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SMC Announces Acceptance of Degarelix (FIRMAGON®▼)for use within NHS Scotland

Berkshire, United Kingdom, 17 January 2011 , Today's decision by the Scottish Medicines Consortium (SMC) (www.scottishmedicines.org.uk) to accept the use of FIRMAGON (gonadotropin-releasing hormone (GnRH) antagonist) within NHS Scotland for the treatment of all adult male patients with advanced hormone-dependent prostate cancer has been welcomed by clinicians and patient groups throughout the UK.

"The SMC decision is good news for patients as degarelix is an important treatment option. It provides simple, rapid and profound suppression of testosterone and a rapid PSA reduction without the need for additional oral anti-androgen therapy. This is particularly important in patients presenting with advanced disease and a heavy symptom burden." Professor Nicholas James, Professor of Clinical Oncology, Birmingham.

Rob Banner, Director and Trustee of Prostaid commented "We welcome today's SMC decision which will mean access to FIRMAGON in Scotland and elsewhere in the UK, as we believe it is vital for prostate cancer patients to have access to modern and improved drugs that work quickly and effectively. For all men suffering from advanced hormone dependent prostate cancer to now have access to a drug that negates the need for anti-androgen drugs and their possible side effects, will be a terrific improvement."

Prostate Specific Antigen (PSA) is widely recognised as a surrogate marker for tumour activity in prostate cancer. FIRMAGON is the first antagonist to be launched in the UK and has a distinct mechanism of action that is different from commonly used hormonal therapies. Results from the pivotal Phase III study indicate a significant reduction in the rate of PSA failure or death in patients who received Firmagon compared with leuprorelin, an existing treatment, especially in patients with high baseline PSA (>20 ng/ml). This means that, compared with leuprorelin, treatment with Firmagon may delay the need for additional, later-stage treatments such as chemotherapy, which can be intensive and costly.

Administered as subcutaneous injections, FIRMAGON rapidly reduces levels of testosterone 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 dependent 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.

"Until now surgical castration has been the gold standard treatment because it ensures immediate suppression of testosterone. FIRMAGON offers an additional beneficial treatment option for men with prostate cancer, and may be a preferable choice to surgical castration for many men as it mimics surgical castration more closely than current medical based castration therapies." Mr John Anderson, Consultant Urological Surgeon, Sheffield.

Commenting on behalf of Ferring Pharmaceuticals, General Manager Steve Howson said

"Since FIRMAGON's launch in May 2009 patient access to this treatment option has been variable. Today's announcement by the SMC, confirms that FIRMAGON offers significant clinical benefits and is a cost effective treatment for all patients with advanced hormone dependent prostate cancer. This should help more patients gain access to this valuable treatment option."

The SMC assessment (SMC No 560/09, Jan 17th, 2011) states that FIRMAGON provides an additional beneficial treatment option for prostate cancer sufferers in NHS Scotland. The advice states that 'it induces a rapid and sustainable decrease in both testosterone and prostate specific antigen (PSA) levels, without an initial testosterone surge after administration, thereby negating the need for short-term treatment with an anti-androgen'.2 It is this direct mechanism of action, which more closely resembles orchidectomy, that distinguishes degarelix from the existing LHRH agonists and means that there is no risk of acute stimulation of prostate cancer tumour growth and its potential complications.3,4 Castrate levels (testosterone ≤0.5 ng/ml) are achieved in 96% of patients within three days of starting treatment.5-7

The overall incidence of side-effects with FIRMAGON is similar to leuprorelin, an existing treatment for advanced prostate cancer. Patients treated with FIRMAGON subcutaneous injections had a higher incidence of injection site reactions, which were mostly transient, of mild to moderate intensity and led to very few discontinuations (<1%).

The use of FIRMAGON is supported by a Patient Access Scheme (PAS); which is available to the NHS throughout the UK. The Patient Access Scheme Assessment Group (PASAG) has agreed that the Patient Access Scheme (PAS) for degarelix (Firmagon®, Ferring Pharmaceuticals Ltd) is acceptable for implementation in NHS Scotland for treatment of adult male patients with advanced hormone-dependent prostate cancer. ( http://www.scottishmedicines.org.uk/Submission_Process/Submission_

- ENDS -

Notes to editors
The SMC has completed its assessment of the above product and advises NHS Health Boards and Area Drug and Therapeutic Committees on its acceptance for use in NHS Scotland. The advice is summarised as follows:


ADVICE: following a resubmission

degarelix (Firmagon) is accepted for use within NHS Scotland.

Indication under review: degarelix is a gonadotropin-releasing hormone (GnRH) antagonist indicated for the treatment of adult male patients with advanced hormone-dependent prostate cancer.

In one study that included patients with all stages of prostate cancer, degarelix was shown to be non-inferior to a luteinising hormone releasing hormone (LHRH) agonist in suppressing testosterone levels over a one-year treatment period without an initial testosterone flare.

This SMC advice takes into account the benefits of a patient access scheme (PAS) that improves the cost-effectiveness of degarelix. This SMC advice is contingent on the continuing availability of the PAS in NHS Scotland.

* Patients are given anti-androgen therapy because existing agonists initially increase testosterone levels. This could cause symptoms in patients with advanced disease. For this reason most patients in the UK are also pre-treated with anti-androgen therapy, which carries a potential risk of additional side-effects.




[1] Tombal B, Miller K, Boccon-Gibod L et al. Additional analysis of the secondary end point of biochemical recurrence rate in a phase 3 trial (CS21) comparing degarelix 80 mg versus leuprolide in prostate cancer patients segmented by baseline characteristics. Eur Urol 2010; 57: 836-842.

[2] Scottish Medicines Consortium. FIRMAGON® (degarelix) (No. 560/09), Glasgow: SMC, 2011.

[3] Sasagawa I, Kubota Y, Nakada T et al. Influence of luteinizing hormone-releasing hormone analogues on serum levels of prostatic acid phosphatase and prostatic specific antigen in patients with metastatic carcinoma of the prostate. Int Urol Nephrol 1998; 30: 745-753.

[4] Tomera K, Gleason D, Gittelman M et al. The gonadotropin-releasing hormone antagonist abarelix depot versus luteinizing hormone releasing hormone agonists leuprolide or goserelin: initial results of endocrinological and biochemical efficacies in patients with prostate cancer. J Urol 2001; 165: 1585-1589.

[5] Gittelman M, Pommerville PJ, Persson BE, Jensen JK, Olesen TK. A 1-year, open label, randomized phase II dose finding study of degarelix for the treatment of prostate cancer in North America. J Urol 2008; 180: 1986-1992.

[6] Klotz L, Boccon-Gibod L, Shore ND 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: 1531-1538.

[7] van Poppel H, Tombal B, de la Rosette JJ et al. Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker--results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancer. Eur Urol 2008; 54: 805-813.

About Ferring
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.

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