The HealthCare segment at
) recently received encouraging news from the European Committee
for Medicinal Products for Human Use (CHMP), when it gave a
positive opinion on the EU approval of eye drug, VEGF Trap-Eye.
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Bayer is looking to get VEGF Trap-Eye approved in the EU for the
treatment of visual impairment due to macular edema secondary to
central retinal vein occlusion (CRVO). A final verdict from the
European Commission on the approval of VEGF Trap-Eye in this
indication is expected later this year.
We note that though the European Commission is not bound to
follow the CHMP's decision, it generally does so.
Bayer has a collaboration agreement with
Regeneron Pharmaceuticals Inc.
) for the global development of Eylea (U.S. trade name of VEGF
Trap-Eye). Per the terms of the agreement, Regeneron owns the
entire U.S. rights pertaining to the eye drug. Bayer is however
responsible for marketing Eylea in ex-U.S. markets on approval.
The profit earned from the sales of Eylea in those markets will
be shared equally by the companies. However, in Japan, Regeneron
will receive royalties on Eylea's net sales.
VEGF Trap-Eye is already approved in the U.S. for the CRVO
indication since Sep 2012 under the trade name of Eylea. Eylea is
also approved in the U.S. for the treatment of neovascular (wet)
age-related macular degeneration (AMD).
We also note that EYLEA is approved in Europe, Japan, Australia,
and several other countries for the wet AMD indication.
Bayer is looking to expand VEGF Trap-Eye's indication further in
the myopic choroidal neovascularization (mCNV) indication. In Jun
2013, the company reported positive top-line results from the
phase III MYRROR study on VEGF Trap-Eye in patients suffering
from mCNV. Bayer intends to submit its first regulatory approval
application in Asia for VEGF Trap-Eye in this indication later in
Eylea sales came in at €49 million in the first quarter of 2013
as per Bayer.
Bayer, a large cap pharma stock, presently carries a Zacks Rank
#3 (Hold). However, another large cap pharma stock,
Johnson & Johnson
), currently looks better positioned with a Zacks Rank #2 (Buy).
Other companies in the pharma space that are worth considering
Jazz Pharmaceuticals Public Limited Company
), which carries a Zacks Rank #1 (Strong Buy).