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Sanofi Launches MyStar Extra®, the First Blood Glucose Monitoring Device to Support Insulin Therapy Management With Estimated HbA1c

GUILDFORD, England, March 20, 2014 /PRNewswire/ --

- Discover how smart technologies can help people with diabetes better understand their insulin therapy and health improvements -

MyStarExtra®, a new generation blood glucose monitoring device developed by Sanofi, is now available in the United Kingdom. MyStar Extra® is the first self-monitoring device that provides estimates of the HbA1c value, a key indicator for long-term glucose control.[i],[ii] This unique blood glucose monitoring device may help people with diabetes better understand the meaning of their test results in the context of overall treatment goals. Several extra features of the device may help people with diabetes stay motivated and engaged in managing their insulin therapy.

"Living with Type 1 diabetes is hard work with no time off. It's a constant balancing act between ensuring I have the correct amounts of insulin to keep my blood glucose at safe levels. This takes motivation. For me to stay motivated in my diabetes management I need accurate and consistent data from my blood glucose device. Without this, I am unable to make the informed decisions that I need to manage my diabetes the way that I want to. Next to insulin, reliable data from my blood glucose device is the most important tool that I have to manage my diabetes. I welcome any new technologies that may support me stay motivated and engaged" said Chris Aldred, @grumpy_pumper, http://www.the-grumpy-pumper.com/

MyStar  Extra®  provides  key  benefits  to  support  patients  manage  their  insulin  therapy

The new MyStar Extra® blood glucose device from Sanofi provides relevant blood glucose information and comes with new features. It can help keep patients motivated to take an active role in managing their insulin therapy.[iii] One of the parameters used to assess the level of glycaemic control in people with diabetes is the HbA1c (haemoglobin A1c) value. The HbA1c value reflects average glucose levels over the previous three months and is therefore regarded as an indicator for long term glucose control.[v],[vi] Until now, HbA1c levels were obtained through a laboratory test which patients receive on average once or twice a year, but now MyStar Extra® can provide an HbA1c estimate. The device uses unique algorithms to provide estimates of HbA1c. While this does not replace the laboratory test, it provides more immediate feedback on therapy progress.[iv],[vii]

In addition to the HbA1c estimate, MyStar Extra® calculates a three-day fasting plasma glucose average (FPG) and FPG trends. For people with diabetes who find it challenging to follow treatment regimes, three-day fasting averages simplify access to practical glucose information. FPG values measure the blood glucose concentration in a blood sample after an overnight fast. Three-day FPG averages are commonly used to titrate basal insulin, one of the most used treatment approaches in type 2 diabetes.[viii] The innovative technology of MyStar Extra®, simplifies diabetes management through using smart technology to produce immediate feedback.

"We are delighted that MyStar Extra® will now be available for people with diabetes in the United Kingdom. Sanofi has developed MyStar Extra® with the needs of people using or starting on insulin in mind. The device provides the personal glucose information people with diabetes need in a simple form, enabling them to manage their diabetes and track their long-term therapy success. This is what smart technology is all about: MyStar Extra® helps patients understand control of their diabetes better, and helps to motivate them to stick to their recommended therapy", said Becky Reeve, Head of Professional Relations, Sanofi UK.

MyStar Extra® and the new lancing device MyStar SylkFeel® will be available in the United Kingdom from March 2014. They will complement the 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 (hyperglycaemia). Over time, uncontrolled hyperglycaemia leads to macro vascular and micro vascular complications of diabetes. Macro vascular complications, which affect the large blood vessels, include heart attack, stroke and peripheral vascular disease. Micro vascular 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.

A blood glucose monitoring device reads the amount of sugar released in the blood, which has previously been absorbed from food or built up by the body. The glucose value is measured with a small sample of blood, usually taken from a finger and then applied to a disposable test strip. Based on blood glucose readings, many people with diabetes have to adjust their medication or insulin doses to keep the amount of glucose in the blood to target levels.

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

i. 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.

ii. 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.

iii Delamater A, et al. Improving patient adherence. Clinical Diabetes April 2006;24 (2): 71-77.

iv MyStar Extra™ Blood Glucose Monitoring System Owner's Guide.

v Clinical Guideline Task Force, Global Guidelines for Type 2 diabetes, International Diabetes Federation, 2005. Available at:  http://www.idf.org/webdata/docs/IDF%20GGT2D.pdf. Accessed July 2013.

vi World Health Organization, Use of glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus, 2011. Available at: http://www.who.int/diabetes/publications/report-hba1c_2011.pdf. Accessed July 2013.

vii 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.

viii Strange et al. J Diabetes Sci Technol 2007;1(4):540-548.

ix Kovatchev BP, et al. Effect of automated bio-behavioral feedback on the control of type 1 diabetes. Diabetes Care. 2011 Feb; 34 (2):302-7. Epub 2011 Jan 7.

x Breton M. Robustness of dynamical real-time estimation of A1C using routine self-monitoring of blood glucose (SMBG) data Abstr 1079 EASD 2013


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