New gonadotrophin-releasing hormone (GnRH) receptor antagonist
demonstrates rapid, long-term suppression of testosterone
- Ferring Pharmaceuticals announced today that it
has received marketing authorisation from the European Commission,
for FIRMAGON® (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
"We are delighted with the approval of FIRMAGON® (degarelix),
which demonstrated in clinical trials 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 work with
local authorities to ensure the launch of FIRMAGON to patients across
European Union countries as soon as possible."
The European Commission approval for FIRMAGON® (degarelix) follows
approval from the FDA in the US in December 2008.
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
prostate cancer. Ferring plans to communicate a range of information
about the treatment at the European Academy of Urology (EAU) congress
in Stockholm in March.
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 45 countries. To learn more about
Ferring or our products please visit www.ferring.com
ots Originaltext: Ferring International SA
(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, Schröder 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