BioArctic AB reported a substantial increase in royalties from Leqembi (lecanemab) in its Q3 2024 interim report, alongside promising advancements in its BrainTransporter technology. The company's partner, Eisai, is actively pursuing regulatory approvals and expanded access for Leqembi globally, while BioArctic continues to innovate in neurodegenerative disease therapies.
Leqembi Global Expansion and Market Dynamics
Leqembi has recently been approved and launched in Hong Kong, Israel, the United Arab Emirates, and Great Britain, contributing to a significant boost in royalty revenues for BioArctic. Royalties for Leqembi reached SEK 69.8 million, a notable increase from SEK 2.5 million in the same period last year. However, the European Medicines Agency (EMA) issued a negative opinion on the Marketing Authorisation Application for lecanemab, which Eisai has requested for re-examination. Eisai has also requested a reconsideration from the Australian Medicines Agency (TGA) after an initial decision not to approve lecanemab.
Despite these regulatory hurdles, the US market for Leqembi continues to grow, with Japan and China developing above expectations. Eisai is addressing bottlenecks in the US healthcare system related to infusion capacity to improve patient access. However, Eisai has lowered its Leqembi sales outlook for fiscal year 2024 (April 2024 – March 2025) to JPY 42.5 billion, which would generate approximately SEK 300 million in royalty to BioArctic.
Long-Term Lecanemab Data and Subcutaneous Administration
Data from the lecanemab three-year extension study (OLE) demonstrated continued and increasing patient benefit, with a maintained safety profile. Eisai presented data at the CTAD congress, highlighting that about half of the patients with low amyloid levels at the start of treatment either improved or remained at the same cognitive level during three years of lecanemab treatment. These results support the ongoing phase 3 study AHEAD 3-45, which is evaluating lecanemab in individuals with preclinical Alzheimer's disease. The study was fully recruited in October.
Eisai has completed the stepwise application for subcutaneous maintenance therapy with Leqembi in the US, with potential approval expected by next summer. This could significantly increase the number of patients who can benefit from the treatment, especially when combined with better diagnostics.
BrainTransporter Technology
BioArctic's proprietary BrainTransporter platform shows potential for significantly enhancing antibody delivery to the brain. Preclinical data presented at the PEGS conference in Barcelona demonstrated up to 70 times higher brain exposure of amyloid-beta antibodies, with rapid and broad distribution throughout the brain. According to BioArctic, this technology could potentially provide better clinical efficacy, fewer side effects, and lower doses compared to current treatments. The technology is being applied across BioArctic's project portfolio, with the first BrainTransporter project expected to enter the clinic within a couple of years.
Gunilla Osswald, CEO of BioArctic AB, stated, "Our BrainTransporter technology provides up to 70 times higher brain exposure of amyloid-beta antibodies with a rapid, broad and deep distribution."
Parkinson's Disease Program
BioArctic is preparing to dose the first patient in the phase 2a exidavnemab study for Parkinson's disease. Screening to find suitable patients is ongoing, with the first patient expected to start treatment before the end of the year. The company is also advancing PD-BT2238, a BrainTransporter-linked alpha-synuclein antibody, in Parkinson's disease research.
