Ongoing Extension Study Results Provide Further Evidence for First-Line Use of FIRMAGON(R) (degarelix) in Advanced Prostate Cancer

By Ferring, PRNE
Sunday, March 20, 2011

For Non-US Media

VIENNA, Austria, March 21, 2011 - Recent data from the ongoing five-year FIRMAGON(R) (degarelix) extension
study (CS21a) has demonstrated the long term efficacy and tolerability of
FIRMAGON(R) in study patients with advanced hormone-dependent prostate cancer
and support its use as first-line androgen deprivation therapy.[1] Full
details were shared today at the European Association of Urology (EAU) 2011
Annual Meeting.

FIRMAGON(R), a gonadotropin-releasing hormone (GnRH) receptor blocker, is
indicated for the treatment of patients with advanced hormone-dependent
prostate cancer. The extension study of the pivotal FIRMAGON(R) vs leuprorelin
trial (CS21) was designed to collect extended safety and tolerability data on
FIRMAGON(R). Following the close of the Phase III trial, all patients were
offered the option to receive FIRMAGON(R) as part of the extension study. All
patients who had received FIRMAGON(R) continued with their treatment and those
who had previously been treated with leuprorelin (a GnRH agonist) were
re-randomised to receive FIRMAGON(R) 240/80mg or 240/160mg.

To date, data from the extension study show that all patients receiving
FIRMAGON(R) experienced improved PSA control, specifically:

- Beyond one year, prostate-specific antigen (PSA) suppression was
maintained in patients continuing treatment on FIRMAGON(R) [1,2]

- After switching to FIRMAGON(R) patients who initially received
leuprorelin experienced:

- Improved PSA control (0.20 vs 0.08 events/year; p=0.003)[1,2]

- A significantly lower rate of PSA failure or death[1,2]

- Tolerability of FIRMAGON(R) was maintained throughout the extended study

"The data from the ongoing extension study demonstrated that the efficacy
of FIRMAGON(R) remains strong over the long term, providing prostate cancer
patients with sustained PSA control," said Professor Laurent Boccon-Gibod,
Professor of Urology, Centre Hospitalo-Universitaire Bichat, Paris. "This is
further evidence of the benefits of starting and staying on FIRMAGON(R) and
that FIRMAGON(R) can be used as a first-line androgen deprivation therapy for
advanced hormone-dependent prostate cancer patients."


FIRMAGON(R) has unique chemical characteristics and a novel mechanism of
action, different from traditionally used hormonal therapies. Administered as
a subcutaneous injection, FIRMAGON(R) rapidly reduces levels of prostate
specific antigen (PSA) within two weeks by immediately blocking the GnRH
receptors in the pituitary gland. Blocking the receptors suppresses the
release of the luteinising hormone (LH) and follicle-stimulating hormone
(FSH), resulting in a decrease in production of testosterone by the testicles
to castration levels within three days. Prostate cancer is dependent on
testosterone for its growth, and reducing testosterone levels slows the
growth of cancer cells.

In clinical studies, FIRMAGON(R) suppressed testosterone and PSA faster
than leuprorelin, an existing treatment for advanced prostate cancer.[3]

In clinical trials FIRMAGON(R) was generally well tolerated. Common side
effects are hot flushes, injection site pain and erythema, increased weight,
nasopharyngitis, fatigue and back pain.[3,4]

About Prostate Cancer

Prostate cancer is the most common form of male cancer in the western
world,[5] and the second leading cause of cancer death in men in some
countries.[6] In 2008, around 338,000 men were diagnosed with prostate cancer
in Europe and 258,000 men died from prostate cancer.[7] Worldwide, 913,000
men were diagnosed with prostate cancer in 2008 and more than two out of
three cases were diagnosed in the more developed regions.7 For further media
information and news alerts on prostate cancer please visit Ferring's
information website

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 reproductive health,
urology, gastroenterology, endocrinology and osteoarthritis. In recent years
Ferring has expanded beyond its traditional European base and now has offices
in over 45 countries. To learn more about Ferring or our products please


[1] Tombal, B, Schroder, F, Miller, K et al. Long-term prostate-specific
antigen (PSA) control in prostate cancer: continuous degarelix or degarelix
following leuprolide. EAU 2011, Symposium Abstract 1088. 26th Annual EAU
Congress, Vienna, 18-22 March 2011.

[2] Crawford, ED, Moul, JW, Shore, ND et al. Switching from leuprolide to
degarelix vs continuous degarelix treatment - effects on long-term
prostate-specific antigen control. J Urol 2010; 183 (Suppl): e262, abstract

[3] Klotz L, Boccon-Gibod L, Schroder FH 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

[4] Van Poppel H, De La Rosette JJ, Persson B.E et al. Degarelix Study
Group; Long-term evaluation of degarelix, a gonadotrophin-releasing hormone
(GnRH) receptor blocker, investigated in a multicentre randomised study in
prostate cancer (CAP) patients. Abstract (23.) Euro Urol Suppl 2007;6(2):28

[5] University of Iowa Hospitals and Clinics. Available at:
[Accessed 16 February 2011]

[6] American Cancer Society. Available at:
[Accessed 16 February 2011]

[7] Cancer Research UK. Available at: [Accessed 16
February 2011

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the hyperlinks into your Internet browser's URL address field. Remove the
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Media enquiries: Sarah Stanmore, Tonic Life Communications, Tel: +44-207-798-9906, sarah.stanmore at; Helen Swift, Tonic Life Communications, Tel: +44-207-798-9924, helen.swift at; Patrick Gorman, Ferring Pharmaceuticals, Tel: +41-58-301-00-53, patrick.gorman at

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