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Lixisenatide significantly reduces hba1c without increasing hypoglycemia in patients uncontrolled on sulfonylureas

Sanofi-aventis Press Release
Lixisenatide Significantly Reduces HbA1c Without Increasing Hypoglycemia in Patients Paris, France – April 12, 2011 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced
today that lixisenatide, a once-daily GLP-1 receptor agonist under development for people with
Type 2 diabetes, achieved its primary efficacy objective of significant HbA1c reduction and
improved glycemic control from baseline versus placebo. The top-line results also showed that
people treated with lixisenatide had a significant decrease in body weight.
The GetGoal-S trial, one of nine studies in the GetGoal Phase III clinical program, investigated the
efficacy and safety of lixisenatide as an add-on therapy for people with Type 2 diabetes whose
condition was inadequately controlled by sulfonylureas, with or without metformin. GetGoal-S was a
randomized (double-blind), placebo-controlled study with a 24-week main treatment period. A total
of 859 patients were randomized to receive either lixisenatide or placebo. Both groups received a
step-wise increase in dose, up to a maintenance dose of 20µg daily.
Top-line results of the GetGoal-S study showed that people in the lixisenatide group experienced a
significant reduction in their HbA1c levels, with a -0.74% difference versus placebo (p<0.0001) at
week 24. Lixisenatide also significantly improved patients’ 2-hour post-prandial glucose (p<0.0001)
and fasting plasma glucose (p<0.0001) levels. In addition, people treated with lixisenatide had a
significant decrease in body weight (p<0.0001), versus those receiving placebo.
Results from GetGoal-S also showed that lixisenatide did not significantly increase the risk of
symptomatic hypoglycemia at week 24 (p=0.23), compared with placebo.
The results of GetGoal-S are another positive step for lixisenatide and reinforce the efficacy and
safety profile of this new GLP-1,”
said Pierre Chancel, Senior Vice President, Global Diabetes
Division, sanofi-aventis. “The demonstration of benefits in terms of improving glycemic control and
reducing body weight in this population, without significantly increasing the risk of
symptomatic
hypoglycemia, confirmed that lixisenatide is a potential important new therapy in Type 2 diabetes to
help people manage their condition more effectively.


The full study findings are planned to be presented at the 47th European Association for the Study
of Diabetes (EASD) Annual Meeting, in September 2011.
About Lixisenatide (AVE 0010)
Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in development for the treatment of
patients with Type 2 diabetes mellitus. Lixisenatide was in-licensed from Zealand Pharma A/S
(Copenhagen, Denmark), www.zealandpharma.com.
GLP-1 is a naturally-occurring peptide that is released within minutes of eating a meal. It is known
to suppress glucagon secretion from pancreatic alpha cells and stimulate insulin secretion by
Sanofi-aventis www.sanofi-aventis.com
Media Relations: Tél. : (+) 33 1 53 77 44 50 - E-mail : MR@sanofi-aventis.com
Investor Relations : Tél. : (+) 33 1 53 77 45 45 - E-mail : IR@sanofi-aventis.com
pancreatic beta cells. GLP-1 receptor agonists are in development as an add-on treatment for Type
2 diabetes and their use is endorsed by the European Association for the Study of Diabetes, the
American Diabetes Association, the American Association of Clinical Endocrinologists and the
American College of Endocrinology.
About the GetGoal Phase III Clinical Program
The GetGoal Phase III clinical program is providing expanding evidence for the efficacy and safety
of lixisenatide in adults with Type 2 diabetes treated with various oral anti-diabetic agents or insulin.
With nine trials in the program, GetGoal started in May 2008 and has enrolled more than 4300
patients. To date GetGoal-X, GetGoal-Mono and GetGoal-L Asia have reported positive top-line
results supporting efficacy and safety for lixisenatide. Further results are expected during 2011.
About the sanofi-aventis Diabetes Division
Sanofi-aventis strives to deliver innovative and integrated patient-focused solutions for people living
with diabetes. The Company currently has insulin products that are also available in injection pens
for people with Type 1 or Type 2 diabetes, as well as an oral, once-daily sulfonylurea treatment for
Type 2 diabetes. In order to provide comprehensive care in diabetes management, sanofi-aventis
also provides innovative blood glucose monitoring systems. Investigational compounds in the
pipeline include the potential first regenerative treatment for diabetes as well as a once-daily
injectable GLP-1 agonist to be used alone, in combination with basal insulins, and/or in combination
with oral anti-diabetic agents.

About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes
therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT:
SAN) and in New York (NYSE: SNY). For more information, please visit www.sanofi-aventis.com.
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-aventis’ 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-aventis, 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 products candidates, the absence of guarantee that the products 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 as well as those discussed or identified in the public filings with the SEC and the AMF made
by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking
Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2010. Other than as required
by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or
statements.

Contacts
Marisol Peron
Corporate Media Relations
Tel: +33 (0)1 53 77 45 02 Mobile: +33 (0)6 08 18 94 78
E-mail: marisol.peron@sanofi-aventis.com
Cornelia Schaeffer
Global Diabetes Division Communications
Tel: +49 69 305 22353
E-mail: Cornelia.Schaeffer@sanofi-aventis.com

Source: http://jsda.cab.infoweb.ne.jp/shiraberu/foreign/info3/kobetsu/4872(20110414)1.pdf

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