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PARIS, June 14, 2014 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that Lyxumia® (lixisenatide) met the primary endpoint in an 8-week head-to-head pharmacodynamic study versus liraglutide, showing a significantly more pronounced post-prandial (after-meal) glucose (blood sugar) lowering effect after a test-meal than liraglutide when both were added to optimally titrated Lantus® (insulin glargine). Lowering of post-prandial glucose was measured as change from baseline in incremental area under the glucose curve for 4 hours after a standardized solid breakfast, at week 8.
Findings also showed that while both lixisenatide and liraglutide lowered blood glucose (HbA1c) when added to optimally titrated insulin glargine, lixisenatide treatment resulted in fewer reports of gastrointestinal adverse events, a lower mean increase in heart rate and smaller increases from baseline to week 8 in pancreatic enzyme (amylase and lipase) levels. The most commonly reported adverse events in the study were symptomatic hypoglycemia and nausea. Symptomatic hypoglycemia was more frequent in the lixisenatide group compared to the liraglutide group. (Full results are available in the Results of Analysis section.) Lixisenatide is currently approved in Europe and an investigational drug in the United States, where it is not approved.
"In this Phase II head-to-head study we saw a significant difference in the post-prandial glucose lowering effects of lixisenatide and liraglutide, two GLP-1 receptor agonists, with similar overall blood sugar reductions," said Riccardo Perfetti, Senior Medical Officer, Vice President Global Medical Affairs, Diabetes Division, Sanofi. "The results showed that both medicines reduced blood glucose, but we found that lixisenatide did this with a greater delay in gastric emptying, and its use was associated with differences in safety and tolerability compared to liraglutide. These differences are interesting and could be further explored to determine whether differences in gastric emptying benefit patients by lowering the post-prandial glucose excursion and whether gastric emptying corresponds to differences in safety and tolerability."
These results were presented at the 74th Scientific Sessions of the American Diabetes Association, San Francisco, CA. The abstract is titled: Effect of Lixisenatide vs Liraglutide on Glycemic Control, Gastric Emptying, and Safety Parameters in Optimized Insulin Glargine T2DM +/- Metformin. (Meier et al. Poster presentation #1017-P, June 14, 2014).
Results of Analysis
This 8-week, randomized, open-label, three-arm parallel trial, comparing lixisenatide 20 microg with liraglutide 1.2mg and 1.8mg QD in 142 patients with type 2 diabetes on optimally titrated (SMPG of 80–100mg/dL) insulin glargine treatment with or without metformin, met its primary endpoint. Results showed a greater reduction in post-prandial glucose (PPG) from baseline with lixisenatide (-240.2h.mg/dL, SE 20.0) than with liraglutide 1.2mg (-131.8h.mg/dL, SE 20.2) and 1.8mg (-157.1h.mg/dL, SE 21.0) for 4 hours after a standardized solid breakfast (p<0.0001).
At week 8, HbA1c decreased significantly from baseline (p<0.05) for all groups, and final HbA1c levels were similar in all treatment arms (6.2 +/- 0.4 for lixisenatide, 6.1 +/- 0.3 for liraglutide 1.2mg, and 6.1 +/- 0.3 for liraglutide 1.8mg). Body weight decreased significantly in all groups (-1.61 +/- 0.47kg, p<0.05 for lixisenatide, -1.78 +/- 0.48kg, p<0.05 for liraglutide 1.2mg, and -2.42 +/- 0.49kg, p<0.0001 for liraglutide 1.8mg).
Symptomatic hypoglycemia was slightly more frequent with lixisenatide (14 events with lixisenatide versus 9 and 10 events with liraglutide 1.2mg and 1.8mg, respectively). There was one case of severe symptomatic hypoglycemia in the lixisenatide arm and one case of mild asymptomatic confirmed pancreatitis in the liraglutide 1.8mg arm.
In addition, lixisenatide significantly delayed gastric emptying more than liraglutide 1.2mg and 1.8mg (LS mean change +/- SE for gastric emptying lag time: 175.6 +/- 23.7 [lixisenatide, p<0.0001 for change from baseline] vs. 70.1 +/- 23.8 [liraglutide 1.2 mg, p<0.05 for change from baseline] and 48.9 +/- 24.6 [liraglutide 1.8 mg p<0.05 for change from baseline]; LS mean change +/- SE for gastric emptying half time: 453.6 +/- 58.2 [lixisenatide, p<0.0001 for change from baseline] vs. 175.3 +/- 58.5 [liraglutide 1.2 mg, p<0.05 for change from baseline] and 130.5 +/- 60.3 [liraglutide 1.8 mg p<0.05 for change from baseline]). There were more gastrointestinal adverse events (GI AEs) reported with liraglutide than with lixisenatide (21 and 22 with liraglutide 1.2mg and 1.8mg, respectively, versus 17 with lixisenatide) with nausea reported in 8 and 11 with liraglutide 1.2mg and 1.8mg respectively, versus 9 with lixisenatide. Liraglutide treatment also resulted in greater increases from baseline to week 8 in the levels of the pancreatic enzymes amylase and lipase compared with lixisenatide (amylase: +8.01IU/L, SE 4.00 and +5.68IU/L, SE 4.13 for liraglutide 1.2mg and 1.8mg, respectively, versus +2.98IU/L, SE 4.00 for lixisenatide; lipase: +21.12IU/L, SE 7.16 and +20.76IU/L, SE 7.38, versus +6.97IU/L, SE 7.11). Mean ambulatory monitored 24-hour increase in heart rate was greater with liraglutide 1.2mg and 1.8mg than with lixisenatide (9bpm for liraglutide, 3bpm for lixisenatide, p<0.0001), with no significant differences in 24-hour blood pressure.
In Europe, Lyxumia® (lixisenatide) is approved as a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus. It remains under investigation in the U.S. 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.
Lyxumia was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com, and was approved in Europe in 2013 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. Lyxumia is currently approved in over 40 countries worldwide for the treatment of adults with type 2 diabetes, with commercial launches in Europe, Japan, Mexico and other markets. Sanofi plans to resubmit the New Drug Application for lixisenatide in the United States in 2015, after completion of the ELIXA cardiovascular outcomes study. Lyxumia is the proprietary name approved by the European Medicines Agency and other health authorities for the GLP-1 RA lixisenatide.
The Lyxumia pen is the winner of a number of innovative design awards, including the Good Design Award 2012 and the iF Product Design Award. The variant of the Lyxumia pen used in Japan won the Good Design Award (G Mark) 2013.
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.
Sanofi, a 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).
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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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