Eisai updates Leqembi® outlook for fiscal year 2024 (April 2024 - March 2025). Sales now expected to reach JPY 42.5 billion
Eisai updates Leqembi® outlook for fiscal year 2024 (April 2024 - March 2025). Sales now expected to reach JPY 42.5 billion |
| [07-November-2024] |
STOCKHOLM, Nov. 7, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today updated their revenue outlook for Leqembi for their 2024 fiscal year (FY), which runs from April 2024 through March 2025. Eisai now expects Leqembi sales to total JPY 42.5 billion (approximately SEK 3 billion) for the period, down from JPY 56.5 billion announced in May. This would generate approximately SEK 300 M in royalty to BioArctic in the same period. Leqembi sales for the first half of Eisai's FY2024 amounted to JPY 16.3 billion, resulting in SEK 112.4 M in royalty to BioArctic. Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and Eisai and BioArctic are currently preparing for a joint commercialization in the region. BioArctic's report for the third quarter 2024 will be published on November 14 at 08.00 a.m. CET. This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person below, on November 8, 2024, at 05.00 a.m. CET. For further information, please contact: Lecanemab is approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE and Great Britain for the treatment of MCI due to AD and mild AD dementia. Lecanemab's approvals in these countries were primarily based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall. Please find full US prescribing information here including Boxed WARNING. Lecanemab marketed in the U.S., Japan and China. Eisai has also submitted applications for approval of lecanemab in several other countries and regions, including the European Union. 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 U.S, funded by the National Institute on Aging, part of the National Institutes of Health and Eisai. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. About the collaboration between BioArctic and Eisai About BioArctic AB This information was brought to you by Cision http://news.cision.com The following files are available for download:
SOURCE BioArctic | ||||
Company Codes: Bloomberg:BIOAB@SS, ISIN:SE0010323311, RICS:BIOAB.ST, Stockholm:BIOA-B, Stockholm:BIOA-B.ST |
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