The HealthCare unit of
) recently announced that its cancer candidate alpharadin fared
well in a phase III study (ALSYMPCA: n=921), which evaluated
patients suffering from castration-resistant prostate cancer with
bone metastases. Bayer is co-developing alpharadin with
Norway-based entity Algeta ASA.
The updated results from the randomized, double blind,
placebo-controlled international study revealed that treatment with
alpharadin improved overall survival compared to patients in the
placebo arm. Moreover, the study met other objectives such as delay
in time to first skeletal-related events. Data revealed that
treatment with alpharadin resulted in a 44.4% improvement in
overall survival and caused a 30.5% reduction in the risk of death
compared to patients in the placebo arm. The updated results were
consistent with the interim data from the study presented by Bayer
in June 2011.
Bayer intends to seek marketing approval for the candidate in
the second half of the year based on data from the phase III study.
We note that alpharadin enjoys fast track status from the US Food
and Drug Administration (FDA) for treating castration-resistant
prostate cancer in patients with bone metastases. The primary
reason behind disability and death in patients suffering from
castration-resistant prostate cancer are bone metastases.
The move by the FDA to grant such a status to alpharadin is
highly encouraging since prostate cancer is the most common form of
cancer affecting men in developed nations (other than skin cancer)
and the market has huge unmet medical need.
) launched its prostate cancer therapy, Provenge, in 2010.
Apart from alpharadin, another promising late-stage oncology
candidate at Bayer is regorafenib for treating metastatic
colorectal cancer (mCRC). Recently, Bayer presented encouraging
data from a late-stage study (CORRECT) which evaluated regorafenib
for treating mCRC patients. Bayer is seeking approval of the
candidate for the mCRC indication in the US and the EU. The
approval of both the oncology candidates would further strengthen
Bayer's top line.
Regorafenib is also being evaluated for treating patients
suffering from gastrointestinal stromal tumors.
We have a Neutral recommendation on Bayer. The stock carries a
Zacks #3 Rank (Hold rating) in the short run.
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