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

cautioning against over-interpretation of and over reaction to these data. The limitations of these studies were also highlighted by the authors of each publication and by EASD (European Association for the Study of Diabetes). The recommendation of experts and regulatory bodies converged to say that no definitive conclusions can be drawn at this stage.

The experts proposed a set of actions to be implemented by the company and by independent experts or professional associations that they believe will lead to a clear and definite conclusion on this situation. These recommendations are the matter of the Expert Statement that can be read on: www.sanofi-aventis.com/minisites/breaking-news/accueil/asp.

"This position from leading world experts is consistent with previous assessments of the published analyses. What we know about the safety of Lantus(R) comes from a robust clinical program that includes prospective, randomized clinical trials, supported by solid post-marketing surveillance observations," said Dr. Jean-Pierre Lehner, Chief Medical Officer of sanofi-aventis. "We are moving forward confidently with the external scientific and medical experts and health authorities toward next steps to resolve this controversy."

Patient safety is and has always been the primary concern of sanofi-aventis. Sanofi-aventis has 80 years of experience in the development of insulins and stands behind the safety of Lantus(R). Extensive data involving over 70,000 patients in clinical studies, including randomized, controlled clinical trials that represent the gold standard of evidence, and the results of post-marketing surveillance arising from 24 million patient-years of clinical experience do not indicate an association between insulin glargine and cancer.

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