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TOKYO and CAMBRIDGE, Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the results from Eisai’s large global Phase 3 confirmatory Clarity AD clinical study of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference, in San Francisco, California and virtually.

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received notification from Japan’s Ministry of Health, Labour, and Welfare (MHLW) that the “all-case study” specified post-marketing observational study condition required at the time of approval of antiepileptic agent Inovelon? Tablets 100 mg and 200 mg (rufinamide) as an adjunctive therapy to other antiepileptic drugs (AEDs) for treatment of Lennox-Gastaut syndrome (LGS) has been cleared.

TO STRENGTHEN ITS RESEARCH AND DEVELOPMENT FUNCTION FOR INJECTABLE DRUG FORMULATIONS

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and nippon medac Co., Ltd. (Headquarters: Tokyo, CEO: Hirohisa Iriyama, “nippon medac”), a subsidiary of medac Gesellschaft für klinische Spezialpr?parate mbH (Headquarters: Germany) announced today that they have obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare for the indication of the anti-rheumatic agent “Metoject? Subcutaneous Injection 7.5mg syringe 0.15mL, 10mg syringe 0.20mL, 12.5mg syringe 0.25mL and 15mg syringe 0.30mL” (methotrexate, “MTX”) for the treatment of rheumatoid arthritis. Metoject will be the first self-administrable MTX subcutaneous injection formulation for rheumatoid arthritis in Japan. Based on the license agreement signed by Eisai and medac GmbH in May 2019, nippon medac will hold the marketing authorization of Metoject, while Eisai will be responsible for product distribution of Metoject in Japan.

Analysis Evaluates Efficacy of Eribulin in Metastatic HER2-low Breast Cancer Across Three Clinical Studies