Astellas Pharma Inc. and Welldoc, Inc. announced that the companies have entered into a collaboration and license agreement directed toward the development and commercialization of digital health solutions. Under the agreement, Astellas and Welldoc will jointly develop and commercialize BlueStar®(1) in Japan and certain other Asian markets for patients with diabetes, collaborate to broaden the adoption of BlueStar® in the U.S. market, and jointly develop and commercialize digital therapeutics in other therapeutic areas globally. BlueStar® is a digital health solution that is cleared by the U.S. Food and Drug Administration (FDA)- in the United States for use by healthcare providers and their patients aged 18 years and older who have type 1 or type 2 diabetes. BlueStar® not only assists patients in managing their disease by capturing, storing, and transmitting blood glucose data and tracking medication, diet, activity and exercise, but also uses individual patient treatment data and machine learning to provide tailored motivational, behavioral, and educational coaching messages to aid in diabetes self-management. FDA initially cleared BlueStar® in 2010 and since then Welldoc has received 6 additional 510(k) clearances from the FDA. In the United States, BlueStar® is marketed as both a prescription and non-prescription digital health solutions for diabetes. BlueStar® is currently marketed in the U.S. and Canada. Under the terms of the agreement, Astellas will make an upfront payment of $15 million to Welldoc. In addition, the agreement includes development and commercialization milestones as well as royalties on any future product sales. The impact of this alliance on Astellas' financial results in the fiscal year ending March 31, 2020 is expected to be limited. BlueStar®: BlueStar® is a digital health solution that is cleared by FDA for use by adults with type 1 or type 2 diabetes. In addition to assisting patients in managing their disease in line with the guidelines compiled by the American Association of Diabetes Educators (AADE), namely, taking medication, eating well, and being active, it offers a management method for individual patients' blood glucose levels made possible by machine learning and artificial intelligence that uses compiled treatment data to provide tailored coaching messages to aid in diabetes self-management. BlueStar® also comes with a diagnosis support system for physicians, which allows patients to share data on blood glucose levels, medication, and physical conditions, as well as the status of progress, with physicians before examination. Astellas' Rx+ Business: A business that leverages the expertise and knowledge of Astellas, which have been cultivated through its prescription drug (Rx) business, integrates innovative medical technology with cutting-edge technology in different fields, contributes to patients through Patient Journey (overall medical care, including diagnostic, preventive, therapeutic, and prognostic care), and creates new revenue streams separate from Astellas' core Rx products.