Firmagon(R) has a Significantly Greater Probability of PSA Recurrence-Free Survival Than Leuprolide in Prostate Cancer Patients

SAINT-PREX, Switzerland, December 21 - Results from a phase III pivotal study sub-analyses reported in European
Urology show that prostate cancer patients who received Firmagon(R)
(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.[i] 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.[i]

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.i

Suppression of testosterone to castrate levels occurred significantly
faster in patients receiving degarelix than in those receiving leuprolide.i
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 (greater than or equal to)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.[ii]

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). [iii]

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.

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[i] 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.

[ii] 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.

[iii] 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.

    For further information:
    Michael George,
    Ferring Pharmaceuticals.
    Tel: +41-58-301-0053,
    michael.george@ferring.com .

For further information: Michael George, Ferring Pharmaceuticals. Tel: +41-58-301-0053, michael.george at ferring.com .