UK NICE Agrees to Re-review FIRMAGON® (degarelix) for the Treatment of Advanced Hormone-Dependent Prostate Cancer Following Oral Appeal Hearing

WEST DRAYTON, England, August 18, 2014 /PRNewswire/ --

Ferring Pharmaceuticals confirmed today that, following an oral hearing in London on 25 June, the panel upheld Ferring's appeal against the National Institute for Health and Care Excellence (NICE)'s final appraisal determination for the use of FIRMAGON^® (degarelix) as an option for treating advanced hormone-dependent prostate cancer.

Ferring UK General Manager, Steven Howson, commented, "We welcome the Appeal panel's decision that the way in which the recommendation for FIRMAGON^® was issued was unfair and lacked transparency. Treatment options for men with advanced prostate cancer are limited and NICE has continued to restrict access to new treatments. FIRMAGON^® has distinct advantages over other first-line recommended treatments in advanced hormone-dependent prostate cancer and is offered at a comparable cost, which is why Ferring, alongside representatives of healthcare professionals and patients, appealed against NICE's recommendations."

In addition to Ferring, appeals were successfully made by the British Uro-oncology Group (BUG) and Tackle Prostate Cancer. The appeals were upheld on two grounds: that NICE failed to issue a second Appraisal Consultation Document (ACD) following a substantial change to the preliminary recommendations and that the decision in the Final Appraisal Determination (FAD) to restrict the use of FIRMAGON^® to patients with spinal compression (as opposed to those who are "at risk" of spinal compression) lacked transparency and failed to give adequate reasons.

The original FAD, issued on 15 April, restricted the use of FIRMAGON^® to prostate cancer patients who present with signs and symptoms of spinal cord compression, rather than those considered at risk - thereby significantly reducing the number of patients to less than a third of those deemed eligible for treatment, compared to the prior ACD.

Ferring looks forward to working with NICE to re-present the advantages of FIRMAGON^® in advanced hormone-dependent prostate cancer. Through this process, Ferring hopes to expand treatment options for men living with this disease in England, to be in line with those already available in Wales and Scotland.

FIRMAGON^® has shown several advantages over existing hormonal therapies, including a more rapid reduction in prostate specific antigen (PSA), better control of serum alkaline phosphatase (S-ALP, which is indicative of tumour activity in the bones), and significant reduction in PSA progression. All these factors point towards improved disease control. Furthermore, clinical studies have demonstrated fewer musculoskeletal events and a lower incidence of urinary tract events in men treated with FIRMAGON^®, than in those treated with LHRH agonists.^[1] FIRMAGON^® has shown significantly longer progression-free survival^[2] and a more rapid response,^[3] compared with agonist treatment. FIRMAGON^® is also associated with a significantly reduced risk of cardiovascular disease compared with LHRH agonists.^[4-6]

About FIRMAGON^®  

FIRMAGON^® (degarelix) was approved for the treatment of advanced hormone-dependent prostate cancer in both the EU and US in 2009. Today it is available in approximately 40 countries around the world, including a growing number in Asia, Latin America and the Middle East.

FIRMAGON^® has chemical characteristics and a novel mechanism of action, different from traditionally used hormonal therapies. Administered as a deep subcutaneous injection, FIRMAGON^® rapidly reduces levels of testosterone by blocking the GnRH receptors in the pituitary gland. Blocking the receptors suppresses the release of the luteinising hormone and follicle-stimulating hormone, resulting in a decrease in production of testosterone by the testicles to castration levels within 3 days. Prostate cancer is dependent on testosterone for its growth, and reducing testosterone levels slows the growth of cancer cells.

In clinical trials, FIRMAGON^® decreased the production of testosterone in a rapid and sustained way.^[2],[3],[7] FIRMAGON^® also maintains the PSA control over the long term and reduces the risk of PSA progression.^[2]

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.^[2]

About Prostate Cancer  

Prostate cancer is the most common form of male cancer in the Western world,^[8] and the second leading cause of cancer death in men in some countries.^[9] In the UK, one man dies from prostate cancer every hour - that's more than 10,000 every year.^[10] Around 400,000 new cases of prostate cancer are diagnosed in Europe each year.^[8] Worldwide, this figure rises to 900,000 new cases.^[11] For further media information and news alerts on prostate cancer please visit Ferring's information website: http://www.ProstateCancerLiving.com.

About Ferring  

Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology and endocrinology. Ferring has its own operating subsidiaries in 50 countries and markets its products in more than 90 countries. To learn more about Ferring or its products please visit http://www.ferring.com.

References  

1. Klotz L, Miller K, Crawford ED et al. Disease control outcomes from analysis of pooled individual patient data from five comparative randomised clinical trials of degarelix versus luteinising hormone-releasing hormone agonists. EurUrol 2014. [Epub ahead of print] doi:10.1016/j.eururo.2013.12.063. Available at: http://www.ncbi.nlm.nih.gov/pubmed/24440304.

2. Van Poppel H. et al. Int J Urol 10.1111/k.1442-2042.2012.

3. Klotz L, Boccon-Gibod L, Shore NDet 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):1531-8.

4. Keating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J ClinOncol 2006;24(27):4448-56. Available at: http://jco.ascopubs.org/content/24/27/4448.full.pdf

5. GandagliaG, Sun M, Popa I et al. The impact of the androgen deprivation therapy on the risk of coronary heart disease in patients with non-metastatic prostate cancer: a population-based study. BJU Int 2014. [Epub ahead of print] doi: 10.1111/bju.12732. Available at: http://www.ncbi.nlm.nih.gov/pubmed/24612110

6. Albertson PC, Klotz L, Tombal Bet al. Cardiovascular morbidity associated with gonadotropin releasing hormone agonists and an antagonist. EurUrol2014;65(3):565-73. Available at: http://dx.doi.org/10.1016/j.eururo.2013.10.032

7. FIRMAGON^® (degarelix). Summary of Product Characteristics. November 2013. Available at: http://www.medicines.org.uk/emc/medicine/21686/SPC. Accessed August 2014.

8. Cancer Research UK. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/keyfacts/prostate-cancer/. Accessed June 2014.

9. American Cancer Society. Available at: http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-key-statistics. Accessed March 2014.

10. Prostate Cancer UK. Prostate cancer facts and figures. Available at: http://prostatecanceruk.org/information/prostate-cancer-facts-and-figures. Accessed 24 March 2014.

11. Cancer Research UK. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/prostate/incidence/. Accessed June 2014.

© 2013 Ferring B.V.

FIRMAGON^® is a trademark owned by Ferring B.V.

 For More Information:
Darcy Bowman
AXON Communications
Tel: +44(0)7738-832-142
dbowman@axon-com.com
or
Olga Dai
Ferring Pharmaceuticals
Tel: +44(0)7748-184-749
Olga.Dai@ferring.com