Press Release
<p>DEGARELIX (FIRMAGON<sup><sup>®</sup></sup>) VS LEUPROLIDE (LUPRON DEPOT<sup><sup>®</sup></sup>) IN PATIENTS WITH ADVANCED PROSTATE CANCER: FURTHER ANALYSIS FROM A PHASE III PIVOTAL TRIAL</p>
<p><strong>Investigators Presented Results at the Society of Urologic Oncology Annual Meeting</strong></p>
<p><strong>BETHESDA, MD – December 4, 2009 –</strong> Drs. Neal Shore and E. David Crawford presented
results for prostate-specific antigen (PSA) recurrence from the additional analysis of secondary
end points of biochemical recurrence rate in a Phase III pivotal study of FIRMAGON<sup>®</sup> (monthly
degarelix for injection) or monthly leuprolide in prostate cancer patients during the first year of
treatment. Prostate cancer patients who received FIRMAGON 240/80 mg/month had a
recurrence rate of 7.7% during the first year of treatment compared with 12.9% of patients
treated with leuprolide 7.5 mg/month (p=0.05). Patients being treated with FIRMAGON also
had longer time to recurrence compared with those on leuprolide (p=0.04).
Results of the PSA analysis were presented in a poster at the 10th Annual Meeting of the
Society of Urologic Oncology, held in conjunction with the World Urological Oncology
Federation, on December 3 in Bethesda, MD.</p>
<p><strong>About the Study</strong></p>
<p>In the Phase III multicenter, randomized, open-label trial comparing degarelix with
leuprolide, prostate cancer patients (n=610) were randomized to a starting dose of degarelix
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). Results showed that degarelix is as effective as
leuprolide 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 The study also showed that degarelix achieves faster suppression
of luteinizing hormone and follicle-stimulating hormone.1,2
PSA recurrence was defined as two consecutive increases in PSA of 50% compared
with nadir and ≥5 ng/mL on two consecutive measurements at least two weeks apart. PSA
progression-free survival was analyzed using the Kaplan-Meier method and “time to event” was
defined as the number of days from first dosing to the first occurrence of PSA recurrence or
death. PSA recurrences were analyzed by baseline PSA level.</p>
<p>PSA recurrence was 12.9% for leuprolide 7.5 mg/month patients compared to 7.7% with
the approved degarelix 240/80 regimen. The probability of completing the study without
experiencing PSA recurrence by day 364 was 91.1% (95% CI: 85.9-94.5) for degarelix and
85.9% (95% CI: 79.9-90.2) for leuprolide 7.5 mg/mo. The probability of completing the study
without dying by day 364 was 97.4% (95% CI: 93.8-98.9) for degarelix versus 95.1% (95% CI:
90.7-97.4) for leuprolide 7.5 mg/mo. In patients with baseline PSA >20 ng/mL, risk of PSA
recurrence was lower for patients receiving degarelix compared with leuprolide (p=0.04). The
risk of PSA recurrence was comparable in patients with baseline PSA >50 ng/mL (p=0.10).
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. Degarelix was as effective as leuprolide in suppressing
testosterone levels from Day 28 to the end of the study (Day 364), with 97.2% of the degarelix
patients maintaining medical castrate levels compared with 96.4% for leuprolide.</p>
<p><strong>About FIRMAGON</strong></p>
<p>FIRMAGON is an injectable gonadotropin-releasing hormone (GnRH) receptor
antagonist approved 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.1-4
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 prostate cancer.
The most commonly observed adverse reactions during FIRMAGON therapy included
injection site reactions (e.g. pain, erythema, swelling or induration) and other androgen
deprivation therapy (ADT) associated side effects including hot flashes, increased weight and
fatigue. 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.</p>
<p>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 ADT 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.</p>
<p><strong>About Ferring Pharmaceuticals Inc.</strong></p>
<p>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<sup>®</sup>
(urofollitropin for injection, purified), MENOPUR<sup>®</sup> and REPRONEX<sup>®</sup> (menotropins for injection,
USP), NOVAREL<sup>®</sup> (chorionic gonadotropin for injection, USP), ENDOMETRIN<sup>®</sup> (progesterone)
Vaginal Insert, 100 mg, FIRMAGON<sup>®</sup> (degarelix for injection), PROSED<sup>®</sup> DS (methenamine,
phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and
EUFLEXXA<sup>®</sup> (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.</p>
<p>*Lupron Depot<sup>®</sup> (leuprolide acetate for depot suspension) is a registered trademark of TAP Pharmaceuticals Inc.</p>
EUFLEXXA (1% sodium hyaluronate) is used to relieve knee pain due to osteoarthritis. It is used in people who do not get enough relief from simple pain medications such as acetaminophen or from exercise and physical therapy.
Important Safety Information
You should not receive this product if you have had any previous allergic reaction to EUFLEXXA or hyaluronan products. You should not have an injection into the knee if you have a knee joint infection or if you have skin disease or infection around the injection site.
EUFLEXXA is only for injection into the knee performed by a qualified doctor. After you receive this injection you may need to avoid activities such as jogging, tennis, heavy lifting, or standing on your feet for a long time (more than one hour). The safety and effectiveness of repeat treatment cycles of EUFLEXXA have not been established. The safety and effectiveness of EUFLEXXA have not been shown in people under 18 years of age.
Side effects sometimes seen when EUFLEXXA is injected into the knee joint were pain, swelling, skin irritation, and tenderness and these were generally mild and did not last long.
Please see Full Prescribing Information.
Please see Important Information for Patients.
PLEASE CONSULT WITH YOUR DOCTOR, OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL BEFORE USING ANY PRODUCT DISCUSSED WITHIN THIS WEB SITE.
This website is intended only for US residents.
Euflexxa® is a registered trademark of Ferring Pharmaceuticals Inc.
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