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Expert Statement Issued about Lantus(R) Following Recent Publications in Diabetologia
Date:7/15/2009

BRIDGEWATER, N.J., July 15 /PRNewswire-FirstCall/ -- 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(R) (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.

"Regarding the merits of the published data, we agreed that all four published manuscripts have significant methodological limitations and shortcomings," said Professor Matthew Riddle, Professor of Medicine, Diabetes Section Head, Division of Endocrinology/Diabetes/Clinical Nutrition, Oregon Health Sciences University, Portland, OR, USA. "The nature of these limitations and their potential magnitude are such that, individually or in aggregate, these studies provide inconsistent and inconclusive results which do not justify new clinical recommendations to patients."

This statement, signed by 14 international experts following their independent, rigorous and thorough review of the published data, comes in the midst of a wave of recent releases from Health Authorities around the globe, such as the European Medicines Agency (EMEA), the U.S. Food and Drug Administration (FDA), as well as patient and scientific association such as the American Diabetes Association (ADA), the American Association of Clinical Endocrinologists (AACE), the International Diabetes Federation (IDF)
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