) and partner,
Regeneron Pharmaceuticals Inc.
) 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,
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
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 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
REGENERON PHARM (REGN): Free Stock Analysis
SANOFI-AVENTIS (SNY): Free Stock Analysis
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