Ferring Pharmaceuticals, USA received approval from the US Food and Drug Administration (FDA) for degarelix, a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist, indicated for patients with advanced prostate cancer. Potential trade names are still under review with the FDA. Following issuance of a trade name, Ferring Pharmaceuticals, USA will immediately begin commercialization in the US On December 18, the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMEA), recommended granting a marketing authorization for degarelix in Europe. Degarelix is awaiting approval in other key global markets. It is a milestone for the company and represents Ferring's first global product launch.

Phase-III studies showed that degarelix is at least as effective as leuprolide (Lupron Depot) in sustaining castrate levels or lower of testosterone, and had a statistically significant faster reduction of testosterone. At day-3 of treatment, 96 per cent of degarelix patients achieved castrate levels of testosterone, compared with zero percent receiving leuprolide. By day 14, 99 per cent of degarelix patients achieved castrate levels of testosterone, compared with 18 per cent receiving leuprolide.

In the clinical trial, prostate specific antigen (PSA) levels were also monitored as a secondary endpoint. PSA levels were lowered by 64 per cent two weeks after administration of degarelix, 85 per cent after one month, 95 per cent after three months, and remained suppressed throughout the one year of treatment. These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline is related to a clinical benefit.

Prostate cancer is known to grow in the presence of testosterone. Suppression of testosterone has been a treatment goal for advanced prostate cancer for many years. Surgical castration was the standard method of reducing testosterone from the 1940s until the mid-1980s when the earliest forms of medical castration, luteinizing hormone releasing hormone (LHRH) agonists, were introduced.

Degarelix is the only GnRH receptor antagonist approved by the FDA for the treatment of hormonally-sensitive advanced prostate cancer. Degarelix achieves medical castration differently than LHRH agonists, specifically by binding reversibly to GnRH receptors on cells in the pituitary gland, quickly reducing the release of gonadotropins and consequently testosterone.

"Degarelix was discovered in San Diego, developed by Ferring Pharmaceuticals in the U.S. and Europe, and in its pivotal phase-III study demonstrated both an immediate onset of action and a profound long-term suppression of testosterone and PSA," commented Dr Pascal Danglas, executive vice president Clinical & Product Development, at Ferring. "We are delighted to deliver a new treatment option for advanced prostate cancer to the medical community. Ferring has a considerable pipeline of urology products in development, and we expect to introduce additional treatment advances in the urology field in the near future."

"Use of a GnRH receptor antagonist is a highly efficient way to stop the production of testosterone," said Neal Shore, medical director for Carolina Urologic Research Center, a clinical trial investigator and advisor to Ferring. "The approval of degarelix offers the medical community an effective alternative in the treatment of hormonally-sensitive prostate cancer. Now prostate cancer can be treated with immediate inhibition of the GnRH receptors, inducing rapid reduction of testosterone to castrate levels, and sustaining those levels over time, which are the goals of systemic therapy. When a patient has disease recurrence, it is always encouraging to clinicians and patients to see PSA levels fall so rapidly."

Wayne Anderson, president and CEO Ferring Pharmaceuticals, USA added, "We are enthusiastically preparing to enter this therapeutic area of urology. We respect the challenges physicians and patients face in their fight against prostate cancer and hope that we can help them with this new treatment option. This is a big milestone for the U.S. operating unit, and we have been carefully preparing for over two years for this launch."

Ferring Pharmaceuticals is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of urology, orthopaedic and infertility products in the US market.