Bayer submits Algeta's radium-223 dichloride in US and EU
This article was originally published in Scrip
Bayer HealthCare has submitted a new drug application to the US FDA and a marketing authorization application to the European Medicines Agency for radium-223 dichloride (radium-223) for the treatment of castration-resistant prostate cancer patients with bone metastases.
Bayer submitted in Europe on 12 December, swiftly followed by the US submission on 14 December. In the US, the drug was granted fast-track designation.
Both submissions were based on data from the ALSYMPCA trial, which met its primary endpoint in September last year, before a final analysis in February 2012 showed even better results than first thought (scripintelligence.com, 13 February 2012 & 26 September 2011).
Norwegian cancer company Algeta, the product's originator, exercised its option for a 50/50 co-promotion and profit-sharing stake in the US market in April (scripintelligence.com, 12 April 2012) under the terms of the 2009 global development and commercialization agreement it had with Bayer. The submissions trigger a €50 million milestone payment from Bayer to Algeta. The company will also be entitled to royalty payments in Europe should the drug be approved and launched.
Algeta mentioned that it will now initiate "new trials evaluating the broader clinical potential of radium-223 for treating cancer patients with bone metastases".