positive chmp opinion in the eu for once daily lyxumia (lixisenatide)

Sanofi Receives Positive CHMP Opinion in the European Union for
Once-Daily Lyxumia® (lixisenatide)
- Diabetes portfolio poised to significantly expand in 2013 to meet patient needs -

London, UK – 23 November, 2012 – Sanofi 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® (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. In the GetGoal Phase III clinical trial program, once-daily Lyxumia®
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
Dr Richard Brice, GP with Special Interest in diabetes commented, “We welcome the CHMP’s
recommendation of lixisenatide. The number of people with diabetes in the UK is rapidly increasing
and many of the patients we see in clinic are not reaching their treatment goals. This new treatment
has the potential to help many primary care patients with type 2 diabetes, a disease that still has a
huge unmet medical need. We eagerly anticipate its approval for use in the UK.”
He went onto say, “I am particularly impressed that the clinical trial program has incorporated
elderly patients, as the prevalence of type 2 diabetes is growing in this population and their needs
can be different. It is unusual for a new medication to be so widely trialled in the elderly at this stage
in its development so I appreciate having the potential to use it in this group as well as in younger
patients. The low risk of hypoglycaemia associated with Lyxumia may make it particularly suitable
for older patients.”
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 lixisenatide. 1,2,3,4,5,6,7,8,9 The data
showed that lixisenatide was well-tolerated overall, with only mild and transient adverse effects
(primarily nausea and vomiting) and a limited risk of hypoglycaemia. 1,2,3,4,5,6,7,8,9 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 (over 700 patients in three trials).1,2,3,4,5,6,7,8,9
The CHMP positive opinion will now be forwarded to the European Commission, which has the
authority to approve medicines for the European Union. Following EC marketing authorisation,
which is typically granted 2–3 months after a positive opinion, lixisenatide will significantly expand
the company’s diabetes franchise.
Jonathan Valabhji, Association of British Clinical Diabetologists (ABCD) commented, “ABCD
welcomes all new treatments for diabetes, as they increase the options available for patients.
Diabetes is a chronic disease which can cause serious complications especially when glucose
control is poor. By having more options available, more patients may be able to achieve good
control and so avoid such complications. This class of drug has the additional advantage of having
demonstrated weight loss in association with improvements in glucose control.”
There are 2.9 million people diagnosed with diabetes in the UK and an estimated 850,000 people who have the condition but don’t know it.10 According to a new analysis by Diabetes UK, the number of people with diabetes in Britain is expected to rise by 700,000 by the end of the decade.10 The analysis, based on data from the Yorkshire & Humber Public Health Observatory, shows that 4.4 million people in England, Scotland and Wales are projected to have the condition by 2020.10 This would be an increase of almost a fifth.10 In addition to increasing numbers of people being diagnosed, achieving and maintaining control of diabetes still represents a major challenge. Long-term complications of poorly managed diabetes include blindness, kidney disease and heart attacks. The cost of diabetes to the NHS is over £1.5m an hour or 10% of the NHS budget for England and Wales.11 This equates to over £25,000 being spent on diabetes every minute.11 In total, an estimated £14 billion pounds is spent a year on treating diabetes and its complications, with the cost of treating complications representing the much higher cost.11
About Lyxumia® (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.
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.
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.
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. Lixisenatide is not currently approved or licensed
anywhere in the world.
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 anti-
diabetic 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).
1. Aronson M et al. Efficacy and safety of once-daily lixisenatide in Type 2 diabetes insufficiently controlled with basal insulin ± metformin: GetGoal-L study. Abstract presented at the European Association for the Study of Diabetes 2012 2. Ahrén B et al. Efficacy and Safety of Lixisenatide QD Morning and Evening Injections vs Placebo in T2DM Inadequately Controlled on Metformin (GetGoal-M). Presentation given at the 21st World Diabetes Congress 2011 3. Rosenstock J et al. Once-daily lixisenatide added on to consistently titrated insulin glargine plus oral agents in type 2 diabetes: the GetGoal-Duo 1 study. Abstract presented at the European Association for the Study of Diabetes 2012 4. Gerich JE et al. Monotherapy with GLP-1 receptor agonist, Lixisenatide, significantly improves glycaemic control in type 2 diabetic patients. Abstract presented at the European Association for the Study of Diabetes 2012 5. Pinget M et al. Efficacy and safety of lixisenatide once daily versus placebo in patients with Type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). Abstract presented at the European Association for the Study of Diabetes 2012 6. Rosenstock J et al. Efficacy and safety of lixisenatide once daily versus exenatide twice daily in patients with T2DM insufficiently controlled on metformin (GetGoal-X). Poster presented at the European Association for the Study of Diabetes 2011 7. Bolli G et al. Long-Term (Up to 2 Years) Safety of Lixisenatide Once Daily vs Placebo in T2DM Insufficiently Controlled on Metformin (GetGoal-F1). Poster presented at the European Association for the Study of Diabetes 2011 8. Ratner RE et al. Efficacy and safety of lixisenatide once daily versus placebo in patients with T2DM insufficiently controlled on sulfonylurea ± metformin (GetGoal‐ S). Abstract presented at [insert congress and date] 9. Seino Y et al. Lixisenatide Significantly Improves Glycemic Control in Asian Patients with T2DM Insufficiently Controlled on Basal Insulin±SU. Diabetes, 2011 pA76 Abstr 278-OR Diabetes UK. Date accessed: November 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 plans, objectives, intentions and
expectations with respect to future financial results, events, operations, services, product development and potential, and
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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.


Source: http://sanofi-aventis.co.uk/l/gb/medias/EC233107-37DB-4143-AC1D-A06DBC9705A9.pdf

Cv gisele

Gisele Dazzi Lorenzoni Gisele Dazzi Lorenzoni Curriculum Vitae ______________________________________________________________________________________ Dados Pessoais Nome ______________________________________________________________________________________ Formação Acadêmica/Titulação 2009 - 2011 Universidade Federal do Rio de Janeiro, UFRJ, Rio De Janeiro, Brasil

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