) HealthCare segment recently received encouraging news as the US
Food and Drug Administration (FDA) approved its oncology drug
Xofigo (radium 223 dichloride). Xofigo was approved for the
treatment of patients with castration-resistant prostate cancer
(CRPC), symptomatic bone metastases and no known visceral
Bayer expects to launch the drug within the next few weeks. We
note that Xofigo will be co-promoted by Bayer and Algeta US, LLC
in the US. We remind investors that the FDA granted priority
review to the New Drug Application (NDA) for Xofigo in Feb 2013.
The NDA was submitted in Dec 2012.
The US approval of Xofigo was based on positive results from
the phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate
CAncer) study. Results from the study revealed that treatment
with Xofigo resulted in a 44% improvement in overall survival and
caused a 30.5% reduction in the risk of death compared to
patients in the placebo arm. Moreover, in January this year a
licensing decision on the medical use of Xofigo was issued by the
US Nuclear Regulatory Commission.
We note that Bayer is also seeking European approval of the
candidate. In Dec 2012, the company had submitted a Marketing
Authorization Application (MAA) to the European Medicines Agency
(EMA) for the treatment of CRPC patients with bone
The US approval of Xofigo is encouraging. The prostate cancer
market already has companies like
Bayer presently carries a Zacks Rank #4 (Sell). Other stocks
Alexion Pharmaceuticals Inc.
) currently look more attractive in the pharma space with a Zacks
Rank #2 (Buy).
ALEXION PHARMA (ALXN): Free Stock Analysis
BAYER A G -ADR (BAYRY): Free Stock Analysis
DENDREON CORP (DNDN): Free Stock Analysis
MEDIVATION INC (MDVN): Free Stock Analysis
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