(MAA) Bayer’s Xofigo Cleared by the US Food and Drug Administration

Bayer’s (BAYRY) 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 metastatic disease.

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 metastases.

The US approval of Xofigo is encouraging. The prostate cancer market already has companies like Dendreon Corporation (DNDN) and Medivation Inc. (MDVN).

Bayer presently carries a Zacks Rank #4 (Sell). Other stocks such as Alexion Pharmaceuticals Inc. (ALXN) currently look more attractive in the pharma space with a Zacks Rank #2 (Buy).
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