New data demonstrating long-term benefits of FIRMAGON® (degarelix) for advanced hormone-dependant prostate cancer published in The Journal of Urology

Rapid and sustained testosterone suppression and improved PSA control may delay time to second-line therapy

Saint-Prex, Switzerland – 31 August 2011 –

New data, published in the September issue of The Journal of Urology, showed that long-term use of FIRMAGON® (degarelix) a gonadotropin-releasing hormone therapy (GnRH) approved for the treatment of advanced prostate cancer in both the EU and US, continued to be effective and well tolerated beyond three years.¹ The new study (CS21A) extends the conclusions of the pivotal Phase III study (CS21) in which the risk of prostate specific antigen (PSA) failure or death was significantly lower in patients on FIRMAGON® compared to leuprolide (an LHRH agonist) up to one year.¹ The extension study has now shown that for patients who remained on FIRMAGON®, PSA suppression and the effects on PSA progression free survival (PFS) remained consistent over the long term (42 months).¹

In addition, the study looked at patients who crossed over from leuprolide to FIRMAGON® after one year. At a median follow up of 27.5 months the data showed that the risk of PSA PFS had decreased (p=0.003).¹

Longer PSA PFS is desirable as it is indicative of time to castration-resistant prostate cancer (CRPC) and may delay initiation of second-line therapy, which includes chemotherapy.² Time to castration resistance is also an important predictor of survival.³ These findings support using FIRMAGON® as first-line androgen deprivation therapy.¹

CS21A was designed to collect extended safety and tolerability data on FIRMAGON®. Following the close of the Phase III trial, all patients were offered the option to receive FIRMAGON® as part of the extension study. All patients who had received FIRMAGON® continued with their treatment and those who had previously been treated with leuprorelin were re-randomised to receive FIRMAGON®.

“Being able to delay castration resistance for as long as possible is an important outcome for any first-line therapy,” said E. David Crawford, MD, Head, Section of Urologic Oncology and Professor of Urologic and Radiation Oncology, University of Colorado Denver, US. “The data from the Phase III extension study demonstrate that FIRMAGON® provided prostate cancer patients with fast and effective testosterone and PSA control over the long term, which may in turn delay castration resistance.”

Prostate cancer is the second leading cause of cancer death amongst men in the Western world.⁴ Up to 40% of men diagnosed with prostate cancer will eventually develop advanced disease, and although most respond to initial medical or surgical castration, progression to CRPC is inevitable.⁵ The average survival for patients with CRPC is two to three years.⁵

FIRMAGON® works by immediately inhibiting the GnRH receptors in the pituitary gland and suppressing the luteinising hormone, which decreases production of testosterone by the testicles with no initial surge. Prostate cancer is dependent on testosterone for its growth, so the goal of therapy is to rapidly reduce testosterone levels to slow the growth of cancer cells. Avoiding flare in testosterone prevents initial worsening of clinical status, allows for faster relief of symptoms such as bone pain, ureteral obstruction, and spinal cord compression and removes the need for adjuvant treatment with anti-androgens.^6,7,8

– ENDS –

About CS21A

The extension study of the pivotal FIRMAGON® vs leuprorelin trial (CS21) was designed to collect extended safety and tolerability data on FIRMAGON®. Following the close of the Phase III trial, all patients were offered the option to receive FIRMAGON® as part of the extension study. All patients who had received FIRMAGON® continued with their treatment and those who had previously been treated with leuprorelin were re-randomised to receive FIRMAGON® 240/80mg or 240/160mg.

The primary end point was safety and tolerability and the secondary endpoints were testosterone, PSA, luteinizing hormone and follicle-stimulating hormone responses, and PSA failure and PFS.

CS21A was initiated in March 2007 and an analysis conducted in March 2010 at a median follow up of 27.5 months. CS21A is ongoing and will run for five years.

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 PSA within two weeks by immediately 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 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.⁹

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.^9,10

About Prostate Cancer

Prostate cancer is the most common form of male cancer in the western world,¹¹ and the second leading cause of cancer death in men in some countries.⁴ Around 300,000 new cases of prostate cancer are diagnosed in Europe each year.¹² Worldwide this figure rises to 670,000 new cases.¹²

For further media information and news alerts on prostate cancer please visit Ferring’s information website 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 70 countries.

