Eisai launched the medium-term business plan “EWAY Future & Beyond” in April 2021. Eisai will endeavor to make steady contributions to patients with goals going forward to accomplish in the medium- to long-term, as a pharmaceutical company that develops new drugs in the long-term.
As for research and development under “EWAY Future & Beyond”, through the evolution of biomarkers, we will shift from diagnosis based on symptoms and/or tumors to disease continuum analysis based on pathophysiology, and we will aim for the provision of precision medicine. In neurology, with regard to Alzheimer’s disease (AD), we will realize continuous brain health panel diagnosis, which makes quantitative and continuous measurements of pathophysiological biomarkers for precise diagnosis of each person’s stage within the disease continuum and aim to realize provision of optimal treatment in which drugs are determined based on precise diagnosis.
Accelerate Development of Flagship Pipeline in Neurology Areas under Business Group Structure
Eisai has established business groups, end-to-end organizations that integrate functions from research and development to commercial, in the two major areas of neurology and oncology, upon the initiation of 'EWAY 2025'. One of the objectives of the establishment of business groups is to enhance productivity in business through Early Decision Making. Another is to develop Scientific Acumen, an important organizational culture, through integrated business structure which includes discovery research. Development of flagship drugs based on "Ricchi" in neurology areas is accelerating since the organizational shift to business group structure has been made.
The Neurology Business Group (NBG) aims to realize prevention and cure in the field of dementia by leveraging the experience, knowledge and know-how accumulated over 35 years of developing new dementia drugs and conducting information provision activities relating to Aricept.
Neurology Area–The time to contribute to patients by next-generation dementia treatments is approaching
Aducanumab＊1 is an investigational next-generation Alzheimer’s disease (AD) treatment, and Biogen Inc., our partner is currently actively engaging with the U.S. Food and Drug Administration (FDA) and regulators in Europe and Japan. In the United States in particular, Biogen Inc. completed submission of a Biologics License Application (BLA) to the FDA. Working closely together, Biogen Inc. and we are proceeding to prepare and formulate various initiatives such as establishing go-to-market strategy, building out medical teams, preparing market access, and so on.
As regards BAN2401＊1,2 an investigational antiamyloid beta (Aβ) protofibrils antibody, Clarity AD, a pivotal Phase Ⅲ study in early AD is steadily ongoing and the readout of the primary endpoint is targeted for the second quarter of fiscal 2022. Also, regarding preclinical (asymptomatic) AD, AHEAD 3-45, a Phase Ⅲ study to evaluate potential prevention of future cognitive decline, has been initiated in July 2020 and is underway, as a public-private partnership with the ACTC＊3.
＊1 Co-development with Biogen Inc. ＊2 Licensed-in from BioArctic AB ＊3 Alzheimer’s Clinical Trials Consortium