Stockholm, Sweden, 18 March 2009 - Today marks the European launch of FIRMAGON® (degarelix), a new treatment option in hormonal therapy for prostate cancer, with details presented at the 24th Annual European Association of Urology (EAU) Congress in Stockholm. FIRMAGON® is a new GnRH receptor blocker indicated for the treatment of patients with advanced hormone-dependent prostate cancer.
FIRMAGON® has a novel mechanism of action that is different from commonly used hormonal therapies. Administered as a subcutaneous injection, FIRMAGON® rapidly reduces levels of prostate specific antigen (PSA) by immediately blocking the GnRH receptors in the pituitary gland. Blocking the receptors suppresses the luteinising hormone, which decreases production of testosterone by the testicles. Prostate cancer is dependant on testosterone for its growth, so reducing testosterone levels can slow the growth of cancer cells.
In clinical studies, FIRMAGON® suppressed testosterone and PSA faster than leuprolide, an existing treatment for advanced prostate cancer. 2
"This is an important new step for the treatment of advanced, hormone-dependent prostate cancer, with FIRMAGON® offering a new option and hope for many patients," comments John Anderson, Consultant Urological Surgeon, The Royal Hallamshire Hospital, Sheffield, United Kingdom. "Our goal is to achieve fast and sustained reduction in testosterone levels, and FIRMAGON® offers a rapid impact which is comparable to the immediacy achieved by surgery."
The European launch of FIRMAGON® follows the decision of the European Commission to grant marketing authorisation in the European Union last month. This approval was based on pivotal Phase III studies where FIRMAGON® produced a reduction in levels of testosterone 1, 2 below 0.5ng/ml within three days in more than 96% of study patients. 2 Testosterone plays a major role in the growth and spread of prostate cancer cells, and the data showed FIRMAGON® provided a fast reduction of testosterone to very low levels, close to the immediate effect achieved with surgery (orchidectomy). 2, 3 This effect was sustained over the whole study period.
In clinical trials FIRMAGON® was generally well tolerated. Common side effects are hot flushes, injection site pain and erythema, increased weight, nasopharyngitis, fatigue and back pain.
FIRMAGON® will be marketed in Europe by Ferring Pharmaceuticals. Today's launch represents another important milestone in the company's long-standing commitment to develop new and improved treatment options in the field of urology.
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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. For further media information and news alerts on prostate cancer please visit Ferring's information website www.prostatecancerliving.com
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 www.ferring.com.
. 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
. Klotz L, Boccon-Gibod L, Schröder FH, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK; 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.
. 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