Provider: Wright Reports
Algeta ASA: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
Provider: Reuters Investment Profile
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Algeta ASA's Partner Bayer Submits New Drug Application to FDA for Radium-223 Dichloride for Treatment of Castration-Resistant Prostate Cancer with Bone Metastases
Algeta ASA announced that its partner Bayer has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for radium-223 dichloride (radium-223) for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases. Bayer submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) on December 12, 2012 for radium-223 for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases. Under the terms of the 2009 agreement with Bayer, the first complete submission for marketing approval triggers a EUR50 million payment from Bayer to Algeta. The submission is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial, which was conducted by Algeta. In the study, radium-223 significantly increased overall survival by 44% (HR=0.695, p=0.00007), resulting in a 30.5%-reduction in the risk of death compared to placebo. The median overall survival (OS) benefit in patients with radium-223 was 3.6 months, based on 14.9 months OS with radium-223 plus best standard of care (BSoC) vs. 11.3 months with placebo plus BSoC. These updated results were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012.
Latest Developments for Algeta ASA
- Algeta ASA confirms that it is in receipt of preliminary acquisition proposal from Bayer AG
- Algeta ASA's Partner Bayer Receives Marketing Authorisation from European Commission for Xofigo
- EMA Recommends Algeta ASA's Radium Ra 223 Dichloride Developed in Cooperation with Bayer for Approval
- United States FDA Approves Algeta ASA's Xofigo
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