-Biogen Highlights at ECTRIMS 2018 Data on Its Industry-Leading Multiple
`Sclerosis Portfolio and a Range of Initiatives Aimed at Transforming Patient
`Care
`ENP Newswire
`October 4, 2018 Thursday
`
`Copyright 2018 Normans Media Limited All Rights Reserved
`
`Length: 1713 words
`Body
`
`CAMBRIDGE - At the 34th Congress of the European Committee for Treatment and Research in MS in Berlin,
`Germany (ECTRIMS; 10-12 October), Biogen Inc. (Nasdaq: BIIB) will present data in more than 70 oral and poster
`presentations on its industry-leading portfolio of multiple sclerosis (MS) products and innovative research efforts
`aimed at transforming the care of people living with the disease.
`
`Key updates at ECTRIMS include clinical data and real-world evidence that further support the long-term efficacy
`and well-characterized safety of Biogen's leading MS therapies, including data supporting the use of TECFIDERA
`(dimethyl fumarate) and TYSABRI (natalizumab) early within the disease course. Additional data highlight the
`potential utility of serum neurofilament light (sNfL) as a biomarker of MS disease activity. Biogen will also share
`updates on its efforts to improve monitoring of cognition and other key MS outcomes through MS PATHS (Multiple
`Sclerosis Partners Advancing Technology and Health Solutions).
`
`'Biogen believes the need for finding new approaches to treat MS is as important as ever,' said Michael Ehlers,
`executive vice president, research development at Biogen. 'The research we are presenting at ECTRIMS reflects
`our proven track record of developing innovative medicines for MS, and our commitment to the pursuit of new
`clinical approaches aimed at generating data that will encourage more individualized treatment decisions to help
`meet the needs of people living with MS today and into the future.'
`
`Data Further Support Efficacy and Safety of Biogen's Industry-Leading MS Portfolio
`
`TECFIDERA is the most prescribed oral MS medication in the world. Results from the ENDORSE study show that
`newly diagnosed patients treated with TECFIDERA experienced low annualized relapse rates and the majority of
`patients remained free from confirmed disability progression. Some of these patients have been treated for up to
`nine years. Similar benefits were seen in the ongoing real-world ESTEEM study that includes patients who are early
`in their MS disease course. New safety analyses found that among a majority of patients that experience
`lymphopenia during TECFIDERA treatment, meaningful lymphocyte reconstitution occurs after three months of
`treatment discontinuation, reinforcing the importance of absolute lymphocyte counts (ALC) monitoring as outlined in
`the product label.
`
`Page 1 of 4
`
`Biogen Exhibit 2009
`Mylan v. Biogen
`IPR2018-01403
`
`

