Regeneron Pharmaceuticals Inc.
) recently suffered a setback in its efforts to expand the label of
its drug Arcalyst. The US Food and Drug Administration (FDA)
declined to approve Arcalyst for preventing gout flares in patients
initiating uric acid-lowering therapy on the basis of the submitted
The US regulatory body issued a complete response letter (CRL)
to the company after reviewing the supplemental biologics license
application (sBLA) for Arcalyst submitted last year. While issuing
the CRL, the FDA asked for additional data, apart from additional
Chemistry, Manufacturing and Controls (CMC) information related to
a proposed new dosage form. Regeneron is currently reviewing the
contents of the CRL.
We note that Arcalyst is available in the US since 2008 as an
injection for subcutaneous use for the treatment of
cryopyrin-associated periodic syndromes (CAPS), a group of rare
genetic inflammatory conditions, including familial cold
auto-inflammatory syndrome and Muckle-Wells Syndrome. The drug is
marketed for treating adults and children 12 years and above.
Regeneron has two more action dates this year. The FDA is
expected to decide on whether to approve its pipeline candidate
Zaltrap for treating previously treated patients suffering from
metastatic colorectal cancer by August 4, 2012.
The other action date corresponds to Regeneron's efforts to
expand the label of its other marketed product - Eylea. Regeneron
is looking to get eye-drug Eylea approved for central retinal vein
occlusion in the US (action date: September 23). Regeneron would be
hoping for positive news from the FDA on those two dates. Moreover,
multiple pipeline related news is expected in 2012.
Eylea is marketed for treating patients suffering from the
neovascular form of age-related macular degeneration. The drug has
performed very well since its US launch in November 2011.
The setback regarding Regeneron's efforts to expand the label of
Arcalyst notwithstanding, we have an Outperform recommendation on
the company 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
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