New data from a pooled analysis shows improved overall survival for prostate cancer patients treated with FIRMAGON® (degarelix) compared to LHRH agonists

Saint-Prex, Switzerland – 25 November 2014 –

New data published in the December issue of the European Journal of Urology indicates improvement in overall survival (OS) and prostate specific antigen progression free survival (PSA PFS) for degarelix (FIRMAGON®), a gonadotropin releasing hormone (GnRH) antagonist, compared to commonly prescribed luteinising hormone-releasing hormone (LHRH) agonists. In addition, the data showed a reduction in the incidence of joint, musculoskeletal and urinary tract adverse events for those men with prostate cancer treated with degarelix rather than LHRH agonists. However, the overall rate of any adverse event (including hot flush and injection-site reactions) was higher in the degarelix group than the LHRH agonist group.

Results showed a 29% improvement in PSA PFS* (p=0.017) and 53% improvement in overall survival (p=0.023) for men with prostate cancer who were treated with degarelix instead of an LHRH agonist.

Lead study author Professor Laurence Klotz, MD, Sunnybrook Health Sciences Centre, University of Toronto, Canada, said, “These pooled data showed degarelix improved overall survival rates compared to LHRH agonists. This is encouraging for physicians making treatment decisions for their prostate cancer patients.”

These findings are based on a pooled analysis of 1,925 men with prostate cancer from five prospective, phase III or IIIb randomised trials.¹ Men requiring androgen deprivation therapy for the treatment of prostate cancer received degarelix (n=1,266) or an existing LHRH agonist (goserelin, n=458; leuprolide, n=201). The full analysis set used for efficacy analysis consisted of 1,920 patients. Of those, 1,263 received degarelix, 456 goserelin and 201 leuprolide. Those patients being treated with degarelix received a 240 mg dose in all trials and most patients received a maintenance dose of 80 mg. The majority of patients (1,458) received treatment for one year, while the remaining patients were treated for three months.

In terms of disease-related adverse events, for those patients taking degarelix, there were significantly fewer musculoskeletal events (p=0.007) and a significantly lower incidence of any urinary tract infections (p=0.023) compared to the LHRH agonist-treated patients. In addition, in the degarelix group there were fewer patients that experienced a fracture (p=0.064) (although this was not statistically significant) and there were significantly less frequent joint-related signs and symptoms (p=0.041) compared to the LHRH agonist treatment arm.

The overall rate of any adverse event was significantly higher in the degarelix group (74%) compared to the LHRH agonist group (68%), (p=0.002). Specifically, hot flush and injection-site reactions, including pain, erythema, swelling and nodules, were more frequent in the degarelix group.

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.

– ENDS –

About FIRMAGON®

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 three days. Prostate cancer is dependent on testosterone for its growth, and reducing testosterone levels slows the growth of cancer cells.

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,³ and the second leading cause of cancer death in men in some countries.⁴ Around 417,000 new cases of prostate cancer are diagnosed in Europe each year. Worldwide this figure rises to 1.1 million new cases.⁵

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, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

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

For more information, please contact

Emma Coughlan
Tonic Life Communications
+44 (0) 7896 075431
emma.coughlan@toniclc.com

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

© 2013 Ferring B.V.
FIRMAGON® is a trademark owned by Ferring B.V.

References

1. Klotz,L. 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, European Urology. 66(6), p. 1101-1108
2. 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 Urology Supplement 2007;6(2):28
3. University of Iowa Hospitals and Clinics. Available at: http://www.medicine.uiowa.edu/ [Accessed 02 April 2014]
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 02 April 2014]
5. Publications. Cancer Research UK. Available at http://publications.cancerresearchuk.org/downloads/product/CS_KF_PROSTATE.pdf [Accessed 24 November 2014]

New paper indicates a potential fifty-percent reduction in cardiac events for prostate cancer patients with pre-existing cardiovascular disease when treated with FIRMAGON® (degarelix) compared to LHRH agonists

