Thursday, February 25, 2021
Welldoc, Inc., and Eli Lilly and Company announced a collaboration and licensing agreement to integrate Welldoc's software into Lilly's connected insulin solutions, currently in development. Under the terms of the agreement, Lilly and Welldoc will collaborate to create a new version of the BlueStar® insulin management solution that integrates insulin dosing data for several Lilly insulins. Lilly will commercialize the pen platform, which will include the new app and Lilly's connected insulin pen solutions.
Welldoc's BlueStar app is a digital health solution cleared by the U.S. Food and Drug Administration (FDA) for use by adults with type 1 or type 2 diabetes. The app has both prescription and non-prescription features such as insulin titration support, a bolus calculator and personalized health coaching, and integrates blood glucose monitoring and continuous glucose monitoring for people who use insulin.
The new app will integrate insulin dosing data for several Lilly insulins. In the first version of the pen platform, a data transfer module will attach to the top of a prefilled, disposable insulin pen. When paired with the compatible app, the module will automatically transfer insulin dosing data. Lilly is also developing a fully disposable connected insulin pen to be used in future versions of the platform. The app will aggregate various dimensions of personalized data and connect with healthcare providers to deliver actionable insights and provide new opportunities to optimize diabetes care.
"Insulin dosing data are a critical piece of the diabetes management puzzle for people who use insulin to manage their diabetes, and Lilly has made significant progress in developing connected insulin pen solutions to provide access to those data," said Kevin McRaith, President and CEO of Welldoc. "Our software will now bring all of the most important diabetes data directly into the hands of people living with the condition, their caregivers and their healthcare providers. Bringing various elements of a patient's care under one platform is critical for those who are managing multiple comorbidities and providers who are working to effectively manage population health. Welldoc's platform combines a holistic approach with an evidence-based care model tailored to specific chronic conditions including diabetes, hypertension, behavioral health and more."
Lilly plans to submit to the FDA in 2021 for the data transfer module, and Welldoc plans to submit to the FDA in 2021 for the new app. The prefilled, disposable insulin pen to be used in the first version of the pen platform was approved by the FDA in late 2019. If cleared, Lilly plans to commercialize the initial pen platform in the United States and will evaluate opportunities to launch the platform in other geographies. Welldoc will continue to separately commercialize the BlueStar app.
"Today, less than half of people who use insulins are achieving their target A1C goals. We want to simplify the experience of using insulin by integrating our medicines with the most innovative technology available," said Marie Schiller, vice president of product development for Connected Care and Insulins at Lilly. "We are excited to collaborate with Welldoc. Together, we will combine their advanced software capabilities and expansive insulin management features with our connected insulin pen solutions with the goal of easing the burden of diabetes care on people living with the condition."
Approximately 34 million Americans1 (just over 1 in 10) and an estimated 463 million adults worldwide2 have diabetes. Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone1. Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY
Welldoc® is revolutionizing chronic disease management to help transform lives. BlueStar®, an FDA-cleared digital health solution, guides individuals through the complicated journey of living with diabetes by enabling them to self-manage their conditions and enhancing connections to their healthcare team. Welldoc streamlines the relationships between payers, employers and healthcare systems resources, with the goal of improving population health and reducing the costs of chronic diseases. For more information, visit www.welldoc.com.
Lilly Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Lilly and Welldoc's collaboration and licensing agreement, including planned regulatory submissions and development and commercialization strategies, and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of development and commercialization of pharmaceutical products and medical devices. Among other things, there is no guarantee that Lilly will realize the expected benefits from the collaboration and license agreement, that Lilly's connected insulin solutions will receive regulatory clearance or be commercially successful, that Lilly will meet the anticipated timelines described in this release, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
1 Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept. of Health and Human Services; 2020.
2 International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels, Belgium: International Diabetes Federation, 2019. Available at: http://diabetesatlas.org.