Sanofi to Present New Clinical Data, Including Results From the Investigational New Insulin U300, at the American Diabetes Association 73rd Scientific Sessions

Paris (ots/PRNewswire) -

Sanofi announced today that clinical data highlighting the
company's ongoing commitment to advancing diabetes care will be
presented at the American Diabetes Association (ADA) 73rd Scientific
Sessions in Chicago, USA (June 21-25, 2013). In total, more than 60
abstracts representing new data sets on Sanofi diabetes drugs,
investigational drugs or medical devices are part of the official
scientific program.

"The American Diabetes Association annual meeting provides an
important opportunity for Sanofi to share significant data with the
medical community and to demonstrate our focus on advancing
scientific thinking in the field of diabetes treatment," said Pierre
Chancel, Senior Vice President, Global Diabetes at Sanofi. "The data
being presented further support the company's leadership in
integrated diabetes care and delivering personalized solutions that
directly target the needs of people living with this disease."

Among the study findings being presented in poster and oral
scientific sessions are the following (abstracts have been posted on
the ADA website):

Investigational new insulin U300

The EDITION I study compared the efficacy and safety of
investigational new insulin U300 vs. Lantus(R) (insulin glargine) in
people with type 2 diabetes using basal plus mealtime insulin. The
EDITION I study is part of a larger Phase III clinical program.

"New insulin glargine formulation: glucose control and hypoglycemia in people with type
2 diabetes using basal and mealtime insulin (EDITION I)"
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: M. Riddle, Oregon Health and Science University, Portland, USA
Location: Poster Hall

The pharmacodynamic and pharmacokinetic properties of the
investigational new insulin U300 were examined in a double-blind,
randomized study in patients with type 1 diabetes:

"Euglycemic clamp profile of new insulin glargine U300 formulation in patients with
type 1 diabetes (T1DM) is different from glargine U100"
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: R. Dahmen, Sanofi, Frankfurt am Main, Germany
Location: Poster Hall (also available as an ePoster on the ADA website after 10
am, June 22)

"New insulin glargine U300 formulation evens and prolongs steady state PK and PD
profiles during euglycemic clamp in patients with type 1 diabetes (T1DM)"
Embargo lifts: Saturday, June 22, 1:45 pm CST
Presenter: T. Jax, Profil, Neuss, Germany
Location: W-375A

Lyxumia(R) (lixisenatide)*

Lyxumia(R), the first once-daily prandial GLP-1 receptor agonist,
is approved in the European Union 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(R) data include two analyses investigating its
post-prandial mechanism of action:

"Once-daily lixisenatide as add-on to basal insulin plus or minus OADs in patients with
type 2 diabetes selectively reduces postprandial hyperglycemic daytime exposure"
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: M. Riddle, Oregon Health and Science University, Portland, USA
Location: Poster Hall (also available as an ePoster on the ADA website after 10
am, June 22)

"Efficacy of lixisenatide in the GetGoal clinical trial program: pooled analysis of
postprandial metabolic outcomes"
B. Ahren, Lund University, Sweden. Abstract publication only.

Further data include analyses of the effects of Lyxumia(R) in
combination with basal insulin on HbA1c, weight gain and symptomatic
hypoglycemia in patients with type 2 diabetes:

"Expanding the basal-plus regimen: basal insulin + lixisenatide is more likely to
achieve the composite outcome of HbA1c <7%, no documented symptomatic hypoglycemia and
no weight gain compared with basal + prandial insulin"
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: J. Rosenstock, Dallas Diabetes & Endocrine Center, Texas, USA
Location: Poster Hall (also available as an ePoster on the ADA website after 10
am, June 22)

"Meta-analysis of randomized controlled trials of lixisenatide as add-on to basal
insulin in patients with type 2 diabetes mellitus"
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: B. Charbonnel, University of Nantes, France
Location: Poster Hall (also available as an ePoster on the ADA website after 10
am, June 22)

ORIGIN (Outcome Reduction with Initial Glargine INtervention)[1]

ORIGIN is a unique, seven-year landmark cardiovascular (CV)
outcomes trial, evaluating Lantus(R) vs. standard care in over 12,500
individuals who are at high CV risk with pre-diabetes or early type 2
diabetes mellitus. Spanning 40 countries worldwide, it is the world's
longest and largest randomized clinical trial of its type in this
population, and the first to formally evaluate the effects of insulin
on CV outcomes.

