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

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

  PR Newswire

  PARIS, February 4, 2013

PARIS, February 4, 2013 /PRNewswire/ --

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

Sanofi (EURONEXT: SANand NYSE: SNY) announced today that the European
Commission has granted Marketing Authorisation in Europe for Lyxumia ^®
(lixisenatide). Lyxumia ^® , 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 t he European approval of Lyxumia ^® , we now have  a  simple  new
tool to help patients with type 2 diabetes  further  reduce HbA [1c] , 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 HbA [1c]
 targets , " said Pierre Chancel, Senior Vice-President, Global Diabetes at
Sanofi .  " With a single daily injection  and only one step to maintenance
dose,  Lyxumia ^® is a  positive addition to the Sanofi portfolio , and 
represents  another step forward in our efforts to  advanc e  scientific 
excellence  and develop new therapeutic solutions  that  improv e 
outcomes  for people with diabetes, an area of significant unmet medical need
. "

The European Commission decision to grant Marketing Authorisation in Europe
for Lyxumia ^® is based on results from the GetGoal clinical programme, which
enabled Lyxumia ^® 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 ^® demonstrated significant HbA [1c]
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 ^® 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 ^® in three trials). ^[ ^1 ^]

" Lyxumia ^® in combination with oral and / or basal insulin therapies can
play a key role in meeting the important need  to maintain  HbA [1c] 
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 pati e n ts to the target  HbA
[1c]  leve l .  However, as diabetes progresses over time, patients treated
with basal insulin may no longer stay at their  HbA [1c]  goals, despite
good control of fasting plasma glucose. When this happens, ad ding a medicine
such as Lyxumia ^® , which has a pronounced post - prandial glucose lowering
effect, may be an effective strategy to further lower blood glucose levels and
maintain  HbA [1c]  goals. "

Marketing Authorisation in Europe for Lyxumia ^® 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 ^®  (lixisenatide)

Lyxumia ^® 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 . Lyxumia ^® 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
(EURONEXT: SAN) and in New York (NYSE: SNY).


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

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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
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