TOKYO and CAMBRIDGE,
Mass., May 9, 2022 /PRNewswire/ -- Eisai Co.,
Ltd. (Headquarters: Tokyo, CEO:
Haruo Naito, "Eisai") and Biogen
Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today that
Eisai has completed the rolling submission to the U.S. Food and
Drug Administration (FDA) of a Biologics License Application (BLA)
under the accelerated approval pathway for the investigational
anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401) for
the treatment of mild cognitive impairment (MCI) due to Alzheimer's
disease (AD) and mild AD (collectively known as early AD) with
confirmed presence of amyloid pathology in the brain. As part of
the completed rolling submission, Eisai has requested Priority
Review. If the FDA accepts the BLA, the Prescription Drug User Fee
Act (PDUFA) action date (target date for completion of examination)
will be set. While Eisai is currently submitting lecanemab under
the accelerated approval pathway, the lecanemab Phase 3
confirmatory Clarity AD clinical trial conducted with 1,795
patients will report out in the Fall of 2022. The FDA has agreed
that the results of Clarity AD, when completed, can serve as the
confirmatory study to verify the clinical benefit of lecanemab.
Dependent upon the results of the Clarity AD clinical trial, Eisai
may submit for full approval of lecanemab to the FDA during fiscal
year 2022.
The BLA submission for lecanemab is based on clinical, biomarker
and safety data from the proof-of-concept Phase 2b (Study 201 Core) in 856 people with early AD
with confirmed presence of amyloid pathology, biomarker and safety
data from the Study 201 OLE (open-label extension study,
180 subjects), and blinded safety data from the confirmatory
Clarity AD Phase 3 study (1,795 subjects). The large number of
participants across these studies provides the FDA with extensive
safety data. Study 201 explored the impact of treatment with
lecanemab on reducing amyloid plaque and clinical decline. At 18
months of treatment, 10 mg/kg biweekly lecanemab reduced brain
amyloid by a mean of 0.306 SUVr units (from a baseline mean of
1.37), and over 80% of subjects became amyloid negative by visual
read. Furthermore, the extent of reduction in amyloid was
correlated with slower clinical decline on ADCOMS (Alzheimer's
Disease Composite Score), CDR-SB (Clinical Dementia
Rating-Sum-of-Boxes), and ADAS-cog (Alzheimer Disease Assessment
Scale-Cognitive Subscale) at the treatment group and patient level.
In the Core study, the overall rate of amyloid-related imaging
abnormalities-edema/effusion (ARIA-E), an adverse event associated
with anti-amyloid beta antibodies therapies was 9.9% (16/161) of
patients treated with lecanemab 10 mg/kg biweekly compared with
0.8% (2/245) of placebo patients. The results from Study 201
were published in a peer-reviewed journal Alzheimer's Research
and Therapy in April 2021.
"We would like to thank the people living with early AD and the
healthcare professionals who participated in the lecanemab 201
study for their cooperation allowing completion of this BLA to the
U.S. FDA. Alzheimer's disease is a progressive and devastating
disease with few treatment options," said Haruo Naito, Chief Executive Officer at Eisai
Co., Ltd. "Eisai employees have spent time with people living with
Alzheimer's disease and their families to truly understand their
feelings and challenges and have been working to create new
treatments for many years. Our comprehensive medicine creation
approach along the Alzheimer's disease continuum reflects Eisai's
long-term commitment to providing innovative treatments to the
people living with AD, their families and healthcare professionals
who urgently need new treatment options."
"With Alzheimer's disease, patients and their loved ones don't
have the luxury of time. There is an enormous unmet need in this
space, and we continue to make progress in advancing additional
treatment options for people living with this devastating disease,"
said Michel Vounatsos, Chief
Executive Officer at Biogen. "Anti-amyloid antibodies are a new
wave of important medicines, which could provide patients and their
physicians more options in addressing this complex disease."
Lecanemab was granted Breakthrough Therapy and Fast Track
designations by the FDA in June and December
2021, respectively. In March
2022, Eisai initiated submission of application data to the
Pharmaceuticals and Medical Devices Agency (PMDA) under the prior
assessment consultation system in Japan with the aim of obtaining early approval
for lecanemab, and aims to file for the manufacturing and marketing
approval based on the results of Clarity AD during Eisai's fiscal
year 2022.
Eisai serves as the lead of lecanemab development and regulatory
submissions globally with both Eisai and Biogen co-commercializing
and co-promoting the product and Eisai having final decision-making
authority.
