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2015-09-14

Sanofi : Sanofi Reports Positive Top-Line Results in Second Pivotal LixiLan Phase III Study

Sanofi
Reports Positive Top-Line Results in Second Pivotal

LixiLan Phase III Study

- LixiLan met primary endpoint showing superior reduction
in HbA1c vs Insulin Glargine alone

-

Paris, France - September 14, 2015
-
Sanofiannounced today that the LixiLan-L Phase III clinical trial met its
primary endpoint in patients with type 2 diabetes treated with insulin
glargine with or without metformin. The fixed-ratio combination of insulin
glargine 100 Units/mL and lixisenatide, a GLP-1 receptor agonist,
demonstrated statistically superior reduction in HbA1c (average blood glucose
over the previous three months) compared with insulin glargine 100 Units/mL.
Overall, the fixed-ratio combination had a safety profile reflecting those of
insulin glargine 100 Units/mL and lixisenatide.

"
This study examined an important possible use of this investigational
medicine,"
said Richard M Bergenstal MD, Executive Director, International Diabetes
Center at Park Nicollet, Minneapolis, Minn., U.S. "The result highlights that
this could provide a treatment option for the
roughly fifty percent of patients who are no longer able to remain at their
HbA1c target, despite basal insulin treatment."

LixiLan-L investigated the efficacy and safety of the fixed-ratio combination
of insulin glargine 100 Units/mL and lixisenatide versus treatment with
insulin glargine 100 Units/mL over a 30 week period in 736 patients whose
type 2 diabetes was not adequately controlled at screening on basal insulin,
alone or combined with one to two oral anti-diabetic agents. Treatment with
metformin, if previously taken, was continued throughout the study. Full
results will be communicated in a future scientific forum.

Sanofi previously announced in July 2015 that the LixiLan-O study met its
primary objective over a 30 week period in 1,170 patients whose type 2
diabetes was not adequately controlled on metformin alone or on metformin
combined with a second oral anti-diabetic agent.

"The Phase III LixiLan-O and LixiLan-L clinical trials were initiated at the
beginning of 2014 to explore the safety and efficacy of our investigational
fixed-ratio combination when used before and after basal insulin,
respectively,"
said Elias Zerhouni, MD, President, Global R&D at Sanofi. "These studies
reflect Sanofi's commitment to developing and evaluating
medicines intended to meet patient needs throughout their journey with
diabetes."

Regulatory submissions are planned for Q4 2015 in the United States and Q1
2016 in the European Union.

What is Lantus®(insulin glargine injection) 100 Units/mL?

Prescription Lantus is a long-acting insulin used to treat adults with type 2
diabetes and adults and pediatric patients (children 6 years and older) with
type 1 diabetes for the control of high blood sugar.

* Do not use Lantus to treat diabetic ketoacidosis.

Important Safety Information For Lantus (insulin glargine injection) 100
Units/mL

Do not take Lantus during episodes of low blood sugar or if you are allergic
to insulin or any of the inactive ingredients in Lantus.

Do not share needles, insulin pens, or syringes with others. Do NOT reuse
needles.

Before starting Lantus, tell your doctor about all your medical conditions,
including if you have liver or kidney problems, if you are pregnant or
planning to become pregnant or if you are breast-feeding or planning to
breast-feed.

Heart failure can occur if you are taking insulin together with certain
medicines called TZDs (thiazolidinediones), even if you have never had heart
failure or other heart problems. If you already have heart failure, it may
get worse while you take TZDs with Lantus. Your treatment with TZDs and
Lantus® may need to be changed or stopped by your doctor if you have new or
worsening heart failure. Tell your doctor if you have any new or worsening
symptoms of heart failure, including:

-----------------------------------------------------------
| * Shortness of breath * Sudden weight gain |
| * Swelling of your ankles or feet |
-----------------------------------------------------------
Tell your doctor about all the medications you take, including OTC medicines,
vitamins, and supplements, including herbal supplements.

Lantus should be taken once a day at the same time every day. Test your blood
sugar levels while using insulin, such as Lantus. Do not make any changes to
your dose or type of insulin without talking to your healthcare provider. Any
change of insulin should be made cautiously and only under medical
supervision.

Do NOT dilute or mix Lantus with any other insulin or solution.
It will not work as intended and you may lose blood sugar control, which could
be serious. Lantus must only be used if the solution is clear and colorless
with no particles visible. Always make sure you have the correct insulin
before each injection.

While using Lantus, do not drive or operate heavy machinery until you know how
Lantus® affects you. You should not drink alcohol or use other medicines that
contain alcohol.

The most common side effect of insulin, including Lantus, is low blood sugar
(hypoglycemia), which may be serious and life threatening.
It may cause harm to your heart or brain. Symptoms of serious low blood sugar
may include shaking, sweating, fast heartbeat, and blurred vision.

Lantus may cause serious side effects that can lead to death, such as severe
allergic reactions. Get medical help right away if you have:

--------------------------------------------------------------------------------
| * A rash over your whole body * Swelling of your face, tongue, or throat |
| * Trouble breathing * Shortness of breath |
| * A fast heartbeat * Extreme drowsiness, dizziness, or confusion |
| * Sweating |
--------------------------------------------------------------------------------
Other possible side effects may include swelling, weight gain, low potassium
levels, injection site reactions, including changes in fat tissue at the
injection site, and allergic reactions.

Please see accompanying full prescribing information for Lantus or
visitwww.Lantus.com.

About Lixisenatide

Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist
(GLP-1 RA) for the treatment of adult 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.

Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen:
ZEAL),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. Lixisenatide is currently approved in over 60 countries
worldwide for the treatment of adults with type 2 diabetes, with commercial
launches in most EU countries, Japan, Brazil, Mexico and other markets.
Lixisenatide is an investigational product in the U.S. It was resubmitted to
the Food&Drug Administration (FDA) in the third quarter of 2015.

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 injectable, inhaled 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 diabetes solutions, human vaccines, innovative drugs, consumer healthcare,
emerging markets, animal health and Genzyme. Sanofi is listed in Paris
(EURONEXT:SAN) and in New York (NYSE:SNY).

Sanofi 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,
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respect to future financial results, events, operations, services, product
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"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, 2014. Other than as required by applicable law,
Sanofi does not undertake any obligation to update or revise any
...

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