) along with partner,
Regeneron Pharmaceuticals Inc.
) recently announced positive 52-week data from the phase III
VIVID-DME and VISTA-DME studies on VEGF Trap-Eye for the
treatment of diabetic macular edema (DME).
The VIVID-DME and VISTA-DME phase III studies are evaluating the
safety and efficacy of VEGF Trap-Eye in patients suffering from
DME. Results from the studies showed that patients treated with
VEGF Trap-Eye experienced significantly greater improvements in
best-corrected visual acuity (BCVA) from baseline in comparison
to laser photocoagulation.
Bayer mentioned in its press release that improvements in BCVA in
both the studies were similar. The studies further revealed that
the candidate was well tolerated with a comparable overall
incidence of adverse events (AEs), ocular serious AEs, and
non-ocular serious AEs. The studies are expected to continue up
to 148 weeks.
The HealthCare segment at Bayer now intends to file a marketing
application for VEGF Trap-Eye in Europe by the end of 2013 for
the DME indication. Meanwhile, partner Regeneron also intends to
do the same in the U.S. by year end, one year earlier than
Bayer has a collaboration agreement with Regeneron 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.
Bayer recently received a positive opinion from the European
Committee for Medicinal Products for Human Use (CHMP) on the EU
approval of VEGF Trap-Eye 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
We note that 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 also approved in Europe, Japan,
Australia and several other countries for the wet AMD indication.
Bayer is also evaluating the eye-drug in the myopic choroidal
Eylea sales came in at €73 million in the second 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
Biogen Idec Inc.
), which carries a Zacks Rank #1 (Strong Buy).
BAYER A G -ADR (BAYRY): Free Stock Analysis
BIOGEN IDEC INC (BIIB): Free Stock Analysis
JOHNSON & JOHNS (JNJ): Free Stock Analysis
REGENERON PHARM (REGN): Free Stock Analysis
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