Sanofi to Present New Clinical Data at American Diabetes Association 74th Scientific Sessions

PR57011

PARIS, France, June 11 /PRN=KYODO JBN/ --

      - 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 -

    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[1] and II[2] 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.

                                   Data highlights

    - 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 Naive 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

                                   Data highlights

    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 plus or minus 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.

    About Sanofi

    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).

    References

    1) 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.

    2) 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.

    3) 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.

    4) 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.

    5) 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.

    6) 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

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Sanofi's management believes that the expectations reflected in such

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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,

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that could affect the availability or commercial potential of such product

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will be commercially successful, the future approval and commercial success of

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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.

    SOURCE: Sanofi Diabetes