Algeta, a Norwegian developer of treatments for cancer, has officially opened a commercial production facility for Xofigo (radium Ra 223 dichloride) at the Institute for Energy Technology (IFE) in Kjeller, Norway.
The official ribbon cutting ceremony was attended by Andrew Kay, Algeta's President and CEO, and senior management colleagues, who were joined by Trond Giske, the Norwegian Minister for Trade and Industry, Eva Dugstad, President of IFE and Andreas Fibig, President and Chairman of the Board of Management at Bayer HealthCare Pharmaceuticals, and other guests.
The US FDA approved Xofigo on 15 May for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. It is the first alpha particle-emitting radioactive therapeutic agent to be approved by the FDA.
Algeta US and Bayer Healthcare are co-promoting the product in the US. Bayer paid a €50m milestone payment to Algeta following the launch of the product in the US.
IFE has been an important partner to Algeta throughout the clinical development of radium 223
Radium Ra 223 dichloride (radium 223) is currently not approved by the European Medicines Agency (EMA) or other authorities outside the US. Bayer submitted a Marketing Authorisation Application to the EMA for radium 223 in December 2012 for the treatment of CRPC patients with bone metastases.
‘The recent approval and launch of Xofigo in the US are momentous achievements for Algeta and put us firmly on the path to deliver on our vision of becoming a world-class oncology company bringing novel targeted medicines to cancer patients through our leadership in alpha particle-emitting pharmaceuticals,’ said Kay.
‘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. We are all extremely grateful for the expertise, dedication and support that IFE has provided to Algeta on this journey and look forward to continuing our productive partnership.’
The new facility has been designed according to highest quality standards, from raw material handling to the release of the final commercial product.
Algeta signed an agreement with Bayer for the development and commercialisation of Xofigo in September 2009. Under the terms of the agreement, Bayer will develop, apply for approvals worldwide and market Xofigo globally.