Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Algeta, a pharmaceutical company, has officially opened its commercial manufacturing facility for Xofigo (radium Ra 223 dichloride) injection at the Institute for Energy Technology (IFE) in Norway.
Subscribe to our email newsletter
The first alpha particle-emitting radioactive therapeutic agent, Xofigo has been approved by the US Food and Drug Administration (FDA) to treat castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.
IFE president Eva Dugstad said that the opening of a new commercial production facility at IFE underlines the Norwegian pharmaceutical industry’s ability to develop products with significant global potential.
"The new facility which is being officially opened today has been designed according to highest quality standards – from raw material handling to the release of the final commercial product," Dugstad added.
Algeta signed an agreement with Bayer in September 2009 to develop and commercialize Xofigo.
Under the terms of the agreement, Bayer will develop, apply for global health authority approvals and commercialize Xofigo worldwide.
Algeta president and CEO Andrew Kay said "IFE has been an important partner to Algeta throughout the clinical development of radium 223, and it has been instrumental in helping us build a commercial production facility for the global supply of Xofigo."
Radium Ra 223 dichloride (radium 223) has not been currently approved by the European Medicines Agency (EMA) or other authorities outside the US. In December 2012, Bayer submitted a Marketing Authorisation Application to the EMA for radium 223.