US NRC rules sites can procure radium-223 dichloride for Algeta/Bayer's prostate cancer candidate

Norwegian drug developer Algeta (OSE: ALGETA) this morning announced that the US Nuclear Regulatory Commission (NRC) has issued a positive licensing decision on the medical use of radium-223 dichloride (radium-223). The NRC licensing decision follows the recommendation from the Advisory Committee on the Medical Use of Isotopes (ACMUI) report, dated November 20, 2012.

Radium-223 is an investigational agent and is not approved by the European Medicines Agency, the US Food and Drug Administration or other health authorities. German drug major Bayer (BAYN: DE) has submitted regulatory filings in the European Union and USA for Alpharadin (radium-223 dichloride for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases (The Pharma Letters December 13 and 16, 2012). Algeta will co-promote the product in the USA.

The US NRC has ruled that sites can procure and administer radium-223 under 10 CFR Part 35, Subpart E, which includes 10 CFR section 35.300. It has also ruled that physicians authorized under 10 CFR sec 35.390 or 10 CFR sec 35.396 can be authorized for the medical use of radium-223. The US NRC has notified the Agreement States regarding its licensing decision on radium-223.