) received favorable news from the European Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) when it provided a positive opinion on the approval
of radium Ra 223 dichloride (radium-223) last week.
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Bayer is looking to get radium-223 approved for treating adults
suffering from castration-resistant prostate cancer (CRPC),
symptomatic bone metastases and no known visceral metastases.
A final verdict from the European Commission on the approval of
radium-223 is expected by year end. We note that though the
European Commission is not bound to follow the CHMP's decision,
it generally does so.
The positive CHMP recommendation on the approval of radium-223
was based on positive results from the phase III ALSYMPCA
(ALpharadin in SYMptomatic Prostate CAncer) study. Results from
the study revealed that treatment with radium-223 resulted in a
significant improvement in overall survival and also caused a
reduction in the risk of death compared to patients in the
We remind investors that the U.S. Food and Drug Administration
(FDA) approved the drug in May 2013 for the above indications,
based on the positive results from the ALSYMPCA study. Following
the approval, the drug is marketed in the U.S. under the trade
name Xofigo. Xofigo is co-promoted by Bayer and Algeta U.S., LLC
in the U.S. as per a 2009 agreement. Bayer however has the rights
to commercialize the product worldwide.
We are encouraged by Bayer's progress on radium-223. However, the
prostate cancer market looks extremely crowded with the presence
of companies like
Johnson & Johnson
Bayer, a large-cap pharma company, presently carries a Zacks Rank
) looks more attractive in the large-cap space with a Zacks Rank
#1 (Strong Buy).