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®” (brand name in China: “乐意保®”,
generic name: lecanemab) has been launched in China. LEQEMBI
received approval in January 2024 as a treatment of mild cognitive
impairment (MCI) due to Alzheimer’s disease (AD) and mild AD
dementia. China is the third country to launch LEQEMBI following
the United States and Japan.
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 world’s first and only approved treatment shown to reduce
the rate of disease progression and to slow cognitive and
functional decline through this mechanism.
Eisai estimates there will be 17 million
patients with MCI or mild dementia due to AD (collectively referred
to as early AD) in China in 2024, which is expected to increase as
the population ages. Eisai is distributing the product in
China and conducting information provision activities through
specialized Medical Representatives, while also working to build a
unique early AD diagnosis and treatment pathway that combines
online and offline services. In collaboration with commercial
health insurance companies, private health checkups, and nursing
homes, Eisai will widely provide disease awareness and
pre-screening opportunities and encourage high-risk individuals to
visit specialized hospitals early or refer them to "Yin Fa Tong,"**
an online health platform for the elderly that is focused on
dementia, developed in a joint venture with JD Health. “Yin Fa
Tong” currently has approximately 300,000 registered users and
6,000 registered physicians, and introduces information on nearby
hospitals and specialists, as well as online medical consultations,
and follow-up after LEQEMBI treatment. Eisai is also working to
build evidence for the implementation of definitive diagnosis of
early AD using blood biomarkers.
In China, LEQEMBI will first be launched in the
private market. In collaboration with Eisai, a major Chinese
medical insurance company has developed and launched a healthcare
insurance plan specifically for AD including partial coverage of
the drug cost. Through these efforts, Eisai is committed to
promoting the early detection, diagnosis, and treatment of AD in
China, building the dementia ecosystem, and supporting people with
early AD to “live their fullest lives”.
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.
* 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.1
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.2
MEDIA
CONTACTS |
|
Eisai Co., Ltd.Public Relations DepartmentTEL: +81
(0)3-3817-5120Eisai Inc. (U.S.)Julie
Edelman+1-201-753-1945Julie_Edelman@eisai.com |
Biogen Inc.Jack Cox+
1-781-464-3260public.affairs@biogen.com |
INVESTOR
CONTACTS |
|
Eisai Co., Ltd.Investor Relations DepartmentTEL:
+81 (0) 3-3817-5122 |
Biogen Inc.Chuck Triano+
1-781-464-2442IR@biogen.com |
Notes to Editors
1.
“乐意保®”(LEQEMBI®)
Product Outline
Chinese Trade name:
“乐意保” (LEQEMBI)Chinese generic name: 仑卡奈单抗注射液 (lecanemab
injection)Indication for use: Treatment of mild cognitive
impairment (MCI) due to Alzheimer’s disease (AD) and mild AD
dementiaDosage and administration: The usual dose of lecanemab
(recombinant) is 10mg/kg infused intravenously over approximately 1
hour, once every 2 weeks.Active ingredients and strength: 200mg
(2mL)/1 vialDrug price: Lecanemab injection 200mg 2,508 CNY per
vial
2. About lecanemab
(LEQEMBI®)
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).3 Lecanemab
is approved in the U.S.,4 Japan,5 China,6 and South Korea.7 In the
U.S., Japan, China and South Korea, the indications are as
follows:
- U.S.: For the treatment of
Alzheimer’s disease (AD). It should be initiated in patients with
mild cognitive impairment (MCI) or mild dementia stage of
disease.4
- Japan: For slowing progression of
MCI and mild dementia due to AD.5
- China: For the treatment of MCI due
to AD and mild AD dementia.6
- South Korea: For treatment in adult
patients with MCI due to AD or mild AD (early AD).7
|
LEQEMBI’s FDA
approval 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.8 The
primary endpoint was the global cognitive and functional scale,
Clinical Dementia Rating Sum of Boxes (CDR-SB). In the Clarity AD
clinical trial, treatment with lecanemab reduced clinical decline
on CDR-SB by 27% at 18 months compared to placebo.8 The mean CDR-SB
score at baseline was approximately 3.2 in both groups. The
adjusted least-squares mean change from baseline at 18 months was
1.21 with lecanemab and 1.66 with placebo (difference, −0.45; 95%
confidence interval [CI], −0.67 to −0.23; P<0.001).8 In
addition, the secondary endpoint from the AD Cooperative
Study-Activities of Daily Living Scale for Mild Cognitive
Impairment (ADCS-MCI-ADL), which measures information provided by
people caring for patients with AD, noted a statistically
significant benefit of 37% compared to placebo.8 The adjusted mean
change from baseline at 18 months in the ADCS-MCI-ADL score was
−3.5 in the lecanemab group and −5.5 in the placebo group
(difference, 2.0; 95% CI, 1.2 to 2.8; P<0.001).8 The ADCS
MCI-ADL assesses the ability of patients to function independently,
including being able to dress, feed themselves and participate in
community activities. 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.8
Eisai has also
submitted applications for approval of lecanemab in 14 countries
and regions, including the European Union (EU). A supplemental
Biologics License Application (sBLA) for intravenous maintenance
dosing was submitted to the U.S. Food and Drug Administration (FDA)
in March 2024, which was accepted in June 2024. The rolling
submission of a Biologics License Application (BLA) for maintenance
dosing of a subcutaneous injection formulation, which is being
developed to enhance convenience for patients, was initiated in the
U.S. under Fast Track status in May 2024.
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.
3. About Ying Fa
Tong
Yin Fa Tong is an
online business (Chinese name: 銀髪通) of Jingyi Weixiang (Shanghai)
Health Industry Development Limited Company, a joint venture
company with Eisai’s Chinese subsidiary Eisai China Holdings Ltd.
and JD Health. Yin Fa Tong is a platform that provides community
services such as self-checks for cognitive function, and
counseling, as well as medical services such as referrals to
medical institutions and online consultations, reservations, and
medical examinations. For Leqembi, Yin Fa Tong has a dedicated
dementia module that allows patients to receive online
consultations before a face-to-face appointment, as well as
referrals to hospitals where diagnostic tests can be performed
before Leqembi administration, notifications regarding the timing
of MRI scans, and online consultations during treatment.
4. 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.
5. 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 lecanemab back-up was signed in May
2015.
6. 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.
7. About
Biogen
Founded in 1978,
Biogen is a leading biotechnology company that pioneers innovative
science to deliver new medicines to transform patient’s 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 LEQEMBI; 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
LEQEMBI; 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
- 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.
- LEQEMBI. Prescribing information.
Eisai Inc. 2023.
- US Food and Drug Administration.
FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment.
Available at:
https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment.
Last accessed: June 2024.
- Eisai Global. 2023. “LEQEMBI® Intravenous Infusion” (Lecanemab)
Approved for the Treatment of Alzheimer’s Disease in Japan
Available at: https://www.eisai.com/news/2023/news202359.html. Last
accessed: June 2024.
- Eisai Global. 2024. “LEQEMBI®”
(Lecanemab) Approved for the Treatment of Alzheimer’s Disease in
China. Available at:
https://www.eisai.com/news/2024/news202403.html. Last accessed:
June 2024.
- Eisai Global. 2024. “LEQEMBI®”
(Lecanemab) Approved for the Treatment of Alzheimer’s Disease in
South Korea. Available at:
https://www.eisai.com/news/2024/news202436.html. Last accessed June
2024.
- van Dyck, H., et al. Lecanemab in
Early Alzheimer’s Disease. New England Journal of Medicine.
2023;388:9-21.
https://www.nejm.org/doi/full/10.1056/NEJMoa2212948.
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