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Positive Results for Investigational Compound Lyxumia® (Lixisenatide) Presented at American Diabetes Association's 71st Annual Scientific Sessions

PARIS, June  24, 2011 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) announced today data from four studies  of its once-daily GLP-1 receptor agonist Lyxumia® (lixisenatide) that  is in Phase III clinical development, including data that demonstrates positive results in type 2 diabetes patients not at goal on oral therapies or with  basal insulin. These data are being presented or published at the American Diabetes Association's 71st Scientific Sessions in San Diego, California.

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"Efficacy and Safety of Lixisenatide Once-Daily Versus Exenatide Twice-Daily in Type 2 Diabetes Inadequately Controlled on Metformin (GetGoal-X)" [ABSTRACT 0033-LB]"Lixisenatide once daily demonstrated efficacy in blood glucose control by meeting an endpoint of non-inferiority  at week 24 in a head-to-head study versus exenatide twice daily," said Julio Rosenstock, MD, director of the Dallas Diabetes and Endocrine Center at Medical City Dallas and lead investigator of the GetGoal-X trial.

In the GetGoal-X trial, a randomized, open-label, active-controlled, two-arm parallel-group, multicenter study with a 24-week main treatment period, lixisenatide once daily achieved its primary endpoint of non-inferiority in A1C reduction from baseline with less symptomatic hypoglycemia (low blood sugar) and better gastrointestinal tolerability versus exenatide twice daily, as an add-on to metformin in patients with type 2 diabetes. A total of 634 people were randomized to receive either lixisenatide or exenatide. Both groups received a stepwise increase in dose, up to a maximum daily dose of 20 microgram.  At baseline, the mean age in the trial was 57.4 years, mean diabetes duration 6.8 years, mean body mass index (BMI) 33.6 kg/m2 and mean A1C 8.0 percent.

Key Findings:

  • Lixisenatide once daily achieved its primary endpoint of  non-inferiority in A1C reduction versus exenatide twice daily (LS mean +/- SE change from baseline: -0.79 +/- 0.05 vs. -0.96 +/- 0.05)
  • Improvements in mean fasting plasma glucose – measurement of blood glucose levels when a patient is fasting – (LS mean +/- SE change from baseline: -22.0 +/- 2.1 vs. -26.1 +/- 2.1) and the percentage of patients achieving the study target A1C < 7.0 percent (48.5% vs. 49.8%) were comparable between groups
  • Mean body weight significantly decreased from baseline in the lixisenatide group compared to the exenatide group (94.5 to 91.7 kg with lixisenatide vs. 96.7 to 92.9 kg with exenatide)
  • The proportion of patients with serious adverse events was generally comparable between groups
  • Discontinuations due to adverse events (mainly gastrointestinal events including nausea, diarrhea and vomiting) were 33 (10.4%) in the lixisenatide group and 41 (13.0%) in the exenatide group
  • Significantly fewer patients experienced symptomatic hypoglycemia with lixisenatide (2.5% vs. 7.9%, p<0.05), with 6-fold fewer hypoglycemic events (8 vs. 48) versus exenatide
  • More lixisenatide patients tolerated the target dose of 20 microgram per day and completed the trial versus the exenatide 10 mcg target dose (93% vs. 83%)

  • "Lixisenatide  Significantly  Improves  Glycemic  Control  in  Asian  Patients   with  Type  2 Diabetes Insufficiently Controlled on Basal Insulin +/- Sulfonylurea" [ABSTRACT 0278-OR]Data from the GetGoal-L Asia trial, showed in  Asian patients with type 2 diabetes insufficiently controlled by basal insulin +/- sulfonylurea, that lixisenatide once daily significantly improved glycemic control (as  measured by the number of patients reaching  a target A1C < 6.5 percent or < 7.0 percent) versus placebo at week 24 with a pronounced post-prandial glucose and fasting plasma glucose effect, and was well tolerated.

    Key Findings:

  • Lixisenatide once daily significantly improved A1C versus placebo (LS mean difference -0.9%)
  • Significantly more lixisenatide patients achieved A1C less than or equal to 6.5 percent (17.8%) and <7.0 percent (35.6%) versus placebo (1.3% and 5.2%; p<0.0001)
  • Lixisenatide significantly improved two-hour  post-prandial  glucose, glucose excursion and average  7-point  self-measured  plasma  glucose  (SMPG)  over  placebo  (LS  mean  +/-  SE change from baseline: 7.96 +/- 0.598 vs. -0.14 +/- 0.563, p<0.0001; -7.09 +/- 0.576 vs. 0.14 +/- 0.542, p<0.0001; -1.91 +/- 0.272 vs. -0.56 +/- 0.271, p<0.0001, respectively)
  • Lixisenatide  was  well  tolerated  and  86  percent  of  patients  in  the  lixisenatide  group completed the study versus 92 percent on placebo
  • Nine placebo patients (5.7%) and ten lixisenatide patients  (6.5%) experienced a serious treatment emergent adverse event and more lixisenatide patients (14 [9.1%]) discontinued participation in the study due to treatment emergent adverse events than placebo patients (5 [3.2%]), mainly due to gastrointestinal adverse events
  • As expected in an insulin +/- sulfonylurea-treated population, the percentage of patients with symptomatic hypoglycemia was higher with lixisenatide (42.9%) versus placebo (23.6%); the rate decreased to 31.8 percent versus 28.3 percent in those not receiving sulfonylurea
  • There were no cases of severe hypoglycemia

