Saint Prex, Switzerland (ots/PRNewswire) -
- New Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist
Demonstrates Rapid, Long-Term Suppression of Testosterone
Ferring Pharmaceuticals received today notification that the
Committee for Medicinal Products for Human Use (CHMP), part of the
European Medicines Agency (EMEA), has adopted a positive opinion and
is recommending to grant a marketing authorization for FIRMAGON(R)
(degarelix), a new GnRH receptor antagonist indicated for patients
with advanced, hormone-dependent prostate cancer. In Phase III
studies degarelix produced a significant reduction in levels of
testosterone (i),(ii) within three days in more than 96% of study
patients.(ii) Testosterone plays a major role in the growth and
spread of prostate cancer cells.
The data show that degarelix provided an extremely fast effect on
testosterone levels, close to the immediate effect achieved with
The Phase III study compared monthly administration of degarelix
with monthly luteneising hormone releasing-hormone (LHRH) agonist
leuprorelin's 7.5 mg in a 12-month randomised, open-label,
parallel-group study in prostate cancer patients. In comparison to
leuprorelin, degarelix suppressed serum testosterone and Prostate
Specific Antigen (PSA) significantly faster. In addition, degarelix
was able to sustain these low levels during the entire 12 month
By day 3 of the study, testosterone levels were suppressed to
=0.5ng/mL in 96.1% of patients in the degarelix arms of the study
compared to 0% in the leuprorelin arm. By day 14, 100% of patients in
the degarelix arms achieved suppression of testosterone levels at
=0.5ng/mL compared to 18.2% in the leuprorelin arm.(ii) After 14 days
of treatment, PSA levels had declined in the degarelix treated
patients by a median of 64%, while patients who were administered
leuprorelin saw an 18% decline. Both treatments were well tolerated
and showed similar side effect profiles. The most common side effects
are hot flushes, injection site pain, injection site erythema,
increased weight, nasopharyngitis, fatigue and back pain.
"Degarelix was discovered and developed by Ferring
Pharmaceuticals and in its pivotal Phase III study demonstrated both
an immediate onset of action and a profound long-term suppression of
testosterone and PSA," commented Dr Pascal Danglas, Executive Vice
President Clinical & Product Development at Ferring Pharmaceuticals.
"We will be delighted to deliver a new treatment option for advanced
prostate cancer to the medical community. Ferring has a considerable
pipeline of urology products in development and we expect to
introduce additional innovations in the urology field in the near
"Our goal is always to have a fast and sustained reduction in
testosterone levels," said Mr John Anderson, Consultant Urological
Surgeon, The Royal Hallamshire Hospital, Sheffield, United Kingdom
"Degarelix produces an extremely rapid impact, approaching the
immediacy of surgery and it is good news that the product should
become imminently available."
Ferring Pharmaceuticals plans to launch FIRMAGON(R) (degarelix)
in Europe in the first quarter of 2009 and is also awaiting an
imminent FDA decision on approval for commercialisation in the US. It
is expected that commercialisation in other key global markets will
follow during 2009 and 2010 once approval is received from the
relevant local regulatory authorities.
Michel Pettigrew, Chief Operating Officer Ferring
Pharmaceuticals, stated: "The recommendation from the EMEA to grant
marketing authorisation for FIRMAGON(R) is a significant milestone
for Ferring. It is the first positive opinion we have received from a
regulatory authority for FIRMAGON(R) which, in turn, will be the
first product that Ferring will launch on a global basis. We are
truly excited to be on the brink of introducing this new therapy to
physicians and patients, and we look forward to providing an
innovative tool that will add meaningfully to the treatment options
for addressing prostate cancer."
Degarelix went through an extensive clinical programme of more
than 20 studies. All studies have found degarelix to be well
tolerated and with no evidence of systemic allergic
Notes to Editors
About Prostate Cancer
Prostate cancer is the most common form of cancer in men, and the
second leading cause of cancer death. In the US 218,890 new cases
were estimated for 2007, with a mortality rate of 27,050. In 2005
127,490 new cases were diagnosed in the 5 biggest European countries
and 18,310 in Japan.
Degarelix is a GnRH receptor antagonist indicated for advanced
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, endocrinology, gastroenterology, gynaecology, and fertility.
In recent years Ferring has expanded beyond its traditional European
base and now has offices in over 40 countries. To learn more about
Ferring or our products please visit http://www.ferring.com.
(i) Van Poppel H, De La Rosette JJ, Persson B.E, Oleson TK, 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
(ii) Boccon-Gibod L, Klotz L, Schroder FH, Andreou C, Persson BE, Cantor
P, Jensen JK, Olesen TK; Degarelix compared to leuprolide depot
7.5 mg in a 12-month randomised, open-label, parallel-group phase
III study in prostate cancer patients. Abstract 537 presented at
the 23rd EAU Congress, Milan, Italy, 2008.
(iii) Nielsen S, Connolly M, Persson B, Variation between countries in
the perceived use of antiandrogens to prevent flare symptoms:
results of a comprehensive survey. Abstract 539 presented at the
23rd EAU Congress, Milan, Italy, 2008
(iv) Gittelman M, Pommerville P, Persson B, Olesen T, A 1-year, open
label, randomised Phase II dose finding study of degarelix for the
treatment of prostate cancer in North America. Journal of Urology,
Vol. 180, November 2008.
(v) Tammela T, Iversen P, Johansson J, Persson B, Jensen J, Olesen T.
Degarelix-a phase II multicentre, randomised dose escalating study
testing a novel GnRH receptor blocker in prostate cancer patients
(Abstract No. 904) European Urology Supplements 4 (2005) No.3,
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