Biogen Inc. (Nasdaq: BIIB) today announced it will share multiple
oral and poster presentations from its Alzheimer’s disease clinical
development portfolio at the Alzheimer’s Association International
Conference (AAIC), which will be held in Denver, Colorado and
online July 26-30, 2021. The company’s contributions to AAIC will
include several presentations highlighting data on ADUHELM™
(aducanumab-avwa) injection 100 mg/mL solution, which was recently
granted accelerated approval by the U.S. Food and Drug
Administration (FDA) as a treatment for Alzheimer’s disease, as
well as its broader Alzheimer’s disease portfolio and research in
the field.
ADUHELM is indicated for the treatment of Alzheimer’s disease.
Treatment with ADUHELM 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.
There are no safety or effectiveness data on initiating treatment
at earlier or later stages of the disease than were studied. This
indication is approved under accelerated approval based on
reduction in amyloid beta plaques observed in patients treated with
ADUHELM. Continued approval for this indication may be contingent
upon verification of clinical benefit in confirmatory trial(s).
Data presentations on ADUHELM will include presentations on
multiple topics, including results of an analysis of the PRIME,
EMERGE and ENGAGE studies on the correlation between reductions in
biomarkers of Alzheimer’s disease and clinical decline after
treatment with ADUHELM. The company’s contributions to the congress
include four presentations on ADUHELM data and a total of 11
abstracts.
The company will also lead a late-breaking presentation on the
design of the real-world observational Phase 4 study in Alzheimer’s
disease, a prospective registry of ADUHELM, called International
Collaboration for Real-World Evidence in Alzheimer’s Disease (ICARE
AD-US). ICARE AD-US is focused on collecting real-world, long-term
effectiveness and safety data on ADUHELM.
Biogen’s commitment to generate new data about ADUHELM includes
three components: the ICARE AD study, the ongoing redosing study,
EMBARK, for eligible patients previously enrolled in aducanumab
trials, and the upcoming confirmatory, controlled Phase 4 trial
that is part of the post-marketing requirement in connection with
ADUHELM’s accelerated approval.
Posters and presentations will be available for 30 days on the
AAIC conference website. Biogen will also post the aducanumab and
BIIB080 posters and presentations on the investors section of its
website at investors.biogen.com at the times indicated below.
Biogen Oral and Poster Presentations:
- Oral presentation: ICARE AD-US: Design of a Prospective,
Single-arm, Multicenter, Noninterventional Real-world Study of
Aducanumab in United States: July 29, 10:00 am to 11:15 am ET
(#57522). This presentation will be available on Biogen’s website
concurrent with the presentation.
- Poster presentation: Reduction in Biomarkers of Alzheimer’s
Disease Pathophysiology Following Treatment with Aducanumab Were
Associated with Slowing Clinical Decline – virtual poster #57499.
This poster will be available on Biogen’s website on July 26 at
10:00 am ET.
- Poster presentation: Subgroup Analyses of the Amyloid PET
Substudies from EMERGE and ENGAGE, Phase 3 Clinical Trials
Evaluating Aducanumab in Patients with Early Alzheimer’s Disease–
virtual poster #57496. This poster will be available on Biogen’s
website on July 26 at 10:00 am ET.
- Poster presentation: Considerations for the Real-World
Management of ARIA from the Aducanumab Phase 3 Studies EMERGE and
ENGAGE – virtual poster #57498. This poster will be available on
Biogen’s website on July 26 at 10:00 am ET.
- Poster presentation: Item-level Analysis of Clinical Measures
in Patients with Early Symptomatic Alzheimer’s Disease Following
Treatment with High-Dose Aducanumab in the Phase 3 Study EMERGE –
virtual poster #57619. This poster will be available on Biogen’s
website on July 26 at 10:00 am ET.
- Poster presentation: Ten-minute Cognitive Screening Tool for
Mild Cognitive Impairment and Prediction of Pathological ß-amyloid
- virtual poster #54618.
- Oral presentation: Development of a Site Readiness Framework to
Improve Health System Preparedness for Potential New Alzheimer’s
Disease Therapies –July 29, 3:00 pm – 4:15 pm ET (#57672).
- Oral presentation: Drivers and Barriers to Participation of
Black and Hispanic Groups in Alzheimer’s Disease Clinical Trials: a
Qualitative Study – Developing Topics 1 - July 29, 10:00 am – 11:15
am ET (#57652).
