LEQEMBI® to be launched in Japan for Alzheimer’s disease on December 20

Stockholm, Sweden, December 13, 2023 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced that LEQEMBI (lecanemab) will be launched in Japan on December 20, following its scheduled inclusion in the price listing on the Japan National Health Insurance (NHI) drug price list.

LEQEMBI obtained manufacturing and marketing approval for the indication of slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in Japan on September 25, 2023. In addition to inclusion in Japan’s NHI drug price list, the products Optimal Clinical Use Guidelines were agreed at a general meeting of the Central Social Insurance Medical Council, an advisory body of the Japanese Ministry of Heath, Labour and Welfare, held today. The launch, planned for December 20, will make Japan the second country to have the product on the market, following the U.S.

"This is a great Christmas present! Alzheimer's disease patients in Japan will now have access to the first disease modifying treatment. This gives hope for the large aging population in Japan with a great need for new treatment options," says Gunilla Osswald, CEO of BioArctic.

LEQEMBI selectively binds to soluble amyloid-beta (Aβ) aggregates (protofibrils[1]), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.

Eisai will conduct a post-marketing special use results survey in all patients who are administered LEQEMBI (all-case surveillance) until data from a certain number of patients are accumulated, in accordance with an approval condition imposed by the Ministry of Health, Labour and Welfare. In addition, the appropriate use of LEQEMBI will be promoted in accordance with the package insert and the Optimal Clinical Use Guidelines, and training materials will be provided for healthcare professionals to assist with the management and monitoring of amyloid-related imaging abnormalities (ARIA).

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 currently Eisai and BioArctic are preparing for a joint commercialization in the region... BioArctic's Press Release - Eisai's Press Release- Biogen's Press Release -

Mylan : Approval for Generic Version of Aricept® Tablets

June 7, 2011 - Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride (HCl) Tablets, 5 mg and 10 mg, the generic version of Eisai's Aricept® Tablets, which are used to treat dementia associated with Alzheimer's disease.

Donepezil HCl Tablets had U.S. sales of approximately $2.3 billion for the 12 months ending March 31, 2011, according to IMS Health. Mylan Pharmaceuticals Inc. is launching this product immediately.



Currently, Mylan has 164 ANDAs pending FDA approval representing $95.6 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2010, according to IMS Health... Mylan's Press Release -

Eisai, Application for Aricept Oral Jelly Formulation in Japan

March 14, 2008 - Eisai Co., Ltd. announced that the company submitted an application for a new oral jelly formulation of Aricept® (donepezil hydrochloride) in Japan. If approved, it will become the first Alzheimer's disease treatment available in an oral jelly formulation in the world.
Generally, Alzheimer's disease affects eldery population, and there are some patients who have difficulty swallowing a tablet or granule formulation with water due to the decline in their ability to swallow or the water enters into their trachea while taking the medication... Eisai's Press Release -

BioArctic Neuroscience and Eisai, Agreement with Novel Antibody Treatment for Alzheimer’s Disease

December 3rd 2007. The Swedish biopharmaceutical company BioArctic Neuroscience AB and the Japanese pharmaceutical company Eisai Co. Ltd., today announced that they have signed an exclusive licence agreement for BAN2401, a novel humanized monoclonal antibody, which is being developed as a next-generation treatment for Alzheimer’s disease... [PDF] BioArctic's Press Release -