New Data on Long-Term Use of FIRMAGON® (degarelix for injection) for Advanced Hormone-Dependant Prostate Cancer Published in Journal of Urology

Long-term safety and tolerability of FIRMAGON

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Sep 01, 2011, 11:44 ET

PARSIPPANY, N.J., Sept. 1, 2011 /PRNewswire/ -- New data, published today in the Journal of Urology, demonstrated the long-term safety and tolerability of FIRMAGON^® (degarelix) a gonadotropin-releasing hormone therapy (GnRH) for advanced prostate cancer when used over three years.(1) The new study (CS21A) was an open-label extension of the pivotal Phase III study (CS21) in which FIRMAGON^®was shown to be non-inferior to leuprolide in reducing testosterone to castrate levels through one year of treatment.(1) In a retrospective analysis of CS21, risk of PSA failure was significantly lower in patients receiving degarelix versus leuprolide up to 1 year.(2) The extension study showed in an exploratory analysis that for patients who remained on FIRMAGON^®, PSA suppression and the risk of PSA failure remained consistent over the long term (42 months).(1)

In addition, the extension study evaluated patients who crossed over from leuprolide to FIRMAGON^®after one year in an exploratory analysis. At a median follow up of 27.5 months the data showed that the risk of PSA failure had decreased.(1)

Longer time to PSA failure is thought to be desirable as it may be indicative of time to castrationresistant prostate cancer (CRPC) and may delay initiation of second-line therapy, which includes chemotherapy.(3) Time to castration resistance is also an important predictor of CRPC survival.(4)

"This extension study supports using FIRMAGON^® as first line-line androgen deprivation therapy(1) in patients with advanced prostate cancer locally advanced prostate cancer," said E. David Crawford, MD, Head, Section of Urologic Oncology and Professor of Urologic and Radiation Oncology, University of Colorado Denver, US. "The data from the Phase III open-label extension study showed that FIRMAGON^® provided advanced prostate cancer patients with safe and effective testosterone and PSA control over the long term, reducing the risk of PSA failure."

Prostate cancer is the second leading cause of cancer death amongst men in the Western world.(5) Up to 40% of men diagnosed with prostate cancer will eventually develop advanced disease, and although most respond to initial medical or surgical castration, progression to CRPC is inevitable(6). The average survival for patients with CRPC is two to three years.(6)

FIRMAGON^® works by immediately inhibiting the GnRH receptors in the pituitary gland and suppressing the luteinising hormone, which decreases production of testosterone by the testicles with no initial surge. Prostate cancer is dependent on testosterone for its growth, so the goal of therapy is to rapidly reduce testosterone levels to slow the growth of cancer cells.

Notes to Editors

About Study CS21

In the Phase III multicenter, randomized, open-label trial comparing FIRMAGON with leuprolide, prostate cancer patients (n=610) were randomized to a FIRMAGON starting dose of 240 mg for one month, followed by monthly maintenance doses of 80 mg (n=207) or 160 mg (n=202), or leuprolide 7.5 mg/month (n=201). The trial was powered to demonstrate non-inferiority of degarelix versus leuprolide for the primary end point (proportion of patients with testosterone suppression < 50 ng/dL during 12 months' treatment). Data for the 240/160 mg group have not been analyzed beyond 1 year; after 1 year patients randomized to the 160 mg dose were switched to the approved 80 mg dose following regulatory approval of this dose. Patients crossed over from the leuprolide group were given FIRMAGON starting dose 240 mg followed by monthly maintenance dose of 80 mg.

About Prostate Cancer

Prostate cancer is the most common form of male cancer in the western world,(2) and the second leading cause of cancer death in men in some countries. Around 300,000 new cases of prostate cancer are diagnosed in Europe each year.(3) Worldwide this figure rises to 670,000 new cases. For further media information and news alerts on prostate cancer please visit Ferring's information website www.ProstateCancerLiving.com

About FIRMAGON®

FIRMAGON is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist approved in 2009 by the U.S. Food and Drug Administration (FDA) for the treatment of advanced prostate cancer. As a receptor antagonist, FIRMAGON 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.(7-10)

FIRMAGON also reduces levels of prostate-specific antigen (PSA). Unlike luteinizing hormone-releasing hormone (LHRH) agonists, such as leuprolide, an established treatment for prostate cancer, FIRMAGON does not induce an initial testosterone surge. FIRMAGON is administered monthly by subcutaneous injection. The starting dose is 240 mg, followed by monthly maintenance doses of 80 mg. FIRMAGON is available for order through traditional and specialty pharmacy distributors. The average monthly cost of one year of FIRMAGON treatment is comparable to other hormone treatments for advanced prostate cancer.

Important Safety Information

FIRMAGON is contraindicated in patients with a known hypersensitivity to degarelix or to any of the product components and in women who are or may become pregnant. FIRMAGON can cause fetal harm when administered to a pregnant woman.

Long-term androgen deprivation therapy (ADT) prolongs the QT interval. Physicians should consider whether the benefits of ADT outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA or Class III antiarrhythmic medications.

Diagnostic test results of pituitary gonadotropic and gonadal functions conducted during and after FIRMAGON may be affected. The therapeutic effect of FIRMAGON should be periodically monitored by measuring serum concentrations of PSA; if PSA increases, serum concentrations of testosterone should be measured. The most common adverse reactions (greater than or equal to 10%) during FIRMAGON therapy included injection site reactions (eg, pain, erythema, swelling or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase.

The majority of adverse reactions were Grade 1 or 2; 1% or less were Grade 3/4. Injection site reactions were mostly transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%).

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 products in the U.S. market. They include: BRAVELLE® (urofollitropin for injection, purified), MENOPUR® and REPRONEX® (menotropins for injection, USP), Novarel® (chorionic gonadotropin for injection, USP), ENDOMETRIN® (progesterone) Vaginal Insert, LYSTEDA™ (tranexamic acid tablets), FIRMAGON® (degarelix for injection), PROSED® DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA® (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 more information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.

(1) Crawford, ED et al. Journal of Urology September 2011;186(3):889-897

(2) Tombal B, Miller K, Boddon-Gibod L, et al. Additional analysis of the secondary end point of biochemical recurrence rate in a phase 3 trial (CS21) comparing degarelix 80 mg versus leuprolode in prostate cancer patients segmented by baseline characteristics. Eur Urol. 2010;57(5):836-842.

(3) Mahon KL, et al. Endocr Relat Cancer 2011;18:R103–R123

(4) Bournakis E, et al. Icancer Res 2011: Apr;31(4):1475-82 http://www.ncbi.nlm.nih.gov/pubmed/21508406

(5) American Cancer Society. Available at: http://www.cancer.org/docroot/cri/content/cri_2_4_1x_what_are_the_key_statistics_for_prostate_cancer_36.asp [Accessed 25 May 2010]

(6) Beltran, H et al. European Urology 60(2011) 279–290 http://www.europeanurology.com/article/S0302-2838(11)00477-5/pdf/New+Therapies+for+Castration-Resistant+Prostate+Cancer%3A+Efficacy+and+Safety

(7) 7 Degarelix [prescribing information]. Parsippany, NJ: Ferring Pharmaceuticals Inc.; December 2008.

(8) 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.

(9) Van Poppel H, Tombal B, de la Rosette JJ, Persson B-E, Jensen J-K, Olesen TK. Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker—results from a 1-yr, multicentre, randomised phase 2 dosage-finding study in the treatment of prostate cancer. Eur Urol. 2008;54(4):805-813.

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

SOURCE Ferring Pharmaceuticals