BIIB Biogen Inc.

265.11
-5.1  -2%
Previous Close 270.21
Open 269.38
52 Week Low 223.25
52 Week High 468.55
Market Cap $38,942,741,568
Shares 146,892,712
Float 130,147,069
Enterprise Value $44,310,144,900
Volume 468,203
Av. Daily Volume 995,252
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Upcoming Catalysts

Drug Stage Catalyst Date
Aducanumab - ENGAGE
Alzheimer’s disease
Phase 3
Phase 3
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Zuranolone (SAGE-217) - SKYLARK Study (PPD-301)
Postpartum depression (PPD)
Phase 3
Phase 3
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Zuranolone (SAGE-217) - WATERFALL Study (MDD-301B)
Major depressive disorder (MDD)
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
IONIS-MAPTRx (ISIS 814907; BIIB080)
Alzheimer's disease
Phase 1/2
Phase 1/2
Phase 1b trial of 1b/2 study met its primary objective of safety and tolerability. Phase 2 trial planned.
Natalizumab - NOVA
Multiple sclerosis (MS)
Phase 3
Phase 3
Phase 3b data displayed that the proportion of patients with No Evidence of Disease Activity (NEDA) was 70.0 percent for Q6W and 67.4 percent for Q4W. The proportion of patients free of disability worsening was 90.0 percent in the Q6W arm and 92.0 percent in the Q4W arm. Time to first relapse with the proportion who were relapse-free at 72 weeks at 96.9 percent for Q6W and 97.6 percent for Q4W, noted October 13, 2021
SPINRAZA (Nusinersen) - ASCEND
Spinal muscular atrophy (SMA)
Phase 3
Phase 3
Phase 3b trial to be initiated in 2021.
SPINRAZA (Nusinersen) - DEVOTE
Spinal muscular atrophy (SMA)
Phase 2/3
Phase 2/3
Phase 2/3 commencement of dosing announced April 2, 2020.
BAN2401 (lecanemab)
Alzheimer’s disease
BLA Filing
BLA Filing
BLA rolling submission initiated September 28, 2021.
BAT1806 - biosimilar
Rheumatoid arthritis (RA)
Phase 3
Phase 3
Phase 3 trial met primary endpoint - June 1, 2021.
BIIB093
Large hemispheric infarction
Phase 3
Phase 3
Phase 3 trial ongoing.
BIIB104
Cognitive Impairment Associated With Schizophrenia (CIAS)
Phase 2b
Phase 2b
Phase 2b trial ongoing.
BIIB131 (TMS-007)
Acute ischemic stroke
Phase 2
Phase 2
Phase 2 trial met primary objective - May 12, 2021.
BIIB112 - Xirius
X-linked Retinitis Pigmentosa
Phase 2/3
Phase 2/3
Phase 2/3 trial did not meet its primary endpoint - May 14, 2021. Phase 2/3 trial discontinued noted October 20, 2021.
BIIB111 (STAR)
Choroideremia
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - June 14, 2021.
BIIB059 (TOPAZ-1)
Lupus
Phase 3
Phase 3
Phase 3 commencement of dosing announced June 17, 2021.
Vixotrigine (BIIB074) - CONVEY
Small Fiber Neuropathy
Phase 2
Phase 2
Phase 2 200mg dosing data met primary endpoint, did not meet statistical significance for secondary endpoints. Phase 2 330 mg dosing data did not meet the primary endpoint or secondary endpoints, September 16, 2021.
Tofersen (VALOR study)
Amyotrophic lateral sclerosis (ALS)
Phase 3
Phase 3
Phase 3 top-line data stated that trial did not meet primary endpoint. In an open-label extension study it showed a decreased decline across multiple measures of motor function, respiratory function, muscle strength, and quality of life, noted October 17, 2021.
BYOOVIZ
Biosimilar (ranibizumab)
Approved
Approved
Approved September 20, 2021.
Natalizumab - OPUS
Epilepsy
Phase 2
Phase 2
Phase 2 primary endpoint not met - noted April 2020.
Gosuranemab (BIIB092)
Alzheimer’s disease
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint - June 16, 2021.
ADUHELM (Aducanumab)
Alzheimer’s disease
Approved
Approved
FDA approval announced June 7, 2021.
VUMERITY (Diroximel fumarate)
Multiple sclerosis (MS)
Approved
Approved
FDA Approval announced October 30, 2019.
BIIB054
Parkinson's disease
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint - February 3, 2021.
Elenbecestat (E2609) - (MissionAD1)
Alzheimer’s disease
Phase 3
Phase 3
Phase 3 trial discontinued due to unfavorable risk-benefit ratio.
Elenbecestat (E2609) - (MissionAD2)
Alzheimer’s disease
Phase 3
Phase 3
Phase 3 trial discontinued due to unfavorable risk-benefit ratio.
Opicinumab (AFFINITY)
Multiple sclerosis (MS)
Phase 2b
Phase 2b
Phase 2b trial did not meet primary endpoint.
BG00011 (STX-100)
Idiopathic pulmonary fibrosis (IPF)
Phase 2b
Phase 2b
Phase 2b trial discontinued August 2019 due to safety concerns.
Dapirolizumab pegol (anti-CD40L)
Lupus
Phase 2b
Phase 2b
Phase 2b data released October 23, 2018 - primary endpoint not met.
Raxatrigine - BIIB074 (Nav1.7 inhibitor)
Painful Lumbosacral Radiculopathy (PLSR)
Phase 2
Phase 2
Phase 2 data released September 2018 - primary endpoint not met.
Natalizumab (α4-integrin inhibitor)
Acute ischemic stroke
Phase 2b
Phase 2b
Phase 2b data released February 8, 2018 - primary endpoint not met.