Saint-Prex, Switzerland – 5 February 2014 –

A paper published today in European Urology, the official journal of the European Association of Urology, indicates that the gonadotropin releasing hormone (GnRH) antagonist degarelix (brand name: FIRMAGON®), may halve the relative risk of cardiovascular (CV) events and death in men with pre-existing CV disease (CVD) compared to treatment with commonly prescribed luteinising hormone-releasing hormone (LHRH) agonists. The report is based on a pooled analysis of 2,328 men with prostate cancer from six prospective, randomised trials.¹

Study co-author Jan Nilsson MD, Department of Clinical Sciences, Lund University, Sweden, said, “One recent study suggests that cardiovascular disease is among the most common causes of early mortality in men with advanced prostate cancer, not the cancer itself².  As a cardiologist I want urologists to be aware of this and to consider CV risk when selecting treatment options for their patients and analyses such as this are a positive step towards helping them to do just that.”

The paper entitled “Cardiovascular Morbidity Associated with Gonadotropin Releasing Hormone Agonists and an Antagonist,” reported that for men with pre-existing CVD at baseline there were ‘significantly fewer cardiac events or deaths’ experienced by patients receiving degarelix (6.5%) compared with patients receiving LHRH agonists (14.7%). A Cox proportional hazard model showed a 56% lower risk of a cardiac event or death during the initial year of treatment for men receiving degarelix compared with men receiving LHRH agonists (CI 0.26-0.74, p=0.002). The absolute risk reduction during the first year was 8.2% which yields a number needed to treat of 12.

Among the men who had no pre-existing cardiovascular disease at baseline there was no difference in the incidence of either death from any cause or the incidence of cardiac events. Moderate alcohol consumption and a low baseline serum testosterone level were the only other predictors of a lower risk of a cardiac event or death.

In the six prospective randomised trials included in the analysis, cancer patients were randomised to receive androgen deprivation therapy (ADT) in the form of GnRH antagonist degarelix (1,491) or an existing LHRH agonist (458 received goserelin and 379 received leuprolide). Most patients (72%) received treatment for one year, while the remaining patients were treated for three to seven months. Both treatment groups were well balanced for baseline characteristics e.g. statin medication, elevated blood pressure, diabetes, cholesterol and history of CV disease. The CV event analysis was based on death from any cause or a serious CV event defined as arterial, embolic / thrombotic; haemorrhagic / ischemic cerebrovascular; myocardial infarction or other ischemic heart disease.

Laurence Klotz MD, Division of Urology, University of Toronto, Ontario, Canada said, “Androgen deprivation therapies play an important role in the treatment of men with prostate cancer. As these therapies become more widely used and for longer periods of time, we are understanding more about what needs to be done to help patients beyond management of the cancer itself. I believe this analysis provides insights which have the potential to help physicians better manage the cardiovascular health of their androgen deprivation therapy patients – particularly those with pre-existing cardiovascular disease”.

The paper authors note that this post-hoc analysis of prospective randomised trials should be interpreted as hypothesis generating and highlights the need for additional studies.

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.

– ENDS –

About FIRMAGON® (degarelix)

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 three 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.^3,4,5 FIRMAGON® also maintains the PSA control over the long term and reduces the risk of PSA progression.⁶

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.^5,7

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 Around 300,000 new cases of prostate cancer are diagnosed in Europe each year.¹⁰ Worldwide this figure rises to 670,000 new cases.

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 55 countries and markets its products in more than 100 countries.

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

For more information, please contact

Emma Coughlan
Tonic Life Communications
+44 (0) 7896 075431
emma.coughlan@toniclc.com

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

© 2014 Ferring B.V.
FIRMAGON® is a trademark owned by Ferring B.V.