`

`-Biogen Highlights at ECTRIMS 2018 Data on Its Industry-Leading Multiple Sclerosis Portfolio and a Range of
`Initiatives Aimed at Transforming Patient Care
`
`Updated data from the TYSABRI Observational Program (TOP), the largest ongoing, real-world study of TYSABRI-
`treated patients, underscore the established and consistent effectiveness of TYSABRI over 10 years, especially for
`those patients earlier in their disease course. Safety findings are consistent with the known and well-established
`safety profile of TYSABRI, and no new safety concerns were identified.
`
`Data presented at ECTRIMS reinforce the safety and efficacy profiles of PLEGRIDY (peginterferon beta-1a) and
`AVONEX (interferon beta-1a), two widely prescribed MS interferon beta treatments. The European Interferon Beta
`Pregnancy Registry and Nordic EPID MS Pregnancy Study demonstrated that exposure to interferon beta treatment
`(including PLEGRIDY and AVONEX) before conception and/or during pregnancy did not adversely affect pregnancy
`or infant outcomes. In a propensity score matching analysis of data from ADVANCE and CONFIRM, PLEGRIDY
`showed better clinical outcomes compared to glatiramer acetate. A newly diagnosed subgroup analysis of
`ADVANCE demonstrates PLEGRIDY lowered the risk of chronic black holes evolving from acute MRI lesions.
`
`Seeking New Ways to Monitor and Manage MS
`
`Biogen will also present research that further evaluates the potential of sNfL as a biomarker for MS disease activity
`and as a treatment monitoring tool. Researchers will discuss the current state, opportunity and paths to enable
`implementation of sNfL into MS clinical practice.
`
`New results will also be presented from MS PATHS evaluating cognitive changes and showing the impact of
`clinically meaningful benchmarks of disease progression on patients' daily lives. MS PATHS is a research
`collaboration with 10 leading MS centers in Europe and the U.S. that generates real-world evidence at the point of
`care to enable physicians to make personalized decisions with the aim of improving the lives of those living with
`MS.
`
`Highlights of Biogen's platform and poster presentations
`
`TECFIDERA
`
`Real-world Efficacy of Delayed-Release Dimethyl Fumarate in Early Multiple Sclerosis: Interim Results from
`ESTEEM - Poster P595 - Wednesday, 10 October, 17:00-19:00 CET
`
`Delayed-release Dimethyl Fumarate Demonstrates Sustained Efficacy over Nine Years in Newly Diagnosed
`Patients with Relapsing-Remitting Multiple Sclerosis - Poster P920 - Thursday, 11 October, 17:15-19:15 CET
`
`Among Real-world Multiple Sclerosis Patients That Experience Delayed-release Dimethyl Fumarate-associated
`Lymphopenia, Meaningful Lymphocyte Reconstitution Occurs Within 3 Months After Discontinuation of Delayed-
`release Dimethyl Fumarate - Poster P1201- Friday, 12 October, 12:15-14:15 CET
`
`Delayed-release Dimethyl Fumarate-associated Lymphopenia: On-treatment and Post-treatment Implications -
`Poster P929 - Thursday, 11 October, 17:15-19:15 CET
`
`TYSABRI
`
`Incidence of Natalizumab-associated Progressive Multifocal Leucoencephalopathy and its Relationship with the
`Pattern of Natalizumab Exposure Over Time - Poster P604 - Wednesday, 10 October, 17:00-19:00 CET
`
`Longitudinal Stability of Anti-JC Virus Antibody Index Over Two Years in Patients Treated with Natalizumab in the
`ASCEND Study - Poster P924 - Thursday, 11 October, 17:15-19:15 CET
`
`Page 2 of 4
`
`

