Saint-Prex, Switzerland, 21 December 2009 - Results from a phase III pivotal study sub-analyses reported in European Urology show that prostate cancer patients who received FIRMAGON® (degarelix) in the study have a statistically significant greater probability of PSA (prostate-specific-antigen) recurrence-free survival compared with those taking leuprolide (P=0.05).
FIRMAGON® is a gonadotropin-releasing hormone (GnRH) antagonist which is approved in the EU and USA.
PSA recurrence was more frequent with leuprolide (12.9%) than with degarelix 240/80 mg (7.7%) during the first year. Among patients who had elevated PSA levels at study entry (PSA >20 ng/mL at baseline), those on the GnRH blocker, degarelix had a significantly longer time to recurrence compared with those on leuprolide (P=0.04).
"These data add to the evidence demonstrating that FIRMAGON® offers an important treatment choice for men with prostate cancer," said Professor Bertrand Tombal, Chairman of Urology, Cliniques Universitaires Saint-Luc, Bruxelles. "It achieved a fast and sustained suppression of testosterone combined with fewer testosterone breakthroughs and the 1-year benefit of a significantly lower risk of PSA recurrence or death."
A further sub-analysis from the same study published in the British Journal of Urology International suggests that FIRMAGON® offers better control of serum alkaline phosphatase (S-ALP) than leuprolide.
In prostate cancer, elevated S-ALP levels are associated with progression of skeletal metastases as well as being significant predictors of early death. In the study, FIRMAGON® patients with metastatic disease had greater reductions in S-ALP levels than those with leuprolide. Furthermore, this S-ALP suppression with FIRMAGON® was sustained throughout the study, unlike leuprolide which demonstrated a significant rise towards the end of the 12 month treatment period.
"These results showed that there was better S-ALP control with FIRMAGON® than leuprolide, which is an important finding for physicians treating patients with prostate cancer because of S-ALP's association with skeletal metastases," commented Professor Fritz Schröder, Professor of Urology, Erasmus Medical Center, Rotterdam, the Netherlands.
- ENDS -
Notes to Editors
Initial Phase III study results comparing the efficacy and safety of degarelix, a gonadotropin-releasing hormone (GnRH) antagonist, with the luteinizing hormone-releasing hormone (LHRH) agonist, leuprolide, in prostate cancer treatment showed that degarelix was as effective as leuprolide in suppressing testosterone to castrate levels over time.  Its immediate onset of action produced fast testosterone suppression without the initial testosterone surge of LHRH agonists. The study also showed that degarelix achieved significantly faster suppression of luteinizing hormone and follicle-stimulating hormone. 
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. 
Suppression of testosterone to castrate levels 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 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.
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 the number of days from first dosing to the first occurrence of PSA recurrence or death. PSA recurrences were analyzed by baseline PSA level. PSA recurrence was more frequent with leuprolide (12.9%) than with degarelix 240/80 mg (7.7%). 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. 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. 
All PSA recurrences occurred in patients with baseline PSA >20 ng/mL. In patients with baseline PSA >20 ng/mL, risk of PSA recurrence was significantly lower for patients receiving degarelix (p=0.04). In patients with baseline PSA >50 ng/mL, 29.2% of those receiving degarelix and 40.0% of those receiving leuprolide experienced PSA recurrence (p=0.10).
Effects of treatment on S-ALP levels were analyzed by baseline prostate cancer disease stage (localized, locally advanced or metastatic). After initial peaks in both groups, by day 56, S-ALP was suppressed below baseline levels with degarelix 240/80 mg in patients with metastatic disease. S ALP levels were also suppressed during leuprolide treatment but dropping below baseline levels by day 84. The rise in S ALP levels with leuprolide late in the study was not observed with degarelix. Overall, the difference in S ALP suppression in patients with metastatic prostate cancer was statistically significant between degarelix 240/80 mg and leuprolide 7.5 mg at day 364 (96 IU/L vs 179 IU/L; P=0.0137). 
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Prostate cancer is the most common form of cancer in men, and the second leading cause of cancer death. In 2005 127,490 new cases were diagnosed in the 5 biggest European countries and 18,310 in Japan. In the US 218,890 new cases were estimated for 2007, with a mortality rate of 27,050.
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 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.
 Tombal B, Miller K, Boccon-Gibod L et al. Additional anaylsis of the secondary end point of biochemical recurrence rate in a Phase III trial (CS21) comparing degarelix 80mg versus Leuprolide in prostate cancer patients segmented by basedline characteristics. Eur Urol, 2009.
 Schröder F, Tombal B, Miller K et al. Changes in alkaline phosphatase levels in patients with prostate cancer receiving degarelix or leuprolide: results from a 12 month, comparative, phase III studay. BJU Unt 2009.