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European Commisssion grants Ferring Pharmaceuticals approval of FIRMAGON® (degarelix) for treatment of prostate cancer
New gonadotrophin-releasing hormone (GnRH) receptor antagonist demonstrates rapid, long-term suppression of testosterone
Saint-Prex (ots) - 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 surgery (orchidectomy).(ii,iii)
"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