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French pharma giant Sanofi (SNY - Analyst Report) recently announced that detailed data on Zaltrap (aflibercept)  from the pivotal phase III VELOUR study was published in the Journal of Clinical Oncology’s (JCO) October 2012 edition. The study evaluated Zaltrap for the treatment of patients with previously treated metastatic colorectal cancer.

On August 3, 2012, the US Food and Drug Administration (FDA) had approved Zaltrap as a combination therapy (with 5-fluorouracil, leucovorin, irinotecan – FOLFIRI) for treating patients suffering from metastatic colorectal cancer who are either resistant to or whose disease has progressed following the treatment with an oxaliplatin-containing regimen.

The FDA cleared Zaltrap on the basis of data from the phase III VELOUR study (n=1,226). The multinational, randomized, double-blind phase III study evaluated the use of FOLFIRI in combination with either Zaltrap or placebo. Significant improvement in median survival was observed in the Zaltrap arm (13.50 months) as compared to placebo (12.06 months).

Zaltrap in combination with FOLFIRI also demonstrated a statistically significant improvement in progression-free survival (PFS) and overall response rate (ORR) compared to placebo with FOLFIRI.

Sanofi has a worldwide collaboration with Regeneron Pharmaceuticals, Inc. (REGN - Analyst Report) for the development and commercialization of Zaltrap. As per the agreement between Regeneron and Sanofi, the companies will share the profits from global Zaltrap sales equally after Regeneron's obligation to repay its share of development costs is met.

Our Recommendation

We currently have a Neutral recommendation on Sanofi. The stock carries a Zacks #2 Rank (Buy rating) in the short run. We are pleased with the company’s efforts to develop its pipeline. We expect Sanofi to continue to contain operating costs in order to increase earnings in the face of weakening sales of some of its biggest products. We also expect the company to pursue bolt-on acquisitions.

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