Janssen Pharmaceuticals K.K. submitted a marketing approval application for abiraterone acetate to the Japanese Ministry of Health, Labour and Welfare in July 2013 for the treatment of prostate cancer. The product was approved in the US by the Food and Drug Administration in April 2011, and in the EU by the European Commission in September 2011 for the treatment of patients with metastatic castration-resistant prostate cancer.
Marc Dunoyer, Executive Vice President, Global Products and Portfolio Strategy at AstraZeneca said: "Japan is one of the fastest growing pharmaceutical markets, where AstraZeneca has a proven track record of successfully developing and marketing innovative medicines. Abiraterone acetate is a great addition to our existing portfolio of leading cancer treatments, with real potential to address an important and growing patient need. This deal is a strong strategic fit for AstraZeneca, reinforcing both our focus on oncology as a core therapy area and Japan as one of our key growth drivers."
Financial terms of the agreement were not disclosed.
About abiraterone acetate
Abiraterone acetate is indicated in the US and the EU for the treatment of patients with metastatic castration-resistant prostate cancer in combination with prednisone (steroid) before and after treatment with docetaxel (chemotherapy). Abiraterone acetate has been approved in 83 countries.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.