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Sanofi Announces Positive Phase 3 Data for Once-Daily Lixisenatide for Type 2 Diabetes
Date:6/22/2013

BRIDGEWATER, N.J., June 22, 2013 /PRNewswire/ -- Sanofi US (EURONEXT: SAN and NYSE: SNY) announced today data that showed lixisenatide, an investigational once-daily prandial glucagon-like peptide 1 (GLP-1) receptor agonist, decreased HbA1c by reducing PPG (postprandial glucose) daytime exposure when added to standard of care which includes basal insulin with or without oral anti-diabetic agents (OADs). Lixisenatide is for the treatment of adults with type 2 diabetes mellitus. This data was presented at the American Diabetes Association 73rd Scientific Sessions in Chicago.

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The pooled analysis included data of 753 patients from three randomized Phase 3 studies of either once-daily lixisenatide plus standard of care versus placebo plus standard of care to quantify the effects of lixisenatide on FPG (fasting plasma glucose) and PPG. FPG and PPG are the levels of glucose in a patient's blood with an empty stomach (fasting) and after a meal (postprandial), respectively.

"Basal insulin can control overnight glucose for people living with type 2 diabetes, but HbA1c levels may remain high due to persisting high levels of glucose during the day," said principal investigator Matthew Riddle, M.D. Professor of Medicine in the Division of Endocrinology, Diabetes & Clinical Nutrition at Oregon Health & Science University, U.S. "This analysis suggests that once-daily lixisenatide complements the effects of basal insulin on glycemic control mainly by reducing after-meal glucose levels."

After 24 weeks of treatment, adjusted LS mean HbA1c -- average blood sugar levels for the past two to three months -- change was -0.77% with lixisenatide plus standard of care compared with -0.29% with placebo plus standard of care (p<0.0001). The reduction in BHG exposure between lixisenatide plus standard of care and placebo plus standard of care were similar (adjusted LS mean change for AUC24h -234 mg/dl*h vs. -198 mg/dl*h [NS]), but PPG exposure was reduced more with lixisenatide plus standard of care compared with placebo plus standard of care (adjusted LS mean change -378 mg/dl*h vs. -180 mg/dl *h, p<0.0001).

The three Phase 3 studies included in this analysis were part of the GetGoal clinical program and included GetGoal-L, GetGoal-L Asia and GetGoal Duo1. The most common adverse events were nausea, vomiting, diarrhea and symptomatic hypoglycemia which are detailed in the following chart. GetGoal-L

GetGoal-L Asia

GetGoal Duo1Lixisenatide

Placebo

Lixisenatide

Placebo

Lixisenatide

PlaceboDiarrhea

7.3%

5.4%

6.5%

2.5%

6.7%

3.1%Nausea

26.2%

8.4%

39.6%

4.5%

27.4%

4.9%Vomiting

8.2%

0.6%

18.2%

1.9%

9.4%

1.3%Symptomatic

Hypoglycemia

27.7%

21.6%

32.6%

47.2%*

28.3%

21.6%*

22.4%

13.4%Severe

Hypoglycemia

1.2%

0%

-

-

0.4%

0%* Sulfonylurea added to lixisenatide plus basal insulin

"Sanofi is committed to addressing the needs of the 26 million people in the U.S. who are living with diabetes," said Dennis Urbaniak, Vice President and Head of U.S. Diabetes Patient Centered Unit, Sanofi US. "We are encouraged by these results that suggest the potential for lixisenatide to be the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes in the U.S."

The study findings are highlighted at the American Diabetes Association Scientific Sessions in the following abstract: Once-Daily Lixisenatide As Add-On to Basal Insulin ± OADs in Patients with Type 2 Diabetes Selectively Reduces Postprandial Hyperglycemic Daytime Exposure (Riddle et al.) [Abstract No. 2013-A-4270, Poster Presentation on Saturday, June 22, 11:30 a.m. to 1:30 p.m. CDT].

About Lixisenatide
Lixisenatide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.

Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com, and is approved in Europe for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lixisenatide is also approved in Mexico and Australia for the treatment of adults with type 2 diabetes. Lixisenatide is currently under review by the U.S. Food and Drug Administration after the acceptance of the New Drug Application (NDA) submission for lixisenatide in February 2013. Lyxumia® is the proprietary name approved by the European Medicines Agency (EMA), Australia and Mexico, and submitted to other health authorities for the GLP-1 RA lixisenatide. The proprietary name for lixisenatide in the United States is under consideration.

The Lyxumia® pen is the winner of a number of innovative design awards including the Red Dot Award, the Good Design Award, and the iF Product Design Award. 

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, an integrated global 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).

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 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.

Contacts:US Diabetes Communications
Susan Brooks
Tel: + (1) 908 981 6566
susan.brooks@sanofi.com


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