New Data Support Flexibility in Timing of Administration for Sanofi's Lyxumia®

Paris (ots/PRNewswire) -

- Similar glucose lowering effect when once-daily Lyxumia

is administered before breakfast or the main meal -

Sanofi announced today the results of a 24-week Phase IIIb
clinical study showing that Lyxumia(R) (lixisenatide) met the primary
endpoint of non-inferiority in blood sugar lowering (HbA1c) when
administered either before breakfast or the main meal of the day.
These results indicate that lixisenatide can effectively lower blood
sugar at either time of administration.

"Helping patients reach their HbA1c goal is the main objective of
type 2 diabetes treatment," said Professor Bo Ahren, Faculty of
Medicine, Lund University, Sweden. "Flexibility in timing of
administration is also an important attribute, especially for
injectable diabetes therapies. This study shows that once-daily
lixisenatide meets these criteria, which is significant for an agent
that is prescribed for use in combination with existing treatment
regimens."

The results also showed that a comparable reduction in body
weight, regardless of the meal before which lixisenatide was
administered, was achieved. In addition, gastrointestinal
tolerability was comparable regardless of time of administration,
with no cases of severe hypoglycemia in either arm. The data were
shared during an oral presentation at the World Diabetes Congress
2013 in Melbourne, Australia.

Results of Analysis

The 24-week Phase IIIb study examined 451 patients with type 2
diabetes, uncontrolled on metformin alone, randomized to lixisenatide
either prior to the main meal or prior to breakfast. Lunch (as
defined by questioning patients) was the main meal of the day for 53%
of patients.

The primary endpoint of the study, demonstrating non-inferiority
in HbA1c decrease at 24 weeks from baseline when lixisenatide was
injected prior to the main meal of the day vs. breakfast, was
successfully achieved with mean HbA1c reductions of 0.65% and 0.74%
respectively. In addition, 43.6% of patients in the main meal group
and 42.8% in the breakfast group achieved HbA1c below 7%. The mean
change in body weight was -2.6kg in the main meal group and -2.8kg in
the breakfast group. Gastrointestinal tolerability was comparable
between the two groups (nausea 14.7% and 15.5% and vomiting 2.7% and
3.5%, respectively) and the incidence of symptomatic hypoglycemia was
low in both groups, with no severe cases.

This study abstract is entitled: 'Flexibility in timing of
lixisenatide administration prior to either the main meal of the day
or the breakfast in T2DM patients' (Ahren B, et al. Oral presentation
December 5, 2013, 10:45-12:45 [ABS OP-0454]).

About Lyxumia(R) (lixisenatide)

Lyxumia(R) (lixisenatide) is a once-daily prandial 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 ,
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, Brazil, Colombia and Chile 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 Good Design Award 2012 and the iF Product
Design Award. The variant of the Lyxumia pen used in Japan won the
Good Design Award (G Mark) 2013.

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 .

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

Contact:
Media Relations: Jack Cox, Tel.: +(33)1-53-77-46-46,
mr@sanofi.com; Investor Relations: Sébastien Martel, Tel.:
+(33)1-53-77-45-45, ir@sanofi.com