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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 : SAN and 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).

Reference

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

Forward Looking Statements

This press release   contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These statements
include projections and estimates and their underlying assumptions, statements
regarding plans, objectives, intentions and expectations with respect to
future financial results, events, operations, services, product development
and potential, and statements regarding future performance. Forward-looking
statements are generally identified by the words "expects", "anticipates",
"believes", "intends", "estimates", "plans" and similar expressions. Although
Sanofi's management believes that the expectations reflected in such
forward-looking statements are reasonable,   investors are   cautioned that
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.

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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