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Phase 3 Trial of Aflibercept in Second-Line Metastatic Colorectal Cancer to Continue as Planned at Recommendation of Independent Data Monitoring Committee
Date:9/8/2010

PARIS and TARRYTOWN, N.Y., Sept. 8 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced today that the Phase 3 VELOUR clinical trial of aflibercept (VEGF Trap) in patients with metastatic colorectal cancer (mCRC) will continue to completion as planned, with no modifications due to efficacy or safety concerns.  This decision is based on the recommendation of an Independent Data Monitoring Committee (IDMC) following a planned interim analysis.  Both sanofi-aventis and Regeneron management and staff remain blinded to the interim study results.

"We look forward to the final results of the trial, which are expected in the second half of 2011 with belief that the combination of aflibercept and FOLFIRI has the potential to benefit patients with this difficult-to-treat disease," said Tal Zaks, Head of Development, Global Oncology Division, sanofi-aventis.

About the VELOUR StudyThe main objective of the VELOUR (Aflibercept Versus Placebo in Combination with Irinotecan and 5-FU [FOLFIRI] in the Treatment of Patients with Metastatic Colorectal Cancer after Failure of an Oxaliplatin Based Regimen) study is to evaluate the safety and effectiveness of aflibercept as a second-line treatment in combination with folinic acid (leucovorin), 5-fluorouracil, and irinotecan (FOLFIRI) in 1,226 patients with mCRC who previously had been treated with an oxaliplatin-based regimen.  The primary endpoint is improvement in overall survival.  Secondary endpoints include progression-free survival, response to treatment, and safety.

About the Aflibercept Clinical Development ProgramSanofi-aventis Oncology and Regeneron are collaborating on a broad oncology development program combining aflibercept (VEG
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SOURCE Regeneron Pharmaceuticals, Inc.
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