BioArctic AB?s (publ) partner Eisai announced that the Department of Health in Hong Kong has approved Leqembi for treatment of Alzheimer?s disease (AD). Treatment with Leqembi should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Hong Kong is the fifth approval following the US, Japan, China and South Korea.

Leqembi?s approval in Hong Kong is based on the large global Phase 3 Clarity AD study. In the Clarity AD study, Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results. In Hong Kong, 9.3% of people aged 70 years and older are living with dementia, and 32% of those aged 85 years and older, of whom 73.5% are reported to have Alzheimer's disease.

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 no development costs for Leqembi in Alzheimer?s disease and is entitled to payments in connection with certain regulatory approvals, and sales milestones as well as royalty of 9% on global sales. In addition, BioArctic has the right to commercialize Leqembi in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.