Sanofi Receives Positive CHMP Opinion in the European Union for Once-Daily Lyxumia® (lixisenatide)

PR Newswire/Les Echos/ 
PRESS RELEASE 
Sanofi Receives Positive CHMP Opinion in the European Union for Once-Daily 
                         Lyxumia(r) (lixisenatide) 
- Diabetes portfolio poised to significantly expand in 2013 to meet patient 
                                   needs - 
Paris, France - November 16, 2012 - Sanofi (EURONEXT: SAN and NYSE: SNY)
announced today that the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency (EMA) has issued a positive opinion
recommending the approval of once-daily Lyxumia(r) (lixisenatide) 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. The CHMP positive opinion will now be forwarded to the
European Commission (EC), which has the authority to approve medicines for the
European Union. Following EC marketing authorization, which is typically granted
2-3 months after a positive opinion, Lyxumia will significantly expand the
company's diabetes franchise. 
"The CHMP positive opinion for Lyxumia marks an important milestone in the
development of this compound and brings us one step closer to serving even more
patients by expanding the Sanofi Diabetes product portfolio," said Pierre
Chancel, Senior Vice-President, Global Diabetes at Sanofi. "This recommendation
validates our belie f that Lyxumia, a once-daily GLP-1 receptor agonist with a
pronounced post-prandial glucose lowering effect, is a promising medicine that
can be combined with other treatments, such as basal insulin, to help patients
with type 2 diabetes achieve target HbA 1c levels. We look forward to receiving
the European Commission decision." 
The CHMP positive opinion is based on results from the GetGoal Phase III
clinical trial program, which examined the efficacy, safety and tolerability
profile of Lyxumia.(1) In the GetGoal program, once-daily Lyxumia significantly
reduced HbA1c - glycated haemoglobin - in patients with type 2 diabetes (primary
endpoint) and showed an associated significant reduction in post-prandial
glucose and a beneficial effect on body weight. The GetGoal program also showed
that Lyxumia was well-tolerated overall, with only mild and transient adverse
effects (primarily nausea, vomiting and diarrhoea) and a limited risk of
hypoglycaemia. The international GetGoal program 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 in three trials).(1) 
In addition to the European Union, lixisenatide has been submitted for
regulatory approval in 11 countries. Submission of a New Drug Application to the
United States Food and Drug Administration is planned for December 2012. 
About Lyxumia(r) (lixisenatide)
Lixisenatide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), is in
development for the treatment of patients with type 2 diabetes mellitus.
Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen:
ZEAL), www.zealandpharma.com. Lyxumia(r) is the proprietary name submitted to
the EMA for the company's investigational GLP-1 RA lixisenatide. The proprietary
name for lixisenatide in the United States is under consideration. Lixisenatide
is not currently approved or licensed anywhere in the world. 
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 glucosedependent insulin secretion by pancreatic beta
cells. 
The GetGoal Phase III clinical trial program provides data for lixisenatide in
adults with type 2 diabetes treated in monotherapy, with various oral
anti-diabetic agents or in combination with basal insulin. The GetGoal program
started in May 2008, has enrolled more than 5,000 patients and serves as support
for the application for regulatory approval of lixisenatide. 
About Diabetes
Diabetes is a chronic disease that occurs as type 1 diabetes, which is an
autoimmune disease characterised by the lack of insulin (the hormone that
regulates blood glucose concentrations) production by the pancreas, and type 2,
a metabolic disorder in which there are two main biological defects: a deficient
production of insulin and reduced ability of the body to respond to the insulin
being produced. Type 1 and type 2 diabetes are characterised by an increase in
blood glucose concentrations (hyperglycaem ia). Over time, u ncontrolled
hyperglycaemia leads to the macrovascular and microvascular complications of
diabetes. Macrovascular complications, which affect the large blood vessels,
include heart attack, stroke and peripheral vascular disease. Microvascular
complications affect the small blood vessels of the eyes (retinopathy), kidney
(nephropathy) and nerves (neuropathy). More than 18 million people worldwide are
living with type 1 diabetes.(2) And, the incidence of type 2 diabetes is growing
at an alarming rate, with nearly 348 million people worldwide living with the
condition today.(2) 
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 innovative blood glucose monitoring systems.
Sanofi markets both injectable and oral medications for people with type 1 or
type 2 diabetes. Investigational compounds in the pipeline include an injectable
GLP-1 receptor agonist being studied as a single agent, in combination with
basal insulin, and/or in combination with oral antidiabetic agents. 
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) 
References
1. http://clinicaltrials.gov/ct2/results?term=GetGoal. Date accessed: October 
2012
2. IDF Diabetes Atlas, 5th Edition (2012) 
Forward Looking Statement
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
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management believes that the expectations reflected in such forward-looking
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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. 
Contacts:
Corporate Media Relations             Investor Relations
Marisol Peron                         Sébastien Martel
Tel: +33 (0)1 53 77 45 02             Tel: +33 (0)1 53 77 45 45
Mobile: +33 (0)6 08 18 94 78
E-mail: Marisol.Peron@sanofi.com      E-mail: ir@sanofi.com  
Global Diabetes Division Communications
Philip McNamara
Tel: + 1-908-981-5497
Mobile: +1-908-210-4047
E-mail: Philip.McNamara@sanofi.com 
                  
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-0- Nov/16/2012 13:14 GMT
 
 
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