To learn more about Ferring or its products please visit www.ferring.com.

For more information, please contact

Orla Barnewell
Tonic Life Communications
+44 207 798 9915
orla.barnewell@toniclc.com

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

Patrick Gorman
Ferring Pharmaceuticals
+41 (0) 58 301 00 53
patrick.gorman@ferring.com

References

1. Crawford, ED  et al. The Journal of Urology September 2011;186(3):889-897
2. Mahon KL, et al. Endocr Relat Cancer 2011;18:R103-R123
3. Bournakis E, et al. Icancer Res 2011: Apr;31(4):1475-82 http://www.ncbi.nlm.nih.gov/pubmed/21508406
4. 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]
5. Beltran, H et al. European Urology 60(2011) 279-290 http://www.europeanurology.com/article/S0302-2838(11)00477-5/pdf/New+Therapies+for+Castration-Resistant+Prostate+Cancer%3A+Efficacy+and+Safety
6. Van Poppel, H et al. Urology: June 2009; Volume 71, Issue 6:1001-1006 http://www.goldjournal.net/article/S0090-4295(07)02662-3/abstract
7. Persson B-E, et al. Neuroendocrinology 2009;90:235-244
8. Boccon-Gibod L, et al. Therap Adv Urol June 2011
9. Klotz L, et al. BJU Int.  2008;102(11):1531-1538.
10. Van Poppel H et al. Abstract (23.) Euro Urol Suppl 2007;6(2):28
11. University of Iowa Hospitals and Clinics. Available at:  http://www.uihealthcare.com/topics/medicaldepartments/urology/prostatecancer/index.html [Accessed 25 May 2010]
12. Cancer Research UK. Available at: http://info.cancerresearchuk.org/cancerstats/types/prostate/index.html [Accessed 25 May 2010]

MEGASET Study demonstrated effectiveness and tolerability of MENOPUR® after ICSI in GnRH antagonist cycles

New study completes a missing piece of the fertility treatment jigsaw

Stockholm, Sweden – Wednesday 6 July 2011 –

New data¹, presented today at the European Society of Human Reproduction and Embryology (ESHRE) meeting, demonstrated the efficacy and tolerability of MENOPUR® (highly purified menotropin) in the Gonadotropin Hormone Releasing Hormone (GnRH) antagonist setting using the infertility treatment technique known as ICSI (Intracytoplasmic Sperm Injection). Results from the MEGASET¹ study reinforce the views of fertility experts and provide additional evidence that MENOPUR is effective in all types of assisted reproduction technology (ART) and fertility treatment protocols, completing a missing piece of the fertility treatment jigsaw.

For some years there has been strong evidence of the efficacy of MENOPUR in IVF using long GnRH agonist protocols, including superior live birth rates compared to recombinant follicle-stimulating hormone (rFSH) treatment^2,3. However, until now, limited data has been available on the benefits of MENOPUR in GnRH antagonist and ICSI cycles. Current trends in ART are moving toward ICSI as a preferred technique, which is particularly useful in combating male infertility problems⁴. As such, the new MEGASET data add an additional piece to the fertility treatment puzzle as the study was carried out using ICSI technique for fertilisation and stimulation with a GnRH antagonist protocol.

“These results reinforce clinical opinion about the efficacy and tolerability of MENOPUR, and enhance our understanding of effective fertility treatment options” explained Pr Anders Nyboe Andersen, Head of the Fertility Clinic at Copenhagen University Hospital. He continued, “Previous studies have demonstrated that MENOPUR is a high quality and efficient product when used in IVF, and the results from MEGASET will strengthen these perceptions”.

The MEGASET¹ (MENOPUR in GnRH Antagonist Cycles with Single Embryo Transfer) study was initiated as a randomised, multicentre study, and was designed to demonstrate non-inferiority compared to rFSH with respect to ongoing pregnancy rates. The study demonstrated that controlled ovarian stimulation with MENOPUR in a GnRH antagonist protocol gave ongoing pregnancy rates comparable to those achieved with recombinant follitropin beta.

