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Firmagon® has a significantly greater probability of PSA recurrence-free survival than Leuprolide in prostate cancer patients

Saint-Prex, Switzerland (ots)

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.
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.[1]  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.[1]
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]
Suppression of testosterone to castrate levels occurred 
significantly faster in patients receiving degarelix than in those 
receiving leuprolide.[1] 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 equal or more than 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.[2]
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). [3]
About Prostate Cancer
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.
About Ferring
Ferring is a Swiss-headquartered, research driven, speciality 
biopharmaceutical group active in global markets. The company 
identifies, develops and markets innovative products in the areas of 
urology, gastroenterology, and reproductive health. In recent years 
Ferring has expanded beyond its traditional European base and now has
offices in 45 countries.  To learn more about Ferring or our products
please visit www.ferring.com
[1] 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.
[2] 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.
[3] 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.

Contact:

Michael George
Ferring Pharmaceuticals
Tel.: +41/58/301'00'53
E-Mail: michael.george@ferring.com

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