Sanofi Diabetes

Sanofi Announces the CE Mark for JuniorSTAR®, a New Half-Unit Insulin Reusable Pen for People with Type 1 Diabetes

Paris (ots/PRNewswire) - Sanofi announced today at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD), Barcelona, the CE Mark of JuniorSTAR(R), a new halfunit insulin reusable pen that can be used with Lantus(R) (insulin glargine), Apidra(R) (insulin glulisine) or Insuman(R) (recombinant human insulin). Delivering from 1 to 30 units per injection, JuniorSTAR(R) is an easy-to-use lightweight pen with a large dose display and a single-step dial back that does not leak insulin. JuniorSTAR(R) has been developed and is manufactured by Sanofi's partner Haselmeier GmbH, Stuttgart, Germany.

"Everyone deserves high-quality care while learning to manage their diabetes, for the best chances in life," said Pierre Chancel, Senior Vice President, Global Diabetes, Sanofi. "With JuniorSTAR(R), we aim to meet the needs of type 1 patients worldwide, specifically the younger ones, who need an easy-to-use pen device. This is a welcome addition to our comprehensive portfolio of established insulins, which leads the way in personalized diabetes care."

Half-unit dose increment pens provide flexibility to achieve target insulin doses especially in young patients with diabetes. JuniorSTAR(R) has been tested by people with type 1 diabetes (6 to 18 years old), parents and nurses in a non-comparative survey with 167 insulin pen users from five European countries[1]:

- 81% of patients/parents and 86% of nurses agreed it is easy to carry on a
  daily basis, due to its light weight (approximately 34 grams)
- 98% of patients/parents and 94% of nurses agreed it is easy to read due to its
  large dose display and legible numbers
- Additionally, 91% of patients/parents and 89% of nurses agreed that dialling
  back was easy due to its single-step dial back, a feature that avoids insulin leakage
- Overall, 93% of survey participants agreed on its ease of use.
 

A rising number of people with type 1 diabetes are being diagnosed worldwide at an increasingly younger age[2]. People with diabetes deserve the best support to meet their needs and Sanofi is committed to providing efficient and simplified care to lighten the lives of young people living with type 1 diabetes with a comprehensive treatment portfolio, which includes established insulins, optimized insulin pens, innovative blood glucose monitoring systems and tailored patient support.

JuniorSTAR(R) meets the new ISO 11608-1 2012 standard, passed all requirements for robustness and dose accuracy, and is in three different colors (blue, red and silver) for flexibility and insulin differentiation.

JuniorSTAR(R) is expected to become available in Europe during 2014.

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.[2]

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 and in New York .

About Haselmeier

Haselmeier is a leading designer and manufacturer of pen and auto-injection systems. The Company's devices feature unique function, design and technology and are marketed by leading pharmaceutical and biotechnology companies around the world. For more information please visit http://www.haselmeier.com.

References:

1) Klonoff D et al., Evaluation of the JuniorSTAR(R) half-unit insulin pen
  in young people with type 1 diabetes - user perspectives. European Endocrinology.
  2013; 9(2):82-5.
2) International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: 2012
  update. Brussels, Belgium, 2011. http://www.idf.org/diabetesatlas (accessed: June,
  2013)
 

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.

Contact:

Corporate Media Relations: Jack Cox, Tel.: +33-1-53-77-45-02,
jack.cox@sanofi.com ; Investor Relations: Sébastien Martel, Tel.:
+33-1-53-77-45-45, ir@sanofi.com ; Global Diabetes Division
Communications,
Tilmann Kiessling, Tel.: +49-172-615-9291,
tilmann.kiessling@sanofi.com ;
Marketing Haselmeier GmbH : Nadia Di Secli, Tel.: +41-44-250-52-40,
n.secli@haselmeier.com



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