References

1. Peter C. Albertson et al. Cardiovascular Morbidity Associated with Gonadotropin Releasing Hormone Agonists and an Antagonist European Urology, Volume 65, Issue 3, Pages 565-573. Available at: http://dx.doi.org/10.1016/j.eururo.2013.10.032
2. Conteduca V, DiLorenzo G, Tartaron A, Aita M. The cardiovascular risk of gonadotropin releasing hormone agonists in men with prostate cancer. An unresolved controversy. Critical Reviews in Oncology/Hematology 2013; 86:42-51
3. Klotz L et al. BJU Int 2008; 102:1531-1538
4. Firmagon (degarelix).  Summary of product characteristics.  July 2013
5. Tombal B et al. Eur Urol 2010; 57:836-42
6. Crawford ED et al.  J Urol 2011;186(3):889-897
7. Van Poppel H et al. Abstract (23.) Euro Urol Suppl 2007;6(2):28
8. University of Iowa Hospitals and Clinics. Available at:  http://www.uihealthcare.com/topics/medicaldepartments/urology/prostatecancer/index.html [Accessed 08 March 2013]
9. 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 08 March 2013]
10. Male Cancer.org. Available at: http://www.malecancer.org/nnm/abouts/leaflets  [Accessed 08 March 2013]

Data suggest lower risk of cardiovascular events or deaths in prostate cancer patients treated with degarelix compared to LHRH agonists

Saint-Prex, Switzerland – 17 March 2013 –

Data presented today at the European Association of Urology (EAU) 2013 annual meeting in Milan, indicate that the gonadotropin releasing hormone (GnRH) antagonist degarelix (brand name: FIRMAGON^®) may be associated with lower risk of a cardiovascular (CV) event or death compared to commonly prescribed luteinising hormone-releasing hormone (LHRH) agonists.¹ These data are based on a pooled analysis of 2,328 men with prostate cancer from six prospective, randomised trials. Analysis of the data also revealed that the men in the studies treated with FIRMAGON had significantly higher overall survival and improved disease control as evidenced by fewer fractures and a lower incidence of renal or urinary tract adverse events compared to men treated with LHRH agonists.²

Risk of CV events or deaths
Concerns about the cardiovascular toxicity of LHRH agonists have been raised following the October 2010 warning by the US Food and Drug Administration (FDA) about an increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, and stroke). The FDA based its warning on the review of several published studies.³

In the data presented at the EAU congress, results were pooled and retrospectively analysed from six prospective, comparative trials of 2,328 patients randomised to receive FIRMAGON (n=1,491) or an LHRH agonist (goserelin, n=458; leuprolide, n=379). Both treatment groups were well balanced for baseline characteristics and history of CV disease (CVD). Characteristics associated with CVD (e.g. statin medication, elevated blood pressure, diabetes, cholesterol >6.2mmol/L) were also similar between groups. The CV event analysis was based on death from any cause or a serious CV event (life-threatening or requiring hospitalisation). CV events were defined as arterial, embolic / thrombotic; haemorrhagic / ischemic cerebrovascular; myocardial infarction or other ischemic heart disease, whatever came first. A time to event analysis for patients with baseline CVD demonstrated that the risk of a serious CV event or death was significantly lower for those men receiving FIRMAGON, compared to those receiving an LHRH agonist during the first year of treatment (p=0.0066 based on the log-rank test).

“Our findings suggest that prostate cancer patients with a history of CVD treated with degarelix have a decreased incidence of a serious CV event or death during the first year of therapy compared to treatment with an LHRH agonist”, pointed out study investigator Professor Bertrand Tombal from the Cliniques Universitaires Saint Luc, Brussels. “These results are from a pooled analysis of prospective randomized trials. Although preliminary, healthcare professionals starting patients on androgen deprivation therapy should be aware of these important findings, including the fact that the observed difference in cardiovascular risk in patients with baseline CVD was approximately 50 percent lower for Firmagon vs. LHRH agonists.”

