Biogen Files New Drug Application for Aducanumab in Japan
Today, Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan)
announced that Biogen has submitted a Japanese New Drug Application
(J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for
aducanumab, an investigational therapy for Alzheimer’s disease.
Aducanumab, an amyloid beta-targeting antibody, has been shown in
clinical trials to remove amyloid beta in the brain and
significantly slow clinical decline in patients with Mild Cognitive
Impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s
disease dementia.
“Japan is the third market where we have applied for regulatory
approval for aducanumab, and the filing represents continued
progress on our commitment to bring this therapy to patients around
the world,” said Michel Vounatsos, Chief Executive Officer at
Biogen. “Japan has met the challenges of a rapidly aging population
by demonstrating global leadership in setting policies that aim to
increase support for Alzheimer’s disease patients and caregivers.
We look forward to the regulatory review of aducanumab with the
hope that, if approved, it could help further manage the impact of
this devastating disease.”
“As Japan has the oldest population in the world, it is
anticipated that the social burden of Alzheimer’s disease will
continue to grow,” said Dr. Haruo Naito, Chief Executive Officer at
Eisai Co., Ltd. “For more than 30 years, Eisai has been dedicated
to dementia research and development, and working with people
living with Alzheimer’s and their caregivers to fight this disease.
The filing of the application is an important step in serving
patients and their families as aducanumab may help reduce clinical
decline and potentially maintain the ability to live an independent
life for as long as possible. Aducanumab also has the potential to
help address the public health challenges our aging population
faces in Japan.”
The Japanese regulatory authority will review the application
through the standard review process. In addition to the filing in
Japan, aducanumab is under Priority Review with the U.S. Food and
Drug Administration, with a Prescription Drug User Fee Act (PDUFA)
action date of March 7, 2021 and is also under review with the
European Medicines Agency.
About AducanumabAducanumab (BIIB037) is an
investigational human monoclonal antibody studied for the treatment
of Alzheimer’s disease. Based on clinical data from patients with
Mild Cognitive Impairment due to Alzheimer’s disease and mild
Alzheimer’s disease, 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 Co., Ltd. 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 Alzheimer’s DiseaseAlzheimer’s disease is
a progressive neurological condition that impairs thinking, memory
and independence, leading to premature death. The disease currently
cannot be stopped, delayed or prevented and is a growing global
health crisis, affecting those living with the disease and their
families. According to the World Health Organization (WHO), tens of
millions of people worldwide live with Alzheimer’s disease, and the
number will grow in the years ahead, outpacing the healthcare
resources needed to manage it and costing billions of dollars.
According to the Health, Labor and Welfare Ministry, it is
estimated approximately 4.6 million people live with dementia and
about 4 million people live with Mild Cognitive Impairment (MCI) in
Japan (2012). Alzheimer’s disease is suspected to represent around
60-70% of dementia cases.
Alzheimer’s disease is characterized by changes in the brain,
including the abnormal accumulation of toxic amyloid beta plaque,
which begins approximately 20 years before patients exhibit
symptoms of the disease. MCI due to Alzheimer’s disease is one of
the earliest stages of the disease when symptoms start to be more
visible and can be detected and diagnosed. Current research efforts
are focused on catching and treating patients as early as possible
for the best chance of slowing or stopping the progression of
Alzheimer’s disease.
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
– Twitter, LinkedIn, Facebook, YouTube.
About Eisai Co., Ltd.Eisai Co., Ltd. is a
leading global pharmaceutical company headquartered in Japan.
Eisai’s corporate philosophy is based on the human health care
(hhc) concept, which is to give first thought to patients and
their families, and to increase the benefits that health care
provides to them. With a global network of R&D facilities,
manufacturing sites and marketing subsidiaries, we strive to
realize our hhc philosophy by delivering innovative products to
target diseases with high unmet medical needs, with a particular
focus in our strategic areas of Neurology and Oncology.
Leveraging the experience gained from the development and
marketing of a treatment for Alzheimer’s disease, Eisai aims to
establish the “Eisai Dementia Platform.” Through this platform,
Eisai plans to deliver novel benefits to those living with dementia
and their families through constructing a “Dementia Ecosystem,” by
collaborating with partners such as medical organizations,
diagnostic development companies, research organizations, and
bio-ventures in addition to private insurance agencies, finance
industries, fitness clubs, automobile makers, retailers, and care
facilities. For more information about Eisai Co., Ltd., please
visit https://www.eisai.com.
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 potential
regulatory discussions, submissions and approvals and the timing
thereof; the potential clinical effects of aducanumab; the
potential benefits, safety and efficacy of aducanumab; the
treatment of Alzheimer’s disease; the anticipated benefits and
potential of Biogen’s collaboration arrangements with Eisai; the
potential of Biogen’s commercial business and pipeline programs,
including aducanumab; and risks and uncertainties associated with
drug development and commercialization. These statements may be
identified by words such as “aim,” “anticipate,” “believe,”
“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 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 Biogen’s
drug candidates, including aducanumab; 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;
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 Biogen’s
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 Biogen’s 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 Biogen’s
expectations in any forward-looking statement. Investors should
consider this cautionary statement as well as the risk factors
identified in Biogen’s most recent annual or quarterly report and
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.
Contacts |
MEDIA CONTACT:Biogen Inc.David
Caouette+ 617 679 4945public.affairs@biogen.comINVESTOR
CONTACT:Biogen Inc.Joe Mara+781 464 2442IR@biogen.com |
MEDIA CONTACT:Eisai Co.,
Ltd.Public Relations DepartmentTEL: +81-(0)3-3817-5120Eisai
Inc.Public Relations DepartmentTEL: +1-201-753-1945 INVESTOR
CONTACT:Eisai Co., Ltd.Investor Relations DepartmentTEL:
+81-(0)3-3817-5327 |
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