Sanofi-aventis stands behind the safety of Lantus

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) has just been made aware of data associated with a retrospective follow-up of four patient registries. The results of these data clearly show that no definitive conclusions can be drawn regarding a possible causal relationship between Lantus® (insulin glargine) use and the occurrence of malignancies, as the authors of the study point out.

Clinical studies, which represent the gold standard of evidence, do not indicate an association between insulin glargine and cancer.

“Given the extensive clinical evidence covering over 70,000 patients and the results of post-marketing surveillance arising from 24 million patient-years of experience, sanofi-aventis stands behind the safety of Lantus®,” said Jean-Pierre Lehner, M.D., Chief Medical Officer. “We consider that the results of these patient registries are not conclusive.”

Patient safety is the primary concern of sanofi-aventis. The Group will continue to vigorously monitor the safety of Lantus® in close collaboration with regulatory agencies and scientific experts.

About Diabetes
Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. More than 230 million people worldwide are living with the disease and this number is expected to rise to a staggering 350 million within 20 years. It is estimated that nearly 24 million Americans have diabetes, including an estimated 5.7 million who remain undiagnosed. At the same time, approximately 40 percent of those diagnosed are not achieving the blood sugar control target of HbA1c <7 percent recommended by the ADA. The HbA1c test measures average blood glucose levels over the past two- to three-month period.

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).

Diabetelogia, the journal of the European Association for the Study of Diabetes (EASD), published a series of research papers on June 26, 2009, examining a possible link between insulin glargine (brand name, Lantus) and cancer. Findings from these research papers are conflicting and inconclusive, and the American Diabetes Association cautions against over-reaction until more information is available.
Four different population based studies were reported and published in Diabetelogia and the data within these studies and between these studies are conflicting and confusing. Until more information is available, the American Diabetes Association advises patients using insulin not to stop taking it.
For patients using glargine and considering switching to another form of insulin, the data in these studies make it unclear as to whether any one type of insulin increases the risk of cancer more than other types of insulin.
Patients concerned about these studies or their insulin regimen should talk to their doctor and should not stop taking their insulin on the basis of the findings reported here.
Insulin is a hormone normally produced by the pancreas that helps the body use glucose for energy. All people with type 1 diabetes need to take insulin to survive; many patients with type 2 diabetes also need to take insulin to control their blood glucose.
Glargine insulin, which as been widely used since 2000, is an artificial form of insulin that is typically administered once a day.
The American Diabetes Association is the nation’s leading voluntary health organization supporting diabetes research, information and advocacy. The Association’s mission is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. Founded in 1940, the Association provides service to hundreds of communities across the country. For more information please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit www.diabetes.org. Information from both these sources is available in English and Spanish.

Forward Looking Statements
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