Renal, urinary tract and musculoskeletal adverse events (AEs)
The treatment groups were also analysed for differences in adverse events from the musculoskeletal, renal and urinary systems. Findings from the pooled analysis showed that
men treated with FIRMAGON had significantly fewer fractures, a lower incidence of any renal or urinary tract adverse events, and a higher overall survival compared to patients treated with LHRH Agonists.²

The overall probability of fracture and incidence of joint-related adverse events were significantly lower for FIRMAGON-treated men than those receiving an LHRH agonist, p=0.0234, and p=0.0116,⁴ respectively, based on the log-rank test. The incidence of muscle or bone pain was also lower for men treated with FIRMAGON (p=0.0822).² The probability of any renal or urinary tract AEs was significantly lower in men receiving FIRMAGON (p<0.0001).²  Overall survival during one year of treatment was significantly higher for men treated with FIRMAGON compared to those receiving LHRH agonist treatment (98.3 vs. 96.7%, p=0.0329).⁴

“The improvement in disease control, higher overall survival, and reduction in musculoskeletal, renal and urinary system adverse events observed for prostate cancer patients treated with degarelix compared to LHRH agonist treatment, should be taken into consideration when considering treatment options for patients”, said Professor Kurt Miller, from Charité-Universitätsmedizin, Berlin.

– ENDS –

About FIRMAGON^®

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 three 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.^5,6,7 FIRMAGON^® also maintains the PSA control over the long term and reduces the risk of PSA progression.⁸

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.^5,9

About prostate cancer

Prostate cancer is the most common form of male cancer in the western world,¹⁰ and the second leading cause of cancer death in men in some countries.¹¹ 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 90 countries.

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

For more information, please contact

Emma Coughlan
Tonic Life Communications
+44 (0) 7896 075431
emma.coughlan@toniclc.com

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

© 2013 Ferring B.V.
FIRMAGON^® is a trademark owned by Ferring B.V.

References

1. Tombal B. et al. Lower risk of cardiovascular (CV) events and death in men receiving ADT by gonadotropin releasing hormone (GnRH) antagonist, degarelix, compared with luteinising hormone-releasing (LHRH) agonists. Abstract #42, EAU 2013
2. Miller K. et al. Disease control-related outcomes from an analysis of six comparative randomised clinical trials of degarelix versus luteinising hormone-releasing hormone (LHRH) agonists. Abstract #68, EAU 2013
3. http://www.fda.gov/Drugs/DrugSafety/ucm229986.htm (Accessed 08 March 2013)
4. Miller K. et al. Disease control-related outcomes from an analysis of six comparative randomised clinical trials of degarelix versus luteinising hormone-releasing hormone (LHRH) agonists, EAU 2013, Poster #678
5. Klotz L et al. BJU Int 2008; 102:1531-1538
6. Firmagon (degarelix).  Summary of product characteristics. July 2012
7. Tombal B et al. Eur Urol 2010; 57:836-42
8. Crawford ED et al. J Urol 2011;186(3):889-897
9. Van Poppel H et al. Abstract (23.) Euro Urol Suppl 2007;6(2):28
10. University of Iowa Hospitals and Clinics. Available at:
    http://www.uihealthcare.com/topics/medicaldepartments/urology/prostatecancer/index.html [Accessed 08 March 2013]
11. 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 08 March 2013]
12. Male Cancer.org. Available at: http://www.malecancer.org/nnm/abouts/leaflets  [Accessed 08 March 2013]

New data show that FIRMAGON® (degarelix) is non-inferior to the combination of goserelin plus bicalutamide at reducing prostate volume in patients with advanced hormone-dependent prostate cancer while offering better relief from lower urinary tract symptoms

Paris, France – 28 February 2012 –

Two new studies presented at the 27th Annual European Association of Urology (EAU) Congress reported that FIRMAGON® (degarelix), a gonadotropin-releasing hormone (GnRH) receptor blocker, was similar to the combination of goserelin (a luteinizing-hormone-releasing hormone (LHRH) agonist) plus bicalutamide at reducing total prostate volume in men with advanced hormone-dependent prostate cancer, and offered better control of lower urinary tract symptoms (LUTS).^1,2 LUTS can include frequency, urgency and hesitancy in urination and have a major negative impact on quality of life^3,4 for men with prostate cancer.

