-- New results for Toujeo(R) (insulin glargine [rDNA origin] injection, 300 U/mL; "U300") from EDITION I/II/III meta-analysis, EDITION III, IV, JP 1 and JP 2 studies are among over 65 abstracts to be presented
PARIS, June 11, 2014 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that new data on U300, Lyxumia(R) (lixisenatide) and Lantus(R) will be presented at the American Diabetes Association (ADA) 74th Scientific Sessions in San Francisco, June 13‒17. Abstracts are available on the ADA website( http://professional.diabetes.org/Congress_Display.aspx?TYP=9&CID=93229 ).
Eight abstracts from the EDITION Phase III program for U300 will be presented. The worldwide and comprehensive EDITION program evaluated, in broad and diverse populations of people with diabetes, the efficacy and safety of U300 vs. Lantus(R). Following presentation of EDITION I and II results in 2013, a meta-analysis of EDITION I/II/III; full results from the other four studies in the EDITION program; and year one results from EDITION I and II showing the first longer-term data for U300, will be presented at ADA 2014.
More than 55 additional abstracts from across the Sanofi Diabetes portfolio will also be presented. Data highlights from lixisenatide, the fixed-ratio combination of lixisenatide and Lantus(R), Lantus(R), and the TEENs study are listed below.
-- Abstract # 90-LB: New Insulin Glargine 300 U/mL: Glycemic Control and Hypoglycemia in a Meta-analysis of Phase 3a EDITION Clinical Trials in People with T2DM
-- Abstract # 68-OR: New Insulin Glargine 300 U/mL: Glycemic Control and Hypoglycemia in Insulin Naïve People with T2DM (EDITION 3)
-- Abstract # 80-LB: Glycemic Control and Hypoglycemia with New Insulin Glargine 300U/mL in People with T1DM (EDITION 4)
-- Abstract # 88-LB: New Insulin Glargine 300 U/mL: Glycemic Control and Hypoglycemia in Japanese People with T1DM (EDITION JP 1)
-- Abstract # 94-LB: Glycemic Control and Hypoglycemia in Japanese People with T2DM Receiving New Insulin Glargine 300 U/mL in Combination with OADs (EDITION JP 2)
-- Abstract # 81-LB: Sustained Glycemic Control and Less Hypoglycemia with New Insulin Glargine 300 U/mL Compared with 100 U/mL: 1-Year Results in People with T2DM Using Basal + Mealtime Insulin (EDITION 1)
-- Abstract # 93-LB: Less Nocturnal Hypoglycemia and Weight Gain with New Insulin Glargine 300 U/mL Compared with 100 U/mL: 1-Year Results in People with T2DM Using Basal Insulin with OADs (EDITION 2)
-- Abstract # 892-P: Low Within- and Between-Day Variability in Exposure to New Insulin Glargine 300 U/mL
-- Abstract # 919-P: New Insulin Glargine 300 U/mL: Efficacy and Safety of Adaptable vs. Fixed Dosing Intervals in People with T2DM
16 abstracts (including 1 publication-only) will be presented on lixisenatide, including:
-- Abstract # 1017-P: Effect of Lixisenatide vs. Liraglutide on Glycemic Control, Gastric Emptying, and Safety Parameters in Optimized Insulin Glargine T2DM ± Metformin
-- Abstract # 118-LB: Effectiveness of Lixisenatide Before Breakfast or the Main Meal Using CGM with AGP Analysis
2 abstracts will be presented on the fixed-ratio combination of lixisenatide and Lantus(R), including:
-- Abstract # 332-OR: Benefits of a Fixed-Ratio Formulation of Once-Daily Insulin Glargine/Lixisenatide (LixiLan) vs. Glargine in Type 2 Diabetes (T2DM) Inadequately Controlled on Metformin
27 abstracts will be presented on Lantus(R), including:
-- Abstract # 6-LB: Enhanced Prediction of Cardiovascular Events By Adding Novel Biomarkers to Clinical Risk Factors in the ORIGIN Trial
3 abstracts for the first global presentation of the TEENs study results will be presented, including:
-- Abstract # 32-OR: Global Assessment of Factors Associated with Target Glycemic Control in Youth with Type 1 Diabetes (T1D): the TEENs Study
About Toujeo(R) (insulin glargine [rDNA origin] injection, 300 U/mL)
Toujeo(R) (insulin glargine [rDNA origin] injection, 300 U/mL; "U300") is a new basal insulin currently in development for the treatment of people with diabetes mellitus. U300 has a pharmacokinetic and pharmacodynamic profile with studies demonstrating it is smoother and more prolonged than Lantus(R).[3-6] Toujeo(R) is the intended trade name for U300. U300 is not currently approved or licensed anywhere in the world.
About Lyxumia(R) (lixisenatide)
Lyxumia(R) (lixisenatide) is a once-daily prandial 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.
Lyxumia was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL),http://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 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 (SAN.PA) and in New York (SNY).
-- Riddle M, et al. New insulin glargine formulation: glucose control and hypoglycaemia in people with type 2 diabetes using basal and mealtime insulin (EDITION I). Diabetologia. 2013;56 (Suppl 1):A220.
-- Yki-Jarvinen et al. An investigational new insulin U300: glucose control and hypoglycemia in people with type 2 diabetes on basal insulin and OADs (EDITION II). Abstract at World Diabetes Congress 2013. Oral presentation OP0075 Abstract.
-- Dahmen R et al New Insulin Glargine U300 Formulation Evens and Prolongs Steady State PK and PD Profiles During Euglycemic Clamp in Patients With Type 1 Diabetes (T1DM). 73rd Scientific Sessions of the ADA, abstract no. 113-OR.
-- Tillner J, et al. Euglycaemic single dose clamp profile of new insulin glargine formulation in subjects with type 1 diabetes is flat and prolonged.Diabetologia. 2013;56 (Suppl 1):A1033.
-- Jax T, et al. New insulin glargine formulation has a flat and prolonged steady state profile in subjects with type 1 diabetes. Diabetologia. 2013;56 (Suppl 1):A1029.
Shiramoto M, et al. Single dose of new insulin glargine Gla-300 formulation has a flatter and prolonged PK/PD profile than Gla-100 in Japanese subjects with type 1 diabetes. Diabetologia. 2013;56 (Suppl 1):A1031.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.