Latest News

  1. Following the pre-NDA meeting, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD

    The planned initial submission package will be for the treatment of MDD with an anticipated PPD filing thereafter

    Sage Therapeutics, Inc. (NASDAQ:SAGE) and Biogen Inc. (NASDAQ:BIIB) today announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of major depressive disorder (MDD) and an additional filing for postpartum depression (PPD…

    Following the pre-NDA meeting, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD

    The planned initial submission package will be for the treatment of MDD with an anticipated PPD filing thereafter

    Sage Therapeutics, Inc. (NASDAQ:SAGE) and Biogen Inc. (NASDAQ:BIIB) today announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of major depressive disorder (MDD) and an additional filing for postpartum depression (PPD) is anticipated in the first half of 2023. The decision to submit the application follows recent discussions with the FDA, including a pre-NDA meeting held this fall. Data from completed studies in the LANDSCAPE and NEST programs, as well as data from the ongoing clinical and pharmacology studies, are planned to be included as part of the submission packages.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211019005298/en/

    "In the pre-NDA meeting, the FDA's response on the regulatory pathway for zuranolone continued to be consistent with previous discussions. In the clinical development programs, zuranolone has shown remarkably consistent, rapid, and sustained reductions in depressive symptoms, including anxiety and sleep loss, in addition to a well-tolerated safety profile. We believe we have a solid filing package with four adequate and well controlled trials now in hand and, if approved, zuranolone will fill a real unmet need and be welcomed by people living with depression," said Barry Greene, Chief Executive Officer at Sage Therapeutics. "We have identified what we believe is the most efficient path forward for an FDA filing and potential approval."

    Sage and Biogen also announced the CORAL Study is fully enrolled and closed to further screening, with topline data expected in early 2022. The CORAL Study is designed to demonstrate a rapid onset of depression relief when zuranolone is co-initiated with a standard antidepressant therapy.

    "We are pleased to share what we believe is an efficient filing pathway for zuranolone, with the goal of bringing a new treatment option to the millions of people who suffer from depression worldwide," said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. "The efficacy and safety data planned for FDA submission support our vision of zuranolone being an as-needed, two-week, once-daily treatment option for MDD and PPD that produces rapid relief from symptoms within days."

    Sage and Biogen plan to submit a separate and distinct filing for PPD once the ongoing PPD 301-SKYLARK Study completes so as not to affect the MDD review timeline. The companies plan to commence marketing for the approved indications as soon as possible pending the FDA's approval. The review cycles may allow commercialization of both indications simultaneously, if approved.

    About Major Depressive Disorder (MDD)

    Major depressive disorder (MDD) is a common but serious mood disorder in which people experience depressive symptoms that impair their social, occupational, educational, or other important functioning, such as a depressed mood or loss of interest or pleasure in daily activities, consistently for at least a two-week period. It is estimated that approximately 19 million people in the U.S. and more than 250 million people worldwide suffer from MDD each year. While antidepressants are widely used to treat MDD, large-scale studies have demonstrated the need for additional therapies with a differentiated profile.

    About Postpartum Depression (PPD)

    Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy. PPD can have a serious negative impact on a woman, including significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. PPD is estimated to affect approximately one in eight women who have given birth in the U.S. or approximately over 500,000 women annually.

    About Zuranolone

    Zuranolone (SAGE-217/BIIB125) is a once-daily, two-week, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. Zuranolone has been granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration.

    Zuranolone is being evaluated in the NEST and LANDSCAPE clinical trial programs. The two development programs include multiple studies examining use of zuranolone in several thousand patients with a variety of dosing, clinical endpoints, and treatment paradigms. The LANDSCAPE program includes five studies of zuranolone in patients with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL Studies). The NEST program includes two placebo-controlled studies of zuranolone in patients with PPD (ROBIN and SKYLARK Studies). Additionally, Shionogi recently completed a Phase 2 study of zuranolone in Japan.

    About Sage Therapeutics

    Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain. We are pursuing new pathways with the goal of improving brain health, and our depression, neurology and neuropsychiatry franchise programs aim to change how brain disorders are thought about and treated. Our mission is to make medicines that matter so people can get better, sooner. For more information, please visit www.sagerx.com.

    About Biogen

    At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative 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, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer's disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

    We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Twitter, LinkedIn, Facebook, YouTube.

    Forward-Looking Statements

    Sage Therapeutics Safe Harbor

    Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation statements regarding: plans for an NDA filing for zuranolone in MDD and PPD, and the potential timing of such submissions; our belief in the adequacy of the data we plan to submit in the NDA; the potential for FDA acceptance of an NDA for zuranolone; the potential for regulatory approval and commencement of commercialization of zuranolone and our goals as to timing; our planned timing for reporting of data from ongoing clinical trials; the potential profile and benefit of zuranolone in MDD and PPD; our belief in the regulatory filing pathways and opportunities for zuranolone; other planned next steps for the program; our estimates as to the number of patients with MDD and PPD; and other statements regarding the goals, opportunity and potential for zuranolone and for our business. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: we may experience delays or unexpected hurdles in our efforts to submit an NDA for zuranolone and we may not be able to submit the NDA on the timelines we expect or at all; the FDA may find inadequacies and deficiencies in our NDA for zuranolone, including in the data we submit, and may decide not to accept the NDA for filing; even if the FDA accepts the NDA for filing, the FDA may not meet expected review timelines and may ultimately decide not to approve zuranolone in MDD or PPD; the FDA may decide that the design, conduct or results of our completed and ongoing clinical trials for zuranolone, even if positive, are not sufficient for approval in MDD or PPD and may require additional trials or data which may significantly delay and put at risk our efforts to obtain approval and may not be successful; other decisions or actions of the FDA or other regulatory agencies may affect the zuranolone program and our plans, progress or results; we may experience negative results in ongoing or future studies of zuranolone that negatively affect our ability to obtain approval of zuranolone or that impair the potential profile of zuranolone; success in earlier clinical trials may not be repeated or observed in ongoing or future studies, and ongoing and future clinical trials may not meet their primary or key secondary endpoints or generate results sufficient to gain regulatory approval to market zuranolone without further development work; unexpected concerns may arise from additional data, analysis or results from any of our completed studies; we may encounter adverse results or adverse events at any stage of development that negatively impact further development or that require additional nonclinical and clinical work which may not yield positive results; we may encounter delays in conduct of our clinical trials, including slower than expected site initiation or enrollment, that may impact our ability to meet our expected time-lines; the actual size of the MDD and PPD patient populations may be significantly lower than our estimates and, even if zuranolone is approved, it may only be approved or used to treat a subset of the relevant patient populations; we may encounter technical and other unexpected hurdles in the development and manufacture of zuranolone or our other product candidates which may delay our timing or change our plans; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