The Phase IIIb CS30 trial assessed the use of FIRMAGON® as neoadjuvant hormone therapy in men with intermediate to high-risk prostate cancer. A review published recently shows that androgen deprivation therapy (ADT) prior to radiotherapy can improve disease-specific mortality and overall survival compared to radiotherapy alone in men with high-risk localised or locally advanced prostate cancer.⁵ Week 12 results of the CS30 trial showed the non-inferiority of FIRMAGON® compared with goserelin plus bicalutamide at prostate shrinking (mean percent change in prostate volume: -36.0% for FIRMAGON® vs. -35.3% for goserelin plus bicalutamide). In addition, FIRMAGON® demonstrated more pronounced LUTS relief compared to goserelin plus bicalutamide. Overall incidences of adverse events (AEs) were similar in both groups; the most common AEs were the expected consequences of ADT.¹

The Phase IIIb CS31 trial assessed the ability of FIRMAGON® to decrease prostate volume in a range of prostate cancer patients. Again, Week 12 results showed prostate volume reduction achieved by FIRMAGON® was similar to the combination of goserelin and bicalutamide. In addition, FIRMAGON® had a significantly more pronounced positive effect on LUTS in symptomatic patients.²

“These new data show that FIRMAGON® is non-inferior to the combination of goserelin and bicalutamide at reducing prostate volume, and also offers the added benefit of better LUTS control,” commented Professor Malcolm Mason, Cardiff University, Institute of Cancer & Genetics, Velindre Hospital, Cardiff, UK. “LUTS can have a significant impact on a man’s quality of life, so relief of these symptoms is hugely important to patients suffering from prostate cancer.”

The goal of ADT is to rapidly reduce testosterone levels in a sustained way to slow the growth of cancer cells. The use of LHRH agonists is associated with an initial rapid release of androgens (surge), which delays the onset of ADT and may be source of complications.⁶ To avoid these limitations, LHRH agonists have to be co-administered with an antiandrogen at the initiation of treatment.⁷

In contrast FIRMAGON® is a GnRH receptor blocker, which, unlike LHRH agonists, promptly blocks testosterone production, avoiding any initial testosterone surge therefore, mitigating the need for concurrent antiandrogens. In the pivotal study showing the non inferiority of FIRMAGON® compared to leuprolide, FIRMAGON® reduced testosterone to an effective level very quickly in more than 97% of patients^8,9 Additional analysis of the pivotal study showed that it also reduced the risk of prostate specific antigen (PSA) progression or death by 34% (HR =0.664 – 95%CI, 0.385-1.146). Further studies are needed to confirm these findings.¹⁰ In an extension trial of the pivotal study, FIRMAGON® continued to control PSA at three years.¹¹  Delaying PSA progression is desirable as it may delay the need for second-line therapies which include chemotherapy.¹² Now, new data suggest that FIRMAGON® provides prostate cancer patients with better relief from LUTS.

– ENDS –

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 testosterone by immediately blocking the GnRH receptors in the pituitary gland. Blocking the receptors suppresses the release of the luteinizing 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 trials, FIRMAGON® decreased the production of testosterone very rapidly, profoundly and in a sustained way.^8,10 FIRMAGON® also maintains the PSA control over the long term and reduces the risk of PSA progression.¹¹

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.^8,13

About Prostate Cancer

Prostate cancer is the most common form of male cancer in the western world,¹⁴ and the second leading cause of cancer death in men in some countries.¹⁵ Around 300,000 new cases of prostate cancer are diagnosed in Europe each year.¹⁶ Worldwide this figure rises to 670,000 new cases.¹⁶

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 90 countries.