Results from a new sub-analysis of ORIGIN will be presented:

"Cancer outcomes in patients with dysglycemia on basal insulin: results of the ORIGIN
trial"
Embargo lifts: Monday, June 24, 8 am CST
Presenter: LJ. Bordeleau, McMaster University, Ontario, Canada
Location: S-103B

ATLAS (Asian Treat to Target Lantus(R) Study)

The ATLAS study compared the effectiveness of a patient-led vs.
physician-led initiation of Lantus(R) in 552 patients with type 2
diabetes in Asia and Russia. Due to the specific challenges faced by
people living with diabetes in Asia, this study investigated whether
self-adjustment of insulin in this population is similarly effective
at lowering blood glucose levels as it is in Western diabetes
patients.

Data from ATLAS includes:

"Asian Treat to Target Lantus Study (ATLAS): a 24 week randomized, multinational study"
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: S. Garg, University of Colorado Health Sciences Center, Denver,
Colorado, USA
Location: Poster Hall

"Evaluating the patient experience in the Asian Treat to Target Lantus Study (ATLAS): a
24-week randomized, multinational study"
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: N. Freemantle, University College London, UK
Location: Poster Hall

BGStar(R)

Now available in 14 countries across four continents, our
intuitive blood glucose monitoring (BGM) devices BGStar(R) and
iBGStar(R) form a key part of our comprehensive patient-centric
portfolio and are at the heart of our integrated approach to
diabetes.

Key BGStar(R) data show that the performance of our
self-monitoring BGM device achieves similar system accuracy as point
of care testing systems for professional use:

"Evaluating system accuracy of blood glucose monitoring systems for point of care
testing"
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: G. Freckmann, Institut fuer Diabetes-Technologie Forschungs- und
Entwicklungsgesellschaft mbH an der Universitat Ulm, Germany
Location: Poster Hall (also available as an ePoster on the ADA website after 10
am, June 22)

Sanofi will host a conference call for the financial community
during the upcoming ADA 73rd Scientific Sessions. The call will
include results from the ongoing EDITION Phase III program for the
company's investigational new insulin U300 as well as a status update
on the fixed-ratio combination of insulin glargine and lixisenatide.

The conference call will take place on Monday June 24, 2013, at 7
am CST (2 pm CET). Dial-in numbers and the audio webcast link will be
accessible via http://www.sanofi.com

About Diabetes

Diabetes is a chronic disease that occurs as type 1 diabetes,
which is an autoimmune disease characterized by the lack of insulin
(the hormone that regulates blood glucose concentrations) production
by the pancreas, and type 2, a metabolic disorder in which there are
two main biological defects: a deficient production of insulin and
reduced ability of the body to respond to the insulin being produced.
Type 1 and type 2 diabetes are characterized by an increase in blood
glucose concentrations (hyperglycemia). Over time, uncontrolled
hyperglycemia leads to the macrovascular and microvascular
complications of diabetes. Macrovascular complications, which affect
the large blood vessels, include heart attack, stroke and peripheral
vascular disease. Microvascular complications affect the small blood
vessels of the eyes (retinopathy), kidney (nephropathy) and nerves
(neuropathy). The global incidence of diabetes is growing at an
alarming rate, with more than 371 million people worldwide living
with the condition today.[2]

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, an integrated 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 .

Footnote

*Lixisenatide, a glucagon-like peptide-1 receptor agonist (GLP-1
RA), was in-licensed from Zealand Pharma A/S ,
http://www.zealandpharma.com, and is approved in Europe, Mexico and
Australia for the treatment of patients with type 2 diabetes
mellitus. Lyxumia is the proprietary name approved by the EMA,
Australia and Mexico, and submitted to other health authorities for
the GLP-1 RA lixisenatide. The proprietary name for lixisenatide in
the United States is under consideration.

References

1. Gerstein H (ORIGIN Trail Investigators) et al. Basal Insulin
and Cardiovascular and Other Outcomes in Dysglycemia. New England
Journal of Medicine 2012; 367: 319-328.

2. International Diabetes Federation. IDF Diabetes Atlas, 5th
edition: 2012 update. Brussels, Belgium, 2011.
http://www.idf.org/diabetesatlas (Accessed: June, 2013)

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, 2012. 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: Corporate Media Relations, Marisol Péron, Tel:
+33-1-53-77-45-02, Mobile: +33-6-08-18-94-78, E-mail:
marisol.peron@sanofi.com ; Investor Relations: Sébastien Martel, Tel:
+33-1-53-77-45-45, E-mail: ir@sanofi.com; Global Diabetes Division
Communications: Phil McNamara, Tel: + 1-908-981-5497
Mobile: +1-908-210-4047, E-mail: philip.mcnamara@sanofi.com