- Poster presentation: Baseline Biomarker (Tau PET)
Characteristics from TANGO: A Phase 2 Trial of Gosuranemab
(BIIB092) in Early Alzheimer’s Disease – virtual poster
#54952.
- Poster presentation: Results of the First-in-Human, Randomized,
Double-Blind, Placebo-Controlled Phase 1b Study of Lumbar
Intrathecal Bolus Administrations of Antisense Oligonucleotide
(ISIS 814907; BIIB080) Targeting Tau mRNA in Patients with Mild
Alzheimer’s Disease– virtual poster #51871. This poster will be
available on Biogen’s website on July 26 at 10:00 am ET.
- Poster presentation: Clinical performance of the b-amyloid
(1-42/1-40) ratio determined from automated Lumipulse G1200
cerebrospinal fluid Ab1-42 and Ab1-40 assays, assessed by
concordance with PET imaging status– virtual poster #57725.
About ADUHELM™ (aducanumab-avwa)
injection 100 mg/mL solutionADUHELM is indicated for the
treatment of Alzheimer’s disease. Treatment with ADUHELM 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. There are no safety or effectiveness
data on initiating treatment at earlier or later stages of the
disease than were studied. This indication is approved under
accelerated approval based on reduction in amyloid beta plaques
observed in patients treated with ADUHELM. Continued approval for
this indication may be contingent upon verification of clinical
benefit in confirmatory trial(s).
Aducanumab-avwa is a monoclonal antibody directed against
amyloid beta. The accumulation of amyloid beta plaques in the brain
is a defining pathophysiological feature of Alzheimer’s disease.
The accelerated approval of ADUHELM has been granted based on data
from clinical trials showing the effect of ADUHELM on reducing
amyloid beta plaques, a surrogate biomarker that is reasonably
likely to predict clinical benefit, in this case a reduction in
clinical decline.
ADUHELM can cause serious side effects including: Amyloid
Related Imaging Abnormalities or “ARIA”. ARIA is a common side
effect that does not usually cause any symptoms but can be serious.
Although most people do not have symptoms, some people may have
symptoms such as: headache, confusion, dizziness, vision changes
and nausea. The patient’s healthcare provider will do magnetic
resonance imaging (MRI) scans before and during treatment with
ADUHELM to check for ARIA. ADUHELM can also cause serious allergic
reactions. The most common side effects of ADUHELM include:
swelling in areas of the brain, with or without small spots of
bleeding in the brain or on the surface of the brain (ARIA);
headache; and fall. Patients should call their healthcare provider
for medical advice about side effects.
Please see full Prescribing
Information including Medication
Guide.
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, 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: Biogen’s strategy and
plans; potential of, and expectations for, Biogen’s commercial
business, including ADUHELM; the potential clinical effects of
ADUHELM; the potential benefits, safety and efficacy of ADUHELM;
the treatment of Alzheimer’s disease; the anticipated benefits and
potential of our collaboration arrangements with Eisai; the
clinical development program, clinical trial(s) and data readouts
and presentations for ADUHELM; and risks and uncertainties
associated with drug development and commercialization. These
forward-looking statements may be accompanied by such words as
“aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,”
“forecast,” “goal,” “intend,” “may,” “plan,” “potential,”
“possible,” “prospect,” “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: risks relating to the launch of
ADUHELM, including preparedness of healthcare providers to treat
patients, the ability to obtain and maintain adequate reimbursement
for ADUHELM and other unexpected difficulties or 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 our drug candidates, including
ADUHELM; unexpected concerns that may arise from additional data or
analysis obtained during clinical trials; actual timing and content
of submissions to and decisions made by the regulatory authorities
regarding ADUHELM; the occurrence of adverse safety events,
restrictions on use or product liability claims; risks of
unexpected costs or delays; the risk of other unexpected hurdles;
failure to protect and enforce our data, intellectual property and
other proprietary rights and uncertainties relating to intellectual
property claims and challenges; third party collaboration risks;
risks associated with current and potential future healthcare
reforms; the direct and indirect impacts of the ongoing COVID-19
pandemic on our business, results of operations and financial
condition; and any other risks and uncertainties that are described
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.
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