`

`-Biogen Highlights at ECTRIMS 2018 Data on Its Industry-Leading Multiple Sclerosis Portfolio and a Range of
`Initiatives Aimed at Transforming Patient Care
`
`Real-world Data from Over 10 years in the TYSABRI Observational Program: Long-term Safety and Effectiveness
`of Natalizumab in Relapsing-remitting Multiple Sclerosis Patients - Poster P908 - Thursday, 11 October, 17:15-
`19:15 CET
`
`PLEGRIDY and AVONEX
`
`Pregnancy and Infant Outcomes with Interferon Beta: Data from the European Interferon Beta Pregnancy Registry
`and Population Based Registries in Finland and Sweden - Poster P1753 - Friday, 12 October, 12:15-14:15 CET
`
`Peginterferon Beta-1a Every 2 Weeks Demonstrated Better Clinical Outcomes Than Glatiramer Acetate Once-daily
`in Patients with RRMS: Propensity Score Matching of Phase 3 Data from ADVANCE and CONFIRM - ePoster
`EP1595
`
`Peginterferon Beta-1a Reduces the Number of Black Holes Evolved from Acute MRI Lesions in Newly Diagnosed
`Patients with Relapsing-remitting Multiple Sclerosis: A Post Hoc Analysis ADVANCE - Poster P1262 - Friday, 12
`October, 12:15-14:15 CET
`
`Advancements in MS Care
`
`Temporal Relationship of Serum Neurofilament Light Levels and Radiological Disease Activity in Patients with
`Multiple Sclerosis - Poster P532 - Wednesday, 10 October, 17:00-19:00 CET
`
`Prevalence of Isolated Cognitive Decline in a Large, Heterogeneous Multiple Sclerosis Population - Poster P517 -
`Wednesday, 10 October, 17:00-19:00 CET
`
`Serum Neurofilament Light (NfL) for Disease Prognosis and Treatment Monitoring in Multiple Sclerosis Patients: Is
`it Ready for Implementation into Clinical Care - Platform 5 - Thursday, 11 October, 11:16-11:28 CET
`
`Benchmarks of Manual Dexterity and Walking Speed in a Large, Representative Patient Population - Poster 1018 -
`Friday, 12 October, 12:15-14:15 CET
`
`About TECFIDERA
`
`TECFIDERA is an oral therapy for relapsing forms of MS, including relapsing-remitting MS, the most common form
`of MS. More than 340,000 patients have been treated with TECFIDERA worldwide with over 625,000 patient-years
`of experience, based on clinical trials and prescription data.1 TECFIDERA has been proven to reduce the rate of
`MS relapses, slow the progression of disability, and impact the number of MS brain lesions, while demonstrating a
`favorable benefit-risk profile in people with relapsing forms of MS, notably newly diagnosed and early switch
`populations. In clinical trials, the most common adverse events associated with TECFIDERA were flushing and
`gastrointestinal (GI) events. Other side effects include a decrease in mean lymphocyte counts during the first year
`of treatment, which then plateaued, and liver function abnormalities, which resolved upon treatment discontinuation.
`TECFIDERA is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the
`excipients of TECFIDERA. Rare cases of progressive multifocal leukoencephalopathy (PML), a rare opportunistic
`viral infection of the brain which has been associated with death or severe disability, have been seen with
`TECFIDERA patients in the setting of prolonged moderate to severe lymphopenia.
`
`The efficacy and safety of TECFIDERA have been studied in a large, global clinical program, which includes an
`ongoing long-term extension study.
`
`Page 3 of 4
`
`

`

`-Biogen Highlights at ECTRIMS 2018 Data on Its Industry-Leading Multiple Sclerosis Portfolio and a Range of
`Initiatives Aimed at Transforming Patient Care
`
`About TYSABRI
`
`TYSABRI is a disease modifying therapy (DMT) approved in more than 80 countries including the U.S., the
`European Union, Canada, Australia and Switzerland. In the U.S., TYSABRI is indicated as monotherapy for the
`treatment of patients with relapsing forms of MS. In the European Union, it is indicated as single DMT in adults with
`highly active relapsing-remitting MS (RRMS) for patients with highly active disease activity despite a full and
`adequate course of treatment with at least one DMT or patients with rapidly evolving severe RRMS. TYSABRI is
`proven effective, with over 10 years of experience in treating RRMS, and more than 190,800 people treated
`worldwide and over 658,169 patient-years of experience.2
`
`TYSABRI is a monoclonal antibody that selectively binds to 4-integrin and is thought to interrupt the activity of
`inflammatory cells in MS patients by blocking the interaction between 41-integrin and vascular cell adhesion
`molecule-1. Disruption of these molecular interactions prevents transmigration of leukocytes across the
`endothelium into inflamed parenchymal tissue. The specific mechanism(s) by which TYSABRI exerts its effects in
`MS have not been fully defined.
`
`TYSABRI has advanced the treatment of MS patients with its proven ability to slow the progression of disability,
`reduce relapse rates and impact the number of MRI brain lesions with a well-characterized safety profile. Data from
`the Phase 3 AFFIRM trial, which was published in the New England Journal of Medicine, showed that at two years,
`TYSABRI treatment led to a 68 percent relative reduction (p
`
`Load-Date: October 4, 2018
`
`End of Document
`
`Page 4 of 4
`
`