuppressants within this period may lead to an additive effect on the immune system, therefore caution should be applied when initiating other drugs 4 weeks after the last dose of ZEPOSIA. Most Common Adverse Reactions that occurred in the MS clinical trials of ZEPOSIA-treated patients (≥ 4%): upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension. In the UC clinical trials, the most common adverse reactions that occurred in ≥4% of ZEPOSIA-treated patients and greater than in patients who received placebo were upper respiratory infection, liver test increased, and headache. Use in Specific Populations: Hepatic Impairment: Use is not recommended. For additional safety information, please see the full Prescribing Information and Medication Guide. Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and neurology. We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission – and perhaps even cures – in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most – the promise of living a better life. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that any marketing approvals, if granted, may have significant limitations on their use, and that such product candidate for the indication described in this release, may not be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2021, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news View source version on businesswire.com: Contacts Bristol Myers Squibb Media Inquiries: media@bms.com Investors: investor.relations@bms.com Source: Bristol Myers Squibb View this news release online at:

Final safety and efficacy results from the Phase 3 EVOLVE-MS-1 trial demonstrate decreases in disease activity and favorable tolerability for VUMERITY®(diroximel fumarate) consistent with previous assessments Patient-reported outcomes favored TYSABRI® (natalizumab) compared to Ocrevus® (ocrelizumab); new insights on subcutaneous administration one year after approval in Germany Data on interferon exposure during pregnancy showed that treatment with PLEGRIDY® (peginterferon beta-1a) or AVONEX® (interferon beta-1a) did not negatively impact child development CAMBRIDGE, Mass., Oct. 26, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced new data from its industry-leading portfolio of multiple sclerosis (MS) therapies being presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting October 26-28, 2022. The presentations include the final safety and efficacy results of the VUMERITY® (diroximel fumarate) EVOLVE-MS-1 study, as well as a matching analysis comparing treatment with VUMERITY to Ponvory® (ponesimod) and Aubagio® (teriflunomide); patient-reported outcomes and an analysis of the proprietary StratifyJCV™ assay for TYSABRI® (natalizumab); a study evaluating treatment with TECFIDERA® (dimethyl fumarate) to prevent first clinical manifestation of MS for people with radiologically isolated syndrome; and studies assessing the impact of PLEGRIDY® (peginterferon beta-1a) and AVONEX® (interferon beta-1a) on pregnancy, breastfeeding and child development. “Presentations at this year’s ECTRIMS meeting highlight Biogen’s commitment to pursuing research that has a meaningful impact on patients,” said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. “These new data provide patients and healthcare professionals with further insight on the safety and efficacy of Biogen’s robust MS portfolio to help inform treatment decisions throughout the lifelong MS journey, from the earliest phase of the disease to important milestones such as pregnancy.” Final Safety and Efficacy Results of VUMERITY EVOLVE-MS-1 Study Reported Presentations including data from EVOLVE-MS-1 and OPTIMUM clinical studies further support the safety and efficacy of VUMERITY: Final safety and efficacy results from EVOLVE-MS-1 demonstrate decreases in disease activity and favorable tolerability for VUMERITY in 1,057 patients over 96 weeks, in line with previous assessments. The reduction in annualized relapse rate (ARR) was 81.6%, the estimated proportion of patients who were relapse-free was 82.4%, and the estimated proportion with no evidence of disease activity (NEDA-3) was 41.1%. While 24.3% of patients discontinued treatment, discontinuation due to gastrointestinal adverse events (0.7%) and flushing (0.5%) were low. A matching-adjusted indirect comparison was done between VUMERITY (EVOLVE-MS-1) and Ponvory and Aubagio (OPTIMUM) clinical studies for ARR, 12-week confirmed disability progression (CDP), 24-week CDP, absence of gadolinium-enhancing (Gd+) T1 lesions and absence of new/enlarging T2 lesions. After weighting for cross-trial differences, VUMERITY was associated with a higher proportion of patients free of Gd+ T1 lesions and new/enlarging T2 lesions at the end of follow-up compared to Ponvory, with similar efficacy for ARR and 12- and 24-week CDP. VUMERITY had greater efficacy than Aubagio for all clinical and radiological outcome measures, except for 24-week CDP, in which there was similar efficacy. Studies Highlight Patient-Reported Outcomes for TYSABRI; Analysis Shows Impact of StratifyJCV Assay Two presentations highlight improvements in patient-reported outcomes following treatment with TYSABRI along with preference and satisfaction for the TYSABRI subcutaneous (SC) route of administration: The results of recent survey analysis, which included TYSABRI [n=52] and Ocrevus (ocrelizumab)-treated [n=92] relapsing-remitting multiple sclerosis (RRMS) patients aged 21 and older who had taken at least one prior disease modifying treatment (DMT), found more patients treated with TYSABRI versus Ocrevus reported improvements in disease activity (84.6% vs 59.8%), emotional symptoms (73.1% vs 35.9%), physical symptoms (69.2% vs 43.5%), cognitive symptoms (61.5% vs 32.6%) and social roles/activities (71.2% vs 35.9%). In addition, more patients treated with TYSABRI reported their DMT met or exceeded treatment expectations in comparison to those treated with Ocrevus (96.2% vs 72.8%). In the first interim analysis of 206 patients in the observational, prospective, multi-center SISTER study in Germany, the TYSABRI SC route of administration was preferred by individuals (89.6%; 163 patients) compared with intravenous administration; nearly all patients receiving SC treatment expressed satisfaction with their choice (98.7%; 156 patients) and the most frequent reasons for SC preference were shorter and more convenient administration. The TYSABRI SC administration is available in 26 countries and over 16,000 patients have been treated with SC therapy.1 “Given the recent introduction of natalizumab subcutaneous administration in Europe, these findings validate clinical study data with real-world insights,” said Prof. Ralf Gold, Ruhr-University Bochum, Bochum, Germany. “In our study, we found that nearly 90% of patients prefer subcutaneous administration given its shorter duration and convenience of dosing.” Separately, an analysis assessed utilization of Biogen’s StratifyJCV™ -- a proprietary antibody assay used to detect the presence of anti-JC virus (JCV) antibodies in serum and to quantify antibody index values, which are correlated to progressive multifocal leukoencephalopathy (PML) risk in patients treated with TYSABRI. More than 2 million StratifyJCV tests have been conducted worldwide. Aggregated data of the results of 845,498 StratifyJCV tests conducted from January 2015 to December 2021 showed a decrease in percentage of JCV-positive index results >1.5 in retests, from 15% in 2015 to 8% in 2021, demonstrating that healthcare professionals are using the assay to appropriately identify, monitor and manage patients on TYSABRI. Effect of TECFIDERA on Radiologically Isolated Syndrome Reported for the First Time Results of the Assessment of TECFIDERA in Radiologically Isolated Syndrome (ARISE) study, a placebo-controlled, multi-center, double-blinded clinical trial, will be presented in the late-breaking section. ARISE investigated the impact of therapeutic intervention in preventing the first clinical manifestation of MS for people with radiologically isolated syndrome (RIS). ARISE enrolled 87 patients who were randomized to TECFIDERA or placebo and treated for up to 96 weeks. Researchers found treatment with TECFIDERA resulted in an 82% risk reduction relative to placebo in the prevention of a first clinical event related to CNS demyelination. Impact of PLEGRIDYand AVONEXon Pregnancy, Breastfeeding and Child Development Two presentations assessed the impact of interferon exposure on pregnancy, breastfeeding and child development. Data from the PRIMA post-authorization safety study was consistent with results from previous studies showing that exposure to PLEGRIDY or AVONEX during pregnancy or lactation did not negatively impact child development or intrauterine growth. Further, a preliminary analysis of the German Multiple Sclerosis and Pregnancy Registry assessed child development in infants born to mothers with AVONEX or PLEGRIDY exposure during pregnancy, and treatment did not negatively impact children’s development. Title and Times of Data Presentations Featured at ECTRIMS: Natalizumab-Treated RRMS Patients with Prior DMT Use Report Better Outcomes, Treatment Satisfaction and Unique Benefits Than Similar Patients Treated with Ocrelizumab – EP0851 – October 26, 8 a.m. CET / 2 a.m. ET Disease Activity and Pregnancy Outcomes After Long-Term Exposure to Natalizumab During Pregnancy – 0039 – October 26, 2:56 p.m. CET / 8:56 a.m. ET SISTER – Subcutaneous: Non-Interventional, Observational, Prospective, German Multicentre, Open Label Study Over 12-Months for TYSABRI Patient Preference – Experience from Real-World – Preliminary Results of the 1st Interim Analysis – P365 – October 26, 8 a.m. CET / 2 a.m. ET Long-Term Effectiveness of Natalizumab for RRMS: Dutch and Global Interim Results from TYSABRI Observational Program – P373 – October 26, 8 a.m. CET / 2 a.m. ET Exploratory Magnetic Resonance Imaging Endpoints from NOVA: A Randomized Controlled Study of the Efficacy of 6-Week Dosing of Natalizumab vs Continued 4-Week Treatment for Multiple Sclerosis – P350 – October 26, 8 a.m. CET / 2 a.m. ET Interferon- or Peginterferon-Beta 1a Exposure During Pregnancy in Women with Multiple Sclerosis: Outcomes on Child Development – P075 – October 26, 8 a.m. CET / 2 a.m. ET and October 27, 1:05 p.m. CET / 7:05 a.m. ET StratifyJCV™ Serum Anti-JCV Antibody Assay for Natalizumab Patients: Unilabs Global Cohort Data Descriptive Analysis and Unilabs Customer Satisfaction Survey Results – P750 – October 26, 8 a.m. CET / 2 a.m. ET Matching-Adjusted Indirect Comparisons of Diroximel Fumarate, Ponesimod, and Teriflunomide for Relapsing Multiple Sclerosis – P708 – October 26, 8 a.m. CET / 2 a.m. ET Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Final