Leqembi approved to treat Alzheimer's in Israel

STOCKHOLM, July 12, 2024 -- BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai has announced the approval of Leqembi® (lecanemab) for the treatment of Alzheimer's disease (AD) in Israel. This development marks Israel as the sixth territory to approve the drug following the United States, Japan, China, South Korea, and Hong Kong. Leqembi is recommended for patients with mild cognitive impairment (MCI) or those in the early stages of dementia, reflecting the treatment scope observed during clinical trials.

The approval in Israel is underpinned by the Phase 3 Clarity AD study. The study demonstrated that Leqembi achieved its primary endpoint and all key secondary endpoints with statistically significant results. Leqembi works by selectively binding to both soluble amyloid-beta (Aβ) aggregates, known as protofibrils, and insoluble Aβ aggregates or fibrils, which are key components of Aβ plaques in AD. This action reduces both protofibrils and plaques in the brain, slowing the progression of the disease and cognitive decline.

Leqembi's success is the result of a long-term collaboration between BioArctic and Eisai. Initially developed by BioArctic, based on Professor Lars Lannfelt's discovery of the Arctic mutation in Alzheimer's disease, Eisai took charge of the clinical development, market approval applications, and commercialization of the drug. BioArctic, although not bearing the development costs for Leqembi in Alzheimer's disease, stands to benefit from regulatory approvals and sales milestones, along with a royalty of 9 percent on global sales. Additionally, BioArctic holds the right to commercialize Leqembi in the Nordic region, pending European approval, with preparations for joint commercialization with Eisai currently underway.

Leqembi's development and approval journey have been significant. The drug, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody, targets aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Its approval has been substantiated by the large Phase 3 Clarity AD study, whose results were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference and published in the New England Journal of Medicine.

Eisai has also pushed forward with applications for Leqembi's approval in 12 other countries and regions, including the European Union. In the United States, Eisai submitted a supplemental Biologics License Application (sBLA) for intravenous maintenance dosing in March 2024. The rolling submission for a subcutaneous injection formulation began in May 2024 under Fast Track status to enhance patient convenience.

Eisai's clinical research extends beyond Leqembi. Since July 2020, they have been conducting the Phase 3 AHEAD 3-45 clinical study in individuals with preclinical Alzheimer's disease, in collaboration with the Alzheimer's Clinical Trial Consortium and funded by the National Institute on Aging. Additionally, since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) has been ongoing, led by Washington University School of Medicine in St. Louis, and includes lecanemab as the foundational anti-amyloid therapy.

BioArctic and Eisai have a long-standing partnership dating back to 2005, aimed at developing and commercializing Alzheimer’s treatments. Key agreements include the 2007 Development and Commercialization Agreement for the lecanemab antibody and a 2015 agreement for an antibody backup for Alzheimer’s. BioArctic has the right to commercialize lecanemab in the Nordic region and is preparing for its commercialization together with Eisai.

BioArctic AB is a Swedish biopharmaceutical company dedicated to innovative treatments for neurodegenerative diseases, including Alzheimer's. The company developed Leqembi, the first drug proven to slow disease progression and reduce cognitive impairment in early Alzheimer’s. BioArctic's research portfolio also includes projects targeting Parkinson's disease and ALS, utilizing their proprietary BrainTransporter™ technology to enhance treatment efficacy. BioArctic’s B share is listed on Nasdaq Stockholm Large Cap.

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