TOKYO and CAMBRIDGE, Mass., June 27, 2024 (GLOBE NEWSWIRE) -- 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 (A?) monoclonal antibody "LEQEMBI(®)" (brand name in China:
"???(®)", 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 A? aggregates (protofibrils*), as well as
insoluble A? aggregates (fibrils) which are a major component of A? plaques in
AD, thereby reducing both A? protofibrils and A? 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 A?, 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 A? 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 Department
TEL: +81 (0)3-3817-5120
Eisai Inc. (U.S.) Biogen Inc.
Julie Edelman Jack Cox
+1-201-753-1945 + 1-781-464-3260
Julie_Edelman@eisai.com public.affairs@biogen.com
(mailto:Julie_Edelman@eisai.com) (mailto:public.affairs@biogen.com)
INVESTOR CONTACTS
Biogen Inc.
Eisai Co., Ltd. Chuck Triano
Investor Relations Department + 1-781-464-2442
TEL: +81 (0) 3-3817-5122 IR@biogen.com (mailto:IR@biogen.com)
Notes to Editors
1. "???(®)"(LEQEMBI(®)) Product Outline
Chinese Trade name: "???" (LEQEMBI)
Chinese generic name: ???????? (lecanemab injection)
Indication for use: Treatment of mild cognitive impairment (MCI) due to
Alzheimer's disease (AD) and mild AD dementia
Dosage 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 vial
Drug 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 (A?).(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; P10%) 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: ???) 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
(https://www.eisai.com/index.html)(for global headquarters: Eisai Co., Ltd.),
and connect with us on X (https://twitter.com/Eisai_SDGs), LinkedIn
(https://www.linkedin.com/company/eisaiglobal/) and Facebook
(https://www.facebook.com/EisaiGlobal/).
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 (http://www.biogen.com/). Follow Biogen on social
media - Facebook
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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
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PMC7037706.
3. LEQEMBI. Prescribing information. Eisai Inc. 2023.
4. 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.
5. 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.
6. 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.
7. 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.
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