Data Show Sanofi's Lyxumia(R) Added to Basal Insulin Lowered Blood Sugar Especially when Fasting Plasma Glucose was Controlled

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PARIS, September 24, /PRN=KYODO JBN/ --

- Findings Consistent with Known Post-Prandial Effect of Lyxumia Supporting

Combination with Basal Insulin -

Sanofi (EURONEXT : SAN and NYSE : SNY) announced today new GetGoal-L

sub-analysis results showing that reductions in HbA1c with Lyxumia(R)

(lixisenatide), when added to basal insulin, were greatest in patients with

type 2 diabetes who had well-controlled baseline fasting plasma glucose (FPG).

These findings are consistent with the efficacy profile of Lyxumia, which shows

a clinical and statistically significant reduction in HbA1c across different

patient populations.

The results also showed that reductions in body weight with Lyxumia, when added

to basal insulin, were greatest in this group. The GetGoal-L sub-analysis was

shared during an oral presentation at the 49th Annual Meeting of the European

Association for the Study of Diabetes in Barcelona.

"Thestudy showed that Lyxumia is aneffective post-prandial glucose lowering

option that improves HbA1c levels when added to basal insulin," said Professor

Josep Vidal, Endocrinology and Nutrition, University of Barcelona. "We analyzed

data from patients who were not at their target HbA1c level, despite controlled

fasting plasma glucose, and we found that a treatment regimen that targets

post-prandial glucose, as well as fasting plasma glucose, could be an effective

choice for these patients."

As type 2 diabetes progresses over time, patients treated with basal insulin

may no longer maintain their target HbA1c level (average blood sugar levels

over the past 2 to 3 months) despite typically sustaining good control of FPG

with basal insulin. For these patients, Lyxumia can significantly reduce HbA1c

by primarily reducing post-prandial (after-meal) glucose levels through its

complementary action with basal insulin. Targeting both FPG and post-prandial

glucose could be an effective way to lower HbA1c in certain patients with type

2 diabetes.

Results of Analysis

This sub-analysis examined 496 patients with type 2 diabetes and inadequate

glucose control. Results showed that the addition of lixisenatide to basal

insulin treatment, with or without metformin (oral anti-diabetic therapy),

reduced overall HbA1c, body weight and post-breakfast self-monitored

post-prandial glucose in all groups. These effects were greater in patients

with relatively well-controlled baseline FPG levels (below or equal to 6.7

mmol/L; FPG in people without diabetes is ~5.5 mmol/L[1]) compared to those

with higher baseline FPG levels (between 6.7 and 8.9 mmol/L, and over 8.9

mmol/L, respectively).

The GetGoal-L sub-analysis abstract is entitled: 'Therapeutic efficacy of

lixisenatide added to basal insulin is greater when FPG is well-controlled'

(Vidal J, et al. [Abstract no. oral presentation 6]).

About Lyxumia(R) (lixisenatide)

Lyxumia(R) (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.

Lyxumia was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL),

http://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.

Lyxumia is also approved in Mexico, Australia, Japan and Brazil for the

treatment of adults with type 2 diabetes. 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 a number of innovative design awards,

including the Red Dot Award, the Good Design Award, and the iF Product Design

Award.

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 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).

Reference

International Diabetes Federation. Global Guideline for Type 2 Diabetes (2012).

Available at:

http://www.idf.org/sites/default/files/IDF-Guideline-for-Type-2-Diabetes.pdf.

Date accessed: September 2013.

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Source: Sanofi Diabetes