Sanofi Announces Positive Phase 3 Results for Investigational New Insulin U300

Paris (ots/PRNewswire) -

- EDITION I demonstrated similar blood sugar control with fewer
night-time low blood sugar events compared to Lantus(R)-

- Topline results of EDITION II consistent with EDITION I findings
-

Sanofi announced today that the first phase 3 study results
(EDITION I) for its investigational new insulin U300 showed
equivalent blood sugar control with fewer night-time low blood sugar
events compared to Lantus(R) (insulin glargine [rDNA origin]
injection). The company also announced topline results of a second
Phase 3 study (EDITION II) for investigational new insulin U300 that
also demonstrated similar blood sugar reduction while fewer patients
experienced night-time low blood sugar events compared with
Lantus(R).

These results are from EDITION I and EDITION II respectively and
are part of the EDITION Phase 3 clinical program evaluating the
efficacy and safety of the investigational new insulin U300 in people
with diabetes. The EDITION I data was presented at the 73rd
Scientific Sessions of the American Diabetes Association.

"To properly manage diabetes, it is critical to control blood
sugar and to reduce the risk of low blood sugar events, especially at
night," said Matthew Riddle, Professor of Medicine, Division of
Endocrinology/Diabetes/Clinical Nutrition, Oregon Health and Science
University, U.S., and Principal Investigator for the EDITION I study.
"I am encouraged by these findings, and look forward to the results
of the full Phase 3 EDITION program, which will further reveal how
this investigational basal insulin may help people living with
diabetes."

EDITION I

As the first study of the EDITION Phase 3 program, EDITION I
evaluated the efficacy and safety of investigational new insulin
U300, vs. Lantus(R) in people with type 2 diabetes using basal plus
mealtime insulin. In a multicenter, open-label study 807 people were
randomized (1:1) to once daily evening new insulin U300 (n=404) or
Lantus(R) (n=403) while continuing mealtime insulin. The basal
insulin was titrated to achieve fasting plasma glucose of 80-100
mg/dL. Primary endpoint was change in HbA1c from baseline to month 6,
and main secondary endpoint was % of people with at least 1 severe or
confirmed (less than or equal to70 mg/dL) nocturnal hypoglycemic
event from month 3 to month 6.

EDITION I demonstrated similar reductions in HbA1c (glycated
hemoglobin) from baseline (primary endpoint) between new insulin U300
and Lantus(R) at 6 months [least squares mean change -0.83% (0.06) in
both groups; difference -0.00% (95% CI -0.11 to 0.11)] in people with
type 2 diabetes who had challenging treatment needs (mean age of
study participants: 60 years; duration of type 2 diabetes: 15.8
years; BMI: 36.6 kg/m2; HbA1c: 8.15 %; total insulin dose: 1.2 U/kg;
basal insulin dose: 0.67 U/kg at baseline). In addition,
approximately 40% of study participants with uncontrolled glycemic
(blood sugar) levels despite receiving a combined therapy (oral
antidiabetic agents plus basal and prandial insulins) reached
glycemic control (HbA1c <7%) at month 6 both in the new insulin U300
(39.6%) and in the Lantus(R) arm (40.9%).

The investigational new insulin U300 was associated with a 21%
reduction in severe or confirmed nocturnal hypoglycemia (low blood
sugar) from month 3 to month 6. Significantly fewer patients had
nocturnal (severe and/or confirmed; i.e. less than or equal to70
mg/mL) hypoglycemia (low blood sugar) during months 3 to 6
(pre-specified main secondary endpoint: 36.1% vs. 46.0%; RR 0.79;
p=0.0045) and the occurrence of any nocturnal hypoglycemic event (%
of people with at least one event) during the 6-month study period
was lower on new insulin U300 during the study period compared to the
Lantus(R) group (45.3% vs. 59.7%; RR 0.76; 95% CI 0.66 to 0.87). New
insulin U300 was well-tolerated in this study, with no differences in
other adverse events observed from Lantus(R).

