) has progressed well with its newly launched products in the last
few quarters. Drugs like Eylea (Eye), Stivarga (oncology), Xarelto
(anticoagulant), Xofigo (oncology) and Adempas (pulmonary
hypertension) posted sales of €598 million in the first quarter and
are expected to contribute around €2.8 billion in 2014. The company
is looking to get these products approved for additional
indications as well.
Last week, Bayer and
Regeneron Pharmaceuticals Inc.
), announced encouraging two-year results from the phase III
VIVID-DME study on Eylea (aflibercept solution). Eylea is being
evaluated for the treatment of vision impairment due to diabetic
macular edema (DME).
Results revealed that patients treated with Eylea (dosed monthly or
every two months) showed sustained improvement in best corrected
visual acuity from baseline compared to those under laser
photocoagulation at 100th week. Moreover, Eylea was generally well
tolerated during the study. The VIVID-DME study is expected to
continue up to 148 weeks.
Eylea is already under review in the U.S., Europe, Japan, Asia
Pacific and Latin America for the DME indication. A final
decision on the approval of the drug in the DME indication in the
U.S. is expected by Aug 18, 2014.
We remind investors that the collaboration agreement between Bayer
and Regeneron was inked in 2011 for the global development of
Eylea. Per the terms of the agreement, Regeneron owns the entire
U.S. rights pertaining to the eye drug. Bayer is responsible for
marketing Eylea in ex-U.S. markets. The profit earned from the
sales of Eylea in those markets is shared equally by the companies.
However, in Japan, Regeneron receives royalties on Eylea's net
Eylea, one of the key products at Bayer's HealthCare segment, has
put up an impressive performance since its launch in late 2011 for
the neovascular (wet) age-related macular degeneration (AMD)
indication. Eylea is also approved for the treatment of visual
impairment due to macular edema secondary to central retinal vein
occlusion in several countries. Eylea contributed €157 million in
the first quarter of 2014.
Bayer and Regeneron are also looking to get Eylea approved for the
treatment of patients suffering from visual impairment due to
macular edema secondary to branch retinal vein occlusion (BRVO).
Eylea is submitted both in the U.S. and EU for the BRVO indication.
A final decision from the FDA on the approval of Eylea in the BRVO
indication is expected by Oct 23, 2014.
We are encouraged by the companies' progress with Eylea. Further
label expansion of the drug will boost sales. We expect investor
focus to remain on the drug's upcoming regulatory decisions.
Bayer, a large-cap pharma company, presently carries a Zacks Rank
#3 (Hold). Some better-ranked stocks in the same sector include
). Both the stocks hold a Zacks Rank #2 (Buy).
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