CHMP in Favor of Sanofi's Zaltrap

Recently, Sanofi ( SNY - Analyst Report ) and partner, Regeneron Pharmaceuticals Inc. ( REGN - Analyst Report ) received some encouraging news with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval of their oncology therapy, Zaltrap (aflibercept).

The companies are looking to get Zaltrap approved as a combination therapy (with 5-fluorouracil, leucovorin, irinotecan – FOLFIRI) for treating patients suffering from metastatic colorectal cancer who are either resistant or whose disease has progressed following treatment with an oxaliplatin-containing regimen.

The European Commission (EC) will take a final decision on Zaltrap, which is expected in the first quarter of 2013.

The CHMP rendered a positive opinion on 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.

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.

On August 3, 2012, the US Food and Drug Administration (FDA) approved Zaltrap for the above mentioned indication.

Sanofi has a worldwide collaboration with Regeneron 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.

We are pleased with Sanofi’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.