The EDITION I abstract is titled: New Insulin Glargine
Formulation: Glucose Control and Hypoglycemia in People with Type 2
Diabetes Using Basal and Mealtime Insulin (EDITION I) (Riddle, MC et
al) [Abstract no. 43-LB]

EDITION II

Topline results of EDITION II are consistent with EDITION I
findings. EDITION II demonstrated that investigational new insulin
U300 achieved similar blood sugar reduction while fewer patients
experienced night-time low blood sugar events compared with
Lantus(R).

EDITION II evaluated efficacy and safety of new insulin U300 in a
type 2 diabetes population (811 patients) treated with basal insulin
plus oral antidiabetic therapy. The full EDITION II results will be
submitted for presentation at upcoming scientific meetings.

"There remains a substantial unmet need in people with diabetes
taking oral medication or insulin as many of them do not reach their
glycemic goals," said Pierre Chancel, Senior Vice President, Global
Diabetes, Sanofi. "With the investigational new insulin U300, we are
striving to further enhance the clinical value of basal insulin,
while building on the wealth of evidence of Lantus(R), the world's
most prescribed insulin."

About investigational new insulin U300

Investigational new insulin U300 is a new formulation based on the
glargine molecule, the biological entity of Lantus(R), with its well
established efficacy and safety profile. However, new insulin U300
has unique pharmacokinetic and pharmacodynamic profiles with studies
demonstrating it has even flatter and more prolonged profiles than
Lantus(R).[1],[ 2] New insulin U300 also offers the benefit of a
smaller volume of subcutaneous injection compared with Lantus(R).

About the EDITION Phase 3 Program

The EDITION program is a worldwide and comprehensive series of
Phase 3 studies evaluating the efficacy and safety of new insulin
U300 in broader and diverse populations of people with diabetes. The
full EDITION I (basal + mealtime insulin) and EDITION II (basal
Insulin + oral therapy) results are expected by the end of this year.
Additionally, the following Phase 3 studies from the EDITION program
are ongoing: EDITION III in insulin-naive type 2 diabetes patients ,
EDITION IV in type 1 diabetes patients, EDITION JP I in Japanese type
1 diabetes patients (basal + bolus insulin) and EDITION JP II in
Japanese type 2 diabetes patients (basal insulin + oral therapy).

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 nerve
(neuropathy). The global incidence of diabetes is growing at an
alarming rate, with more than 371 million people worldwide living
with the condition today.

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 .

References

1) Tillner J et al. Euglycemic Clamp Profile of New Insulin Glargine U300
Formulation in Patients With Type 1 Diabetes (T1DM) is Different From Glargine
U100.73rdScientific Sessions of the ADA, abstract no. 920-P
2) 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

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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statements regarding future performance. Forward-looking statements
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Although Sanofi's management believes that the expectations reflected
in such forward-looking statements are reasonable, investors are
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actual results and developments to differ materially from those
expressed in, or implied or projected by, the forward-looking
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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.

Sanofi will host a conference call for the financial community on
Monday June 24, 2013, at 700 AM CST (200 PM Paris Time). The call
will include results from the ongoing EDITION phase 3 program for
U300 as well as a status update on the fixed-ratio combination of
insulin glargine and lixisenatide.

Dial-in numbers and the audio webcast link will be accessible via
http://www.sanofi.com.

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

Contact:
Contacts: Corporate Media Relations, Marisol Peron, Tel.: +33 1
53 77 45 02, Mobile: +33 6 08 18 94 78, E-mail:
marisol.peron@sanofi.com ;
Global Diabetes Communications, Tilmann Kiessling, Mobile: +49 17 26
15 92
91, E-mail: Tilmann.Kiessling@sanofi.com ; Investor Relations,
Sébastien
Martel , Tel.: +33(0)1 53 77 45 45, E-mail: IR@sanofi.com ; US
Diabetes
Communciations, Susan Brooks, Tel : +1(0)908 981 65 66, Mobile:
+1(0)201
572 49 94, E-mail: Susan.Brooks@sanofi.com