European Medicines Agency Accepts Marketing Authorization Application for Lecanemab for Treatment of Early Alzheimer’s Disease: BioArctic

Stockholm, January 27, 2023 /PR Newswire/ — Eisai, a partner of BioArctic AB (publ) (Nasdaq Stockholm: BIOA B), today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for lecanemab (US brand name: LEQEMBI™). Announced.Amyloid beta (Aβ) protofibril antibody[1], to review according to a standard timeline for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology. Upon approval of the file by EMA, BioArctic reserves the right to obtain her MEUR 5 milestone.

In the United States, the US Food and Drug Administration (FDA) has granted accelerated approval of lecanemab for the treatment of AD. January 6, 2023On the same day, Eisai submitted a Biologics Supplemental License Application (sBLA) to the FDA for approval under the conventional approval pathway based on the results of the Phase III Clarity AD validation study.of JapanEisai has submitted a manufacturing and marketing approval application to the Pharmaceuticals and Medical Devices Agency (PMDA). January 16, 2023. of ChinaEisai has started to submit data for BLA to the US National Medicines Agency (NMPA). China of December 2022.

Eisai is the global lead in the development and regulatory submission of lecanemab, with both Eisai and Biogen co-commercializing and co-promoting the product, with Eisai having final decision-making authority. . BioArctic has the rights to commercialize lecanemab in Northern Europe under certain conditions and is currently preparing for commercialization in Northern Europe jointly with Eisai. BioArctic has not incurred any development costs for lecanemab in Alzheimer’s disease and is entitled to payments related to regulatory submissions, approvals, commercial milestones and royalties for worldwide commercialization.

This information is information that BioArctic AB (publ) is required to disclose pursuant to the EU Market Abuse Regulation. Information has been released for publication through the agency of the contact below. January 27, 2023so 12:30 am (Central European Time).

For more information, please contact:
Oscar BossonVP Communications and IR
Email: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80

About lecanemab
Lecanemab (brand name in the US: LEQEMBI™) is the result of a strategic research collaboration between BioArctic and Eisai. Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody against aggregated soluble and insoluble forms of amyloid beta (Aβ). Lecanemab selectively binds to and eliminates Aβ protofibrils thought to contribute to neurotoxicity in Alzheimer’s disease. Therefore, lecanemab may affect disease pathology and slow disease progression. In the United States, LEQEMBI is approved by the U.S. Food and Drug Administration (FDA) as January 6, 2023LEQEMBI is indicated in the United States for the treatment of Alzheimer’s disease. There are no safety or efficacy data regarding initiation of treatment in earlier or later disease than studied. This indication is approved under accelerated approval based on the observed reduction in her Aβ plaques in a patient treated with LEQEMBI. Continued approval for this indication may be contingent on verification of clinical benefit in confirmatory studies. His Clarity AD trial of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. See LEQEMBI US prescribing information.

Eisai has completed a subcutaneous bioavailability study of lecanemab and subcutaneous administration is currently being evaluated in the Clarity AD open-label extension study.

ever since July 2020 Eisai’s Phase 3 clinical trial (AHEAD 3-45) is ongoing in preclinical AD patients with clinically normal and moderate or elevated brain amyloid levels. AHEAD 3-45 will be conducted as a public-private partnership between the Alzheimer’s Disease Clinical Trials Consortium. The Alzheimer’s Clinical Trials Consortium is funded by the National Institute on Aging, part of the National Institutes of Health, to provide the infrastructure for academic clinical trials in Alzheimer’s disease and related dementias in the United States. and Eisai.

ever since January 2022a tau NexGen clinical study for dominantly inherited AD (DIAD) is ongoing, and lecanemab will be administered as background anti-amyloid therapy when considering combination therapy with anti-tau therapy. Conducted by the Alzheimer’s Network Testing Unit (DIAN-TU), University of Washington medical school of St. Louis.

Collaboration between BioArctic and Eisai
Since 2005, BioArctic has had a long-term collaboration with Eisai on the development and commercialization of Alzheimer’s disease medicines. The most significant deal is the signed development and commercialization agreement for the lecanemab antibody. December 2007and a signed Alzheimer’s disease antibody BAN2401 backup development and commercialization agreement May 2015. of March 2014, Eisai and Biogen entered into a co-development and commercialization agreement for lecanemab. Eisai is in charge of clinical development, regulatory submission and commercialization of Alzheimer’s disease drugs. BioArctic has the rights to commercialize lecanemab in Northern Europe under certain conditions and is currently preparing for commercialization in Northern Europe jointly with Eisai. BioArctic has not incurred any development costs for lecanemab in Alzheimer’s disease and is entitled to payments related to regulatory submissions, approvals, commercial milestones and royalties for worldwide commercialization.

About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharmaceutical company focused on disease-modifying treatments for neurodegenerative diseases such as Alzheimer’s, Parkinson’s and ALS. BioArctic focuses on innovative therapies in areas of high unmet medical need. The company was founded in 2003 on the basis of innovative research. Uppsala University, SwedenCollaborations with universities, together with our strategically important global partner Eisai, are of great importance to our company in Alzheimer’s disease. The project portfolio is a combination of fully funded projects executed in partnership with global pharmaceutical companies and innovative in-house projects with large market and out-licensing potential. BioArctic’s Class B shares are listed on the Nasdaq Stockholm Large Cap (ticker: BIOA B). For more information on Bioarctic, please visit www.bioarctic.com.

^[1] Protofibrils are large Aβ-aggregating soluble species of 75–500 Kd.

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