June 1, 2010
FIRMAGON® RESULTS IN FAST, LONG-TERM SUPPRESSION OF TESTOSTERONE IN PROSTATE CANCER PATIENTS WITHOUT INITIAL TESTOSTERONE SURGE
Symposia Presented Innovative Approach to Treatment at Leading Urology Meeting
SAN FRANCISCO – June 1, 2010 – FIRMAGON® (degarelix for injection) resulted in fast, long-term suppression of testosterone in prostate cancer patients, without an initial testosterone surge or microsurge, and rapidly reduced prostate-specific antigen (PSA) levels, according to a review of data presented here today at the AUA 2010 annual meeting by Dr. Judd Moul, Chief of the Division of Urology at Duke University Health Science Center.
Dr. Moul was joined at the symposia by Dr. Juan Morote, of the Department of Urology, Vall d’Hebron Hospital and Autonoma University of Barcelona School of Medicine in Spain. Dr. Morote presented a retrospective analysis demonstrating testosterone escapes higher than castration levels for patients being treated with a GnRH agonist. The analysis also suggested a direct relationship between testosterone increases and androgen-independent progression, and that ineffective testosterone suppression therapy may result in higher prostate cancer mortality. Both presentations were sponsored by Ferring Pharmaceuticals Inc.
“Use of a GnRH receptor antagonist is a highly efficient way to rapidly halt the production of testosterone,” said Dr. Moul. FIRMAGON® is an effective alternative treatment for hormonally sensitive advanced prostate cancer, and reduces testosterone to castrate levels at day 3 of treatment. It immediately inhibits GnRH receptors on the pituitary gland, inducing rapid reduction of testosterone to castrate levels and sustaining those levels over time, which are the goals of systemic prostate cancer therapy.”
“The use of an Androgen Deprivation Therapy (ADT) like FIRMAGON® that is devoid of surges, microsurges and has fewer testosterone escapes vs leuprolide, represents a stride forward in the treatment of advanced prostate cancer and may affect outcomes ” said Dr. Morote.
Dr. Moul discussed the rationale for androgen deprivation therapy in prostate cancer, in that testosterone is essential for the growth and viability of prostate tumor cells.
Medical castration results in clinically meaningful benefits for men with differing states of prostate cancer.1 GnRH agonists are a form of medical castration. However, GnRH agonists initially cause testosterone surge that may last up to two weeks, may stimulate cancer growth, and may cause clinical flare in up to 63% of patients.2 Testosterone reductions to castrate levels may take up to 30 days with GnRH agonists. Microsurges and testosterone breakthroughs may also result from LHRH agonist treatment.
Dr. Moul cited FIRMAGON® as an alternative and innovative approach for the treatment of advanced prostate cancer. FIRMAGON® is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist approved for the treatment of advanced prostate cancer. 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.3-6 It causes more rapid medical castration and eliminates testosterone surge and microsurges without affecting the androgen receptor. Unlike LHRH agonists, such as leuprolide, an established treatment for advanced prostate cancer, FIRMAGON® does not induce an initial testosterone surge.
Dr. Moul referenced a randomized Phase III pivotal trial of 610 prostate cancer patients, in which FIRMAGON® was shown to be non – inferior to leuprolide in sustaining castrate levels of testosterone from Days 28 – 364. This trial formed the primary basis for the successful Food and Drug Administration (FDA) approval of FIRMAGON® in December, 2008. The study results showed that at day 3 of treatment, 96% of FIRMAGON® patients achieved castrate levels of testosterone, compared with zero percent receiving leuprolide. The median testosterone level with FIRMAGON® treatment was sustained at <9 ng/dL with no initial testosterone surge or microsurge following maintenance injections throughout the one-year study.
More About FIRMAGON
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 prostate cancer.
Important Safety Information
FIRMAGON is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components. FIRMAGON is not indicated in women or pediatric patients. Long-term androgen deprivation therapy 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 (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications.
The most commonly observed adverse reactions during FIRMAGON 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 FIRMAGON.
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, gynecology, urology, and orthopaedic products in the U.S. market. They include: LYSTEDA™ (tranexamic acid), (BRAVELLE® (urofollitropin for injection, purified), MENOPUR® and REPRONEX® (menotropins for injection, USP), NOVAREL® (chorionic gonadotropin for injection, USP), ENDOMETRIN® (progesterone) Vaginal Insert, 100 mg, 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.
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|2||Van Poppel H, et al. Urology. 2008;7(6):1001-1006.|
|3||Degarelix [prescribing information]. Parsippany, NJ: Ferring Pharmaceuticals Inc.; December 2008.|
|4||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.|
|5||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.|
|6||Doehn C. Immunotherapy of Prostate Cancer. Eur Urol. (2006);53-4:681-683.|