BioArctic and Eisai Achieve Major Sales Milestone with Leqembi® at €200 Million

Major Sales Milestone Achieved for Leqembi®

BioArctic AB, together with its partner Eisai, has announced a significant milestone in the sales of their Alzheimer's drug, Leqembi®. The sales have reached an impressive €200 million, which pertains to the fiscal year 2024 ending in March 2025. This achievement not only reflects the growing market acceptance of Leqembi® but also entitles BioArctic to a €10 million milestone payment as per their licensing agreement with Eisai.

Background on Leqembi®

Leqembi® (lecanemab) is a cutting-edge treatment designed for patients experiencing mild cognitive impairment and early stages of Alzheimer's disease. The development of this antibody is the result of a fruitful collaboration that began in 2005 between BioArctic and Eisai. The foundation for Leqembi® was laid by the pioneering work of Professor Lars Lannfelt, who discovered the Arctic mutation linked to Alzheimer's.

Eisai has undertaken the vital role of handling clinical development, market approval applications, and commercialization efforts for lecanemab both globally and regionally. Meanwhile, BioArctic retains exclusive rights to commercialize the drug in the Nordic countries, in partnership with Eisai.

Noteworthy Approvals

Leqembi® has already received regulatory approvals in several crucial markets including the United States, Japan, China, and Great Britain. Its successful entrance into these markets was greatly supported by the positive outcomes from Eisai's Phase 3 Clarity AD clinical trial, which established Leqembi®'s efficacy in meeting primary and secondary endpoints.

In January 2025, the U.S. FDA approved a supplemental Biologics License Application allowing for less frequent intravenous dosing, aimed at enhancing patient convenience. Additionally, another application regarding a subcutaneous auto-injection formulation is under review, further exemplifying the commitment to improving the treatment experience for patients.

Continuous Research and Future Prospects

Currently, Eisai is conducting ongoing Phase 3 clinical studies (AHEAD 3-45) involving individuals who display early signs of Alzheimer's but are still clinically normal. As of October 2024, the study is fully recruited and aims to extend over four years. BioArctic is also pursuing other avenues of research targeting neurodegenerative diseases, including Parkinson's and Amyotrophic Lateral Sclerosis (ALS).

With a robust pipeline and a strategic partnership with Eisai, BioArctic is poised to make significant advancements in treating Alzheimer's disease. This ongoing cooperation has provided BioArctic with a unique position, as it does not incur development costs for Leqembi® yet stands to benefit from milestone payments and royalties on sales.

Significance of the Milestone

This €200 million sales achievement not only symbolizes the commercial viability of Leqembi® but also underscores the potential impact of innovative therapies in the fight against Alzheimer's disease. BioArctic’s unique business model allows it to leverage its scientific advancements while minimizing financial risk, creating a favorable environment for future growth.

As both companies continue to prepare for commercialization efforts in the Nordic region, they are committed to delivering solutions that can potentially alter the trajectory for individuals afflicted with Alzheimer’s disease. The joint efforts of BioArctic and Eisai highlight a shared vision of advancing neurological health through innovative research and development.

For those interested in learning more about BioArctic’s journey and their impact on Alzheimer’s treatments, more information can be found on their official website or by reaching out to their media contacts.