Biogen R&D Day to Provide Overview of Diversified Pipeline and
Capabilities with Potential for Multiple Novel Therapies in
Neuroscience
Biogen Inc. (Nasdaq: BIIB) will hold a virtual Investor R&D Day
today, providing a comprehensive overview of the company’s
diversified pipeline in neuroscience. Biogen plans to advance
innovative therapies for patients through the work of its
world-class researchers and the strength of its global network of
collaborators. As part of R&D Day, Biogen’s scientific leaders
will discuss ongoing research and highlight key advancements among
Biogen’s 33 clinical programs, including 12 programs in Phase 3 or
filed.
“Biogen is helping to change the Alzheimer’s disease treatment
paradigm by providing the first therapy in 20 years, and we
continue to lead the way in neuroscience with our diversified
pipeline,” said Michel Vounatsos, Chief Executive Officer at
Biogen. “Across our portfolio, we have achieved significant
scientific progress, and I believe our specialization in terms of
people, capabilities, and programs positions us to deliver multiple
novel therapies with the potential to address the most complex
neurological diseases.”
Key R&D Highlights “The talented team at
Biogen is at the forefront of innovation in neuroscience. We look
forward to sharing the assets and approaches we have developed
aimed at addressing some of the most difficult challenges in
healthcare,” said Alfred Sandrock, Jr., M.D., Ph.D., Head of
Research and Development at Biogen. “Scientific advancements have
increased our understanding of human genetics and allow us to
advance the appropriate treatment modality for the right target for
each disease. We believe this will mitigate risk in neuroscience,
increase the probability of success for each program, and create
opportunities for early and targeted treatments towards
prevention.”
Alzheimer's DiseaseBiogen will present an
overview of its Alzheimer’s disease pipeline with the recent
FDA-approved ADUHELM serving as the foundation of a multi-target,
multi-modality Alzheimer’s disease franchise. In addition to
ADUHELM, the company will present progress on lecanemab (BAN2401),
a new amyloid beta-directed antibody therapy in Phase 3 being
developed by Eisai in collaboration with Biogen, and BIIB080
(IONIS-MAPTRx), a tau-directed antisense oligonucleotide (ASO).
Lecanemab received Breakthrough Therapy designation from the FDA
in June 2021. In clinical studies, lecanemab has shown potential to
slow clinical decline in Alzheimer’s disease and is now being
studied in patients with early Alzheimer’s disease as well as the
preclinical setting, when individuals are clinically normal and
have intermediate or elevated levels of amyloid in their
brains.
A Phase 1b study of BIIB080 met the primary objective of safety
and tolerability, and demonstrated a durable time and dose
dependent reduction of tau protein in cerebrospinal fluid. Growing
evidence suggests tau may be a key driver of neurodegeneration in
Alzheimer’s disease.NeuropsychiatryIn
neuropsychiatry, Biogen and Sage Therapeutics are co-developing
zuranolone, and will present an overview of the two-week,
once-daily drug being studied in major depressive disorder (MDD)
and postpartum depression (PPD). Zuranolone has demonstrated
positive Phase 3 results.
In clinical trials, zuranolone, which represents a potential new
class of drug, demonstrated rapid-acting efficacy and was generally
well-tolerated. Beyond MDD and PPD, zuranolone may have potential
for development in other psychiatric disorders, including
treatment-resistant depression, bipolar disorder, and generalized
anxiety disorder.
Major depressive disorder is a common comorbidity of multiple
neurological disorders in Biogen’s core therapeutic areas.
Biogen will also present an overview of BIIB104, currently under
investigation in a Phase 2 study for cognitive impairment
associated with schizophrenia.
Amyotrophic Lateral Sclerosis (ALS)Biogen has
multiple ALS assets in development, which target both genetic
subtypes of ALS and the broader population. Tofersen, developed in
collaboration with Ionis Pharmaceuticals, is currently in Phase 3
studies. The program targets SOD1, a gene believed to be a genetic
driver of disease in two percent of all ALS cases.
In the recently announced ATLAS study, Biogen will be exploring
the use of tofersen prior to symptoms in SOD1 carriers with the
intent to delay or slow the decline in function associated with
ALS.