    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 zuranolone; the potential clinical effects of zuranolone; the clinical development program for zuranolone; clinical development programs, clinical trials and data readouts and presentations for zuranolone; the potential treatment of MDD and PPD; the potential of Biogen's commercial business and pipeline programs, including zuranolone; the anticipated benefits and potential of Biogen's collaboration arrangement with Sage; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "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. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. 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, uncertainty of success in the development and potential commercialization of zuranolone; unexpected concerns may arise from additional data, analysis or results of clinical studies of zuranolone; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including zuranolone; the occurrence of adverse safety events; the risks of other unexpected hurdles, costs or delays; failure to protect and enforce 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 Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

    View Full Article Hide Full Article
    • In the Phase 3 VALOR study, the primary endpoint as measured by the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) did not reach statistical significance; however, signs of reduced disease progression across multiple secondary and exploratory endpoints were observed
    • The totality of evidence from VALOR and its ongoing open-label extension showed that participants who started tofersen earlier experienced better outcomes, further suggesting a positive clinical effect
    • Topline data being presented today at the American Neurological Association 2021 Annual Meeting
    • Given the high unmet medical need, Biogen will expand its ongoing early access program (EAP) to the broader SOD1-ALS population

    A Media Snippet accompanying this

    • In the Phase 3 VALOR study, the primary endpoint as measured by the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) did not reach statistical significance; however, signs of reduced disease progression across multiple secondary and exploratory endpoints were observed
    • The totality of evidence from VALOR and its ongoing open-label extension showed that participants who started tofersen earlier experienced better outcomes, further suggesting a positive clinical effect
    • Topline data being presented today at the American Neurological Association 2021 Annual Meeting
    • Given the high unmet medical need, Biogen will expand its ongoing early access program (EAP) to the broader SOD1-ALS population

    A Media Snippet accompanying this announcement is available by clicking on the image or link below:

    CAMBRIDGE, Mass., Oct. 17, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) today announced topline results from its pivotal Phase 3 VALOR study of tofersen (BIIB067), an investigational antisense drug being evaluated for people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). While tofersen did not meet the primary endpoint of change from baseline to week 28 in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), trends favoring tofersen were seen across multiple secondary and exploratory measures of biologic activity and clinical function.

    In addition, a pre-specified integration of data from VALOR and its ongoing open-label extension study (OLE) reinforced these findings and showed that early tofersen initiation led to less decline across multiple measures of motor function, respiratory function, muscle strength, and quality of life in people with SOD1-ALS. Most adverse events in both VALOR and OLE were mild to moderate in severity, including procedural pain, headache, pain in extremity, fall and back pain.

    Biogen is actively engaging with regulators, the medical community, patient advocacy groups and other key stakeholders around the world to determine potential next steps.

    "The results from the VALOR study are encouraging as they show reduction of SOD1 protein, reduction of neurofilament, a potential biomarker for neurodegenerative disease, and positive signals across multiple key endpoints including measures of important aspects of the daily lives of SOD1-ALS patients," said Timothy Miller, M.D., Ph.D., principal investigator of VALOR and ALS Center Director at Washington University School of Medicine, St. Louis. "The wait for new options has been long and difficult for the ALS community, and we welcome this important research advancement in this difficult to treat disease space."

    "Data from the tofersen Phase 3 study and its open-label extension showed signs of slowing disease progression in people with SOD1-ALS, a rare, devastating disease that leads to loss of everyday functions and ultimately death," said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. "Following discussions with investigators, bioethicists, and having listened to the voice of patient advocacy groups, we will broaden early access to tofersen to all eligible SOD1-ALS patients through our already established expanded access program. We are grateful for the courageous efforts of patients, families, advocates, and the scientific community who have contributed to this important research."

    ALS is a progressive neurodegenerative disease that is uniformly fatal with an average survival of three to five years. The most common cause of death is respiratory failure. SOD1-ALS is a rare, genetic form of ALS that accounts for approximately two percent of the estimated 168,000 people who have the disease globally. Currently, there are no genetically targeted treatment options for ALS.

    Click here for a fact sheet to learn more about genetic amyotrophic lateral sclerosis (ALS):

    http://ml.globenewswire.com/Resource/Download/ae9c9142-ae2a-4d95-8f6f-0b5cf6e80963

    In light of the critical unmet need, Biogen will expand eligibility for its ongoing early access program (EAP) to all people with SOD1-ALS, in countries where such programs are permitted by local regulations and future access may be secured. EAP programs enable patients to gain access to a medicine free of charge before the treatment is licensed commercially. If a clear path forward for tofersen is not established, or if another controlled trial is required by regulators, Biogen may revise or discontinue the EAP.

