TOKYO and CAMBRIDGE, Mass., Nov. 27, 2024 – Eisai Co., Ltd. and Biogen Inc. are expanding the reach of Alzheimer’s treatment with the launch of LEQEMBI® in South Korea. This humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, already approved by the Ministry of Food and Drug Safety (MFDS) in May 2024, marks a significant step forward in addressing early Alzheimer’s disease (AD). To ensure broad access to this groundbreaking therapy, Eisai Korea Inc. is pioneering the Eisai Primary Care Assistance Program, designed to support patients in South Korea who are seeking treatment for mild cognitive impairment due to Alzheimer’s or mild AD dementia.
Eisai logo (PRNewsfoto/Eisai Inc.)
LEQEMBI stands out as the first approved treatment demonstrating a reduction in the rate of disease progression and a deceleration of cognitive and functional decline in early Alzheimer’s patients. It achieves this by selectively targeting soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), both key components of amyloid plaques in the brain. By reducing both protofibrils and plaques, LEQEMBI addresses the underlying pathology of Alzheimer’s disease. Protofibrils, in particular, are considered highly toxic and are believed to play a primary role in the cognitive decline associated with Alzheimer’s.
The launch in South Korea comes at a critical time, as estimates from 2021 indicate approximately 900,000 dementia patients in the country. Alarmingly, one in ten individuals over 65 suffers from dementia, and one in five experiences mild cognitive impairment (MCI). Alzheimer’s dementia accounts for about 70% of all dementia cases, placing a significant burden on individuals, families, and the healthcare system. The economic impact is substantial, with average annual nursing care and medical costs per dementia patient reaching 21.1 million South Korean Won (KRW), and soaring to 33.1 million KRW for severe dementia cases.
Eisai is taking the lead in the global development and regulatory submissions for LEQEMBI, with co-commercialization and co-promotion efforts in partnership with Biogen. Eisai retains final decision-making authority, ensuring a unified strategy for bringing this vital treatment to patients worldwide. In South Korea, Eisai Korea Inc. will manage distribution and information dissemination, leveraging its established presence and expertise in the region.
Eisai Korea Inc. has a long-standing commitment to the field of dementia, actively working to raise disease awareness and support the dementia community. Recognizing the importance of a comprehensive approach, Eisai Korea Inc. collaborates with various stakeholders, including healthcare professionals, academic societies, patient advocacy groups, care centers, health checkup companies, and diagnostic firms. This collaborative ecosystem aims to enhance AD awareness and promote early diagnosis and treatment, paving the way for more effective interventions.
The Eisai Primary Care Assistance Program is a cornerstone of Eisai Korea’s launch strategy. Initially available in the private market, this program is designed to facilitate access to lecanemab for patients awaiting treatment. By establishing this patient-centric program, Eisai aims to extend the positive impact of LEQEMBI beyond just patients, reaching their caregiving families and contributing to the broader South Korean society. This initiative underscores Eisai’s commitment to not only providing innovative treatments but also ensuring these treatments are accessible and supported by comprehensive patient care programs.
Protofibrils, targeted by LEQEMBI, are increasingly recognized as key contributors to the neuronal injury in Alzheimer’s disease. They are considered the most toxic form of Aβ, directly damaging neurons and disrupting cognitive function through multiple pathways. Beyond contributing to plaque formation, protofibrils can directly harm brain cell membranes and disrupt the crucial connections between nerve cells. By reducing protofibrils, LEQEMBI offers a disease-modifying approach that may prevent the progression of Alzheimer’s by mitigating neuronal damage and cognitive decline.
Key Aspects of Lecanemab (LEQEMBI):
Developed through a strategic alliance between Eisai and BioArctic, lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody. Its unique mechanism targets both soluble (protofibril) and insoluble forms of amyloid-beta (Aβ), offering a comprehensive approach to amyloid reduction.
LEQEMBI has received regulatory approvals in multiple countries, including the United States, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain. These approvals are based on robust Phase 3 clinical data from Eisai’s global Clarity AD trial. The Clarity AD trial demonstrated statistically significant results across primary and all key secondary endpoints, confirming LEQEMBI’s clinical efficacy. The most common adverse events observed in the lecanemab group were infusion reactions, ARIA-H (cerebral microhemorrhages, macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and falls.
Currently marketed in the U.S., Japan, China, Great Britain and other regions, LEQEMBI is undergoing regulatory review in 17 additional countries and regions, including the European Union. In a positive step, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion in November 2024, recommending approval within the EU.
Eisai is also actively pursuing research into preclinical Alzheimer’s. The Phase 3 AHEAD 3-45 clinical study is ongoing for individuals with preclinical AD, who are clinically normal but have intermediate or elevated amyloid levels. This study is a public-private partnership with the Alzheimer’s Clinical Trial Consortium, funded by the National Institute on Aging, Eisai, and Biogen. Furthermore, lecanemab is being investigated as a backbone anti-amyloid therapy in the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), led by Washington University School of Medicine in St. Louis.
Eisai and Biogen: A Collaborative Force in Alzheimer’s Disease
Eisai and Biogen’s collaboration in Alzheimer’s treatment development and commercialization dates back to 2014. This partnership leverages the strengths of both companies, with Eisai taking the lead on lecanemab’s global development and regulatory submissions. Both companies share responsibility for co-commercializing and co-promoting LEQEMBI, while Eisai retains final decision-making authority, ensuring strategic alignment and efficient execution.
Eisai and BioArctic: A Long-Term Partnership in Alzheimer’s Research
The collaboration between Eisai and BioArctic in Alzheimer’s disease spans even further, starting in 2005. This long-term partnership underscores a shared commitment to advancing Alzheimer’s therapies. Eisai obtained global rights to lecanemab in 2007 through an agreement with BioArctic and further solidified their collaboration with an antibody back-up development and commercialization agreement in 2015.
Eisai’s Commitment to Human Health Care
Eisai’s corporate philosophy, known as the human health care (hhc) concept, prioritizes patients and their daily lives. Eisai aims to enhance healthcare benefits and contribute to social good by alleviating health anxieties and reducing health disparities. With a global network of R&D, manufacturing, and marketing facilities, Eisai focuses on developing innovative products for diseases with high unmet medical needs, particularly in neurology and oncology. Eisai is also dedicated to addressing neglected tropical diseases (NTDs), aligning with the United Nations Sustainable Development Goals.
For more information about Eisai, please visit www.eisai.com and connect with Eisai on social media platforms including X, LinkedIn, and Facebook.
Biogen: Pioneering Neuroscience
Founded in 1978, Biogen is a leading biotechnology company committed to innovative science for transformative medicines. Biogen focuses on understanding human biology and developing first-in-class therapies to improve patient lives and create value for stakeholders. Biogen emphasizes bold risk-taking balanced with investment return for long-term growth.
For further information about Biogen, visit www.biogen.com and follow Biogen on social media – Facebook, LinkedIn, X, and YouTube.
Biogen Safe Harbor Statement
This news release contains forward-looking statements regarding the potential clinical effects, benefits, safety, and efficacy of lecanemab; regulatory discussions, submissions, and approvals; Alzheimer’s disease treatment; the Eisai-Biogen collaboration; and Biogen’s commercial business and pipeline programs. These statements are subject to risks and uncertainties, including those related to drug development and commercialization, unexpected clinical trial results, regulatory hurdles, and intellectual property matters. Investors are cautioned not to place undue reliance on these statements, which speak only as of the date of this release. Biogen undertakes no obligation to update these statements. Refer to Biogen’s SEC filings for a complete discussion of risk factors.
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.
SOURCE Eisai Inc.