MEGASET recruited women undergoing fertility treatment and compared the efficacy and safety of two different types of ART: highly purified menotropin (MENOPUR, N=374) and rFSH (Puregon, N=375).

MENOPUR was demonstrated to be non-inferior to rFSH with respect to ongoing pregnancy rate for both the intention to treat (ITT) – participants who were randomised and exposed to the investigational medicinal product – and the per protocol (PP) – all participants except those who were excluded because of a major protocol deviation – populations in a GnRH antagonist protocol. The ongoing pregnancy rate was 30% with MENOPUR and 27% with recombinant FSH for the PP population (95% CI of difference: -3.8; 9.8) and 29% and 27% respectively for the ITT population (95% CI of difference: -4.2; 8.6).

In addition, MEGASET revealed that subcutaneous injections of MENOPUR in a new multi-dose formulation have a good safety profile^1,5 and are associated with good local tolerability in patients undergoing controlled ovarian stimulation.

“Around one in seven couples have fertility problems, and infertility can have a profoundly distressing and devastating impact. However, excellent results can be achieved in treating infertility if patients are rapidly investigated and referred for appropriate treatment” explained Sandra Dill, iCSi international patient coalition. “These data will hopefully provide additional information, clarity and confidence to couples navigating the often confusing assisted conception landscape”.

MENOPUR

MENOPUR is a well-tolerated, ^1,6 high quality and cost-effective⁷ treatment associated with higher live birth rate in IVF cycles compared with that seen for women treated with rFSH^2,3. It belongs to a class of drugs known as gonadotrophins and contains both FSH (follicle stimulating hormone) and hCG-driven (human chorionic gonadotrophin) LH-activity (luteinizing hormone). MENOPUR is used to stimulate the development of multiple follicles in women participating in an ART programme. MENOPUR is also used to treat infertility in women caused by anovulation (no development of follicles and no ovulation). MENOPUR is used by approximately half a million patients each year and is currently licensed in 97 countries across the world.

About Ferring Pharmaceuticals

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’s fertility portfolio of treatments gives infertile couples the chance to have babies and includes its flagship brand MENOPUR (HP-hMG), a recognised high quality treatment for infertility. Ferring has operating subsidiaries in over 45 countries.

To learn more about Ferring or our products please visit www.ferring.com.

– ENDS –

For more information, please contact

Tonic Life Communications
Jim Baxter
+44 (0) 7900 605 652
jim.baxter@toniclc.com

or
Laura Craggs
+44 (0) 207 798 9900
laura.craggs@toniclc,com

References

1. Nyboe Andersen A., A. Pellicer A., Devroey P., Arce J.C. Randomised trial (MEGASET) comparing highly purified menotropin and recombinant FSH in a GnRH antagonist cycle with single blastocyst transfer. O-296 ESHRE 2011
2. Platteau P, Nyboe Andersen A, Loft A, Smitz J, Danglas P, Devroey P. Highly purified HMG versus recombinant FSH for ovarian stimulation in IVF cycles. Reprod Biomed Online 2008;17(2): 190-198Al-Inany HG, Abou-Setta
3.  AM, Aboulghar MA, Mansour RT, Serour GI. Highly purified hMG achieves better pregnancy rates in IVF cycles but not ICSI cycles compared with recombinant FSH: a meta-analysis. Gynecol Endocrinol 2009;25(6):372-8.
4. Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet 1992;340(8810):17-8
5. Helmgaard L., Klein B.M., Arce J.C. Twice-daily assessments of the local tolerability associated with a new MENOPUR multi-dose formulation during controlled ovarian stimulation. Oral communication Andersen and local tolerability poster P-299  ESHRE 2011
6. European and Israeli Study Group on Highly Purified Menotropin versus Recombinant Follicle-Stimulating Hormone. Efficacy and safety of highly purified menotropin versus recombinant follicle-stimulating hormone in in vitro fertilization/intracytoplasmic sperm injection cycles: a randomized, comparative trial. Fertil Steril 2002;78(3): 520-528.
7. Lloyd A, Kennedy R, Hutchinson J, Sawyer W. Economic evaluation of highly purified menotropin compared with recombinant follicle stimulating hormone in assisted reproduction. Fertil Steril 2003: 80(5): 1108-1113.