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

For more information, please contact

Jo Husson 
Tonic Life Communications
+44 (0) 207 798 9913
Jo.husson@toniclc.com

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

References

1. Mason M, et al. Degarelix as neoadjuvant hormone therapy in patients with prostate cancer: Results from a phase IIIb randomised, comparative trial versus goserelin plus bicalutamide. Abstract presented at the 27th EAU Congress, 2012
2. Axcrona K., et al. Androgen deprivation therapy for volume reduction, LUTS relief and quality of life improvement in men with prostate cancer: Degarelix versus goserelin plus bicalutamide. Abstract presented at the 27th EAU Congress, 2012.
3. Welch G, et al. Urology. 2002 Feb;59(2):245-50.
4. Monzón JA, et al. Arch Esp Urol. 2005 Mar;58(2):109-13.
5. Payne, H & Mason, M. British Journal of Cancer. 2011; 105:1628-1634. www.bjcancer.com [Accessed 15 Feb 2012]
6. Sugiono M et al Prostate Cancer Prostatic Dis. 2005;8:91-4.
7. Gittelman M et al; Degarelix Study Group. J Urol. 2008;180:1986-92.
8. Klotz L, et al. BJU Int 2008; 102:1531-1538.
9. Firmagon (degarelix). Summary of Product Characteristics. July 2010
10. Tombal B, et al. Eur Urol 2010;57:836-42
11. Crawford ED, et al. The Journal of Urology September 2011;186(3):889-897
12. Mahon KL, et al. Endocr Relat Cancer 2011;18:R103-R123.
13. Van Poppel H et al. Abstract (23.) Euro Urol Suppl 2007;6(2):28
14. University of Iowa Hospitals and Clinics. Available at:  http://www.uihealthcare.com/topics/medicaldepartments/urology/prostatecancer/index.html [Accessed 15 Feb 2012]
15. 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 15 Feb 2012]
16. Cancer Research UK. Available at: http://info.cancerresearchuk.org/cancerstats/types/prostate/index.html [Accessed 25 May 2010]

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]

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.

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].

Consider the “whole-man” when treating prostate cancer

Too little time spent discussing emotional and sexual impact, says new survey

Barcelona, Spain – 9 April, 2010 –

Healthcare professionals need to consider the impact of prostate cancer on the ‘whole man’ rather than focusing on cancer treatment in isolation, according to results from an international survey of prostate cancer patients and their partners.

Results from the ‘Man-Aging Prostate Cancer’ survey commissioned by prostate cancer specialist company Ferring Pharmaceuticals also reveal that patients need better information about the range of treatment regimens available and how these treatments can impact quality of life. The results showed that:

• • 34% of patients surveyed did not feel sufficiently informed to be able to play a role in their treatment decisions
  • 34% of patients surveyed were ‘dissatisfied’ or ‘not very satisfied’ with the level of information available to them in the months following diagnosis

“One of the most important findings of this survey is that there is a clear need for more resources to help support a man emotionally through prostate cancer”, said Gunter Feick, Chairman of the German patient association Bundesverband Prostatakrebs Selbsthilfe e. V. (BPS). “This is very important, since the majority of men polled (78%) felt that their sex life had been negatively affected by prostate cancer.”

The survey – an on-line questionnaire which enrolled 624 men with prostate cancer from eight countries (France, Germany, Ireland, Italy, Netherlands, Spain, UK, USA) – found that the emotional impact of prostate cancer was rarely discussed during consultations (66% of men said ‘not discussed’) and that more than half (57%) of patients felt they were not provided with adequate emotional support following their diagnosis.

“As opposed to women, it is well documented that men do not employ as many coping devices to deflect their thoughts away from their pain. While women distract themselves with activities, express their feelings to friends and even pray, men generally tend to face their problems alone. This research has highlighted the need for healthcare professionals to provide enhanced emotional support as men navigate their way through the emotional and sexual challenges of prostate cancer”, commented counselling psychologist, Dr Linda Papadopoulos.

• • 56% of patients and 53% of partners would have liked a healthcare professional to spend more time discussing the impact of prostate cancer and its treatment of their sex life
  • 65% of partners would have liked more information on how to discuss the potential effects of prostate cancer on their sex life with their husband/partner

“The results of this survey clearly highlight that we as healthcare professionals need to both help men make the right treatment decision and support them emotionally through prostate cancer”, said Bertrand Tombal, Professor and Chairman of Urology Service d’Urologie, Cliniques universitaires Saint-Luc, Brussels, Belgium. “It is important that doctors spend time discussing with patients the benefits of treatment as well as the management of side-effects to achieve the best quality of life possible for each individual patient.”

