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BioArctic AB’s (publ) partner Eisai announced that Leqembi (generic name: lecanemab) has been launched in South Korea. Leqembi received approval in South Korea in May 2024 for treatment in adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD dementia (early AD).
Eisai estimates there were approximately 900,000 dementia patients in South Korea in 2021, with one in ten people over the age of 65 suffering from dementia, and one in five from mild cognitive impairment (MCI). It is reported that Alzheimer’s dementia patients account for about 70 percent of all dementia patients. In South Korea, Eisai will first launch Leqembi in the private market.
Leqembi selectively binds to soluble amyloid-beta (Aß) aggregates (protofibrils), as well as insoluble Aß aggregates (fibrils) which are a major component of Aß plaques in AD, thereby reducing both Aß protofibrils and Aß 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.
Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer’s disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer’s disease. BioArctic has the right to jointly commercialize Leqembi in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß).
Lecanemab is approved in the US, Japan, China, South Korea, Hong Kong, Israel, United Arab Emirates and Great Britain for the treatment of MCI due to AD and mild AD dementia. Lecanemab’s approvals in these countries, as well as the CHMP’s positive opinion, were primarily 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.
Eisai has also submitted applications for regulatory approval of lecanemab in 17 other 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) recommending approval. A supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing was submitted to the US Food and Drug Administration (FDA) in March 2024, which was accepted in June 2024. In October 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 completed in the US under Fast Track status.
Since July 2020 Eisai’s Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study 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 US, funded by the National Institute on Aging, part of the National Institutes of Health and Eisai. 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.
Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer’s disease. The most important agreements are the development and commercialization agreement for the lecanemab antibody, which was signed 2007, and the development and commercialization agreement for the antibody Leqembi back-up for Alzheimer’s disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer’s disease. BioArctic has the right to commercialize lecanemab in the Nordic region under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer’s disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales.
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases.
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