    The VALOR and Open-Label Extension Studies

    VALOR was a 28-week Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability, pharmacodynamic, and biomarker effects of tofersen 100 mg in adults with ALS associated with a SOD1 mutation. In total, 108 participants were randomized in VALOR (n=72 to tofersen 100 mg and n=36 to placebo). Sixty of these participants met the study's protocol-defined enrichment criteria for rapid disease progression, comprising the primary analysis population ("faster progressing"). Forty-eight participants did not meet these prognostic enrichment criteria ("slower progressing").

    The open-label extension study is an ongoing Phase 3 study for participants who completed VALOR. Of the 108 participants in VALOR, 95 enrolled in the OLE.

    Topline Results

    In VALOR the primary efficacy endpoint of change from baseline to week 28 in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score in the primary analysis (faster-progressing) population did not reach statistical significance as measured by a joint-rank analysis (difference of 1.2; p=0.97).   

    Trends favoring tofersen were seen across multiple secondary and exploratory measures of biologic activity and clinical function, including motor function, respiratory function, and quality of life. On the first key secondary endpoint of change from baseline in total CSF SOD1 protein, a marker of target engagement, differences were observed between the tofersen and placebo groups of 38% and 26% in the faster- and slower-progressing populations, respectively. On the second key secondary endpoint of change from baseline in plasma neurofilament light chain (NfL), a potential marker of neuronal degeneration, differences were observed between the tofersen and placebo groups of 67% and 48% in the faster- and slower-progressing populations, respectively.  

    In the faster-progressing population, trends favored tofersen on measures of respiratory function (Slow Vital Capacity (SVC); difference of 7.9 percent-predicted) and muscle strength (Hand-held dynamometer (HHD); difference of 0.02). Similar trends were observed across multiple exploratory patient-reported outcome measures of disease severity, quality of life, and fatigue. Median time to event could not be estimated for survival analyses due to the low number of events over the 28-week period.

    In addition, with longer-term follow up in the OLE, earlier tofersen initiation consistently led to a reduction in decline in measures of clinical function across the population.

    The most common adverse events (AEs) in participants receiving tofersen in the VALOR study were procedural pain, headache, pain in extremity, fall and back pain. Most AEs in both VALOR and the OLE were mild to moderate in severity. In VALOR, serious AEs were reported in 18.1% of participants receiving tofersen and 13.9% of those receiving placebo. In the tofersen group, 5.6% of participants discontinued treatment due to an AE. There were no discontinuations due to AEs in the placebo group. Serious neurologic events were reported in 4.8% of patients receiving tofersen in VALOR and its OLE, including 2 cases of myelitis (2.0%). There was one death reported in the tofersen-treated group in VALOR, which was determined not to be related to tofersen.

    American Neurological Association (ANA) Annual Meeting Presentation Details

    Results from VALOR and the OLE are being presented at the ANA Annual Meeting.

    Sunday, October 17, 2021, 4:20 p.m. ET – Results from the Phase 3 VALOR study and its open-label extension: evaluating the clinical efficacy and safety of tofersen in adults with ALS and confirmed SOD1 mutation, presented by Timothy Miller, M.D., Ph.D., principal investigator of VALOR and ALS Center Director at Washington University School of Medicine, St. Louis.

    To access the presentation, please go to the Investors section of Biogen's website at investors.biogen.com. Following the event, an archived version will be available on the website.

    Biogen's Commitment to ALS

    For over a decade, Biogen has been committed to advancing ALS research to provide a deeper understanding of the disease. The company has continued to invest in and pioneer research despite making the difficult decision to discontinue a late-stage ALS asset in 2013. Biogen has applied important learnings to its broad portfolio of assets for genetic and other forms of ALS, with the goal of increasing the probability of bringing a potential therapy to patients in need. These applied learnings include evaluating genetically validated targets in defined patient populations, pursuing the most appropriate modality for each target and employing sensitive clinical endpoints. Today, the company has a broad pipeline of investigational drugs being evaluated in ALS.

    About Tofersen

    Tofersen is an antisense drug being evaluated for the potential treatment of SOD1-ALS. Tofersen binds to SOD1 mRNA, allowing for its degradation by RNase-H in an effort to reduce synthesis of SOD1 protein production. Tofersen is also being studied in the Phase 3 ATLAS study, which is designed to evaluate the ability of tofersen to delay clinical onset when initiated in presymptomatic individuals with a SOD1 genetic mutation and biomarker evidence of disease activity. Biogen licensed tofersen from Ionis Pharmaceuticals, Inc. under a collaborative development and license agreement.

    About the Phase 3 VALOR Study (NCT02623699)

    VALOR was a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability and pharmacodynamic effects of tofersen 100 mg in adults with ALS and a confirmed SOD1 mutation. Subjects were randomized to receive tofersen or placebo. In total, 108 participants were randomized in VALOR (n=72 to tofersen 100 mg and n=36 to placebo). Sixty of these participants met the study's prognostic enrichment criteria for rapid disease progression based on SOD1 mutation type and pre-randomization ALSFRS-R slope decline and comprised the primary analysis population ("faster-progressing population"). Forty-eight participants did not meet these prognostic enrichment criteria ("slower-progressing population"). For more information about the Phase 3 VALOR study, visit www.clinicaltrials.gov.

