BIIB Biogen Inc

Biogen Inc. (Nasdaq: BIIB) announced upcoming data presentations and programming at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference, taking place October 29 - November 1, in Madrid, Spain. The presentations will include updates on new scientific findings from Biogen’s Alzheimer’s portfolio, highlighting data on different aspects of treatment and data examining preclinical Alzheimer’s disease and race.

“These data showcase the breadth of our Alzheimer’s disease research and our ongoing commitment to scientific innovation,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “We remain dedicated to advancing the field of research and treatment for this disease in order to better serve the millions of patients, families and providers in the Alzheimer’s community.”

Key Presentations and Symposia:

• Transitioning from Clinical Trial to Clinical Practice for Long-Term Lecanemab Treatment in Early Alzheimer's Disease: Perspectives from an Alzheimer's Disease Treatment Center, Tuesday, October 29
• The AHEAD 3-45 Study: Design and Results of a Novel Screening Process for a Preclinical AD Trial, Tuesday, October 29, 6:10 PM
• Does the Current Evidence Base Support Continued Dosing with Lecanemab for Early Alzheimer's Disease? Wednesday, October 30, 9:40 AM
• Lecanemab for the Treatment of Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease in Adults That Are Apoliprotein E ɛ4 Heterozygotes or Non-Carriers, Wednesday, October 30, 11:20 AM
• One-Year Experience on the Use of Lecanemab in Clinical Practice, Wednesday, October 30, 3:30 PM
• AI-Derived Prognostic Covariates Enhance the Precision of Lecanemab Efficacy Assessments and Optimize Alzheimer's Disease Clinical Trials, Thursday, October 31, 3:25 PM
• Estimating by race and APOE Ɛ4 carrier status counts of US adults with subjective cognitive decline with preclinical Alzheimer’s disease, Friday, November 1

Virtual Experience on Tau PathologyAt the meeting, Biogen will also host a virtual booth for attendees exploring the role of tau in Alzheimer’s disease, including an interactive medical education e-learning module on knowtau.com which has more information on tau pathophysiology.

For more information, please see the CTAD 2024 program and visit the Biogen CTAD virtual booth.

About LEQEMBI® (lecanemab)LEQEMBI (lecanemab) is the result of a strategic research alliance between Eisai and BioArctic. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). LEQEMBI is an amyloid beta-directed antibody for the treatment for Alzheimer’s disease (AD) in the U.S. The U.S. Food and Drug Administration (FDA) granted LEQEMBI traditional approval on July 6, 2023.

LEQEMBI is indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Please see full U.S. Prescribing Information for LEQEMBI, including Boxed WARNING and Medication Guide.

About BiogenFounded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

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Biogen Safe Harbor 

This news release contains forward-looking statements, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs; including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "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 studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; 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 lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of the medicine; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and third party collaboration risks, 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 speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements.

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