  • "Cardioprotective Effect of the GLP-1 Receptor Agonist Lixisenatide on Ischemia- Reperfusion-Induced Injury in the Isolated Rat Heart" [ABSTRACT 0968-P]In this pre-clinical study, data showed that lixisenatide once daily protects against myocardial ischemia-reperfusion injury (tissue damage caused by restriction of oxygen rich blood to the heart) in isolated rat hearts by significantly reducing myocardial infarct size (measurement of damage to the heart) in the isolated rat heart model.

    Key Findings:

  • Administration of lixisenatide at 0.3 nM starting ten minutes prior to and during reperfusion significantly reduced myocardial infarct-size by 36 percent (p=0.0028 versus vehicle control)
  • The observed cardioprotective effect was not associated with a significant change in cardiac hemodynamics (mechanisms involved in circulation), particularly coronary flow, suggesting a direct cardiac effect

  • "Effect of the Once-Daily GLP-1 Receptor  Agonist Lixisenatide on Gastric Emptying  and Prandial  Carbohydrate  Utilization  in  Animal  Models:  A  Comparison   with  Liraglutide" [ABSTRACT 2267-PO]Data from several animal studies showed that  treatment with lixisenatide was more effective in delaying   gastric   emptying   and   lowering   prandial   glucose   excursions   (change   in   glucose concentration after a meal) than liraglutide.

    Key Findings:

  • Lixisenatide  strongly  and  dose-dependently  inhibited  gastric  emptying  in  rats  with  a significant emptying effect already present at 1 microgram/kg sc
  • Even a 100 times higher dose of  liraglutide was ineffective and significant inhibition of gastric emptying was observed only at doses of 500 microgram/kg and above
  • In an oral glucose tolerance test in dogs, 1 microgram/kg sc lixisenatide almost completely abolished blood glucose excursion
  • With  liraglutide,  the  glucose-lowering  effect  during  oral  glucose  tolerance  testing  was significantly weaker than that of lixisenatide, even when liraglutide was administered at 50-100 times higher doses
  • After administration of  a liquid meal, lixisenatide (3 microgram/kg sc) given  to mice was more effective in lowering prandial glucose excursions than liraglutide (200 microgram/kg) and lixisenatide (10 microgram/kg) injected subcutaneously to diabetic mice improved glucose tolerance at least as effectively as liraglutide (200 microgram/kg sc)

  • About Lyxumia® (Lixisenatide)Lixisenatide, a glucagon-like  peptide-1 agonist (GLP-1), is in development for the treatment of patients with type 2 diabetes mellitus. Lixisenatide was  in-licensed from Zealand Pharma A/S (Copenhagen,  Denmark),  Lyxumia®  is  the  intended  trademark  for lixisenatide. Lixisenatide is not currently approved or licensed anywhere in the world.

    GLP-1 is a naturally-occurring peptide that is released within minutes of eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor agonists are in development as an add-on treatment for type 2 diabetes and their use is endorsed by the European Association for the Study of Diabetes, the American Diabetes Association, the American Association of Clinical Endocrinologists and  the American College of Endocrinology.

    The GetGoal Phase III clinical program will provide data for lixisenatide in adults with type 2 diabetes treated with various oral anti-diabetic agents or insulin. With nine trials in the program, GetGoal started in May 2008 and  has enrolled more than 4,300 patients. To date GetGoal-X, GetGoal-Mono  and  GetGoal-L  Asia  and  GetGoal-S,  have  reported  positive  top-line  results supporting efficacy and safety for lixisenatide. Further results are expected during 2011.

    About DiabetesDiabetes is a chronic, widespread condition characterized by high blood sugar in which the body does not produce or properly use insulin, the hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. It is estimated that approximately 285 million adults worldwide are living with the disease and this number is expected to rise to a staggering 438 million within 20 years.  It is estimated  that nearly 26 million  Americans have diabetes, including an estimated 7 million who remain undiagnosed.  At the same time, approximately 40 percent of those diagnosed  with  diabetes  did  not  achieve  the  blood  sugar  control  target  of  A1C  <7  percent recommended by the  American Diabetes Association. The A1C test measures average blood glucose levels over the past two-to-three-month period.

    About the Sanofi Diabetes DivisionSanofi 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.

    About SanofiSanofi, 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).

    Forward Looking StatementsThis 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.Contacts:US CommunicationsGlobal CommunicationsSusan Brooks

    Yanyan ChangT. 908-981-6566

    T. +49 69 305

    Yanyan.chang@sanofi-aventis.comCorporate Media RelationsMarisol PeronTel: +33 (0) 1 53 77 45 02Mobile: +33 (0) 6 08 18 94 78E-mail:

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