Anavex Life Sciences Corp. announced that representatives of Anavex met with team members of the European Medicines Agency (EMA). These meetings discussed the debilitating pathology of Alzheimer?s disease and Anavex?s blarcamesine (ANAVEX®2-73) Alzheimer?s disease clinical program results, including data obtained in the ANAVEX®2-73-AD-004 study.

Pursuant to discussion at the meetings, Anavex initiated the process for submitting a Marketing Authorisation application to the EMA with the submission of the Centralised Procedure request with the goal of the Authorisation allowing direct access to the market of the European Union for oral blarcamesine for the treatment of Alzheimer?s disease. Anavex?s goal is to take care of patients in a patient-centric way with the preference for convenient oral treatment options for Alzheimer?s disease not requiring complex logistics resources and added personnel for drug administration and monitoring for brain edema and brain bleeds. Severe symptoms in relation to Amyloid-Related Imaging Abnormalities (ARIA) is a known risk factor for Alzheimer?s patients taking the class of drugs called monoclonal antibodies, and requires constant and repeated MRI examination, for which not all regions in Europe are currently sufficiently prepared and equipped for in addition to the requirement to address affordability and inequalities in patient access within European Union countries.

There are an estimated 7 million people in Europe with Alzheimer?s disease, a number expected to double by 2030, according to the European Brain Council. In addition to significant improvement in dementia symptoms, blarcamesine demonstrated reduction of pathological aggregation of amyloid in early Alzheimer?s disease as well reduction of brain volume loss, a well-known marker of neurodegeneration.