    About Amyotrophic Lateral Sclerosis and SOD1-ALS

    Amyotrophic lateral sclerosis (ALS) is a rare, progressive and fatal neurodegenerative disease that results in the loss of motor neurons in the brain and the spinal cord that are responsible for controlling voluntary muscle movement. People with ALS experience muscle weakness and atrophy, causing them to lose independence as they steadily lose the ability to move, speak, eat, and eventually breathe. Life expectancy for people with ALS is 3-5 years from time of symptom onset. Multiple genes have been implicated in ALS. Mutations in the SOD1 gene are responsible for approximately two percent of all ALS cases (SOD1-ALS). SOD1-ALS can occur in patients with or without a family history of ALS. Genetic testing may help determine if a person's ALS is associated with a genetic mutation, even in individuals without a family history of the disease.

    About Biogen

    At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative 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, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer's disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

    We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media Twitter, LinkedIn, Facebook, YouTube.

    Biogen Safe Harbor Statement

    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, including statements about results from the Phase 3 VALOR study of tofersen; the potential clinical effects of tofersen; the potential benefits, safety and efficacy of tofersen; the clinical development program for tofersen; the identification and treatment of ALS; our research and development program for the treatment of ALS; the potential of our commercial business and pipeline programs, including tofersen; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "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. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. 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, uncertainty of success in the development and potential commercialization of tofersen; the risk that we may not fully enroll our clinical trials or enrollment will take longer than expected; unexpected concerns may arise from additional data, analysis or results obtained during our clinical trials; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of our drug candidates, including tofersen; the occurrence of adverse safety events; the risks of unexpected hurdles, 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; 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.

    MEDIA CONTACT:



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  2. CAMBRIDGE, Mass., Oct. 14, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) today announced topline results from its pivotal Phase 3 VALOR study of tofersen (BIIB067), an investigational antisense oligonucleotide (ASO) drug being evaluated for people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), will be presented at the upcoming American Neurological Association (ANA) 2021 virtual meeting, October 17-19, 2021.

    ANA Presentation Details:
    Sunday, October 17, 2021, 4:20 p.m. ET – Results from the Phase 3 VALOR study and its open-label extension: evaluating the clinical efficacy and safety of tofersen in adults with ALS and confirmed SOD1 mutation, presented by Timothy Miller, M.D., Ph.D., principal investigator of VALOR…

    CAMBRIDGE, Mass., Oct. 14, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) today announced topline results from its pivotal Phase 3 VALOR study of tofersen (BIIB067), an investigational antisense oligonucleotide (ASO) drug being evaluated for people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), will be presented at the upcoming American Neurological Association (ANA) 2021 virtual meeting, October 17-19, 2021.

    ANA Presentation Details:

    Sunday, October 17, 2021, 4:20 p.m. ET – Results from the Phase 3 VALOR study and its open-label extension: evaluating the clinical efficacy and safety of tofersen in adults with ALS and confirmed SOD1 mutation, presented by Timothy Miller, M.D., Ph.D., principal investigator of VALOR and ALS Center Director at Washington University School of Medicine, St. Louis.

    To access the presentation, please go to the Investors section of Biogen's website at investors.biogen.com. Following the event, an archived version will be available on the website.

    About Tofersen

    Tofersen is an antisense asset being evaluated for the potential treatment of SOD1-ALS. Tofersen binds to SOD1 mRNA, allowing for its degradation by RNase-H in an effort to reduce synthesis of SOD1 protein production. Biogen licensed tofersen from Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) under a collaborative development and license agreement.

    About Biogen

    At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative 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, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer's disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, immunology, neurocognitive disorders, acute neurology and pain.

    We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

    MEDIA CONTACT:

    Ashleigh Koss

    + 1 908 205 2572

    public.affairs@biogen.com



    INVESTOR CONTACT:

    Mike Hencke

    +1 781 464 2442

    IR@biogen.com   



     



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    • Full analysis of Phase 3b NOVA study provides insights on efficacy of every six-week dosing with natalizumab as compared to the approved every four-week dosing
    • Real-world analysis shows significantly lower risk of relapse for patients treated with TYSABRI® compared to Ocrevus® (ocrelizumab)
    • New data from EVOLVE-MS-2 demonstrate that a favorable gastrointestinal (GI) tolerability profile for VUMERITY® (diroximel fumarate) is achieved and maintained with dose titration

    CAMBRIDGE, Mass., Oct. 13, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) today announced new data from its industry-leading portfolio of multiple sclerosis (MS) therapies. These data include additional results from the NOVA study on the efficacy of every six-week…

    • Full analysis of Phase 3b NOVA study provides insights on efficacy of every six-week dosing with natalizumab as compared to the approved every four-week dosing
    • Real-world analysis shows significantly lower risk of relapse for patients treated with TYSABRI® compared to Ocrevus® (ocrelizumab)
    • New data from EVOLVE-MS-2 demonstrate that a favorable gastrointestinal (GI) tolerability profile for VUMERITY® (diroximel fumarate) is achieved and maintained with dose titration

    CAMBRIDGE, Mass., Oct. 13, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) today announced new data from its industry-leading portfolio of multiple sclerosis (MS) therapies. These data include additional results from the NOVA study on the efficacy of every six-week (Q6W) 300mg natalizumab intravenous (IV) administration, results from a comparative real-world evaluation of TYSABRI® (natalizumab) when compared to Ocrevus®(ocrelizumab), as well as outcomes on GI tolerability, persistence and adherence for VUMERITY® (diroximel fumarate). The studies are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

    "Our focus on improving the MS patient experience continues to shape research initiatives across Biogen's MS portfolio, as demonstrated by presentations at this year's ECTRIMS meeting," said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. "These new data build upon the existing body of real-world safety and efficacy evidence for extended interval dosing with natalizumab1,2,3 and highlight outcomes that are important to patients, including a reduced risk of relapse with TYSABRI and new data on the ability for patients to achieve and maintain an improved gastrointestinal tolerability profile with VUMERITY."