Based on learnings from the company’s prior and ongoing trials,
Biogen is also advancing BIIB078, an ASO targeting C9orf72, another
potential genetic driver of ALS, and BIIB105, an ASO targeting
ATXN2, a potential treatment for ALS in the broader population
supported by human genetics.
StrokeBiogen is progressing its research in the
treatment of stroke. The potential to expand the stroke treatment
window has been shown in positive proof of concept studies for
BIIB131, a next generation thrombolytic agent, and BIIB093, a
treatment for brain swelling in large hemispheric infarctions.
BIIB131, a treatment for acute ischemic stroke, was recently
acquired based on positive Phase 2 data. BIIB093 is in a Phase 3
study for large hemispheric infarction, and a Phase 2 trial for
lesion expansion in brain contusion.
LupusDecades of study by Biogen at the
intersection of neurological and immunological pathways provide the
company with expertise in immunology. Biogen is advancing two lupus
therapies in Phase 3 trials. Dapirolizumab pegol is being developed
in collaboration with UCB for systemic lupus erythematosus (SLE).
The second, BIIB059, was fully developed in-house at Biogen and is
now in Phase 3 for SLE, with plans for further study in cutaneous
lupus erythematosus.
Distinct Capabilities and World-Class
TalentBiogen has attracted and collaborated with leading
scientists from industry and academia to focus on treatments with
the highest unmet need. This focus also includes 27 business
development transactions and collaborations since 2017, including
with Sangamo Therapeutics, Inc., Denali Therapeutics Inc., Sage
Therapeutics Inc, and InnoCare Pharma Limited. Biogen will continue
to bolster the pipeline through both internal development and
external collaborations.
Biogen has refined the early discovery process with new
approaches to patient selection, target engagement, and monitoring
of disease progression, increasing the probability of success for
each program. Biogen centers its R&D methodologies on human
biology, employing the predictive effects of genetics to validate
potential targets. Utilizing biomarkers to measure modulation of
disease early on in the drug development process can contribute to
lowering the risk associated with developing novel therapies for
neurological diseases.
Biogen Digital Health Today’s technological
advances open a new era of opportunities for digital health in
neuroscience. In April 2021, the company formed Biogen Digital
Health, a global unit that aspires to transform patients’ lives and
Biogen by making personalized and digital medicine in neuroscience
a reality. In an on-demand presentation, Biogen Digital Health
will share key areas of focus and highlights, including progress on
digital biomarkers and efforts to develop deep-learning
software.
Investor R&D Day Presenters Biogen
scientific leaders will be joined by executives from Eisai, Sage
Therapeutics, and Denali Therapeutics.
To join today's event, please go to the investors section of the
Biogen website at investors.biogen.com or access the event link
directly here. An archived version of the webcast and slides, as
well as additional video presentations and slides, will be
available here.
About ADUHELM®
(aducanumab-avwa) injection 100 mg/mL solution
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).
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.
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 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. To learn more, please
visit www.biogen.com and 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
and pipeline programs, including ADUHELM, lecanemab, and
zuranolone; the potential clinical effects of ADUHELM, lecanemab,
and zuranolone; the potential benefits, safety and efficacy of
ADUHELM , lecanemab, and zuranolone; planning and timing for the
commercial launch of, and access to, ADUHELM; anticipated
manufacturing, distribution and supply of ADUHELM; the treatment of
Alzheimer’s disease, MDD, BPD, ALS, stroke and lupus; the
anticipated benefits and potential of our collaboration
arrangements with Eisai and Sage; clinical development programs,
clinical trials and data readouts and presentations; 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: uncertainty of success in the
development and commercialization of ADUHELM, lecanemab, and
zuranolone; 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, lecanemab, and zuranolone;
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;
risks relating to investment in our manufacturing capacity;
problems with our manufacturing processes; 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; risks
relating to the distribution and sale by third parties of
counterfeit or unfit versions of our products; 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 we have 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.
MEDIA CONTACT:Ashleigh Koss+ 1
908 205 2572public.affairs@biogen.com |
INVESTOR CONTACT:Mike Hencke+1
781 464 2442IR@biogen.com |
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