The HealthCare segment at
) received positive nods from the European Committee for Medicinal
Products for Human Use (CHMP) for two of its newly launched
products for additional indications.
The first one was for Bayer's blockbuster eye drug, Eylea
(aflibercept solution). Bayer is looking to get Eylea approved in
the EU for the treatment of visual impairment due to diabetic
macular edema (DME). A final opinion from the European Commission
on the approval of the drug in the DME indication is expected in
the coming months. Eylea is also under review in the U.S. for the
DME indication with a final decision expected by Aug 18, 2014.
Bayer has a collaboration agreement with
Regeneron Pharmaceuticals Inc.
) 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 however responsible for marketing Eylea in
Eylea is already approved for the neovascular (wet) age-related
macular degeneration (AMD) indication and 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 looking to
get Eylea approved in other indications as well.
The CHMP was also positive on the approval of Bayer's Stivarga for
the treatment of adults suffering from unresectable or metastatic
gastrointestinal stromal tumors (GIST) who progressed on or cannot
tolerate prior treatment with Gleevec (imatinib) and Sutent
(sunitinib). A final decision on the approval of the drug in the
GIST indication in the EU is expected in the third quarter of this
Stivarga is already approved in several countries including the
U.S. and EU for the treatment of metastatic colorectal cancer
(mCRC). The drug is also approved for the GIST indication in some
countries including the U.S. Bayer recorded Stivarga sales of €54
million in the first quarter of 2014. Stivarga is co-promoted by
) in the U.S. Amgen receives royalty payments from Bayer on all
global net sales of Stivarga.
We are encouraged by Bayer's progress with its newly launched
products. Eylea and Stivarga along with drugs like 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. Additional
label expansions of these drugs will drive growth further. We
expect investor focus to remain on these drugs.
Bayer presently carries a Zacks Rank #3 (Hold). Some better-ranked
). Allergan carries a Zacks Rank #2 (Buy).
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