Ongoing extension study results provide further evidence for first-line use of FIRMAGON® (degarelix) in advanced prostate cancer

Vienna, Austria – Monday 21 March 2011 –

Recent data from the ongoing five-year FIRMAGON^® (degarelix) extension study (CS21a) has demonstrated the long term efficacy and tolerability of FIRMAGON^® in study patients with advanced hormone-dependent prostate cancer and support its use as first-line androgen deprivation therapy.¹ Full details were shared today at the European Association of Urology (EAU) 2011 Annual Meeting.

FIRMAGON^®, a gonadotropin-releasing hormone (GnRH) receptor blocker, is indicated for the treatment of patients with advanced hormone-dependent prostate cancer. The extension study of the pivotal FIRMAGON^® vs leuprorelin trial (CS21) was designed to collect extended safety and tolerability data on FIRMAGON^®. Following the close of the Phase III trial, all patients were offered the option to receive FIRMAGON^® as part of the extension study.All patients who had received FIRMAGON^® continued with their treatment and those who had previously been treated with leuprorelin (a GnRH agonist) were re-randomised to receive FIRMAGON^® 240/80mg or 240/160mg.

To date, data from the extension study show that all patients receiving FIRMAGON^® experienced improved PSA control, specifically:

• Beyond one year, prostate-specific antigen (PSA) suppression was maintained in patients continuing treatment on FIRMAGON^® 1,2
• After switching to FIRMAGON^® patients who initially received leuprorelin experienced:
• Improved PSA control (0.20 vs 0.08 events/year; p=0.003)^1,2
• A significantly lower rate of PSA failure or death^1,2
• Tolerability of FIRMAGON^® was maintained throughout the extended study period^1,2

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 leuprorelin, 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 In 2008, around 338,000 men were diagnosed with prostate cancer in Europe and 258,000 men died from prostate cancer.⁷ Worldwide, 913,000 men were diagnosed with prostate cancer in 2008 and more than two out of three cases were diagnosed in the more developed regions.⁷

For further media information and news alerts on prostate cancer please visit Ferring’s information websitewww.ProstateCancerLiving.com

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 reproductive health, urology, gastroenterology, endocrinology and osteoarthritis. In recent years Ferring has expanded beyond its traditional European base and now has offices in over 45 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

Patrick Gorman
Ferring Pharmaceuticals
+41 58 301 00 53
patrick.gorman@ferring.com

References

1. Tombal, B, Schröder, F, Miller, K et al. Long-term prostate-specific antigen (PSA) control in prostate cancer: continuous degarelix or degarelix following leuprolide. EAU 2011, Symposium Abstract 1088. 26th Annual EAU Congress, Vienna, 18-22 March 2011.
2. 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. J Urol 2010; 183 (Suppl): e262, abstract 670
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 16 February 2011]
6. American Cancer Society. Available at: http://www.cancer.org/Cancer/ProstateCancer/DetailedGuide/prostate-cancer-key-statistics [Accessed 16 February 2011]
7. Cancer Research UK. Available at: http://info.cancerresearchuk.org/cancerstats/types/prostate/ [Accessed 16 February 2011]

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’.¹ 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.^2,3 Castrate levels (testosterone ≤0.5 ng/ml) are achieved in 96% of patients within three days of starting treatment.^4,5,6

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_
Guidance_and_Templates_for_Industry/Patient-Access-Schemes).

– 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.

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

Helen Lawn or Charlotte Messer
Helen Lawn & Associates PR Ltd
+44 (0) 1892 525141 (direct)
+44 (0) 7879 818247 (mobile)
+44 (0)1892 682733 (fax)
helen@helenlawn.co.uk

References

1. 1. Scottish Medicines Consortium. FIRMAGON® (degarelix) (No. 560/09), Glasgow: SMC, 2011.
   2. 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.
   3. 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.
   4. 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.
   5. 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.
   6. 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.
   7. 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.