Once-Daily Lyxumia® (lixisenatide) Approved for Treatment of Type 2 Diabetes in Europe

Paris (ots/PRNewswire) -

- Sanofi portfolio expands to offer first once-a-day prandial
GLP-1 receptor

agonist -

Sanofi announced today that the European Commission has granted
Marketing Authorisation in Europe for Lyxumia(R) (lixisenatide).
Lyxumia(R), the first once-daily prandial GLP-1 receptor agonist, is
indicated for the treatment of adults with type 2 diabetes mellitus
to achieve glycaemic control in combination with oral
glucose-lowering medicinal products and / or basal insulin when
these, together with diet and exercise, do not provide adequate
glycaemic control.

"With the European approval of Lyxumia(R), we now have a simple
new tool to help patients with type 2 diabetes further reduce HbA1c,
with the benefit of weight loss and limited risk of hypoglycaemia.
This well-tolerated therapy is of specific interest to patients who
are on oral treatments and / or basal insulin and do not manage to
maintain their HbA1c targets," said Pierre Chancel, Senior
Vice-President, Global Diabetes at Sanofi. "With a single daily
injection andonly one step to maintenance dose, Lyxumia(R)is a
positive addition to the Sanofi portfolio, and represents another
step forward in our efforts to advance scientific excellence and
develop new therapeutic solutions that improve outcomes for people
with diabetes, an area of significant unmet medical need."

The European Commission decision to grant Marketing Authorisation
in Europe for Lyxumia(R) is based on results from the GetGoal
clinical programme, which enabled Lyxumia(R) to be the first
once-daily GLP-1 receptor agonist with a predominantly prandial
glucose lowering effect to be indicated for use on top of basal
insulin and in combination with oral anti-diabetic medications. The
clinical programme showed that Lyxumia(R) demonstrated significant
HbA1c reductions, a pronounced post-prandial glucose lowering effect
and a beneficial effect on body weight in adult patients with type 2
diabetes. GetGoal results also showed that Lyxumia(R) had a
favourable 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 hypoglycaemia. The international GetGoal programme 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 (706 patients
treated with Lyxumia(R) in three trials).[1]

"Lyxumia(R)in combination with oral and / or basal insulin
therapies can play a key role in meeting the important need to
maintain HbA1c targets for people with type 2 diabetes," said Dr. Bo
Ahrén, MD, PhD, from Lund University in Sweden. "Basal insulin
therapies, while targeting fasting plasma glucose, are able to
provide effective control of overall glucose excursion and are able
to bring many patients to the target HbA1c level. However, as
diabetes progresses over time, patients treated with basal insulin
may no longer stay at their HbA1c goals, despite good control of
fasting plasma glucose. When this happens, adding a medicine such as
Lyxumia(R), which has a pronounced post-prandial glucose lowering
effect, may be an effective strategy to further lower blood glucose
levels and maintain HbA1c goals."

Marketing Authorisation in Europe for Lyxumia(R) is applicable to
the 27 Member States of the European Union, as well as Iceland,
Lichtenstein and Norway, and follows the 15 November 2012 positive
opinion issued by the Committee for Medicinal Products for Human Use
of the European Medicines Agency. Applications for regulatory
approval were also submitted in several other countries around the
world and are being reviewed.

About Lyxumia(R) (lixisenatide)

Lyxumia(R) 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(R) was in-licensed from Zealand Pharma A/S ,
http://www.zealandpharma.com. Lyxumia(R) is the proprietary name
approved by the European Medicines Agency (EMA) for the GLP-1 RA
lixisenatide.

About Sanofi Diabetes

Sanofi strives to help people manage the complex challenge of
diabetes by delivering innovative, integrated and personalised
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 and in New
York .

Reference

1) http://clinicaltrials.gov/ct2/results?term=GetGoal. Date accessed:
December 2012.

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

Contact:
Contacts: Corporate Media Relations, Marisol Péron, Tel:
+33-1-53-77-45-02, Mobile: +33-6-08-18-94-78, E-mail:
Marisol.Peron@sanofi.com; Global Diabetes Division Communications,
Phil
McNamara, Tel: +1-908-981-5497, Mobile: +1-908-210-4047, E-mail:
philip.mcnamara@sanofi.com; Investor Relations, Sébastien Martel,
Tel:
+33-1-53-77-45-45, E-mail: ir@sanofi.com