Sanofi and Voluntis Announce a Global Alliance to Deliver Digital Insulin Titration Solutions for People with Type 2 Diabetes

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The alliance will leverage Sanofi's expertise in bringing innovative treatments to people living with diabetes and Voluntis' experience in creating companion software. Sanofi and Voluntis will launch pilot programs using the mobile phone application in North America and several European countries. The application received FDA clearance and the CE mark in 2016.

Sanofi and Voluntis have worked together over several years to develop innovative digital solutions. Their alliance began in 2011 with the development of Diabeo^®, a software medical device that helps people with diabetes in France to manage their basal-bolus treatment.

"We are delighted to expand our long-standing collaboration with Sanofi," said Eric Elliott, Chairman of Voluntis and former CEO of Prime Therapeutics. "This new phase of our partnership with a world leader in diabetes will help us deliver digital titration tools into the hands of providers and their patients. Furthermore, digital therapeutics allow manufacturers and payers to check whether agreed value metrics have been achieved and help to lower costs without compromising on patient outcomes and access. They ensure that prescription medications deliver the effects for which they were brought to market."

"Despite the availability of new medicines for the treatment of diabetes, we see that outcomes are not sufficiently improving and that more than half of patients are not well controlled,"¹ said Peter Guenter, Executive Vice-President, Diabetes & Cardiovascular at Sanofi. "With this in mind, Sanofi is focusing on a beyond-the-pill approach. We know that diabetes management is a 24/7 job, and we recognize that the right tools need to be developed to realize better outcomes. The long-term alliance we have with Voluntis will help us to reach that goal."

About Diabetes
Diabetes is a chronic condition characterized by high blood sugar levels that stem from the body's inappropriate production or use of insulin. In 2014, it was estimated that 29 million Americans² and 422 million people worldwide³ have diabetes. About 90-95% of these individuals have type 2 diabetes and 29% take some form of insulin.⁴ Despite being provided with effective medications, more than half of them do not meet the recommended targets for glycemic control.⁵ Major contributing factors include challenges with insulin initiation and titration. Owing to the complications associated with diabetes, its total annual cost in the US amounts to $245 billion. Optimizing adherence to diabetes medications is recognized as one of the most effective ways of controlling disease expenditures.⁶ The cost saving opportunity in the U.S is estimated to be $4,690 per patient per year.⁷

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

About Voluntis
Pioneering therapeutic companion software, Voluntis innovates healthcare by embedding connectivity in therapeutics and medical intelligence in software. Dedicated to managing chronic conditions, Voluntis' companion software aim to enable treatment personalization, to support team-care coordination and to improve real-world outcomes. Harnessing its proprietary technology, Voluntis has developed digital solutions for diabetes, cancer, anticoagulation treatments and haemophilia. Voluntis is headquartered in Paris, France, and has offices in Cambridge, MA. For more information, visit http://www.voluntis.com.

References

1. Lipska KJ et al. Trends in Drug Utilization, Glycemic Control, and Rates of Severe Hypoglycemia, 2006–2013. Diabetes Care 2016 Sep; dc160985. Retrieved March 13th from https://doi.org/10.2337/dc16-0985
2. National Diabetes Statistics Report, 2014. (2014). Retrieved February 10, 2017, from https://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf
3. Roglic, G. (2016). Global report on diabetes. Retrieved February 10, 2017 from http://apps.who.int/iris/bitstream/10665/204871/1/9789241565257_eng.pdf?ua=1
4. National Diabetes Statistics Report, 2014. (2014). Retrieved February 10, 2017, from https://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf
5. Bailey CJ, Kodack M. "Patient adherence to medication requirements for therapy of type 2 diabetes." Int J Clin Pract. 2011 Mar; 65(3):314-22.
6. National Diabetes Statistics Report, 2014. (2014). Retrieved February 10, 2017, from https://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf
7. Diabetes Care Value Program Guarantees More Affordable, Higher-Quality Diabetes Care. Express Scripts. Sep 1, 2016.

Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the  ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2016. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE Voluntis