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Ferring Pharmaceuticals Launches Phase IIIB Trial of Degarelix as Intermittent Therapy
Date:4/27/2009

Trial Will Build on Pivotal Phase III Study for the Treatment of Advanced Prostate Cancer

PARSIPPANY, N.J., April 27 /PRNewswire/ -- Ferring Pharmaceuticals announced today the launch of a Phase IIIB clinical trial of degarelix for injection, 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. The announcement was made at the 2009 American Urological Association Annual Meeting in Chicago, IL.

The Phase IIIB trial will investigate the use of degarelix for intermittent androgen deprivation therapy (IADT) in patients with advanced prostate cancer who have rising serum PSA levels after previous curative therapies. The study will compare IADT to continuous androgen deprivation therapy (ADT) for 14 months with either leuprolide or degarelix. The trial evaluates whether IADT minimizes the negative effects of ADT and maximizes quality of life, while maintaining tumor response as measured by PSA suppression.

"Intermittent androgen deprivation therapy is a commonly employed treatment for men with biochemical failure, however it needs to be evaluated in a randomized clinical trial," says Dr. E. David Crawford, Head Urologic Oncology, University of Colorado, Denver and a trial investigator. "There is potential value in combining the rapid, sustained suppression of testosterone that degarelix offers in this treatment. IADT appears to improve patient quality of life and that will also be evaluated."

Physicians interested in serving as trial investigators should call 1-973-796-1600 to speak with Ferring Pharmaceuticals' Medical Information office.

Degarelix Phase III Trials

Phase III pivotal studies showed that degarelix is as effective as leuprolide (Lupron Depot(R))(*)in reducing and sustaining castrate levels of testosterone.(1)(2) Suppression of testosterone to castrate levels occurred significantly faster in patients receiving degarelix than in those receiving leuprolide.(1)(2) At Day 3 of treatment, the degarelix group achieved a 90 percent decrease in median testosterone levels compared with the leuprolide group, which experienced a 65 percent increase in median testosterone levels, a statistically significant result. 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.

In addition, 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 a clinical benefit.

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 the luteinizing hormone (LH), follicle-stimulating hormone (FSH), and subsequently, testosterone levels.(3) Degarelix also reduces levels of prostate-specific antigen (PSA). Unlike luteinizing hormone-releasing hormone (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.

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 Prostate Cancer

Prostate 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.(4) 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.(5) The four types of standard treatment are: watchful waiting, surgery, radiation therapy, and hormone therapy, also called androgen deprivation therapy (ADT).

About Ferring Pharmaceuticals Inc.

Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of infertility, urology, and orthopaedic products in the U.S. market. They include: BRAVELLE(R) (urofollitropin for injection, purified), MENOPUR(R) and REPRONEX(R) (menotropins for injection, USP), Novarel(R) (chorionic gonadotropin for injection, USP), ENDOMETRIN(R) (progesterone) Vaginal Insert, 100 mg, PROSED(R) DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, DEGARELIX for injection and EUFLEXXA(R) (1% sodium hyaluronate).

Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, orthopaedics, gastroenterology, obstetrics/gynecology, and infertility. For complete prescribing information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.

(1) Degarelix [prescribing information]. Parsippany, NJ: Ferring Pharmaceuticals Inc; December 2008.

(2) Klotz L, Boccon-Gibod L, Shore ND, et al. The efficacy and safety of degarelix: a 12-month comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008;102(11):1531-1538.

(3) Doehn C. Immunotherapy of Prostate Cancer. Eur Uro. (2006);53-4:681-683.

(4) American Cancer Society. How Many Men Get Prostate Cancer? http://www.cancer.org/docroot/CRI/content/CRI_2_2_1X_How_many_men_get_prostate_cancer_36.asp?sitearea=

(5) American Cancer Society. Cancer Reference Information, Overview: Prostate Cancer. http://www.cancer.org/docroot/CRI/CRI_2_1x.asp?dt=36; Last accessed 11/12/08.

(*)Lupron Depot(R) (leuprolide acetate for depot suspension) is a registered trademark of TAP Pharmaceuticals Inc.


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SOURCE Ferring Pharmaceuticals Inc.
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