Bayer (BAYRY) presented encouraging final data from a late-stage study (ALSYMPCA: n=922) on its cancer candidate alpharadin. The late-stage study evaluated the candidate for treating castration-resistant (hormone refractory) prostate cancer in patients with bone metastases. Bayer is co-developing alpharadin with Norway-based entity Algeta ASA.
Results from the randomized, double-blind, multi-dose, placebo-controlled international study revealed that treatment with alpharadin improved overall survival compared to the patients in the placebo arm. Moreover, the study also met other objectives such as delay in time to first skeletal-related events.
The candidate was found to be as safe and well-tolerated as in the previous studies involving alpharadin. Encouraged by the positive results, Bayer intends to seek marketing approval for the candidate in the US and Europe in mid-2012. Approval is expected to be sought on the basis of data from the late-stage study.
In June 2011, Bayer had presented encouraging interim data from the study. The study was stopped based on the recommendation of the Independent Data Monitoring Committee (IDMC).
We remind investors that in August 2011, the US Food and Drug Administration (FDA) granted fast track status to alpharadin for treating castration-resistant (hormone refractory) prostate cancer in patients with bone metastases. The fast track program not only facilitates the development but also expedites the review of drugs which are developed for treating serious diseases.
The move by the FDA to grant such a status to Bayer’s candidate is highly encouraging since prostate cancer is the most common form of cancer affecting men in the US. Moreover, the market for the disease has a huge unmet medical need. Dendreon (DNDN) launched its prostate cancer therapy, Provenge, in mid-2010. We note that the primary reason behind disability and death in patients suffering from castration-resistant prostate cancer are bone metastases.
Currently, we have a Neutral stance on Bayer in the long run.
