December 7, 2011 - Sanofi U.S., together with its partner AgaMatrix, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) premarket clearance for the iBGStar™ Blood Glucose Monitoring System, the first and only FDA cleared blood glucose meter that directly connects to the Apple® iPhone® and iPod touch®, seamlessly integrating accurate blood glucose monitoring into the lifestyles of people with diabetes. The iBGStar™ is already available in Germany, France, Switzerland, the Netherlands and Italy.
The compact iBGStar™ glucose meter, when plugged directly into the iPhone® or iPod® touch, quickly displays results immediately after testing on the full-color touch screen via the iBGStar™ Diabetes Manager App. iBGStar™ also can be used alone to measure blood glucose levels and results can be synchronized to an iPhone® or iPod® touch at a later time.
The iBGStar™ Diabetes Manager App has a range of features that allow users multiple ways to analyze their glucose patterns over time. Patients can record and track readings, carbohydrate intake and insulin doses if taking insulin. Scorecards show individual test results and are color coded so that high and low blood glucose results can be more easily identified. The ‘Share’ function enables users to select specific data to send as an e-mail to their healthcare professional. The application can be downloaded for free from the App Store.
The iBGStar™ uses patented Dynamic Electrochemistry®1 technology that provides accurate results by helping to detect and correct for errors caused by differences in hematocrit 2 levels, manufacturing variations and certain environmental conditions.
Please click here for more information about iBGStar™.
In March 2010, Sanofi and AgaMatrix signed an agreement for the development, supply and commercialization of Blood Glucose Monitoring (BGM) solutions. iBGStar™ is among the first products of this agreement.
The iBGStar™ received the red dot design award 2011 for outstanding product design in the life science and medicine category. The red dot design award is one of the most renowned international design competitions (www.red-dot.de/presse), with almost 14,000 entries from 68 countries in the year 2010 alone. Winners are considered to be the best design in the industry worldwide.
Apple®, iPhone® and iPod touch® are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.
Dynamic Electrochemistry® is a trademark of AgaMatrix Inc., registered in the United States and other countries.
About the Sanofi Diabetes Division
Sanofi strives to help people manage the complex challenges of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insight that comes from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes. Investigational compounds in the pipeline include an injectable GLP-1 agonist being studied as a single agent, in combination with basal insulins, and/or in combination with oral antidiabetic agents.
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, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US, also referred to as Sanofi-aventis U.S. LLC. For more information on Sanofi US, please visit http://www.sanofi.us or call 1-800-981-2491.
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 labeling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products 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 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, 2010. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
1 Meets requirements of ISO 15197: 2003
2 Hematocrit range 20 to 60 percent