Biogen to Present Data at Virtual 2020 Alzheimer's Association International Conference Highlighting Comprehensive Approach to Alzheimer's Disease
CAMBRIDGE, Mass., July 24, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) today announced there will be multiple data presentations from its Alzheimer’s disease (AD) clinical development portfolio, a virtual satellite symposium and AD PACE poster presentations at the Alzheimer’s Association International Conference (AAIC), which will be held online July 27-31. The company’s contributions to AAIC showcase its work to build a broad AD franchise across multiple targets and modalities, as well as to advance knowledge about early diagnosis, unmet patient needs and health system capacity to diagnose and treat people living with AD.
Biogen’s AD portfolio of investigational assets includes aducanumab, an investigational treatment that, if approved, could meaningfully change the course of the disease. At the conference, Biogen will share an encore platform presentation of the previously reported topline results from the aducanumab Phase 3 EMERGE and ENGAGE studies. No new data from the studies are included in the encore presentation, which will be pre-recorded and followed by a live, virtual question and answer (Q&A) session. This presentation and Q&A session will be held on Wednesday, July 29, 7:00 am – 8:00 am Central Daylight Time (CDT) as part of Developing Topic Session: Developments in Clinical Trials and Cognitive Assessment (SO3-02). To access the presentation and Q&A session, please complete a free registration for AAIC in advance at aaic2020.vfairs.com/en/register. The presentation and Q&A session will be held in the Live Auditorium on the AAIC platform and can be accessed from either aaic2020.vfairs.com or the Investor’s section of Biogen’s website at investors.biogen.com. Following the webcast, an archived version will be available on the Investor’s section of Biogen’s website.
In addition, Biogen’s drug candidates and research will be featured in a platform presentation about the Phase 2 TANGO study to evaluate gosuranemab (BIIB092) in patients with early AD; a poster about the feasibility of clinical research studies reported by patients with behavioral variant frontotemporal dementia and their caregivers; and a poster on tau protein interactions. Conference activities also include a virtual satellite symposium about early diagnosis and readying the health system for the potential entry of a disease-modifying treatment for AD.
Posters and presentations will be available for 30 days on the AAIC conference website.
Biogen Presentations and Symposium:
As part of the conference, the Alzheimer’s Disease Patient and Caregiver Engagement (AD PACE) initiative, a collaboration from advocacy group Us Against Alzheimer’s that includes Biogen and other participants from the pharmaceutical industry, academia, government agencies and patient advocates, will present three posters from the What Matters Most study. The aim of the collaboration is to build a persistent platform to deliver new insights to research, regulatory and payer authorities on preferred treatment and health outcomes sought by those living with AD and their caregivers.
AD PACE Presentations:
In addition, Biogen will also be part of a presentation from The Critical Path for Alzheimer’s Disease (CPAD) Consortium.
Biogen’s collaboration partner Eisai Co., Ltd. (Eisai) will also present data from the companies’ shared AD portfolio.
Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally.
EMERGE and ENGAGE were Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. The primary objective of the studies was to evaluate the efficacy of monthly doses of aducanumab as compared with placebo in reducing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. Secondary objectives were to assess the effect of monthly doses of aducanumab as compared to placebo on clinical decline as measured by the Mini-Mental State Examination (MMSE), Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 Items (ADAS-Cog 13) and Alzheimer’s Disease Cooperative Study-Activities of Daily Living Inventory Mild Cognitive Impairment Version (ADCS-ADL-MCI).
Biogen Safe Harbor
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 trials; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; actual timing and content of submissions to and decisions made by the regulatory authorities regarding aducanumab; 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 our drug candidates, including aducanumab, BAN2401 and gosuranemab; uncertainty of success in the development and potential commercialization of aducanumab; risks relating to the potential launch of aducanumab, including preparedness of healthcare providers to treat patients, the ability to obtain and maintain adequate reimbursement for aducanumab and other unexpected difficulties or hurdles; 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.
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