Algeta and Bayer file for MAA
13.12.2012 - Algeta ASA has baged a €50m milestone after its partner Bayer Healthcare AG submitted a MAA to the European Medicines Agency.
Last year, the companies demonstrated improved overall survival with radium-223 dichloride (radium-223, previously Alpharadin) as a treatment in castration-resistant prostate cancer (CRPC) patients with bone metastases. The milestone is part of a €560m licence deal signed in 2009 by the German drug developer and the Oslo-based specialist for alpha particle-emitting cancer pharmaceuticals.
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 increased overall survival by 44%, 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.
Prostate cancer is the most common non-cutaneous malignancy in men worldwide. In 2008, an estimated 899,000 men were diagnosed with prostate cancer and 258,000 died from the disease worldwide. Prostate cancer is the sixth leading cause of death from cancer in men. A majority of men with CRPC have radiological evidence of bone metastases.