TOKYO and Columbia, Maryland, November 20, 2019  - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and Welldoc, Inc. (President, CEO: Kevin McRaith, “Welldoc”) today 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.

“Welldoc is excited to collaborate with Astellas as part of our evolution as a digital health company with a commitment to help improve the health of those living with chronic disease,” said Kevin McRaith, President and CEO of Welldoc. “Astellas is a critical partner as Welldoc looks to broaden our platform into other disease areas as well as expand into other global markets.”

“Under our Strategic Plan 2018, Astellas is committed to developing Rx+™(2) programs, which aim to create new, clinically relevant healthcare solutions (Rx+™) that combine expertise gained from its prescription drug (Rx) business with technology and knowledge from different fields. Our alliance with Welldoc, a pioneer in the digital therapeutics field, is part of this commitment,” said Naoki Okamura, Representative Director Corporate Executive Vice President, Chief Strategy Officer and Chief Financial Officer, Astellas. “Advances in digital technology are bringing dynamic innovations to the healthcare field. Astellas is proactively investing in this field to take advantage of these advances.”

The impact of this alliance on Astellas’ financial results in the fiscal year ending March 31, 2020 is expected to be limited.


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