The HealthCare unit of Bayer ( BAYRY - Analyst Report ) 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. Dendreon Corporation ( DNDN - Analyst Report ) 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.

Our Recommendation

We have a Neutral recommendation on Bayer. The stock carries a Zacks #3 Rank (Hold rating) in the short run.