Safety and Efficacy Results from the Phase 3 EVOLVE-MS-1 Study – P712 – October 26, 8 a.m. CET / 2 a.m. ET Interferon-Beta Exposure During Pregnancy and Breastfeeding: Impact on Birth Outcome and Child Development – Results from the Post-Authorisation Safety Study PRIMA – P478 – October 26, 8 a.m. CET / 2 a.m. ET Multi-Center, Randomized, Double-Blinded Assessment of Dimethyl Fumarate in Extending the Time to a First Clinical Demyelinating Event in Radiologically Isolated Syndrome (ARISE) – 0179 – October 28, 3:49 p.m. CET / 9:49 a.m. ET About VUMERITY® (diroximel fumarate) VUMERITY is an oral fumarate approved in the U.S. for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Once in the body, VUMERITY rapidly converts to monomethyl fumarate, the same active metabolite of dimethyl fumarate (TECFIDERA). VUMERITY is available in 15 countries, and more than 28,200 patients have been treated with it, representing more than 24,200 patient-years of exposure across clinical trial use and patients prescribed VUMERITY.2 VUMERITY is contraindicated in patients with a known hypersensitivity to diroximel fumarate, dimethyl fumarate or any of the excipients of VUMERITY and in patients taking dimethyl fumarate. VUMERITY can cause anaphylaxis and angioedema after the first dose or at any time during treatment. PML has occurred in patients with MS treated with dimethyl fumarate (which has the same active metabolite as VUMERITY). PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received dimethyl fumarate for four years while enrolled in a clinical trial. Serious cases of herpes zoster have occurred with dimethyl fumarate, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis. These events may occur at any time during treatment. Other serious opportunistic infections have occurred with dimethyl fumarate, including cases of serious viral (herpes simplex virus, West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis) infections. VUMERITY may decrease lymphocyte counts. In the MS placebo-controlled trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment with dimethyl fumarate and then remained stable. Four weeks after stopping dimethyl fumarate, mean lymphocyte counts increased but did not return to baseline. Clinically significant cases of liver injury have been reported in patients treated with dimethyl fumarate in the post-marketing setting. The onset has ranged from a few days to several months after initiation of treatment. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than five-fold the upper limit of normal and elevation of total bilirubin to greater than two-fold the upper limit of normal have been observed. VUMERITY may cause flushing (e.g., warmth, redness, itching, and/or burning sensation). Forty percent of patients taking dimethyl fumarate reported flushing, which was mostly mild to moderate in severity. Three percent of patients discontinued dimethyl fumarate for flushing and <1% had serious flushing events that led to hospitalization. The most common adverse events associated with dimethyl fumarate (incidence ≥10% and ≥2% more than placebo) were flushing, abdominal pain, diarrhea and nausea. A list of adverse events can be found in the full VUMERITY product labeling for each country where it is approved. Please click here for Important Safety Information and full Prescribing Information, including Patient Information for VUMERITY in the U.S., or visit your respective country’s product website. About TECFIDERA® (dimethyl fumarate) TECFIDERA is approved for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. TECFIDERA has been shown to reduce the rate of MS relapses, slow the progression of disability and impact the number of MS brain lesions, while demonstrating a well-characterized safety pro people with relapsing forms of MS. TECFIDERA is approved in 69 countries, and more than 580,500 patients have been treated with it, representing more than 1.2 million patient-years of exposure across clinical trial use and patients prescribed TECFIDERA.3 TECFIDERA is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. PML has occurred in patients with MS treated with TECFIDERA. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received TECFIDERA for four years while enrolled in a clinical trial. Serious cases of herpes zoster have occurred with TECFIDERA, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis. These events may occur at any time during treatment. Other serious opportunistic infections have occurred with TECFIDERA, including cases of serious viral (herpes simplex virus, West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis) infections. TECFIDERA may decrease lymphocyte counts. In the MS placebo-controlled trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment with TECFIDERA and then remained stable. Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but did not return to baseline. Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA in the post-marketing setting. The onset has ranged from a few days to several months after initiation of treatment. