Regeneron Pharmaceuticals Inc.
(
REGN
) and partner
Bayer
(
BAYRY
) recently announced the commencement of a late-stage study
(SIGHT:n~300) in China to evaluate their injectable eye drug Eylea
(aflibercept) for treating patients suffering from neovascular form
of age-related macular degeneration (wet AMD).
The randomized, double-masked study is designed to evaluate the
safety and effectiveness of Eylea, also known as VEGF (vascular
endothelial growth factor) trap-eye, versus the standard therapy
for wet AMD in China.
Wet AMD is the primary cause of blindness in patients aged over
65 years in the US and EU. The disease is quite prevalent in China
as well. Approximately 540,000 patients newly diagnosed with wet
AMD in 2010 were above the age of 50.
Per the agreement, Bayer is responsible for marketing Eylea in
ex-US markets on approval. The profit earned from the sales of the
candidate in those markets will be shared equally by the companies.
However, Regeneron owns the entire US rights pertaining to the
eye-drug.
We remind investors that Eylea was cleared by the US Food and
Drug Administration (FDA) earlier in the month for wet AMD. The
approval of Eylea was based on positive results from the VIEW
program (VEGF (vascular endothelial growth factor) trap-eye:
Investigation of Efficacy and Safety in Wet AMD) which consisted of
two studies, VIEW 1 and VIEW 2. The studies evaluated the efficacy
of VEGF trap-eye versus
Roche
/
Novartis
' (
RHHBY
/
NVS
) Lucentis (ranibizumab), an anti-angiogenic agent approved for
treating wet AMD. Regeneron's eye treatment was found to be
non-inferior to Lucentis.
We believe that if Eylea is successfully developed and
subsequently commercialized for wet AMD in additional markets such
as China then the top lines of both companies will be boosted.
Apart from wet AMD, Regeneron and Bayer are studying VEGF trap
for other eye-disorders.
Our Recommendation
Currently, we have a Neutral stance on Regeneron in the long
run. However we have an Underperform recommendation on Bayer since
we believe that the stock is overvalued at current levels. Both
companies carry Zacks #3 Rank (Hold rating) in the short run.
BAYER A G -ADR (
BAYRY
): Free Stock Analysis Report
NOVARTIS AG-ADR (
NVS
): Free Stock Analysis Report
REGENERON PHARM (
REGN
): Free Stock Analysis Report
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