Biogen to Present Data at Virtual 2020 Alzheimer’s Association
International Conference Highlighting Comprehensive Approach to
Alzheimer’s Disease
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Following the webcast, an archived version will be available on the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:
- Encore platform presentation and Q&A: EMERGE and ENGAGE
topline results: phase 3 studies of aducanumab in early AD. Part of
the Developing Topic Session: Developments in Clinical Trials and
Cognitive Assessment (SO3-02) - Wednesday, July 29, 7:00 am – 8:00
am Central Daylight Time (CDT), Live Auditorium
- Platform presentation: Baseline characteristics from TANGO:
phase 2 study to evaluate gosuranemab (BIIB092) in patients with
early AD - Wednesday, July 29, on-demand session available 12:00 am
CDT, Human: Improving Clinical Trial Methodology, Scheduled
Chatroom Q&A Session 11:30 am – 11:55 am CDT
- Poster presentation: Feasibility of clinical research studies
reported by patients with behavioral variant frontotemporal
dementia (bvFTD) and their caregivers (FORWARD study). Session:
Drug Development: Clinical Trial Design and Implementation –
Wednesday, July 29
- Poster presentation: Proteomics studies to investigate
alterations in the tau interactome under conditions of elevated
cellular O-GlcNAcylation. Session: Basic Science and Pathogenesis:
Inflammation: From Basic Science To Biomarkers - Monday, July
27
- Virtual satellite symposium: The Diagnosis of Early Alzheimer’s
Disease: Readying the System. Panel will feature Dr. José Luis
Molinuevo, Barcelonaβeta Brain Research Center, Dr. Christopher
Rowe, Austin Health, Dr. Marwan Sabbagh, Cleveland Clinic Lou Ruvo
Center for Brain Health, and Dr. Kathleen Welsh-Bohmer, Duke
Clinical Research Institute. The symposium will be available on the
AAIC website starting on July 27 and will remain available for 30
days after the conference.
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:
- Poster presentation: Quantifying what matters most to patients
and care partners in Alzheimer’s disease
- Poster presentation: The importance of care partner input in
Alzheimer’s disease drug development
- Poster presentation: Evaluation of what matters most in
existing clinical outcomes assessments in Alzheimer’s disease
In addition, Biogen will also be part of a presentation from The
Critical Path for Alzheimer’s Disease (CPAD) Consortium.
- Poster presentation: Pre-competitive data sharing and
generation of innovative high-impact quantitative tools to support
Alzheimer’s disease drug development. Session: Drug Development,
Human/Trial design - Wednesday, July 29
Biogen’s collaboration partner Eisai Co., Ltd. (Eisai) will also
present data from the companies’ shared AD portfolio.
Eisai Presentations:
- Poster presentation: A preliminary account of ARIA-E in the
open label extension phase of BAN2401-G000-201 in subjects with
early AD (BAN2401) – Wednesday, July 29
- Poster presentation: A preliminary assessment of longitudinal
amyloid status in the ongoing open label extension phase in
subjects with early AD (BAN2401) – Wednesday, July 29
- Platform presentation: AHEAD3-45 study design (BAN2401) –
Wednesday, July 29, 11:00 am - 11:25 am CDT
- Poster presentation: Amyloid burden assessed by three amyloid
PET tracers in the elenbecestat MissionAD phase 3 program (the
MissionAD program has been discontinued) – July 29
About AducanumabAducanumab (BIIB037) is an
investigational human monoclonal antibody studied for the treatment
of Alzheimer’s disease. Based on clinical data, aducanumab has the
potential to impact underlying disease pathophysiology, slow
cognitive and functional decline and provide benefits on patients’
ability to perform activities of daily living, including conducting
personal finances, performing household chores, such as cleaning,
shopping and doing laundry, and independently traveling out of the
home. If approved, aducanumab would be the first treatment to
meaningfully change the course of the disease for individuals
living with Alzheimer’s.
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).
About BAN2401 BAN2401 is a humanized monoclonal
antibody for Alzheimer’s disease (AD) that is the result of a
strategic research alliance between Eisai and BioArctic. BAN2401
selectively binds to neutralize and eliminate soluble, toxic Aβ
aggregates that are thought to contribute to the neurodegenerative
process in AD. As such, BAN2401 may have the potential to have an
effect on disease pathology and to slow down the progression of the
disease. Eisai obtained the global rights to study, develop,
manufacture and market BAN2401 for the treatment of AD pursuant to
an agreement concluded with BioArctic in December 2007. Currently,
a global clinical Phase 3 study (Clarity AD) of BAN2401 in early AD
is underway. BAN2401 is being jointly developed by Eisai and Biogen
Inc. The National Institute on Aging, a division of the National
Institutes of Health, is providing funding for the A45 Study (grant
number R01AG061848) and A3 Study (grant number R01AG054029).
About Gosuranemab Gosuranemab (BIIB092) is a
humanized monoclonal antibody that targets N-terminal tau.
Gosuranemab is currently being evaluated in the Phase 2 TANGO study
in participants with mild cognitive impairment due to Alzheimer’s
disease or with mild Alzheimer’s disease. Biogen licensed
gosuranemab from Bristol-Myers Squibb Company.
About BiogenAt 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. Follow us on social media
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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 clinical effects
of aducanumab, BAN2401 and gosuranemab; the potential benefits,
safety and efficacy of aducanumab, BAN2401 and gosuranemab; the
results of the Phase 3 studies and Phase 1b study of aducanumab and
the Phase 2 study of gosuranemab; the identification and treatment
of Alzheimer’s disease; potential regulatory approvals and the
timing thereof; the anticipated benefits and potential of our
collaboration arrangements with Eisai; the potential of our
commercial business and pipeline programs, including aducanumab,
BAN2401 and gosuranemab; and risks and uncertainties associated
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“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, 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
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approval of our drug candidates, including aducanumab, BAN2401 and
gosuranemab; uncertainty of success in the development and
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future developments or otherwise.
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MEDIA CONTACT:Biogen Inc.David
Caouette+ 617 679 4945public.affairs@biogen.com |
INVESTOR CONTACT:Biogen Inc.Joe
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