Based on the positive results from phase I, II studies in Japan and phase III studies in abroad, Astellas has applied for the market authorisation in Japan.
Astellas has been researching in the treatment of prostrate cancer since January 2006 and has conducted the Phase II development of Gonax in Japan.
Gonax is a gonadtrophin-releasing hormone (GnRH) blocker with a subcutaneously injectable formulation.
Gonax inhibits the binding of GnRH to the GnRH receptors and controls the growth of prostate cancer by the suppression of testosterone production.
The 2006 licensing agreement between Ferring Pharmaceuticals and Astellas granted right to Astella to develop Gonax.
The marketing approval in Japan will confer Ferring a payment of €10m by Astellas.
Gonax appears to be safe and well tolerated and has been approved in 59 countries.