Ferring Pharmaceuticals Announces Immediate Availability of Degarelix for the Treatment of Advanced Prostate Cancer

Ferring Pharmaceuticals, USA today announced the U.S. commercial availability of degarelix for injection (trade name pending), a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the U.S. Food and Drug Administration (FDA) for the treatment of hormone sensitive advanced prostate cancer. Degarelix is available for order through traditional and specialty pharmacy distributors.

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Degarelix provides fast, long-term suppression of testosterone, a hormone that stimulates prostate cancer growth.(1-3) Clinical trials demonstrated that degarelix is effective in quickly reducing and sustaining castrate levels of testosterone.(2,3) Degarelix works differently than a luteinizing hormone-releasing hormone (LHRH) agonist bybinding immediately and reversibly to GnRH receptors in the pituitary gland, quickly reducing the release of gonadotropins and consequently testosterone. In the Phase III study vs. leuprolide, the degarelix group achieved a 90 percent decrease in median testosterone levels at Day 3 of treatment, compared with the leuprolide group, which experienced a 65 percent increase in median testosterone levels. By Day 3, 96 percent of degarelix patients achieved castrate levels of testosterone, compared with zero percent receiving leuprolide. In addition, degarelix was as effective as leuprolide in suppressing testosterone levels from Day 28 to the end of the study (Day 364), with 97.2 percent of the degarelix patients maintaining medical castrate levels compared with 96.4 percent for leuprolide.

Study findings also showed that prostate specific antigen (PSA) levels were lowered by 64 percent two weeks after administration of degarelix, 85 percent after one month, 95 percent after three months, and remained suppressed throughout the one year of treatment.(1,2) 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 aclinicalbenefit."Degarelix, the lead product in our urology portfolio,demonstrated both a rapid onset of action and a profound long-term suppression of testosterone," said Wayne Anderson, President and CEO Ferring Pharmaceuticals Inc., USA. "Now, advanced prostate cancer can be treated with a direct-acting GnRH receptor antagonist inducing rapid reduction of testosterone and sustaining those levels over time, meeting the goals of systemic therapy. We are excited to provide this effective new treatment option for men fighting advanced prostate cancer."Approved by the FDA on December 24, 2008, degarelix represents Ferring Pharmaceuticals' first global launch and the second urology product launch for Ferring Pharmaceuticals, USA. The European Commission granted marketing authorization for degarelix on February 19, 2009. Degarelix is awaiting approval in other key global markets.

Phase III Study Results
The 12-month, randomized, open-label, parallel-group Phase III study evaluated the efficacy and safety of degarelixcompared with leuprolide administered monthly over one year of prostate cancer treatment. Patients with histologically confirmed prostate cancer were randomized to either degarelix or leuprolide: a degarelix subcutaneous (under the skin) injection of 240 mg for one month with monthly maintenance doses of 80 mg (n=207) or monthly intramuscular (into the muscle) injections of leuprolide depot 7.5 mg (n=201).

The primary endpoint was testosterone suppression to less than or equal to 50 ng/dL during monthly measurements from Day 28 to Day 364. Degarelix was at least as effective as leuprolide in achieving and maintaining castrate levels of testosterone.
                               N          Patients with         % (95% CI)
                                       treatment response
Degarelix                 207               202                97.2
240/80 mg
Leuprolide 7.5 mg         201               194                96.4

Suppression of testosterone levels to less than or equal to 50 ng/dL occurred significantly faster in patients receiving degarelix than in those receiving leuprolide. At Day 3 of treatment, the degarelix group achieved a 90 percent decrease in median testosterone levels, compared to the leuprolide group which experienced a 65 percent increase in median testosterone levels.

The most commonly observed adverse reactions during degarelix therapy included injection site reactions (e.g. pain, erythema, swelling or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT).

Ninety-nine percent of these observed adverse reactions were Grade 1 or 2 (mild to moderate). Specifically relating to the injection site adverse reactions, most were transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in two percent or less
of patients receiving degarelix.

Degarelix is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components. Degarelix is not indicated in women or pediatric patients. Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients
with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications.

About Degarelix
Degarelix is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the U.S. Food and Drug Administration (FDA) for the treatment of hormone sensitive advanced prostate cancer. As a receptor antagonist, degarelix reversibly binds to the GnRH receptors in the pituitary gland, immediately suppressing the secretion of theluteinizinghormone (LH), follicle-stimulating hormone (FSH), and subsequently, testosterone levels.(4) Degarelix also reduces levels ofprostate-specific antigen (PSA). Unlike LHRH agonists, such as leuprolide, an established treatment for prostate cancer, degarelix does not induce an initial testosterone surge. Degarelix is administered monthly by subcutaneous injection. The starting dose is 240 mg, followed by monthly maintenance doses of 80 mg. Degarelix is available for order through traditional and specialty pharmacy distributors. The average monthly cost of one year of degarelix treatment is comparable to other hormone treatments for prostate cancer.
About Prostate CancerProstate cancer is the most common cancer, excluding skin cancers, and the second leading cause of cancer death in American men. About one man in six will be diagnosed with prostate cancer during his lifetime, and one in 35
will die of this disease.(5) Prostate cancer develops from cells in the prostate gland that begin to grow out of control. In most cases, prostate cancer grows slowly and can remain undetected throughout a man's life, although it can grow and spread quickly.(6) The four types of standard treatment are: watchful waiting, surgery, radiation therapy, and hormone therapy, also called androgen deprivation therapy (ADT).