Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA

   Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA

PR Newswire

PARIS, Feb. 19, 2013

PARIS, Feb.19, 2013 /PRNewswire/ --Sanofi (EURONEXT : SANand NYSE: SNY)
announced today that the U.S. Food and Drug Administration (FDA) has accepted
for review a New Drug Application (NDA) for lixisenatide, the first once-daily
prandial GLP-1 receptor agonist for the treatment of adults with type 2
diabetes mellitus. The acceptance of the lixisenatide NDA filing follows the
February 1, 2013, European Commission approval of lixisenatide in the European
Union.

(Logo: http://photos.prnewswire.com/prnh/20110624/NY25833LOGO )

"We are very pleased to announce the FDA acceptance of our submission for
lixisenatide in the U.S.," said Pierre Chancel, Senior Vice President, Global
Diabetes at Sanofi. "This important milestone is the result of our company's
continuing worldwide effort to meet the needs of people living with diabetes,
and we look forward to working with the FDA during the review process."

The NDA submission for lixisenatide is based on results from the GetGoal
clinical program, which showed that lixisenatide demonstrated significant
reductions in HbA[1c], a pronounced post-prandial glucose (PPG)-lowering
effect and a beneficial effect on body weight in adult patients with type 2
diabetes. GetGoal results also showed that lixisenatide had a favorable safety
and tolerability profile in most patients, with mild and transient nausea and
vomiting, the most common adverse events observed in the GLP-1 receptor
agonist class, and a limited risk of hypoglycemia.

The international GetGoal program included 11 clinical trials involving more
than 5,000 patients with type 2 diabetes, with a large number of patients
studied to evaluate a GLP-1 receptor agonist in combination with basal insulin
(1,250 patients treated with lixisenatide or placebo in three trials).The
addition of lixisenatide to basal insulin was studied because these medicines
target separate components of HbA[1c], an important measure of blood glucose
control. Lixisenatide has a pronounced PPG-lowering effect, which complements
the predominantly fasting plasma glucose (FPG)-lowering effect of basal
insulin. For patients treated with basal insulin who have controlled FPG but
who, due to the progression of type 2 diabetes, are no longer able to achieve
their HbA[1c ]goal, adding lixisenatide, which targets PPG, could be an
effective strategy to achieve target glucose control.

Available data from the ongoing ELIXA trial, a cardiovascular outcome (CV)
study of lixisenatide in patients at high CV risk (i.e. patients who recently
experienced an acute coronary event) were also submitted, as required by the
FDA.

Sanofi is preparing to launch lixisenatide in the European Union as of late Q1
2013,under the proprietary name Lyxumia. The proprietary name for
lixisenatide in the United States is under consideration.

About lixisenatide
Lixisenatide is a 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.

Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen:
ZEAL), www.zealandpharma.com, and is approved in Europe 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 also approved in Mexico for the treatment of adults
with type 2 diabetes.

About GetGoal
The 11 GetGoal clinical trials supporting the lixisenatide NDA filing studied
the benefits and risks related to using lixisenatide as monotherapy, in
combination with oral anti-diabetic medicines, in combination with basal
insulin and versus twice-daily exenatide.

Monotherapy
GetGoal-Mono evaluated the efficacy, safety and tolerability of lixisenatide
as monotherapy in comparison to placebo over 12 weeks of treatment.

GetGoal-Mono Japan evaluated the efficacy, safety and tolerability of
lixisenatide as monotherapy in patients with type 2 diabetes in Japan over 76
weeks of treatment.

Add-on to oral anti-diabetic medicines
GetGoal-F1 evaluated the efficacy, safety and tolerability of lixisenatide in
association with metformin in comparison to placebo over 24 weeks of
treatment, followed by an extension period.

GetGoal-S evaluated the efficacy, safety and tolerability of lixisenatide in
association with sulfonylurea with or without metformin in comparison to
placebo over 24 weeks of treatment, followed by an extension period.

GetGoal-M evaluated the efficacy, safety and tolerability of lixisenatide in
association with metformin in comparison to placebo over 24 weeks of
treatment, followed by an extension period.

GetGoal-P evaluated the efficacy, safety and tolerability of lixisenatide in
association with pioglitazone with or without metformin in comparison to
placebo over 24 weeks of treatment, followed by an extension period.

GetGoal-M Asia assessed the effects of lixisenatide as an add-on treatment to
metformin with or without sulfonylureas on glycemic control (in terms of
HbA[1c] reduction) in comparison to placebo over 24 weeks of treatment.

Add-on to basal insulin
GetGoal-L Asia evaluated the efficacy, safety and tolerability of lixisenatide
in association with basal insulin with or without sulfonylurea in comparison
to placebo over 24 weeks of treatment.

GetGoal-L evaluated the efficacy, safety and tolerability of lixisenatide in
association with basal insulin with or without metformin in comparison to
placebo over 24 weeks of treatment, followed by an extension period.

GetGoal-Duo1 assessed the effects of lixisenatide as an add-on treatment to
insulin glargine and metformin on glycemic control in comparison to placebo
over 24 weeks of treatment.

Versus twice-daily exenatide
GetGoal-X compared the efficacy, safety and tolerability of lixisenatide
versus twice-daily exenatide in association with metformin over 24 weeks of
treatment, followed by an extension period.

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 innovative 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 and diversified 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).

Forward-Looking Statements
This press release contains forward-looking statements. 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, 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, 2011. Other than as
required by applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.

Contacts:
Media Relations                          Investor Relations
Marisol Peron                            Sebastien Martel
Tel: + (33) 1 53 77 45 02                Tel: + (33) 1 53 77 45 45
marisol.peron@sanofi.com                ir@sanofi.com
Global Diabetes Division Communications
Phil McNamara
Tel: + (1) 908 981 5497
philip.mcnamara@sanofi.com
US Diabetes Communications
Susan Brooks
Tel: + (1) 908 981 6566
susan.brooks@sanofi.com



SOURCE Sanofi

Website: http://en.sanofi.com
 
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