    Additional Secondary Endpoints and Exploratory Outcomes from Full NOVA Study Include Evaluation of NEDA and EDSS With Q6W Natalizumab

    New late-breaking data from the Phase 3b NOVA study provide additional insights into the efficacy of every six-week (Q6W) 300mg natalizumab IV administration compared to the approved every four-week (Q4W) dose of TYSABRI (n=499) for relapsing-remitting multiple sclerosis. Topline results from the NOVA study were released in August 2021, showing that every six-week administration provides a high level of efficacy in controlling MS disease activity in patients who switched to Q6W after at least one year of disease stability on the approved Q4W IV dosing schedule. New results of exploratory outcomes and additional secondary endpoints presented at ECTRIMS demonstrate that efficacy is maintained on a Q6W schedule:

    • Time to first relapse was similar between the two dosing schedules with the proportion who were relapse-free at 72 weeks at 96.9 percent for Q6W and 97.6 percent for Q4W.
    • The proportion of patients free of disability worsening was 90.0 percent in the Q6W arm and 92.0 percent in the Q4W arm.
    • Disease activity rates were similar between both groups. The proportion of patients with No Evidence of Disease Activity (NEDA) was 70.0 percent for Q6W and 67.4 percent for Q4W. NEDA was defined as no gadolinium enhancing (Gd+) lesions, no new or newly enlarging T2 hyperintense lesions, no relapse and no 24-week confirmed disability worsening (CDW) at 72 weeks. Patients with one or more missing assessments were counted as having not achieved NEDA.
    • The safety findings in the NOVA study were consistent with the known safety profile of IV natalizumab, and the incidence of AEs and SAEs were similar between the two treatment arms. One patient with asymptomatic progressive multifocal leukoencephalopathy (PML) in the Q6W arm was high-risk based on the known risk factors, underscoring the importance of the need for continued PML monitoring and risk factor considerations in patients treated with natalizumab. 

    "Upon complete evaluation of the NOVA data, the results inclusive of secondary and exploratory outcomes offer a more comprehensive understanding of the six-week dosing regimen of natalizumab and its ability to provide a high level of efficacy in controlling MS disease activity," said John Foley, M.D., Rocky Mountain MS Clinic. "Combined with the improvement in safety demonstrated through analyses of data from the TOUCH Prescribing Program, which has shown that a six-week dosing schedule is associated with an 88 percent reduction in the risk of PML4, these data on the efficacy of every six-week dosing offer valuable information for clinicians."

    The NOVA study was designed to assess the efficacy of Q6W dosing with natalizumab IV administration following analyses from the TOUCH (TYSABRI Outreach: Unified Commitment to Health) Prescribing Program, which showed that extended interval dosing was associated with a significant reduction in the probability of PML.4 Natalizumab is available commercially under the brand name TYSABRI and the only approved dose is 300mg on a Q4W regimen.

    A Real-world Analysis Reports Lower Relapse Risk With TYSABRI Than Ocrevus

    A new analysis of relapse-related outcomes and healthcare utilization for MS patients being treated with disease-modifying therapies (DMTs) found that those treated with TYSABRI (n=835) had a lower risk of relapse than those treated with Ocrevus (n=3,497). The retrospective analysis of data from a U.S. claims database from April 2017 to September 2020 found:

    • The probability of remaining free of any relapse was significantly higher with TYSABRI than with Ocrevus at 12 and 24 months (p<0.001);
    • Time to first relapse significantly favored TYSABRI over Ocrevus for any relapse (hazard ratio [HR]=0.70; p<0.01) and outpatient relapse (HR=0.71; p<0.01);
    • Time to hospitalized relapse was numerically better for TYSABRI compared to Ocrevus but did not differ significantly between treatments (HR=0.61; p=0.11);
    • There were no significant differences in annualized costs for relapse-related hospital encounters or steroid use observed between the two treatments and time to first MS-related ER visit did not differ significantly between treatments (HR=1.05; p=0.81).

    New EVOLVE-MS-2 Study Results Suggest Consistent GI Tolerability for VUMERITY Throughout Dose Titration May Prevent Delays in Reaching Maintenance Dose

    In the Phase 3 EVOLVE-MS-2 study, VUMERITY (n=253) demonstrated that an improved GI tolerability profile compared to TECFIDERA® (dimethyl fumarate) (n=251) may simplify initiation of therapy. A new analysis presented at the meeting examines GI tolerability during the dose titration period and during the maintenance dose period over the course of the study for individuals starting therapy on VUMERITY relative to TECFIDERA. In addition to reinforcing VUMERITY's tolerability profile based on less frequent and less severe GI events versus TECFIDERA, key findings include:

    • Weekly incidence of GI adverse events (AEs) remained consistent and low throughout the 5-week treatment period for VUMERITY but increased in number and severity for TECFIDERA after titration to the full dose, peaking in Weeks 3 and 4.
    • Throughout the 5-week treatment period, moderate/severe GI AEs were less likely with VUMERITY (1.6%–4.8% versus 4.4%–13.9% with TECFIDERA).
    • Discontinuations due to GI AEs were 0.8 percent for VUMERITY and 4.8 percent for TECFIDERA; most TECFIDERA discontinuations occurred in Week 3 (58.3 percent)

    "These findings suggest GI tolerability is consistent across the doses with VUMERITY, which may enable patients to potentially reach the maintenance dose with less dose interruptions," said Robert Naismith, M.D., of Washington University School of Medicine. "Reducing the need for physicians to utilize real-world GI mitigation strategies has the potential to have a positive impact on treatment compliance and adherence."

