Ferring Pharmaceuticals, a specialty biopharmaceutical company, has launched Firmagon, a new treatment option in hormonal therapy for prostate cancer, in Europe.
The European launch of Firmagon follows the decision of the European Commission to grant marketing authorization in the EU in February 2009.
This approval was based on pivotal Phase III studies where Firmagon produced a reduction in levels of testosterone(1,2) below 0.5ng/ml within three days in more than 96% of study patients. Firmagon will be marketed in Europe by Ferring Pharmaceuticals.
Firmagon has a novel mechanism of action that is different from commonly used hormonal therapies. Administered as a subcutaneous injection, Firmagon rapidly reduces levels of prostate specific antigen (PSA) by immediately blocking the GnRH receptors in the pituitary gland. Blocking the receptors suppresses the luteinising hormone, which decreases production of testosterone by the testicles. Prostate cancer is dependant on testosterone for its growth, so reducing testosterone levels can slow the growth of cancer cells, said the company.
John Anderson, consultant urological surgeon at The Royal Hallamshire Hospital, Sheffield, UK, said: This is an important new step for the treatment of advanced, hormone-dependent prostate cancer, with Firmagon offering a new option and hope for many patients.
Our goal is to achieve fast and sustained reduction in testosterone levels, and Firmagon offers a rapid impact which is comparable to the immediacy achieved by surgery.