Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that it has entered into an agreement ("the Agreement") with Roche Diabetes Care Japan Co., Ltd. (Country Manager: Noriko Hattori, "Roche Diabetes Care Japan") for the development and commercialization of Roche Diabetes Care's world-renowned Accu-Chek^® Guide Me blood glucose monitoring system with advanced accuracy as a combined medical product with BlueStar^®*1. BlueStar is an FDA-cleared digital health solution for diabetes patients, developed by Welldoc, Inc. (President, CEO: Kevin McRaith, "Welldoc") and is currently marketed in the U.S. and Canada. Astellas and Welldoc are jointly developing BlueStar in Japan. In the future, Astellas will aim to obtain regulatory approval and reimbursement as a combined medical product.

The combined medical product solution, which is being developed in Japan, is expected to support patients with managing their diabetes by capturing, storing, and transmitting blood glucose data which is obtained from Roche Diabetes Care's Accu-Chek^® Guide Me system and track medication, diet, activity and exercise in Welldoc's BlueStar(app). It is also expected to support patients' diabetes self-management with a unique algorithm designed using AI, and personalized digital coaching messages, focused on building better habits over time. Astellas is responsible for the clinical trials of the combined medical product, which are scheduled to start during 2023.

In Japan, the number of people with diabetes and the number of people with prediabetes is estimated to be approximately 10 million respectively¹, and there is a substantial unmet medical need in this area. In addition to existing treatments, the development of novel digital solutions that support patients and healthcare professionals in managing these conditions is gaining traction.

"Under our Corporate Strategic Plan 2021, "Advance the Rx+^® businesses" is one of the strategic goals Astellas is committed to." said Naoki Okamura, Chief Strategy Officer of Astellas. "We hope that we can deliver greater VALUE to patients by expanding our partnership with Welldoc through BlueStar and connected insights with Roche Diabetes Care's glucose meters."

"Together with Astellas, Roche Diabetes Care is making innovations in diabetes care more accessible through connected devices and digital products, to bring true relief for people living with diabetes," said Noriko Hattori, Country Manager of Roche Diabetes Care Japan. "We are creating patient-centered value by enabling access to relevant data insights for informed diabetes therapy management, facilitating clinical development and regulatory and reimbursement decisions."

"BlueStar empowers individuals living with diabetes to take control of their health, manage complexities associated with their condition and connect with their care teams," said Kevin McRaith, CEO of Welldoc. "At Welldoc, we are driving new possibilities for people living with chronic conditions with one, comprehensive, scalable digital health solution. We are proud of our partnership with Astellas, which aims to bring a new standard of care in diabetes to a broader population in Asia."

Astellas, Roche Diabetes Care Japan, and Welldoc aim to provide new treatment options and contribute to patients suffering from diabetes by developing Roche Diabetes Care's Accu-Chek^® Guide Me blood glucose monitoring system as a combined medical product with BlueStar^® in Japan.

*1 BlueStar^®: Welldoc's U.S. Food and Drug Administration (FDA)-cleared Bluestar®* Mobile Digital Health Application is for adults living with type 1 or type 2 diabetes. Bluestar delivers personalized, AI -driven digital coaching and insights to individuals so that they are able to better self-manage their conditions and build better habits throughout their journey. These insights are also easily shared with care teams to support data-driven interventions and clinical decisions. The solution currently has non-prescription and prescription based features for complex diabetes management, such as insulin management capabilities and a basal/bolus insulin calculator.  BlueStar currently holds 9 FDA clearances for diabetes management capabilities and is currently marketed in the U.S and Canada.  Astellas and Welldoc entered a strategic agreement in November 2019 for co-development and co-commercialization of BlueStar in Japan and certain Asian markets.

*2 A combined medical product: Combination of medical equipment needed for diagnosis or treatment, which is subject to regulatory oversight.