Leqembi approved for the treatment of Alzheimer's disease in Israel
BioArctic's partner Eisai announced that Leqembi® (lecanemab) has been approved for Alzheimer's disease (AD) treatment in Israel. The approval is based on the Phase 3 Clarity AD study, which showed that Leqembi met its primary and secondary endpoints with statistically significant results. Israel is the sixth region to approve Leqembi, following the US, Japan, China, South Korea, and Hong Kong. Leqembi works by selectively binding to amyloid-beta aggregates, reducing plaques in the brain. BioArctic, which developed the antibody, will receive milestone payments, a 9% royalty on global sales, and has the right to commercialize Leqembi in the Nordic region.
- Leqembi approved for Alzheimer's treatment in Israel, the sixth territory globally.
- Phase 3 Clarity AD study met all endpoints with statistically significant results.
- BioArctic to receive milestone payments and a 9% royalty on global sales.
- None.
Insights
The approval of Leqembi in Israel signifies a considerable step forward in the treatment of Alzheimer's disease (AD). This medication specifically targets and binds to amyloid-beta (Aβ) aggregates, reducing both soluble and insoluble forms that form plaques in the brain. Such plaques are a hallmark of AD pathology and their reduction is associated with a slower progression of the disease. While leveraging a mechanism that has shown success in clinical trials, it's important for investors to note the significance of clinical endpoints in the Phase 3 Clarity AD study, which Leqembi met comprehensively.
From a clinical perspective, the drug's ability to slow cognitive and functional decline is particularly noteworthy for an investor. This aspect could make Leqembi a significant player in the AD drug market. The approval in Israel, as the sixth territory, also indicates a growing confidence in the drug's efficacy, widening its potential market reach. For investors, this signifies not only immediate sales potential but also long-term revenue possibilities as Leqembi becomes a cornerstone in AD treatment globally.
BioArctic's financial positioning concerning Leqembi is quite strong. Given that the company incurs no development costs and stands to benefit from milestone payments and a
Additionally, BioArctic's right to commercialize Leqembi in the Nordic region, contingent on European approval, provides a future revenue stream. Investors should monitor these potential regulatory milestones as they may significantly amplify BioArctic's financial health. Despite the lack of immediate revenue from Nordic commercialization, the preparatory steps taken highlight prudent forward-planning and risk management, enhancing long-term investor confidence.
From a market perspective, Leqembi's approval in Israel points to a steadily increasing acceptance of the drug across diverse geographies. With Alzheimer's disease being a global concern, the broadening approval base amplifies the drug's market potential and validates its clinical efficacy. The fact that it is the first treatment shown to reduce both disease progression and cognitive decline marks it as a breakthrough in the AD market, likely driving demand.
For investors, it’s important to understand Leqembi's position amidst competitive products. Its unique mechanism of action and proven clinical benefits give it a competitive edge, potentially capturing a substantial market share. Furthermore, the collaborative framework between BioArctic and Eisai ensures sustained marketing and development efforts, important for maintaining market momentum.
Leqembi's approval in
Leqembi selectively binds to soluble amyloid-beta (Aβ) aggregates (protofibrils[2]), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques in AD, thereby reducing both Aβ protofibrils and Aβ 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 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.
The information was released for public disclosure, through the agency of the contact persons below, on July 12, 2024, at 01:30 a.m. CET
For further information, please contact:
Oskar Bosson, VP Communications and IR
E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80
Jiang Millington, Director Corporate Communication and Social Media
E-mail: jiang.millington@bioarctic.se
Phone: +46 79 33 99 16
About lecanemab (generic name, brand name: Leqembi®)
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 (Aβ). Lecanemab is approved in the
Lecanemab approvals were based on the large global Phase 3 Clarity AD study. In the Clarity AD study, lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.
Eisai has also submitted applications for approval of lecanemab in 12 countries and regions, including the European Union (EU). A supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted to the
Since July 2020 Eisai's Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the
About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has 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. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.
[1] van Dyck, H., et al. Lecanemab in Early Alzheimer's Disease. New England Journal of Medicine. 2023;388:9-21. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948
[2] Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition. Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.
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