    Data Presentations Featured at ECTRIMS:

    • Primary Results of NOVA: A Randomised Controlled Study of the Efficacy of 6-Week Dosing of Natalizumab Versus Continued 4-Week Treatment for Multiple Sclerosis (P970)
    • Claims-based Relapse and Hospitalisation Rates in Patients With Multiple Sclerosis Treated With Natalizumab or Ocrelizumab (P833)
    • Comparing the Impact of Dose Titration on Gastrointestinal Tolerability: Diroximel Fumarate Versus Dimethyl Fumarate in Patients With Relapsing-Remitting Multiple Sclerosis (P692)

    About TYSABRI® (natalizumab)

    TYSABRI is a well-established treatment indicated for relapsing forms of multiple sclerosis (MS) in adults that has been proven in clinical trials to slow physical disability progression, reduce the formation of new brain lesions and cut relapses. 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 a single disease-modifying treatment (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 approved in over 80 countries, and approximately 233,000 people worldwide have been treated with TYSABRI, with over 927,000 patient-years of experience, based on clinical trials and prescription data.5

    TYSABRI increases the risk of progressive multifocal leukoencephalopathy (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-JCV antibodies, prior immunosuppressant use and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk.

    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. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis), and infections including opportunistic infections, and a reduction in blood platelet counts.

    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 VUMERITY® (diroximel fumarate)

    VUMERITY is an oral fumarate with a distinct chemical structure from TECFIDERA® (dimethyl fumarate), approved in the U.S. for the treatment of relapsing forms of multiple sclerosis in adults, to include 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.

    VUMERITY is contraindicated in patients with known hypersensitivity to diroximel fumarate, dimethyl fumarate or to any of the excipients of VUMERITY; and in patients taking dimethyl fumarate. Serious side effects for VUMERITY are based on data from dimethyl fumarate (which has the same active metabolite as VUMERITY) and include anaphylaxis and angioedema, progressive multifocal leukoencephalopathy, which is a rare opportunistic viral infection of the brain that has been associated with death or severe disability, a decrease in mean lymphocyte counts during the first year of treatment, herpes zoster and other serious infections, liver injury and flushing. The most common adverse events, obtained using data from dimethyl fumarate (which has the same active metabolite as VUMERITY), were flushing, abdominal pain, diarrhea and nausea.

    Please click here for Important Safety Information and full Prescribing Information, including Patient Information for VUMERITY in the U.S.

    About TECFIDERA® (dimethyl fumarate) 

    TECFIDERA, a treatment for relapsing forms of multiple sclerosis (MS) in adults, is the most prescribed oral medication for relapsing MS in the world and 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 profile in people with relapsing forms of MS. TECFIDERA is approved in 69 countries, and more than 530,000 patients have been treated with it, representing more than 1,000,000 patient-years of exposure across clinical trial use and patients prescribed TECFIDERA.6

    TECFIDERA is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. Serious side effects include anaphylaxis and angioedema, and cases of progressive multifocal leukoencephalopathy, 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 lymphopenia although the role of lymphopenia in these cases is uncertain. Other serious side effects include a decrease in mean lymphocyte counts during the first year of treatment, herpes zoster and other serious infections, liver injury and flushing. In clinical trials, the most common adverse events associated with TECFIDERA were flushing, abdominal pain, diarrhea and nausea.

    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 Biogen

    At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative 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, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer's disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

    We routinely post information that may be important to investors on our website at www.biogen.com.

    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, about the potential benefits, safety and efficacy of TYSABRI (natalizumab), VUMERITY and Q6W; the results of the NOVA Phase 3b study, the results of the EVOLVE-MS-2 study and certain real-world data; clinical trials and data readouts and presentations; and the treatment of MS. 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. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. 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 uncertainty of success in the development and potential commercialization of Q6W; unexpected concerns that may arise from additional data, analysis or results obtained during the NOVA Phase 3b study, the EVOLVE-MS-2 study or other clinical studies of TYSABRI (natalizumab), VUMERITY and Q6W; the occurrence of adverse safety events and/or unexpected concerns that may arise from additional data or analysis; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of expansion of product labeling; 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; 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:

    1. Chisari et al. Clinical effectiveness of different natalizumab interval dosing schedules in a large Italian population of patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2020;0:1–7. doi: 10.1136/jnnp-2020-323472.
    2. Butzkueven H et al. Similar Clinical Outcomes for Natalizumab Patients Switching to Every-6-Week Dosing Versus Remaining on Every-4-Week Dosing in Real-World Practice. Poster presented at 8th Joint ACTRIMS-ECTRIMS Virtual Meeting; September 11–13, 2020. P0393.
    3. Zhovtis Ryerson L et al. No Difference in Radiologic Outcomes for Natalizumab Patients on Extended Interval Dosing Compared with Standard Interval Dosing in MS PATHS. Poster presented at American Academy of Neurology Virtual Annual Meeting; April 17-22,2021. P15.210.
    4. Zhovtis Ryerson et al. Natalizumab Extended Interval Dosing (EID) is Associated with a Reduced Risk of Progressive Multifocal Leukoencephalopathy (PML) Compared with Every-4-week (Q4W) Dosing: Updated Analysis of the TOUCH® Prescribing Program Database. Poster presented at American Academy of Neurology Virtual Annual Meeting; April 17-22, 2021.P15.201
    5. Combined post-marketing data based on prescriptions and clinical trials exposure to TYSABRI as of July 31, 2021.
    6. Combined post-marketing data based on prescriptions and clinical trials exposure to TECFIDERA as of June 30, 2021.
    MEDIA CONTACT:

    Ashleigh Koss

    + 1 908 205 2572

    public.affairs@biogen.com
    INVESTOR CONTACT:

