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SANOFI-AVENTIS PRESENTS SURVIVAL DATA ON CANCER DRUG

January 19, 2007

Sanofi-aventis announced results of a large randomized Phase III study (ACTS-GC) showing that the oral anticancer agent S-1 reduced the relative risk of death in early stage gastric cancer patients by a significant 32 percent compared with curative surgery alone. The data was presented at the 2007 Gastrointestinal Cancers Symposium.

Based on the first interim efficacy analysis in June 2006, the study's data and safety monitoring committee had recommended to the investigators that the study be stopped. The results indicate that for all randomized patients overall survival at three years was 80.5 percent for patients receiving S-1 and 70.1 percent for patients undergoing surgery alone, with a hazard ratio of 0.68.

The symposium steering committee has granted a public health exception for the S-1 abstract. The exemption means that research data should be made public as soon as possible so that physicians and patients may immediately begin to make treatment decisions based on the new information.

S-1 efficacy and safety was prospectively evaluated in a large randomized multicenter trial, which enrolled 1,059 Japanese patients with early stage gastric cancer (stages II and III). This study was conducted in more than 100 medical institutions in Japan. Patients were randomly allocated to receive the oral S-1 anticancer agent for 12 months versus curative surgery alone. The primary study endpoint was overall survival, and the secondary endpoints were relapse-free survival and safety. Both primary and secondary efficacy objectives of the study have been met.

The reduction of the relative risk of relapse with S-1 was 38 percent. For all randomized patients, the three-year relapse-free survival was 72.2 percent in the S-1 arm and 60.1 percent for surgery alone.

S-1 is a novel oral fluorouracil anticancer product that combines three pharmacological agents: tegafur, a prodrug of 5 fluorouracil; gimeracil, which inhibits dihydropyrimidine dehydrogenase enzyme activity; and oteracil (potassium oxonate), a gastrointestinal side effects corrector. The drug is currently approved in Japan for the treatment of gastric, colorectal, head and neck, non-small-cell lung, metastatic breast and pancreatic cancers.