Recently the US Food and Drug Administration (FDA) granted fast track status to Bayer’s (BAYRY) cancer candidate alpharadin. The designation has been granted to the candidate 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 market for such diseases has a huge unmet medical need.
The receipt of such a designation from the FDA ensures frequent communication of the concerned company with the US regulatory body during the drug development and review process. The frequent dialogue ensures quicker resolution of the queries of the FDA regarding the drug, often leading to faster approval.
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. We note that the primary reason behind disability and death in patients suffering from castration-resistant prostate cancer are bone metastases.
We remind investors that in June 2011, Bayer presented encouraging interim data from a phase III trial, which evaluated alpharadin in patients suffering from castration-resistant prostate cancer and symptomatic bone metastases. Results revealed that treatment with alpharadin improved overall survival compared to the patients in the placebo arm.
The study was stopped based on the recommendation of the Independent Data Monitoring Committee (IDMC). Bayer intends to present detailed results from the study at an upcoming medical conference.
Our Recommendation
Currently, we have a Neutral stance on Bayer in the long run. The company carries a Zacks #4 Rank (Sell rating) in the short run.
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