Contacts
|
|
MEDIA CONTACT:
|
MEDIA
CONTACT:
|
Eisai Co., Ltd.
|
Biogen Inc.
|
Public Relations
Department
|
Ashleigh
Koss
|
TEL:
+81-(0)3-3817-5120
|
+
1-908-205-2572
|
|
public.affairs@biogen.com
|
Eisai Inc. (U.S.)
|
|
Laura DiBenedetto
|
INVESTOR
CONTACT:
|
+ 1-551-815-9468
|
Biogen Inc.
|
Laura_DiBenedetto@eisai.com
|
Mike Hencke
|
|
+
1-781-464-2442
|
INVESTOR CONTACT:
|
IR@biogen.com
|
Eisai Co.,
Ltd.
|
|
Investor Relations
Department
|
|
TEL:
+81-(0)70-8688-9685
|
|
[Notes to editors]
1. About Lecanemab
(BAN2401)
Lecanemab is an investigational humanized
monoclonal antibody for Alzheimer's disease (AD) that is the result
of a strategic research alliance between Eisai and BioArctic.
Lecanemab selectively binds to neutralize and eliminate soluble,
toxic amyloid-beta (Aβ) aggregates (protofibrils) that are thought
to contribute to the neurodegenerative process in AD. As such,
lecanemab may have the potential to have an effect on disease
pathology and to slow down the progression of the disease.
Currently, lecanemab is being developed as the only anti- Aβ
antibody that can be used for the treatment of early AD without the
need for titration. With regard to the results from pre-specified
analysis at 18 months of treatment, Study 201 demonstrated
reduction of brain Aβ accumulation (P<0.0001) and slowing of
disease progression measured by ADCOMS* (P<0.05) in early AD
patients. The study did not achieve its primary outcome measure**
at 12 months of treatment. The Study 201 open-label extension was
initiated after completion of the Core period and a Gap period off
treatment of 9-59 months (average of 24 months, n=180 from core
study enrolled) to evaluate safety and efficacy, and is
underway.
Currently, lecanemab is being studied in a confirmatory Phase 3
clinical study in symptomatic early AD (Clarity-AD), following the
outcome of the Phase 2 clinical study (Study 201). Since
July 2020 the Phase 3 clinical study
(AHEAD 3-45) for individuals with preclinical AD, meaning they are
clinically normal and have intermediate or elevated levels of
amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a
public-private partnership between the Alzheimer's Clinical Trial
Consortium that provides the infrastructure for academic clinical
trials in AD and related dementias in the U.S, funded by the
National Institute on Aging, part of the National Institutes of
Health, Eisai and Biogen. Since January
2022, the Tau NexGen clinical study for Dominantly Inherited
Alzheimer's disease (DIAD), that is conducted by Dominantly
Inherited Alzheimer Network Trials Unit (DIAN-TU), led by
Washington University School of
Medicine in St. Louis, is
ongoing. Furthermore, Eisai has initiated a lecanemab
subcutaneous dosing Phase 1 study. Eisai obtained the global rights
to study, develop, manufacture and market lecanemab for the
treatment of AD pursuant to an agreement concluded with BioArctic
in December 2007.
* Developed by Eisai, ADCOMS (AD Composite Score) combines items
from the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive
subscale), CDR (Clinical Dementia Rating) and the MMSE (Mini-Mental
State Examination) scales to enable a sensitive detection of
changes in clinical functions of early AD symptoms and changes in
memory. The ADCOMS scale ranges from a score of 0.00 to 1.97, with
higher score indicating greater impairment.
** An 80% or higher estimated probability of demonstrating 25%
or greater slowing in clinical decline at 12 months treatment
measured by ADCOMS from baseline compared to placebo.
2. About the Collaboration between Eisai
and Biogen for Alzheimer's Disease
Eisai and Biogen are
collaborating on the joint development and commercialization of AD
treatments. Eisai serves as the lead in the co-development of
lecanemab.
3. About the Collaboration between Eisai
and BioArctic for Alzheimer's Disease
Since 2005, BioArctic
has had a long-term collaboration with Eisai regarding the
development and commercialization of drugs for the treatment of AD.
The commercialization agreement on the lecanemab antibody was
signed in December 2007, and the
development and commercialization agreement on the antibody
lecanemab back-up for AD, which was signed in May 2015. Eisai is responsible for the clinical
development, application for market approval and commercialization
of the products for AD. BioArctic has no development costs for
lecanemab in AD.
4. 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.
5. 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 our 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
lecanemab; the potential benefits, safety and efficacy of
lecanemab; potential regulatory discussions, submissions and
approvals and the timing thereof; the expected data readout for the
Clarity AD study; 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 lecanemab; 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
studies may not be indicative of full results or results from later
stage or larger scale clinical studies 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 studies, including the Clarity AD clinical trial
and AHEAD 3-45 study; the occurrence of adverse safety events;
risks of unexpected costs or delays; the risk of other unexpected
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 Biogen's drug
candidates, including lecanemab; actual timing and content of
submissions to and decisions made by the regulatory authorities
regarding lecanemab; uncertainty of success in the development and
potential commercialization of lecanemab; 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.
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SOURCE Eisai Inc.