Japan headquartered Astellas Pharma Inc. and US based Welldoc, Inc. 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 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.