Regeneron Pharmaceuticals Inc.
) and partner the HealthCare unit of
) recently received some encouraging news with the European
Commission (EC) clearing their eye-drug Eylea for treating
patients suffering from neovascular (wet) age-related macular
degeneration (wet AMD).
The recommended dosage for the injectable drug, also known as
VEGF (vascular endothelial growth factor) trap-eye, is 2mg on a
monthly basis for three successive months. The subsequent
recommended dosage is 2 mg every 2 months. However, the interval
between the Eylea injections may be extended after one year of
treatment based on visual and anatomic outcomes.
The approval of Eylea by the EC for the wet AMD indication does
not come as a surprise since in September 2012 the European
Committee for Medicinal Products for Human Use (CHMP) had
recommended its approval for indication.
We note that Eylea is already available in the US since November
2011. The drug has performed exceptionally well since its launch.
We note that Eylea is also approved in countries, such as
Australia, Japan and Switzerland
The sales potential of Eylea was boosted further by the US Food
and Drug Administration's (FDA) clearance for an additional
indication - macular edema following central retinal vein
occlusion (CRVO). Bayer intends to seek European approval for the
CRVO indication by year end.
Eylea is also being studied for other indications, such as
diabetic macular edema (phase III) and macular edema following
branch retinal vein occlusion (phase III).
Per the agreement Bayer is responsible for marketing Eylea in
ex-US markets on approval. The profit earned from the sales of
the drug in those markets will be shared equally by the
companies. In Japan, Regeneron will receive royalties on Eylea's
net sales. However, Regeneron owns the entire US rights
pertaining to the eye drug.
We have an Outperform recommendation on Bayer. The stock carries
a Zacks #2 Rank (Buy rating) in the short run. We have Neutral
stance on Regeneron, which too carries a Zacks #2 Rank (Buy
rating) in the short run.
BAYER A G -ADR (BAYRY): Free Stock Analysis
REGENERON PHARM (REGN): Free Stock Analysis
To read this article on Zacks.com click here.