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–Contribution to patients by next-generation dementia treatments
ADUHELMTM (generic name: aducanumab)＊1 was granted accelerated approval as an Alzheimer’s disease treatment in the United States in June 2021. Biogen Inc. and Eisai are promoting contribution to patients by working on go-to-market strategy, establishment of medical teams and market access. New drug applications seeking approval have been submitted in places such as Europe and Japan. The two companies are also planning to submit new drug applications in other countries and regions.
As regards lecanemab (development code: BAN2401)＊1,2 an investigational anti-amyloid beta (Aβ) protofibrils antibody, a pivotal Phase Ⅲ study (Clarity AD study) in early AD is steadily ongoing and the readout of the primary endpoint is targeted for the second quarter of fiscal year 2022. Also, regarding preclinical (asymptomatic) AD, AHEAD 3-45, a Phase Ⅲ study to evaluate effect of lecanemab, 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 Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic ＊3 Alzheimer’s Clinical Trials Consortium