The survey revealed strong support for patient groups; the vast majority of men (90%) felt that it would have been useful to have a ‘buddy’ with experience of prostate cancer to whom they could talk and ask questions.

Worldwide, more than 670,000 men are diagnosed with prostate cancer each year¹ and there are approximately two million men living with this condition in Europe.² Incidence and prevalence rates vary widely around the world, with by far the highest rates in North America and Northern and Western Europe.³

*Producto autorizado por la EMA, no disponible en el mercado español, pendiente de la decisión administrativa sobre el precio y el reembolso.

– ENDS –

Notes to Editors

About Prostate Cancer

To learn more about prostate cancer and Firmagon, please visit www.ProstateCancerLiving.com.

About Ferring Pharmaceuticals

Ferring is a Swiss-headquartered, research driven, speciality biopharmaceutical group that has recently launched the fast-acting GnRH blocker Firmagon® (degarelix)* for the hormonal treatment of advanced prostate cancer. Ferring 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

References

1. 1. Cancer research UK.
   2. http://www.europa-uomo.org.
   3. M. Quinn and P. Babb. Patterns and trends in prostate cancer incidence, survival, prevalence and mortality. Part I: international comparisons. 2002. BJU International. Volume 90: Issue 2; Pages 162 -173.

FIRMAGON® has a significantly greater probability of PSA recurrence-free survival than leuprolide in prostate cancer patients

Saint-Prex, Switzerland – 21 December, 2009 –

Results from a phase III pivotal study sub-analyses reported in European Urology show that prostate cancer patients who received FIRMAGON® (degarelix) in the study have a statistically significant greater probability of PSA (prostate-specific-antigen) recurrence-free survival compared with those taking leuprolide (P=0.05).

FIRMAGON® is a gonadotropin-releasing hormone (GnRH) antagonist which is approved in the EU and USA.

PSA recurrence was more frequent with leuprolide (12.9%) than with degarelix 240/80 mg (7.7%) during the first year. Among patients who had elevated PSA levels at study entry (PSA >20 ng/mL at baseline), those on the GnRH blocker, degarelix had a significantly longer time to recurrence compared with those on leuprolide (P=0.04).

“These data add to the evidence demonstrating that FIRMAGON® offers an important treatment choice for men with prostate cancer”, said Professor Bertrand Tombal, Chairman of Urology, Cliniques Universitaires Saint-Luc, Bruxelles. “It achieved a fast and sustained suppression of testosterone combined with fewer testosterone breakthroughs and the 1-year benefit of a significantly lower risk of PSA recurrence or death.”

A further sub-analysis from the same study published in the British Journal of Urology International suggests that FIRMAGON® offers better control of serum alkaline phosphatase (S-ALP) than leuprolide.

In prostate cancer, elevated S-ALP levels are associated with progression of skeletal metastases as well as being significant predictors of early death. In the study, FIRMAGON® patients with metastatic disease had greater reductions in S-ALP levels than those with leuprolide. Furthermore, this S-ALP suppression with FIRMAGON® was sustained throughout the study, unlike leuprolide which demonstrated a significant rise towards the end of the 12 month treatment period.

“These results showed that there was better S-ALP control with FIRMAGON® than leuprolide, which is an important finding for physicians treating patients with prostate cancer because of S-ALP’s association with skeletal metastases”, commented Professor Fritz Schröder, Professor of Urology, Erasmus Medical Center, Rotterdam, the Netherlands.

