FDA priority review for Algeta and Bayer's prostate cancer agent radium-223

German pharma major Bayer (BAYN: DE) has received notification from the US Food and Drug Administration granting priority review of the New Drug Application filed in December 2012 for the investigational oncology compound radium-223 dichloride (radium-223), formerly referred to as Alpharadin.

The drug is licensed from Norway’s Algeta (OSE: ALGETA), which will co-promote radium-223 with Bayer in the USA, and is eligible for milestones as well as royalties on Bayer’s sales outside the USA. The US application is under review for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases.

Andrew Kay, Algeta’s president and chief executive, said: “With the granting of priority review for the NDA for radium-223 in the USA, there is recognition that radium-223 has the potential to offer a new treatment option for CRPC patients with bone metastases. While we await the final decision from the regulators later this year, we continue with our commercialization planning in the USA.”