BioArctic’s Partner Eisai Gets Approval for Leqembi to Treat Alzheimer’s Disease in Israel

Overview

BioArctic AB’s partner Eisai announced that Leqembi (generic name: lecanemab) has been approved for treatment of Alzheimer’s disease (AD) in Israel. 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. Israel is the sixth territory to approve Leqembi following the US, Japan, China, South Korea and Hong Kong.

Phase 3 Clarity AD Study 

Leqembi’s approval in Israel 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.

Leqembi: MOA

• 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 world’s first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.

Leqembi: the Collaboration Between Bioarctic and Eisai

• 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 percent 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.

About Lecanemab

• Lecanemab (Leqembi) 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 also approved in the US, Japan, China, and South Korea, Hong Kong.

Since 2005, BioArctic had 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.

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