Biogen : NOTICE REGARDING BIOGEN'S DISCLOSURE ABOUT THE SUBMISSION OF MARKETING AUTHORIZATION APPLICATIONS IN BRAZIL, CANADA, AUSTRALIA, AND SWITZERLAND FOR ADUCANUMAB FOR ALZHEIMER'S DISEASE

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, 'Eisai') announced that Biogen (Nasdaq: BIIB) has disclosed, in its Q1 2021 Earnings Press Release issued on April 22, its current submission status of the Marketing Authorization Applications (MAA) for aducanumab, an investigational treatment for Alzheimer's disease, in countries other than the United States, Japan, and in Europe which have been announced previously.

In the first quarter of 2021 Biogen submitted a MAA to Agencia Nacional de Vigilncia Sanitaria (ANVISA) in Brazil for aducanumab an investigational treatment for Alzheimer's disease. This application is currently in queue for review.

Biogen also submitted MAAs for aducanumab to Health Canada, the Therapeutic Goods Agency in Australia, and Swissmedic in Switzerland, all of which are subject to agency validation of whether the applications are accepted.

Aducanumab is being jointly developed by Biogen and Eisai.

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