Regeneron Pharmaceuticals Inc.
) and partner
) recently received some good news from the US Food and Drug
Administration (FDA) with the regulatory body clearing their
oncology candidate, Zaltrap. The FDA approved Zaltrap as a
combination therapy for treating patients suffering from metastatic
colorectal cancer who are either resistant to or whose disease has
progressed following treatment with an oxaliplatin-containing
We note that the FDA reviewed the new drug application (NDA),
submitted in February 2012, for Zaltrap on a priority basis, since
metastatic colorectal cancer has few treatment options. The US
regulatory authority generally reviews those drugs on a priority
basis which offer major advances in treating diseases that do not
have adequate therapy. The priority review designation implied a
six-month review period of the NDA from the date of its submission
by the companies.
The FDA cleared Zaltrap for the indication on the basis of
encouraging data from a phase III study (n=1,226: VELOUR).
Zaltrap's approval for the indication will be a major boost for
Regeneron/Sanofi as the metastatic colorectal cancer market
represents significant commercial opportunity. Zaltrap is under
review in Europe for the indication.
Sanofi intends to launch Zaltrap in the US shortly. 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.
The approval of Zaltrap makes it the third FDA-approved drug at
Regeneron after Arcalyst (cryopyrin-associated periodic syndromes)
and Eylea (neovascular form of age-related macular degeneration).
Eylea has performed exceptionally well since its US launch in
Regeneron is seeking to expand Eylea's label into other
indications. A key action date is coming up in September this year
when the FDA is expected to decide on approving Eylea for central
retinal vein occlusion. Positive news from the FDA would boost the
We have an Outperform recommendation on Regeneron due to the
strong performance of Eylea and the robust pipeline. Our long-term
recommendation is in line with the Zacks #1 Rank (Strong Buy)
carried by the stock in the short run.
REGENERON PHARM (REGN): Free Stock Analysis
SANOFI-AVENTIS (SNY): Free Stock Analysis
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