Positive phase III data unveiled for new GnRH blocker degarelix

Positive phase III data unveiled for new GnRH blocker degarelix

Degarelix suppressed testosterone within three days in 96% of patients.

Milan, Italy – 27 March 2008 –

Data from a Phase III study presented at the 23rd Annual European Association of Urology Congress demonstrated that the investigational GnRH blocker, degarelix, produced a significant reduction in levels of testosterone^1,2 within three days in more than 96% of study patients.²

The new data show that degarelix provided an extremely fast effect on testosterone levels, close to the immediate effect achieved with surgery (orchidectomy).^2,3

The phase III study compared monthly administration of degarelix with monthly LHRH agonist leuprorelin’s 7.5 mg in a 12-month randomised, open-label, parallel-group study in prostate cancer (PCa) 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 study.²

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.²

“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 “This new data shows that degarelix produced an extremely rapid impact, approaching the immediacy of surgery.”

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.

“What patients want is a medical treatment which has the efficacy impact of orchidectomy but without its more distressing physical and psychological effects,” commented Dr Erik Briers, of patient organization Europa Uomo, Belgium. “A pharmaceutical treatment that could offer extremely rapid suppression of testosterone would be a very welcome addition to the options for men with prostate cancer.”

Degarelix went through an extensive clinical programme of more than 20 studies. All studies have found degarelix to be safe, well tolerated and with no evidence of systemic allergic reactions.^2,4,5

– Ends –

Notes for 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.

About degarelix

Degarelix is a GnRH blocker currently being developed for prostate cancer. Ferring submitted a New Drug Application (NDA) to the FDA and EMEA in February 2008.

About Ferring Pharmaceuticals

Ferring is a Swiss-based, 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.

References

1. 1. 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.
   2. 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 randomized, open-label, parallel-group phase III study in prostate cancer patients. Abstract 537 presented at the 23rd EAU Congress, Milan, Italy, 2008.
   3. 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.
   4. Gittelman M, Pommerville P, Persson B, Olesen T, One-year North American multicentre, randomized dose-finding study of degarelix, a gonadotropin-releasing hormone (GnRH) receptor blocker, in prostate cancer patients. Poster presented at 1st EMUC, Barcelona, 2-4 Nov 2007.
   5. 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, pp 228.