Leqembi Approved for Alzheimer's Treatment in Hong Kong

STOCKHOLM, July 11, 2024 — BioArctic AB's partner Eisai announced that the Department of Health in Hong Kong has approved Leqembi® (generic name: lecanemab) for treating Alzheimer's disease (AD). Leqembi is indicated for patients with mild cognitive impairment (MCI) or those in the mild dementia stage, similar to the demographics involved in its clinical trials. This approval makes Hong Kong the fifth region to approve Leqembi, following the United States, Japan, China, and South Korea.

The approval in Hong Kong is grounded on the Phase 3 Clarity AD study, which confirmed Leqembi's efficacy by meeting its primary and all key secondary endpoints with statistically significant results. Dementia affects 9.3% of individuals aged 70 and older in Hong Kong, with Alzheimer's disease accounting for 73.5% of dementia cases in those aged 85 and above.

Leqembi functions by selectively targeting and binding to both soluble and insoluble amyloid-beta (Aβ) aggregates in the brain. These aggregates are major contributors to the formation of Aβ plaques associated with Alzheimer's disease. By reducing both Aβ protofibrils and Aβ plaques, Leqembi has been shown to slow cognitive and functional decline in patients. It is the first approved treatment to demonstrate a reduction in the rate of disease progression through this specific mechanism.

Leqembi's development is the result of a long-term collaboration between BioArctic and Eisai. The antibody was initially developed by BioArctic, based on the discoveries of Professor Lars Lannfelt and his research on the Arctic mutation related to Alzheimer's disease. Eisai has taken responsibility for the clinical development, regulatory approval, and commercialization of Leqembi for Alzheimer's disease. BioArctic, although not bearing development costs for Leqembi, is eligible for regulatory approval payments, sales milestones, and a 9% royalty on global sales. Additionally, BioArctic has the rights to commercialize Leqembi in the Nordic region, contingent on European approval. Currently, BioArctic and Eisai are preparing for joint commercialization in this region.

Lecanemab, also known as Leqembi, is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody designed to target aggregated forms of amyloid-beta. Besides Hong Kong, it has already been approved in the U.S., Japan, China, and South Korea. The approval in these countries mirrors its use for treating mild cognitive impairment or mild Alzheimer's dementia. The approvals followed the successful results of the Clarity AD study, which 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 submitted applications for approval in 13 other countries and regions, including the European Union. In the U.S., a supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted in March 2024, with a rolling submission for a subcutaneous injection formulation starting in May 2024 to increase patient convenience.

The AHEAD 3-45 study, initiated in July 2020 by Eisai, is a Phase 3 clinical trial for individuals with preclinical Alzheimer's disease in the U.S. This study is part of a public-private partnership involving the Alzheimer's Clinical Trial Consortium and is funded by the National Institute on Aging and Eisai. Additionally, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD), led by Washington University School of Medicine in St. Louis, includes lecanemab as the primary anti-amyloid therapy.

Since 2005, BioArctic has maintained a long-term collaboration with Eisai, focusing on developing and commercializing treatments for Alzheimer's disease. Significant agreements include the Development and Commercialization Agreement for lecanemab in 2007 and a similar agreement in 2015 for a back-up antibody. BioArctic retains the right to commercialize lecanemab in the Nordic region and is currently preparing for this with Eisai. BioArctic bears no development costs for lecanemab and is entitled to payments related to regulatory approvals, sales milestones, and global sales royalties.

BioArctic AB is a Swedish biopharma company focused on developing innovative treatments for neurodegenerative diseases. The company invented Leqembi, the first drug proven to slow Alzheimer's disease progression and mitigate cognitive impairment. BioArctic's broad research portfolio includes projects targeting Parkinson's disease, ALS, and other Alzheimer's disease therapies, utilizing proprietary BrainTransporter™ technology to enhance treatment efficacy. BioArctic is listed on Nasdaq Stockholm Large Cap.