http://www.algeta.com/news/news-article/?articleId=1702300Algeta announces thatXofigo (radium-223 dichloride) has been approved by the US FDANot Intended for US Media New treatment for castration-resistantprostate cancer (CRPC) patients with bone metastases Xofigo shown in a pivotal phase III trial tosignificantly improve overall survival Algeta to host international conference callscheduled for tomorrow at 08:00 CET - details below Oslo, Norway, 15 May 2013 - Algeta ASA (OSE:ALGETA) announces that the US Food and Drug Administration (FDA) has approvedXofigo (radium-223 dichloride) injection for the treatment ofpatients with castration-resistant prostate cancer, symptomatic bone metastasesand no known visceral metastatic disease. Xofigo is the first alphaparticle-emitting radioactive therapeutic agent approved by the FDA, that hasdemonstrated improvement in overall survival (OS) and delay in time to firstsymptomatic skeletal event (SSE) compared to placebo, as shown in the pivotalphase III ALSYMPCA trial.The commercial production of Xofigo is underway,and first doses are expected to be ready for patient treatment within a fewweeks. Bayer has worldwide exclusive marketing rights for Xofigo. Algeta US,LLC and Bayer Healthcare will co-promote the product in the US.Andrew Kay, Algeta's President & CEO, said:"We are delighted that the FDA has taken the decision to approve Xofigo soquickly. We are extremely pleased to be able to make this alphaparticle-emitting pharmaceutical available to US patients withcastration-resistant prostate cancer and symptomatic bone metastases. We willnow finalize our launch preparations for Xofigo in the US, with the intentionof launching it, with Bayer, as soon as possible. This approval is a majormilestone for Algeta and puts us firmly on the path to deliver on our vision tobe a world-class oncology company bringing novel targeted medicines to cancerpatients through our leadership in alpha particle-emittingpharmaceuticals.""The development of bone metastases is afrequent consequence of advanced prostate cancer, and a major cause ofdisability and death in this disease," said Dr Chris Parker, PrincipalInvestigator for the pivotal ALSYMPCA trial, from the Royal Marsden Hospitaland Institute of Cancer Research (London, UK). "Xofigo will be animportant and welcome addition to the treatment regimes that are used for thetreatment of this cancer."Bone is the most common site in the body to beaffected by metastatic cancer and bone metastases are particularly prevalent inpatients with prostate cancer. Approximately 90% of patients with metastaticprostate cancer show evidence of bone metastases. Bone metastases can lead toan increase in frequency of skeletal events. In addition, bone metastases havebeen shown to be the main cause of morbidity and death in patients with CRPC.Efficacy and Safety Data Supporting Xofigo ApprovalThe approval of Xofigo (radium-223 dichloride,radium-223) is based on data from the pivotal phase III ALSYMPCA (ALpharadin inSYMptomatic Prostate CAncer) trial. At the interim analysis, radium-223significantly improved overall survival (OS) [HR=0.695 (95% CI 0.552-0.875),p=0.00185]; median OS was 14.0 months with radium-223 plus best standard ofcare vs. 11.2 months with placebo plus best standard of care. Additionally, atthe interim analysis there was a delay in the time to first symptomaticskeletal event (SSE) for patients treated with radium-223 vs. placebo.An updated analysis, conducted after the study wasunblinded, showed a further improvement in overall survival (OS) for patientstreated with radium-223 vs. placebo, with a median OS of 14.9 months vs. 11.3months; HR=0.695 (95% CI 0.581-0.832).The