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Astellas chases Japanese approval for degarelix prompting milestone payment

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Astellas Pharma, based in Tokyo, Japan, has filed an MAA with the country’s Ministry for Health, Labour and Welfare for a one-month formulation of degarelix acetate, which it licensed from Ferring in January 2006. The MAA filing earns Ferring a EUR 10 million milestone payment from Astellas.

Astellas is seeking approval in Japan of degarelix as a treatment of prostate cancer – an indication for the drug that is already approved in the US and EU. Degarelix is a gonadtrophin-releasing hormone (GnRH) blocker with a subcutaneously-injectable formulation. The GnRH hormone is produced in the hypothalamus and plays a part in the production of testosterone, by binding to the receptors of the pituitary gland. Testosterone has been known to encourage prostate cancer to grow and spread. To prevent this, degarelix inhibits the binding of GnRH receptors and controls the growth of prostate cancer by suppressing the production of testosterone.

Safety data prove that degarelix seems to be safe and well-tolerated, and, following results from Phase I and II studies in Japan, Astellas decided to submit the MAA by using international Phase III data and skipping plans for a Phase III study in Japan.

This latest development highlights the potential that Astellas clearly has on the urology market in Japan, and the treatment of prostate cancer in particular through a new mechanism of action. The company is already marketing treatments for overactive bladder (Vesicare) and for functional symptoms of benign prostate hyperplasia (Harnal). The Japanese company views urology as the “bridgehead” of entry into the oncology market in Japan.

This article was provided by Sophie Bracken, editor of Drug Delivery Insight Espicom’s business news sevice designed to keep you in touch with the latest developments in the rapidly expanding and dynamic drug delivery market.

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Thanks for reading, come back soon, Paul




Espicom Business Intelligence

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