Algeta ASA has celebrated the official opening of its commercial production facility for Xofigo® (radium Ra 223 dichloride) at the Institute for Energy Technology (IFE) in Kjeller, Norway.
Andrew Kay, Algeta’s President & CEO, and senior management colleagues will be joined by Trond Giske, the Norwegian Minister for Trade and Industry, Eva S. Dugstad, President of IFE and Andreas Fibig, President & Chairman of the Board of Management, Bayer HealthCare Pharmaceuticals, and other distinguished guests for an official ribbon cutting ceremony this afternoon.
Xofigo was approved by the US Food and Drug Administration (FDA) 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 approved by the FDA.
Algeta US, LLC and Bayer Healthcare are co-promoting the product in the US. Xofigo has been launched in the US, triggering a EUR 50 million milestone payment to Algeta from Bayer. Bayer Healthcare has licensed the full rights to Xofigo outside of the US.
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 Authorization Application to the EMA for radium 223 in December 2012 for the treatment of CRPC patients with bone metastases.
Andrew Kay, Algeta’s President & CEO, said: “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. 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.”
“Today's opening of a new commercial production facility at IFE underlines the Norwegian pharmaceutical industry’s ability to develop products with significant global potential. We are proud to have played an integral part in the development of Xofigo that has required state-of-the-art quality manufacturing throughout its path to market. 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,” said Eva S. Dugstad, President of the IFE.
“On behalf of Bayer, I am proud and excited to be part of this collaboration with our Norwegian partners, Algeta and IFE,” said Andreas Fibig, Head of the Pharmaceuticals Division of Bayer.
Fibig continued, “Now is the time for the patients to gain from it. Our hope is that Xofigo can help patients with bone metastases caused by prostate cancer all over the world. There is a great need for new treatment options for these patients, and our clinical studies show that Xofigo can help patients to live longer. For me, representing a pharma company having ‘Science for a better life’ as its mission, it is deeply gratifying to know that what will be produced here will improve many peoples’ lives.”