) and partner
Regeneron Pharmaceuticals Inc.
) received encouraging news with the European Commission (EC)
approving their oncology therapy, Zaltrap (aflibercept). The EC
cleared Zaltrap 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
The approval did not come as a surprise as, in Nov 2012, the
European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP) had recommended the approval of
Zaltrap for the indication.
The EC approved Zaltrap on the basis of data from the phase
III VELOUR study (n=1,226). The multinational, randomized,
double-blind phase III study evaluated FOLFIRI in combination
with either Zaltrap or placebo. Significant improvement in median
survival was observed in the Zaltrap arm. Moreover, Zaltrap in
combination with FOLFIRI demonstrated a statistically significant
improvement in progression-free survival (PFS) and overall
response rate (ORR) compared to placebo with FOLFIRI.
We note that Zaltrap is already approved in the US for the
above indication. The US Food and Drug Administration (FDA)
approved Zaltrap for the indication in Aug last year. Approval of
Zaltrap in the EU will boost the drug's sales potential.
We believe the pipeline at Sanofi must deliver since many of
its key products are facing declining sales due to generic
competition. Sanofi is trying to combat the generic threat by
introducing new products, cutting costs and pursuing bolt-on
Sanofi carries a Zacks Rank #2 (Buy) in the short run.
) are examples of pharma stocks which are more favorably placed.
Both companies carry a Zacks Rank #1 (Strong Buy).
NOVO-NORDISK AS (NVO): Free Stock Analysis
REGENERON PHARM (REGN): Free Stock Analysis
SANOFI-AVENTIS (SNY): Free Stock Analysis
VALEANT PHARMA (VRX): Free Stock Analysis
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