Sanofi Announces Positive Phase 3 Data for Once-Daily

BRIDGEWATER, NJ--(Marketwired - Jun 22, 2013) - Sanofi US (EURONEXT: SAN) ( 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 73 ^rd Scientific Sessions in Chicago.

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.

* 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.

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