Extension study with FIRMAGON® (degarelix) showed continued benefits for prostate cancer patients beyond one year

Extension study with FIRMAGON® (degarelix) showed continued benefits for prostate cancer patients beyond one year

San Francisco, CA, USA – 1 June, 2010 –

Data recently presented on FIRMAGON® (degarelix) hormonal therapy for prostate cancer showed that long-term use beyond one year (median observation time 840 days) continued to be effective and well tolerated.¹ Full details were shared at the American Urological Association (AUA) 2010 Annual Meeting.

FIRMAGON® is a gonadotropin-releasing hormone (GnRH) receptor blocker indicated for the treatment of patients with advanced hormone-dependent prostate cancer. The Phase III extension study beyond one year (CS21A) of the pivotal FIRMAGON® vs leuprolide trial (CS21) was designed to collect extended safety and tolerability data on FIRMAGON®. At the end of the CS21 one-year trial, all patients were offered to continue treatment with FIRMAGON®, both those originally on FIRMAGON® and those who had used leuprolide (a GnRH agonist).

The main findings were:

• Efficacy of FIRMAGON® was maintained over the full study period (median observation time 840 days)¹
  • In the intent-to-treat (ITT) study population, FIRMAGON® significantly improved prostate specific antigen (PSA) progression-free survival (PFS) compared with leuprolide during the first year of therapy. The leuprolide patients, who continued treatment with FIRMAGON®, experienced a significantly lower event rate leading to an improved PSA PFS.¹
• Tolerability of FIRMAGON® was maintained throughout the extended study period.¹

“These data reassure physicians that for the best outcomes when using FIRMAGON® as a therapy for hormone dependent prostate cancer, patients should start and stay on FIRMAGON®”, said Dr E. David Crawford, head of Urologic Oncology, University of Colorado, Denver Health Sciences Center, and Practice Director for the Urologic Oncology Clinic. “FIRMAGON® provides a fast and sustained reduction in testosterone levels and these new data indicate that efficacy is maintained over the long-term without any additional negative effects on tolerability.”

Although the extension trial was not specifically designed to test changing from leuprolide to FIRMAGON® after one year, the results suggest that changing from leuprolide to FIRMAGON® improves PSA PFS.¹

Additional analysis of the safety data from the pivotal Phase III trial were also presented at AUA. The analysis evaluated the cardiovascular safety profile of FIRMAGON® vs leuprolide. The results showed that there were no significant differences between the cardiovascular safety profile of the two treatment groups, and the risk of CV events in both treatment arms was low.²

• Mean changes in QTcF interval were similar for FIRMAGON® and leuprolide.
• Rates of CV adverse events were low and similar for FIRMAGON® and leuprolide.

– ENDS –

Notes to Editors

About Firmagon

FIRMAGON® has unique chemical characteristics and a novel mechanism of action, different from traditionally used hormonal therapies. Administered as a subcutaneous injection, FIRMAGON® rapidly reduces levels of prostate specific antigen (PSA) within two weeks by immediately blocking the GnRH receptors in the pituitary gland. Blocking the receptors suppresses the release of the luteinising hormone (LH) and follicle-stimulating hormone (FSH), resulting in a decrease in production of testosterone by the testicles to castration levels within three days. Prostate cancer is dependent on testosterone for its growth, and reducing testosterone levels slows the growth of cancer cells.

In clinical studies, FIRMAGON® suppressed testosterone and PSA faster than leuprolide, an existing treatment for advanced prostate cancer.³

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.^3,4

About Prostate Cancer

Prostate cancer is the most common form of male cancer in the western world,⁵ and the second leading cause of cancer death in men in some countries.⁶ Around 300,000 new cases of prostate cancer are diagnosed in Europe each year.⁷ Worldwide this figure rises to 670,000 new cases.⁷ For further media information and news alerts on prostate cancer please visit Ferring’s information website: www.ProstateCancerLiving.com.

About Ferring Pharmaceuticals

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.

For more information, please contact

Sarah Stanmore
Tonic Life Communications
+44 207 798 9906
sarah.stanmore@toniclc.com

Helen Swift
Tonic Life Communications
+44 207 798 9924
helen.swift@toniclc.com

Helen Gallagher
Ferring Pharmaceuticals
+41 (58) 301 00 51
helen.gallagher@ferring.com

References

1. 1. Crawford, ED,  Moul, JW, Shore, ND et al. Switching from leuprolide to degarelix vs continuous degarelix treatment – effects on long-term prostate-specific antigen control. Poster and abstract presentation at the AUA 2010 Annual Meeting, San Francisco, CA, USA: J Urol 2010; 183 (Suppl): e262, abstract 670.
      http://download.journals.elsevierhealth.com/pdfs/journals/0022-5347/PIIS0022534710013133.pdf.
   2. Klotz, L, Smith, M, Persson, BE et al. Cardiovascular safety of degarelix: results from a 12-month, comparative, randomized, open-label, parallel-group phase III trial in prostate cancer patients. Oral presentation at the AUA 2010 Annual Meeting, San Francisco, CA, USA: J Urol 2010; 183 (Suppl): e228, abstract 582. Presented by M Smith.
      http://www.jurology.com/article/S0022-5347%2810%2901097-9/fulltext.
   3. Klotz L, Boccon-Gibod L, Schröder FH et al. 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.
   4. Van Poppel H, De La Rosette JJ, Persson B.E et al. 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.
   5. University of Iowa Hospitals and Clinics. Available at:  http://www.uihealthcare.com/topics/medicaldepartments/urology/prostatecancer/index.html [Accessed 25 May 2010].
   6. American Cancer Society. Available at: http://www.cancer.org/docroot/cri/content/cri_2_4_1x_what_are_the_key_statistics_for_prostate_cancer_36.asp [Accessed 25 May 2010].
   7. Cancer Research UK. Available at: http://info.cancerresearchuk.org/cancerstats/types/prostate/index.htm [Accessed 25 may 2010].