The HealthCare unit of
) recently announced that the US Food and Drug Administration
(FDA) granted priority review to the New Drug Application (NDA)
for its oncology candidate radium-223 dichloride (radium-223).
Bayer is co-developing radium-223 with Algeta ASA.
Priority review is granted to those medicines that offer major
advances in care or provide treatment where there are no existing
therapies. The FDA completes the priority review within eight
months from the date of the NDA submission rather than the usual
12-month review process.
Bayer had submitted the NDA for the candidate in Dec 12 for
the treatment of castration-resistant prostate cancer (CRPC)
patients suffering from bone metastases. Radium-223 enjoys fast
track status from the FDA for treating CRPC in patients suffering
from bone metastases. A final decision from the US regulatory
body should be out by Aug 2013.
Bayer's NDA submission was based on positive results from the
phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer)
study on radium-223. Data from the study revealed that treatment
with radium-223 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.
Moreover, in January this year a licensing decision on the
medical use of radium-223 was issued by the US Nuclear Regulatory
Commission (NRC). As per the decision the US medical sites can
acquire and administer radium-223 under 10 CFR Part 35, Subpart E
including 10 CFR § 35.300.
We remind investors 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
However, the prostate cancer market is extremely crowded with
the presence of companies like
Bayer currently carries a Zacks Rank #2 (Buy). Another large
Eli Lilly and Company
) also carries a comparable rank.
BAYER A G -ADR (BAYRY): Free Stock Analysis
DENDREON CORP (DNDN): Free Stock Analysis
LILLY ELI & CO (LLY): Free Stock Analysis
MEDIVATION INC (MDVN): Free Stock Analysis
To read this article on Zacks.com click here.