    Mike Hencke

    +1 781 464 2442

    IR@biogen.com

     



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    • MS PATHS data indicate that 100 percent of people with MS treated with natalizumab, interferons or fumarates achieved an antibody response following COVID-19 vaccination
    • Data from this analysis also suggest that approximately 40 percent of people with MS treated with anti-CD20 and S1P disease-modifying therapies (DMT) mount an antibody response to the COVID-19 vaccine
    • Collaborative MS PATHS network enabled rapid collection of data in the COVID-19 environment

    CAMBRIDGE, Mass., Oct. 13, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) today announced results of a new analysis of immune response to the COVID-19 vaccine among people with multiple sclerosis (MS). The results, which demonstrate that patients treated with Biogen's portfolio of…

    • MS PATHS data indicate that 100 percent of people with MS treated with natalizumab, interferons or fumarates achieved an antibody response following COVID-19 vaccination

    • Data from this analysis also suggest that approximately 40 percent of people with MS treated with anti-CD20 and S1P disease-modifying therapies (DMT) mount an antibody response to the COVID-19 vaccine
    • Collaborative MS PATHS network enabled rapid collection of data in the COVID-19 environment

    CAMBRIDGE, Mass., Oct. 13, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) today announced results of a new analysis of immune response to the COVID-19 vaccine among people with multiple sclerosis (MS). The results, which demonstrate that patients treated with Biogen's portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

    Using data from the MS PATHS network in the U.S., Germany and Spain, researchers evaluated blood samples from 322 participants 28-90 days after their last COVID-19 vaccine dose. Preliminary results suggest that anti-CD20 and sphingosine 1-phosphate (S1P) therapies may reduce the antibody response to COVID-19 vaccination. For all other classes evaluated in the analysis, including the broad range of MS therapies offered by Biogen, the antibody response to vaccination is consistent with the response of patients not being treated with an MS disease-modifying therapy (DMT).

    "These results demonstrate that MS DMTs impact antibody responses to COVID-19 vaccination in different ways and understanding these differences is crucial," said Jeffrey Cohen, M.D., Cleveland Clinic, and a paid consultant for Biogen. "These insights are important in helping providers and patients alike manage MS while seeking to protect patients from COVID-19 through vaccination."

    Approximately 92 percent of participants in the analysis received an mRNA vaccine. Immune response was measured using immunoglobulin G (IgG) assays. Specific IgG rates (IgG index >1) from initial post-vaccination testing (28-90 days post last vaccination dose) were 40 percent (32/80) for anti-CD20s (ocrelizumab, rituximab and ofatumumab), 41 percent (16/39) for S1P therapies (fingolimod, ozanimod, and siponimod) and 100 percent (175/175) for all other DMTs (fumarates – dimethyl-fumarate and diroximel fumarate, glatiramer acetate, interferons – IM IFN beta-1a, pegylated IFN beta-1a and IFN beta-1b, natalizumab, teriflunomide and alemtuzumab).

    "We care deeply about people with MS and wanted them and their health care providers to have timely information to help address key questions about COVID-19," said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. "Leveraging the unique MS PATHS network, we were able to quickly generate data on the impact of the different MS DMTs on COVID-19 vaccine antibody responses. This is part of a comprehensive plan to understand B and T cell activation in the context of people with MS on DMTs being vaccinated for COVID-19 and will add to efforts by researchers to gather these important data."

    Additional Data Presentations Featured at ECTRIMS

    Biogen is presenting a total of 38 abstracts from across its MS portfolio as part of its ongoing commitment to improving the understanding of the disease and advancing treatment through innovation. Presentations at ECTRIMS include:

    • IgG Immune Response to SARS-CoV-2 Vaccination in People Living With Multiple Sclerosis Within MS PATHS (P652)
    • Flushing and Flushing-Related Adverse Events With Diroximel Fumarate in Patients With Relapsing-Remitting Multiple Sclerosis: Results from the Phase 3 EVOLVE-MS-2 Study (P673)
    • Early Data Suggest Diroximel Fumarate Has High Rates of Real-World Adherence and Persistence (P850)
    • Diroximel Fumarate in Patients With Relapsing-Remitting Multiple Sclerosis: Interim Safety and Efficacy Results from the Phase 3 EVOLVE-MS-1 Study (P739)
    • Comparison of Time to Clinically Meaningful Improvement in Neuro-QoL in Patients Treated With Natalizumab Versus Ocrelizumab (P252)
    • Comparison of Pharmacokinetic Profiles and Safety Outcomes with Peginterferon Beta-1a Administration in Black/African American and White Participants (P663)
    • Efficacy and Safety of Opicinumab in Participants With Relapsing Multiple Sclerosis: A Randomized, Placebo-Controlled, Phase 2 Trial (AFFINITY Part 1) (P147)

    About MS PATHS

    Biogen sponsored the MS PATHS (Partners Advancing Technology and Health Solutions) network to foster collaboration between leading MS centers in the U.S. and Europe to help transform patient care by generating standardized data from a diverse, real-world patient population. MS PATHS is uniquely able to collect clinical, MRI and biologic data from all patients in real-time, at the point of care, to better understand the disease and ultimately improve the lives of those living with MS.

    About Biogen

    At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative 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, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer's disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

    We routinely post information that may be important to investors on our website at www.biogen.com.

    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 results of certain real-world data; the identification and treatment of MS and the effect of our therapies in relation to COVID-19 vaccination; and our research and development program for the treatment of MS. 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. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. 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.

    MEDIA CONTACT:

    Ashleigh Koss

    + 1 908 205 2572

    public.affairs@biogen.com
    INVESTOR CONTACT:

    Mike Hencke

    +1 781 464 2442

    IR@biogen.com



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