TOKYO and CAMBRIDGE,
Mass., Nov. 27, 2024
/PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo
Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate
headquarters: Cambridge,
Massachusetts, CEO: Christopher A. Viehbacher,
"Biogen") announced today that the humanized anti-soluble
aggregated amyloid-beta (Aβ) monoclonal antibody
"LEQEMBI®" has been launched in South Korea. LEQEMBI received the Ministry of
Food and Drug Safety (MFDS) approval in May
2024 for treatment in adult patients with mild cognitive
impairment due to Alzheimer's disease (AD) or mild AD dementia
(early AD).
LEQEMBI selectively binds to soluble Aβ aggregates
(protofibrils*), as well as insoluble Aβ aggregates (fibrils) which
are a major component of Aβ plaques in AD, thereby reducing both Aβ
protofibrils and Aβ plaques in the brain. LEQEMBI is the first
approved treatment shown to reduce the rate of disease progression
and to slow cognitive and functional decline through this
mechanism.
It is estimated there were approximately 900,000 dementia
patients in South Korea in
2021,1 with one in ten people over the age of 65
suffering from dementia,1 and one in five from mild
cognitive impairment (MCI).2 It is reported that
Alzheimer's dementia patients account for about 70% of all dementia
patients.2 The average annual nursing care/medical costs
per dementia patient is estimated to be 21.1
million South Korean Won (KRW), while the cost for patients
with severe dementia reaches 33.1 million
KRW.1
Eisai serves as the lead of LEQEMBI development and regulatory
submissions globally with both Eisai and Biogen co-commercializing
and co-promoting the product and Eisai having final decision-making
authority. In South Korea, Eisai
Korea Inc. will distribute the product and conduct information
provision activities.
Eisai Korea Inc. has been a pioneer in the field of dementia for
many years, focusing on activities such as raising disease
awareness. In recent years, Eisai Korea Inc. has been working with
various stakeholders, including healthcare professionals, academic
societies, patient groups, care centers, health checkup companies,
and diagnostic companies, to create a dementia ecosystem that
promotes AD awareness and early diagnosis/treatment. Eisai
Korea Inc. will first launch this drug in the private market,
including the establishment of a Patient Assistance Program, to
deliver lecanemab to patients awaiting the treatment, aiming to
make an impact not only on patients but also on their caregiving
families and South Korean society.
* Protofibrils are believed to contribute to the brain injury
that occurs with AD and are considered to be the most toxic form of
Aβ, having a primary role in the cognitive decline associated with
this progressive, debilitating condition.3 Protofibrils
cause injury to neurons in the brain, which in turn, can negatively
impact cognitive function via multiple mechanisms, not only
increasing the development of insoluble Aβ plaques but also
increasing direct damage to brain cell membranes and the
connections that transmit signals between nerve cells or nerve
cells and other cells. It is believed the reduction
of protofibrils may prevent the progression of AD by reducing
damage to neurons in the brain and cognitive
dysfunction.4
Notes to Editors
1. About Lecanemab
Lecanemab is
the result of a strategic research alliance between Eisai and
BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1)
monoclonal antibody directed against aggregated soluble
(protofibril) and insoluble forms of amyloid-beta (Aβ).
Lecanemab is approved in the U.S., Japan, China,
South Korea, Hong Kong, Israel, the United
Arab Emirates and Great
Britain for the treatment of Alzheimer's disease (AD) in
patients with Mild Cognitive Impairment (MCI) or mild dementia
stage of disease (collectively referred to as early AD). The
treatment's approvals in these countries was based on Phase 3 data
from Eisai's global Clarity AD clinical trial, in which it met its
primary endpoint and all key secondary endpoints with statistically
significant results. The most common adverse events (>10%) in
the lecanemab group were infusion reactions, ARIA-H (combined
cerebral microhemorrhages, cerebral macrohemorrhages, and
superficial siderosis), ARIA-E (edema/effusion), headache, and
fall.
Lecanemab is marketed in the U.S., Japan, China,
Great Britain and others, and is
under regulatory review in 17 countries and regions, including the
European Union. In November 2024, the
treatment received positive opinion from the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) recommending approval.
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 AD (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
and includes lecanemab as the backbone anti-amyloid therapy.
2. About the Collaboration between Eisai
and Biogen for AD
Eisai and Biogen have been collaborating on the joint development
and commercialization of AD treatments since 2014. Eisai serves as
the lead of lecanemab development and regulatory submissions
globally with both companies co-commercializing and co-promoting
the product and Eisai having final decision-making authority.
3. About the Collaboration between Eisai
and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration
regarding the development and commercialization of AD treatments.
Eisai obtained the global rights to study, develop, manufacture and
market lecanemab for the treatment of AD pursuant to an agreement
with BioArctic in December 2007. The
development and commercialization agreement on the antibody back-up
was signed in May 2015.
4. About Eisai Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and
people in the daily living domain, and to increase the benefits
that health care provides." Under this Concept (also known as human
health care (hhc) Concept), we aim to effectively achieve
social good in the form of relieving anxiety over health and
reducing health disparities. With a global network of R&D
facilities, manufacturing sites and marketing subsidiaries, we
strive to create and deliver innovative products to target diseases
with high unmet medical needs, with a particular focus in our
strategic areas of Neurology and Oncology.
In addition, we demonstrate our commitment to the elimination of
neglected tropical diseases (NTDs), which is a target (3.3) of the
United Nations Sustainable Development Goals (SDGs), by working on
various activities together with global partners.
For more information about Eisai, please visit
www.eisai.com (for global headquarters: Eisai Co., Ltd.), and
connect with us on X, LinkedIn and Facebook.
5. About Biogen
Founded in 1978, Biogen is a leading biotechnology company that
pioneers innovative science to deliver new medicines to transform
patients' lives and to create value for shareholders and our
communities. We apply deep understanding of human biology and
leverage different modalities to advance first-in-class treatments
or therapies that deliver superior outcomes. Our approach is to
take bold risks, balanced with return on investment to deliver
long-term growth.
The company routinely posts information that may be important to
investors on its website at www.biogen.com. Follow Biogen on
social media – Facebook, LinkedIn, X, YouTube.
Biogen Safe Harbor
This news release contains forward-looking statements, 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 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.
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; 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; and third party
collaboration risks, 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 speak only as of the date of this news
release. Biogen does not undertake any obligation to publicly
update any forward-looking statements.
References
- Korean dementia observatory 2022: National Institute of
Dementia (Korean)
- Korean dementia observatory 2021: National Institute of
Dementia (Korean)
- Amin L, Harris DA. Aβ receptors specifically recognize
molecular features displayed by fibril ends and neurotoxic
oligomers. Nat Commun.
2021;12:3451. doi:10.1038/s41467-021-23507-z
- Ono K, Tsuji M. Protofibrils of Amyloid-β are Important
Targets of a Disease-Modifying Approach for Alzheimer's Disease.
Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952.
PMID: 32023927; PMCID: PMC7037706.
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SOURCE Eisai Inc.