Sanofi Announces Upcoming Launch of MyStar Extra®, the First Self-Monitoring Blood Glucose Meter With Estimated A1c

BARCELONA, Spain, September 25, 2013 /PRNewswire/ --

- CE marks obtained for MyStar Extra^® and MyStar SylkFeel^® lancing device, respectively, enabling commercialization in the European Union -

- Scientific data presented at EASD 2013 demonstrate robustness and accuracy^[1],[2] of estimated A1c algorithm in MyStar Extra^®-

At the annual meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain, Sanofi (EURONEXT : SAN and NYSE : SNY) presented today the innovative blood glucose meter MyStar Extra^®, the first self-monitoring device that provides robust estimates of the A1c value, a key indicator for long-term glucose control.^[3],[4] The hemoglobin A1C (HbA1C) assay has become the cornerstone for the assessment of diabetes control and A1c test results are widely used to guide treatment decisions.^[5],[6] Especially convenient for people starting on insulin or using insulin, MyStar Extra^® is a supportive meter, designed to help people with diabetes be engaged in their insulin management and treatment plan.^[7],[8],[9]

Scientific data confirm accuracy of A1c estimates

The estimated A1c function of MyStar Extra^® is based on a new A1c estimation method tracking average glycemia from self-monitoring data stored in the device. Scientific data presented at EASD 2013 show that the estimation procedure used in MyStar Extra^® provides accurate estimates of the long-term average blood glucose value.^[1],[2] "The major advantage of this method is that it can work with infrequent self-monitoring data, for example fasting blood glucose readings and occasional daily profiles, and still provide reliable estimations where other techniques could fail. In-silico studies confirmed that the dynamical estimation procedure of MyStar Extra^® tracks accurately the changes in average glycemia underlying the changes in A1c," said Dr Boris Kovatchev, Professor at the University of Virginia's School of Medicine and School of Engineering and Applied Science and Director of the UVA's Center for Diabetes Technology, on the occasion of the Sanofi Diabetes press briefing at EASD titled "On the right track with MyStar Extra^®: New blood glucose meter provides estimated A1c and comprehensive guidance for people with diabetes".

Fasting plasma glucose (FPG) trends and a three-day FPG average provided

MyStar Extra^® is especially convenient for people starting on or already using insulin as it provides additional blood glucose information on overall glucose control such as three-, seven- and thirty-day fasting plasma glucose averages and fasting plasma glucose trends. The three-day FPG average is an important parameter for insulin titration.^[10] These supportive features may help patients keep track of how their therapy is working for them so they stay motivated to achieve their treatment targets for the prevention of diabetes complications.

Experts agree support and motivation key to improve diabetes self-care

"People with diabetes need to actively manage their diabetes to achieve good blood sugar control. Support and guidance through new technologies in self-monitoring of blood glucose can increase patients' motivation to stay on track- and motivation is very important in a chronic disease like diabetes. What's more, several studies have shown that ongoing feedback of one's A1c may really help people to see the value of diabetes self-care and ultimately improve diabetes control," said Dr William Polonsky, Associate Clinical Professor in Psychiatry at the University of California, San Diego, and Founder and President of the Behavioral Diabetes Institute.

At the Sanofi press briefing the diabetes experts agreed that simple illustrations of therapy progress can also contribute to improved diabetes care and better health outcomes for people with diabetes, particularly for people starting on or already using insulin.

"At Sanofi, our aim is to truly understand the needs of people with diabetes and to provide efficient, simple tools and guidance that help improve living with and treating diabetes," said Pierre Chancel, Senior Vice President, Sanofi, Global Diabetes. The upcoming launches of MyStar Extra^® and MyStar SylkFeel^® underscore Sanofi's commitment to provide innovations and integrated solutions to enhance diabetes self-care."

The CE marks were obtained by AgaMatrix Inc. for MyStar Extra^® and HTL-STREFA S.A. for MyStar SylkFeel^®, respectively, the legal manufacturers of the devices and Sanofi's partners in the development of these products. MyStar SylkFeel^® is a new lancing device that provides easy to use and gentle lancing with no vibration so it is less painful for people with diabetes to perform blood sugar testing. In addition, adjustable penetration depths and a safety ejector allow for convenient and safe testing.^[11]

Now approved in Europe, MyStar Extra^® and the new lancing device MyStar SylkFeel^® will be available in selected European countries starting in the last quarter of 2013. They will complement the new MyStar^® portfolio of Sanofi, combining devices, services and guidance for simple and effective diabetes management.

About Diabetes

Diabetes is a chronic disease that occurs as type 1 diabetes, which is an autoimmune disease characterized by the lack of insulin (the hormone that regulates blood glucose concentrations) production by the pancreas, and type 2, a metabolic disorder in which there are two main biological defects: a deficient production of insulin and reduced ability of the body to respond to the insulin being produced. Type 1 and type 2 diabetes are characterized by an increase in blood glucose concentrations (hyperglycemia). Over time, uncontrolled hyperglycemia leads to the macrovascular and microvascular complications of diabetes. Macrovascular complications, which affect the large blood vessels, include heart attack, stroke and peripheral vascular disease. Microvascular complications affect the small blood vessels of the eyes (retinopathy), kidney (nephropathy) and nerves (neuropathy). The global incidence of diabetes is growing at an alarming rate, with more than 371 million people worldwide living with the condition today.^[12]

About Sanofi Diabetes

Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services and devices, including blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Forward-Looking Statements

This press release contains forward-looking statements.  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, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies 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, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

References:    

1. Kovatchev B, Flacke F, Sieber J, Breton M "Accuracy of Dynamical Real-Time Estimation of A1c Using Routine Self-Monitoring Blood Glucose (SMBG) Data." Poster presented at EASD 2013.

2. Breton M, Flacke F, Sieber J, Kovatchev B "Robustness of Dynamical Real-Time Estimation of A1c Using Routine Self-Monitoring of Blood Glucose (SMBG) Data." Poster presented at EASD 2013.

3. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993; 329: 977-86.

4. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). The Lancet. 1998; 352: 837-53.

5. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2010; 33:S 11-61.

6. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). The Lancet. 1998; 352: 837-53.

7. Data on file: MyStar Extra™ Blood Glucose Monitoring System Owner's Guide.

8. Cagliero E, et al. Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients. Diabetes Care 1999;22:1785-1789.

9. Fisher WA et al. What Primary Care Providers Can Do to Address Barriers to Self-Monitoring of Blood Glucose. Clinical Diabetes 2013;31(1):34-42.

10. Nathan DM, et al. Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy. Diabetologia 2009;52(1):17-30.

11. Data on file: HTL-Strefa S.A. 2013.

12. International Diabetes Federation. IDF Diabetes Atlas, 5th edn. Brussels, Belgium: International Diabetes Federation, 2011. http://www.idf.org/diabetesatlas (Accessed: August 13, 2013).

Contacts:

Media Relations
Jack Cox
Tel.: +(33)-1-53-77-45-02
mr@sanofi.com

Milena Saleh
Tel.: +(49)-173-68-96-040
Milena.Saleh@sanofi.com

Investor Relations
Sébastien Martel
Tel.: +(33)-1-53-77-45-45
ir@sanofi.com