Astellas and Medivation file for approval of enzalutamide in Japan

Japanese drug major Astellas Pharma (TYO: 4503) has submitted an application for marketing approval of enzalutamide to the Ministry of Health, Labor and Welfare in Japan for the treatment of prostate cancer.

Enzalutamide is a novel, once-daily, oral androgen receptor signaling inhibitor. It inhibits multiple steps in the androgen receptor signaling pathway, which has been shown to decrease cancer cell growth and can induce cancer cell death (apoptosis).

Sales of Xtandi (enzalutamide), which is partnered with USA-based Medivation (Nasdaq: MDV) and was approved in the USA last year (The Pharma Letter September 3, 2012), reached $146 million in local currencies. Astellas said that revenue from the drug is expected to reach $400 million in fiscal 2013. More recently, Xtandi’s approval has been recommended by a European Medicines Agency advisory committee (TPL April 28). The global prostate cancer drug market, which has seen several new entrants (TPLs passim), is now valued at around $1 billion and is expected to rise to $5 billion by 2015 and $8.9 billion by 2019.