Sanofi-aventis' Response to Recent Analysis of Data on LANTUS® (insulin glargine [rDNA] injection)

You may have seen media coverage about a recent analysis of data indicating a potential association between LANTUS® (insulin glargine [rDNA] injection) use and cancer. As the authors of the studies themselves note, the results are inconclusive and inconsistent.

Patient safety is always the primary concern of sanofi-aventis. We will continue to work to vigorously monitor the safety of LANTUS® in close collaboration with regulatory agencies and scientific experts.

Sanofi-aventis stands behind LANTUS® and its safety profile. Randomized, controlled clinical trials, which represent the gold standard of evidence, and other clinical studies, do not indicate an association of LANTUS® with cancer. With the estimated experience of nearly 24 million patient-years worldwide, LANTUS® has been used safely and effectively by adults and children (6 years and older) in the treatment of type 1 diabetes and in adult patients with type 2 diabetes since it received marketing authorization in 2000.

The American Diabetes Association (ADA) issued a statement calling for caution in interpreting the results and advising patients to continue with their insulin treatment and consult their physicians, if seeking advice.

Sanofi-aventis recognizes the seriousness of the content of the publications and is working closely with worldwide Health Authorities and experts to assess the findings and clarify any requirements to ensure patients continue to receive safe and effective treatment for their diabetes.

Sanofi-aventis Launches Major Insulin Research Program in Partnership with the International Scientific Community

Paris, France – September 29, 2009 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today the company’s action plan to provide methodologically robust research that will contribute to the scientific resolution of the debate over insulin safety, including insulin analogs and Lantus® (insulin glargine [rDNA] injection). The research program is designed to generate more information on whether there is any association between cancer and insulin use and to assess if there is any difference in risk between insulin glargine and other insulins. This matter has been the subject of extensive discussion and debate within the scientific and medical communities for many years. While there is a consensus among leading scientists around the world regarding the difficulties of developing conclusive evidence, sanofi-aventis is committed to exploring this matter in depth, as was communicated by the company earlier this year.

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Sanofi-aventis Welcomes the European Medicines Agency's Statement on LANTUS® Safety

– Based on existing evidence CHMP (the EMEA's Committee for Medicinal Products for Human Use) concludes that no changes to the prescribing advice are necessary –

Paris, France – July 23, 2009 – Paris, France – July 23, 2009 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that following the review of the available evidence on LANTUS® (insulin glargine [rDNA] injection), the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed the product’s safety and concluded that changes to the prescribing advice are not necessary.

The EMEA issued a press-release stating that they have re-confirmed their initial assessment, based on an in-depth review of existing evidence and of the recent publications of registry analyses in Diabetologia. All four registry analyses were found to have significant methodological limitations and to provide inconsistent and inconclusive results regarding a potential link between LANTUS® use and an increased risk of cancer.

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Expert Statement Issued about LANTUS® Following Recent Publications in Diabetologia

– Leading international experts conclude that these analyses present inconclusive and conflicting data –

Paris, France – July 15, 2009 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today the release of an Expert Statement by a multidisciplinary board of renowned international experts following an in-depth assessment of the recent publications of registry analyses with LANTUS® (insulin glargine [rDNA] injection) in Diabetologia. This board of international specialists in the field of endocrinology, oncology and epidemiology came to the conclusion, that all four manuscripts have significant methodological limitations and shortcomings, and that they provide inconsistent and inconclusive results regarding a potential link between insulin glargine use and an increased risk of cancer.

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5-year Study Published in Diabetologia Demonstrated Long-Term Safety of LANTUS® Compared to NPH

– Long-term study found no increased progression of retinopathy in LANTUS® over NPH treatment regimen –

Bridgewater, NJ – July 6, 2009 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the results of the long-term, 5-year study of LANTUS® versus NPH insulin on progression of retinopathy in patients with type 2 diabetes, published on-line in Diabetologia
(DOI 10.1007/s00125-009-1415-7) showed similar effects on retinopathy and overall safety in the two treatment groups. This is the longest controlled study ever reported using insulin glargine.

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Sanofi-aventis Stands Behind the Safety of LANTUS®

Bridgewater, NJ – June 26, 2009 – 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 [rDNA] injection) use and the occurrence of malignancies, as the authors of the study point out.

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