Biogen to Present New Research at the International Conference
on Alzheimer’s and Parkinson’s Diseases (AD/PD 2022)
Biogen Inc. (Nasdaq: BIIB) announced the company will present
new Alzheimer’s disease research, as well as data for ADUHELM®
(aducanumab-avwa) injection 100 mg/mL for intravenous use, at the
upcoming International Conference on Alzheimer’s and Parkinson’s
Diseases (AD/PD 2022), taking place March 15-20 in Barcelona, Spain
and virtually. These data include analyses of treatment effect on
biomarkers of Alzheimer’s disease in the long-term extension
studies, with over two years of Phase 3 data.
An invited plenary lecture, “Key Milestones in Alzheimer’s
Disease” on March 16, will include an examination of the ability of
ADUHELM to reduce amyloid beta plaque and plasma p-tau181, and the
relationship between these biomarkers and clinical endpoints during
the long-term extension phase of the ADUHELM clinical program.
An oral presentation on March 18, “Effect of Reduction in Brain
β-Amyloid Levels on Cognitive Decline in Randomized Clinical
Trials: An Updated Instrumental Variable Meta-Analysis,” will
discuss the details of a meta-analysis on the causality between
reduction of amyloid beta levels and reduction of cognitive decline
in randomized clinical trials.
Presentation details:
- Plenary Lecture
- Key Milestones in Alzheimer’s
Disease [Budd Haeberlein S; 0290 – Plenary Lecture 3; PL003 / #12,
Room: 115-117] – Wednesday, March 16, 12:30 p.m. – 1:00 p.m. CET;
7:30 a.m. – 8:00 a.m. EDT
- Onsite Oral Presentations
- Evaluating the Evidence of
Aducanumab Treatment Benefit Using Standardized Test Statistics and
Global Statistical Tests [Dickson S, et al.; 1200 – ABETA Targeting
Therapies in AD (ID 66); SO198 / #2220, Room: 112] - Friday, March
18, 2:45 p.m. – 3:00 p.m. CET; 9:45 a.m. – 10:00 a.m. EDT
- Heterogeneity in Symptom Progression
and Treatment Response: An Analysis of Participants with Early
Alzheimer’s Disease from the EMERGE Aducanumab Trial [Cohen S, et
al.; 1200 – ABETA Targeting Therapies in AD (ID 66); SO199 / #2219,
Room: 112] – Friday, March 18, 3:00 p.m. – 3:15 p.m. CET; 10:00
a.m. – 10:15 a.m. EDT
- Subgroup Analyses of the Plasma
P-tau181 Population From EMERGE/ENGAGE, Phase 3 Clinical Trials
Evaluating Aducanumab in Early Alzheimer’s Disease [Hansson O, et
al.; 1200 – ABETA Targeting Therapies in AD (ID 66); SO200 / #1894,
Room: 112] – Friday, March 18, 3:15 p.m. – 3:30 p.m. CET; 10:15
a.m. – 10:30 a.m. EDT
- Effect of Reduction in Brain β-Amyloid Levels on Cognitive
Decline in Randomized Clinical Trials: An Updated Instrumental
Variable Meta-Analysis [Shen C, et al.; 1060 – Translational
Treatment Strategies and New Targets in AD, Room: 112] – Friday,
March 18, 10:40 a.m. – 10:55 a.m. CET; 5:40 a.m. – 5:55 a.m.
EDT
- Virtual Poster
- Aducanumab Phase 3 Studies: Exposure-Response Analysis
Evaluating the Relationship Between Amyloid Removal and Slowing of
Clinical Decline on CDR-SB Scores [Kandadi Muralidharan K, et al.;
P225 / #1868, Virtual Poster Presentation] – Tuesday, March 15,
starting at 8:00 a.m. CET; 3:00 a.m. EDT
Archived versions of the presentations will be available at the
same time on the investors section of Biogen’s website at
investors.biogen.com.
About
ADUHELM® (aducanumab-avwa)
injection 100 mg/mL for intravenous useADUHELM 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).
ADUHELM 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.
As of October 2017, Biogen and Eisai Co., Ltd. are collaborating
on the global co-development and co-promotion of aducanumab.
Please click here for full Prescribing Information,
including Medication Guide, for ADUHELM.
About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and
delivers worldwide innovative therapies for people living with
serious neurological 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, Sir Kenneth Murray, and Nobel Prize winners Walter
Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of
medicines to treat multiple sclerosis, has introduced the first
approved treatment for spinal muscular atrophy, and is providing
the first and only approved treatment to address a defining
pathology of Alzheimer’s disease. Biogen is also commercializing
biosimilars and focusing on advancing the industry’s most
diversified pipeline in neuroscience that will transform the
standard of care for patients in several areas of high unmet
need.
In 2020, Biogen launched a bold 20-year, $250 million initiative
to address the deeply interrelated issues of climate, health, and
equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil
fuels across the company’s operations, build collaborations with
renowned institutions to advance the science to improve human
health outcomes, and support underserved communities.
The company routinely posts information that may be important to
investors on its website at www.biogen.com. To learn more,
please visit www.biogen.com and follow Biogen 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 clinical effects of
ADUHELM; the potential benefits, safety and efficacy of ADUHELM;
the treatment of Alzheimer’s disease; the anticipated benefits and
potential of Biogen’s collaboration arrangements with Eisai;
clinical development programs, clinical trials and data readouts
and presentations; and risks and uncertainties associated with drug
development and commercialization. These statements may be
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“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 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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foregoing sets forth many, but not all, of the factors that could
cause actual results to differ from Biogen’s expectations in any
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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.
BIOGEN MEDIA
CONTACT: |
BIOGEN
INVESTOR CONTACT: |
Ashleigh Koss |
Mike Hencke |
+1 908 205 2572 |
+1 781 464 2442 |
public.affairs@biogen.com |
IR@biogen.com |
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