– ENDS –

Notes to Editors

Initial Phase III study results comparing the efficacy and safety of degarelix, a gonadotropin-releasing hormone (GnRH) antagonist, with the luteinizing hormone-releasing hormone (LHRH) agonist, leuprolide, in prostate cancer treatment showed that degarelix was as effective as leuprolide in suppressing testosterone to castrate levels over time.¹ Its immediate onset of action produced fast testosterone suppression without the initial testosterone surge of LHRH agonists. The study also showed that degarelix achieved significantly faster suppression of luteinizing hormone and follicle-stimulating hormone.¹

In the Phase III multicenter, randomized, open-label trial comparing degarelix with leuprolide, prostate cancer patients (n=610) were randomized to a starting dose of degarelix 240 mg for one month, followed by monthly maintenance doses of 80 mg (n=207) or 160 mg (n=202), or leuprolide 7.5 mg/month (n=201). Results showed that degarelix is as effective as leuprolide in reducing and sustaining castrate levels of testosterone.¹

Suppression of testosterone to castrate levels occurred significantly faster in patients receiving degarelix than in those receiving leuprolide.¹ At Day 3 of treatment, the degarelix group achieved a 90 percent decrease in median testosterone levels compared with the leuprolide group, which experienced a 65 percent increase in median testosterone levels, a statistically significant result. Degarelix was as effective as leuprolide in suppressing testosterone levels from Day 28 to the end of the study (Day 364), with 97.2 percent of the degarelix patients maintaining medical castrate levels compared with 96.4 percent for leuprolide.

PSA recurrence was defined as two consecutive increases in PSA of 50% compared with nadir and ≥5 ng/mL on two consecutive measurements at least two weeks apart. PSA progression-free survival was analyzed using the Kaplan-Meier method and “time to event” was the number of days from first dosing to the first occurrence of PSA recurrence or death. PSA recurrences were analyzed by baseline PSA level. PSA recurrence was more frequent with leuprolide (12.9%) than with degarelix 240/80 mg (7.7%). The probability of completing the study without experiencing PSA recurrence by day 364 was 91.1% (95% CI: 85.9-94.5) for degarelix and 85.9% (95% CI: 79.9-90.2) for leuprolide. The probability of completing the study without dying by day 364 was 97.4% (95% CI: 93.8-98.9) for degarelix versus 95.1% (95% CI: 90.7-97.4) for leuprolide.²

All PSA recurrences occurred in patients with baseline PSA >20 ng/mL. In patients with baseline PSA >20 ng/mL, risk of PSA recurrence was significantly lower for patients receiving degarelix (p=0.04). In patients with baseline PSA >50 ng/mL, 29.2% of those receiving degarelix and 40.0% of those receiving leuprolide experienced PSA recurrence (p=0.10).

Effects of treatment on S-ALP levels were analyzed by baseline prostate cancer disease stage (localized, locally advanced or metastatic). After initial peaks in both groups, by day 56, S-ALP was suppressed below baseline levels with degarelix 240/80 mg in patients with metastatic disease. S ALP levels were also suppressed during leuprolide treatment but dropping below baseline levels by day 84. The rise in S ALP levels with leuprolide late in the study was not observed with degarelix. Overall, the difference in S ALP suppression in patients with metastatic prostate cancer was statistically significant between degarelix 240/80 mg and leuprolide 7.5 mg at day 364 (96 IU/L vs 179 IU/L; P=0.0137).³

About Prostate Cancer

rostate cancer is the most common form of cancer in men, and the second leading cause of cancer death. In 2005 127,490 new cases were diagnosed in the 5 biggest European countries and 18,310 in Japan. In the US 218,890 new cases were estimated for 2007, with a mortality rate of 27,050.

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, gastroenterology, and reproductive health. In recent years Ferring has expanded beyond its traditional European base and now has offices in 45 countries. To learn more about Ferring or our products please visit www.ferring.com.

For more information, please contact

Michael George
Ferring Pharmaceuticals
+41 58 301 00 53
michael.george@ferring.com

References

1. 1. 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(11):1531-1538.
   2. Tombal B, Miller K, Boccon-Gibod L et al. Additional anaylsis of the secondary end point of biochemical recurrence rate in a Phase III trial (CS21) comparing degarelix 80mg versus Leuprolide in prostate cancer patients segmented by basedline characteristics. Eur Urol, 2009.
   3. Schröder F, Tombal B, Miller K et al. Changes in alkaline phosphatase levels in patients with prostate cancer receiving degarelix or leuprolide: results from a 12 month, comparative, phase III studay. BJU Unt 2009.