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than five-fold the upper limit of normal and elevation of total bilirubin to greater than two-fold the upper limit of normal have been observed. TECFIDERA may cause flushing (e.g. warmth, redness, itching, and/or burning sensation). Forty percent of patients taking TECFIDERA reported flushing, which was mostly mild to moderate in severity. Three percent of patients discontinued TECFIDERA for flushing and <1% had serious flushing events that led to hospitalization. The most common adverse events associated with TECFIDERA (incidence ≥10% and ≥2% more than placebo) were flushing, abdominal pain, diarrhea and nausea. A list of adverse events can be found in the full TECFIDERA product labeling for each country where it is approved. Please click here for Important Safety Information and full Prescribing Information, including Patient Information for TECFIDERA in the U.S., or visit your respective country’s product website. About TYSABRI® (natalizumab) TYSABRI is approved in the U.S. as monotherapy for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML). When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk. TYSABRI is approved in more than 80 countries, and over 248,000 people worldwide have been treated with TYSABRI, with more than 1 million patient-years of experience, based on clinical trials and prescription data.1 TYSABRI increases the risk of PML, a rare opportunistic viral infection of the brain which has been associated with death or severe disability. Risk factors that increase the risk of PML are the presence of anti-JC virus antibodies, prior immunosuppressant use and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI. Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive of PML. TYSABRI is contraindicated in patients who have or have had PML and in patients who have had a hypersensitivity reaction to TYSABRI. TYSABRI also increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses, and serious, life-threatening and sometimes fatal cases have been reported in the post-marketing setting in MS patients receiving TYSABRI. Clinically significant liver injury, including acute liver failure requiring transplant, has also been reported in the post-marketing setting. Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose; signs of liver injury have also been reported for the first time after multiple doses. Hypersensitivity reactions have occurred in patients receiving TYSABRI, including serious systemic reactions (e.g., anaphylaxis) which occurred at an incidence of <1%. The immune system effects of TYSABRI may increase the risk for infections. In Study MS1, certain types of infections—including pneumonias and urinary tract infections (including serious cases), gastroenteritis, vaginal infections, tooth infections, tonsillitis, and herpes infections—occurred more often in TYSABRI-treated patients than in placebo-treated patients. In clinical trials, TYSABRI was observed to induce increases in circulating lymphocytes, monocytes, eosinophils, basophils, and nucleated red blood cells. Observed changes persisted during TYSABRI exposure, but were reversible, returning to baseline levels usually within 16 weeks after the last dose. Cases of thrombocytopenia, including immune thrombocytopenic purpura, have been reported with the use of TYSABRI in the post-marketing setting. Cases of neonatal thrombocytopenia, at times associated with anemia, have been reported in newborns with in utero exposure to TYSABRI. The most common adverse reactions associated with TYSABRI (incidence ≥10% and ≥2% more than placebo) were headache, fatigue, infusion reactions, urinary tract infections, arthralgia, depression, pain in extremity, rash, gastroenteritis, and vaginitis. A list of adverse events can be found in the full TYSABRI product labeling for each country where it is approved. Please click here for Important Safety Information, including Boxed Warning, and full Prescribing Information, including Medication Guide for TYSABRI in the U.S., or visit your respective country’s product website. About PLEGRIDY® (peginterferon beta-1a) PLEGRIDY (peginterferon beta-1a) is indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. PLEGRIDY is currently approved in over 60 countries including the U.S., Canada, Australia and Switzerland and across the European Union. Over 81,000 people worldwide have been treated with PLEGRIDY, with over 170,000 patient-years of experience, based on prescription data.4 Biogen continues to work toward making PLEGRIDY available in additional countries across the globe. PLEGRIDY is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation. Rare cases of severe hepatic injury, including cases of hepatic failure have been reported in patients taking PLEGRIDY. Symptoms of depression, suicidal ideation or psychosis, and cases of suicide, have been reported with increased frequency with patients receiving PLEGRIDY. Serious allergic reactions are rare complications of interferon beta; anaphylaxis has been reported with use of PLEGRIDY. Injection site reactions, including injection site necrosis, can occur with the use of interferon beta, including PLEGRIDY; injection site abscesses and cellulitis have been reported in the post-marketing setting with use of PLEGRIDY. Some cases required treatment with hospitalization for surgical drainage and intravenous antibiotics. Cases of congestive heart failure, cardiomyopathy and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition. Decreased peripheral blood counts have been reported from post-marketing experience; monitor patients for infections, bleeding and anemia; monitor complete blood cell counts, differential white cell counts, and platelet counts. Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported several weeks to years after starting interferon beta products. Autoimmune disorders of multiple target organs including idiopathic thrombocytopenia, hyper- and hypothyroidism, and autoimmune hepatitis have been reported. Seizures have been reported in patients using PLEGRIDY. The most common adverse reactions in clinical trials of subcutaneous PLEGRIDY (incidence ≥10% and at least 2% more frequent on PLEGRIDY than on placebo) were injection site erythema, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia. A list of adverse events can be found in the full PLEGRIDY product labeling for each country where it is approved. Please click here for Important Safety Information and full Prescribing Information, including Medication Guide for PLEGRIDY in the U.S., or visit your respective country’s product website. About AVONEX® (interferon beta-1a) AVONEX is indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. AVONEX is approved in over 90 countries and over 625,000 people worldwide have been treated with AVONEX, with over 2.8 million patient-years of experience, based on prescription data.5 Avonex is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation. Symptoms of depression, suicidal ideation or psychosis, and cases of suicide, have been reported with increased frequency with patients receiving AVONEX. Rare cases of severe hepatic injury, including cases of hepatic failure have been reported in patients taking AVONEX. Anaphylaxis has been reported as a rare complication of AVONEX use; other allergic reactions have included dyspnea, orolingual edema, skin rash and urticaria. Injection site reactions, including injection site necrosis, can occur with the use of interferon beta, including AVONEX. Injection site abscesses and cellulitis and injection site necrosis have been reported in the post-marketing setting with use of AVONEX. Some cases required treatment with hospitalization for surgical drainage and intravenous antibiotics. Cases of congestive heart failure, cardiomyopathy and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition. Decreased peripheral blood counts have been reported from post-marketing experience. Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported several weeks to years after starting interferon beta products. Seizures have been temporally associated with the use of beta interferons in clinical trials and post-marketing safety surveillance. Post-marketing reports of autoimmune disorders of multiple target organs in AVONEX-treated patients including idiopathic thrombocytopenia, hyper- and hypothyroidism, and rare cases of autoimmune hepatitis. Routine periodic blood chemistry, hematology, liver function and thyroid function tests are recommended. The most commonly reported adverse reactions (at least 5% more frequent on AVONEX than on placebo) were flu-like symptoms. A list of adverse events can be found in the full AVONEX product labeling for each country where it is approved. Please click here for Important Safety Information and full Prescribing Information, including Medication Guide for AVONEX in the U.S., or visit your respective country’s product website. About Biogen As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and developed the first and only approved treatment to address a defining pathology of Alzheimer’s disease. Biogen is also commercializing biosimilars and focusing on advancing one of the industry’s most diversified pipelines in neuroscience that will transform the standard of care for patients in several areas of high unmet need. In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil fuels across the company’s operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities. We routinely post information that may be important to investors on our website at . Follow us on social media - Twitter, LinkedIn, Facebook, YouTube. Biogen Safe Harbor This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential benefits, safety and efficacy of TYSABRI and VUMERITY; the results of certain real-world data; clinical trials and data readouts and presentations; the identification and treatment of MS; our research and development program for the treatment of MS; and the potential of our commercial business, including TYSABRI and VUMERITY. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation the occurrence of adverse safety events and/or unexpected concerns that may arise from additional data or analysis; risks of unexpected costs or delays; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this news release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise. References: Combined post-marketing data based on prescriptions and clinical trials exposure to TYSABRI as of July 31, 2022. TYSABRI subcutaneous administration exposure as of September 30, 2022. Combined post-marketing data based on prescriptions and clinical trials exposure to VUMERITY as of June 30, 2022. Combined post-marketing data based on prescriptions and clinical trials exposure to TECFIDERA as of June 30, 2022. Post-marketing data based on PLEGRIDY prescriptions as of June 30, 2022. Post-marketing data based on AVONEX prescriptions as of June 30, 2022. MEDIA CONTACT: Allison Parks + 1 248 229 4461 public.affairs@biogen.com INVESTOR CONTACT: Mike Hencke +1 781 464 2442 IR@biogen.com