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

Paris, France (ots/PRNewswire) -

- 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 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://profe
ssional.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 ,
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 and in New York .

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 include projections and estimates and their
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intentions and expectations with respect to future financial results,
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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.

ots Originaltext: Sanofi Diabetes
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contacts: Media Relations : Jack Cox, Tel.: + (33) 1 53 77 46 46,
jack.cox@sanofi.com ; Investor Relations : Sébastien Martel, Tel.: +
(33)
1 53 77 45 45, ir@sanofi.com ; Global Diabetes Communications : Phil
McNamara, Tel.: + 1 908 981 5497, Mobile: + (1) 908 210 4047,
philip.mcnamara@sanofi.com ; Global Diabetes Communications : Tilmann
Kiessling, Mobile: +(49) 17 26 15 92 91, tilmann.kiessling@sanofi.com