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].

Ferring acquires LYSTEDA™ from Xanodyne Pharmaceuticals, Inc.

Global Acquisition Expands Ferring’s Role in Women’s Health

Saint-Prex, Switzerland – 10 May, 2010 –

Ferring Pharmaceuticals today announced an agreement that will expand its Women’s Health product portfolio with the acquisition of the global rights to Xanodyne Pharmaceutical’s LYSTEDA™ (tranexamic acid), a first-in-class, non-hormonal therapy indicated specifically for treatment of women with cyclic heavy menstrual bleeding (HMB). The company will initially market LYSTEDA in the U.S., and is evaluating opportunities in other markets. LYSTEDA oral tablets received approval on November 13, 2009 following a Priority Review by the U.S. Food and Drug Administration (FDA). It is estimated that up to 22 million women suffer from HMB in the U.S..^1,2

“Ferring, as a global, privately held biopharmaceutical company, has a long-standing commitment to the health of women worldwide”, said Michel L. Pettigrew, President of the Executive Board, and President and CEO, Ferring Holding Inc. “The acquisition of LYSTEDA, in addition to our ongoing support of research and medical education in the field of Reproductive Health, demonstrates this significant commitment and represents an important addition to our Women’s Health portfolio.”

Added Olivier Delannoy, Vice President, U.S. Infertility Business Unit, “In the U.S., the acquisition of LYSTEDA enables us to expand into the field of obstetrics and gynecology. Ferring is a well-established leader in reproductive endocrinology with the broadest portfolio of infertility treatments in the U.S., including MENOPUR®, BRAVELLE® and ENDOMETRIN®. The addition of LYSTEDA furthers our goal of providing treatments for every stage of a woman’s reproductive health, including before, during and after pregnancy.”

Ferring will introduce LYSTEDA to the Obstetric and Gynecology community at the upcoming American College of Obstetricians and Gynecologists (ACOG) 58th Annual Clinical Meeting, May 15-19, 2010 in San Francisco. For more information, visit www.lysteda.com.

About LYSTEDA™

LYSTEDATM (tranexamic acid) tablets are indicated for the treatment of cyclic heavy menstrual bleeding. Prior to prescribing LYSTEDA, exclude endometrial pathology that can be associated with heavy menstrual bleeding.

Important Safety Information

Do not prescribe LYSTEDA to women who are known to have: active thromboembolic disease, a history of thrombosis or thromboembolism, including retinal vein or artery occlusion, an intrinsic risk of thrombosis or thromboembolism. Venous and arterial thrombosis or thromboembolism, and retinal artery and retinal vein occlusions, have been reported with tranexamic acid.

Do not prescribe LYSTEDA to women with known hypersensitivity to tranexamic acid.

Because LYSTEDA is antifibrinolytic, concomitant use with hormonal contraception may exacerbate the increased thrombotic risk (blood clots, stroke, and myocardial infarction) associated with combination hormonal contraceptives. Women using hormonal contraception should use LYSTEDA only if there is a strong medical need and the treatment benefit will outweigh the potential increased risk of a thrombotic event.

In case of severe allergic reaction, discontinue LYSTEDA and seek immediate medical attention. A case of severe allergic reaction (dyspnea, tightening of the throat, and facial flushing) to LYSTEDA was reported in clinical trials and a case of anaphylactic shock was reported in the literature, involving a patient who received an intravenous bolus of tranexamic acid.

Retinal venous and arterial occlusion has been reported in patients using tranexamic acid. Immediately discontinue LYSTEDA if visual or ocular symptoms occur. Ligneous conjunctivitis also has been reported in patients taking tranexamic acid which resolved with drug discontinuation.

LYSTEDA is not recommended for women taking either Factor IX complex concentrates or antiinhibitor coagulant concentrates because the risk of thrombosis may be increased.

Exercise caution when prescribing LYSTEDA to women with acute promyelocytic leukemia taking all-trans retinoic acid for remission induction because of possible exacerbation of the procoagulant effect of all-trans retinoic acid.

Cerebral edema and cerebral infarction may be caused by use of LYSTEDA in women with subarachnoid hemorrhage.

The most common adverse reactions in clinical trials (> 5%, and more frequent in LYSTEDA subjects compared to placebo subjects) were: headache, sinus and nasal symptoms, back pain, abdominal pain, musculoskeletal pain, arthralgia, muscle cramps and spasms, migraine, anemia and fatigue.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals, headquartered in Switzerland, is a privately owned, research driven specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynaecology, fertility and urology. Ferring Pharmaceuticals Inc. offers a line of products in the U.S. market. They include: BRAVELLE® (urofollitropin for injection, purified), MENOPUR® (menotropins for injection, USP) and REPRONEX® (menotropins for injection, USP), NOVAREL® (chorionic gonadotropin for injection, USP), ENDOMETRIN® (progesterone) Vaginal Insert, 100 mg, FIRMAGON® (degarelix for injection), PROSED® DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA® (1% sodium hyaluronate).

To learn more about Ferring or its products please visit www.ferring.com. For U.S.-specific information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.

For more information, please contact

Andrea Preston
U.S. inquiries, Kovak-Likly Communications
+1 (203) 762-8833
+1 (203) 762-9195
apreston@klcpr.com

Helen Gallagher
Global / European inquiries, Ferring Pharmaceuticals
+41 58 301 00 51
+41 58 301 00 39
helen.gallagher@ferring.com

References

1. 1. U.S. Census Bureau, 2006-2008 American Community Survey. Available at: http://factfinder.census.gov/. Accessed April 7, 2010.
   2. Tufts Medical Center website. Heavy Menstrual Bleeding. Available at: www.tufts-nemc.org. Accessed April 7, 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.

Wake Up to Nocturia Studies Reinforce Serious Associated Risk of Nocturia

Barcelona, Spain – 19 April, 2010 –

Study results discussed today at the European Association of Urology (EAU) Congress in Barcelona, have reinforced the association between nocturia and a greater risk of falls and mortality.

In a population-representative study in Japan by Nakagawa et al, it was concluded that adults who suffered from nocturia (defined as two or more episodes of voids/urination per night) had a significantly increased risk of mortality when compared to adults without nocturia, even once adjustments had been made for other contributing factors (e.g. age, gender, physiological conditions).¹

Furthermore, a community-based study by Parsons et al in 5,872 men aged 65 years or above, showed that in adults with moderate or severe lower urinary tract symptoms (LUTS), the risk of having at least two falls significantly increased when compared to those with mild LUTS symptoms. Adults who endured 2-3 awakenings per night due to a need for voiding, had a 21% greater risk of at least two falls, while adults who endured 4-5 awakenings due to voids per night had a 63% greater risk.² Nocturia was among the LUTS most strongly associated with falls.

“These studies have highlighted some vital new insights into nocturia, primarily that it is a serious medical condition that should not be dismissed as a lifestyle matter. The time has come for health providers and the public to give nocturia the attention it deserves,” comments Dr Raymond Rosen from the New England Research Institutes, USA.

Several studies have demonstrated that prevalence of nocturia is high with as many as 20% of adults aged 40-59 years thought to be affected.^3,4,5 This increases to approximately 35% in those over 60 years old.³ Nocturia repeatedly disrupts sleep and is associated with multiple negative outcomes including a significant reduction in quality of life and an increased morbidity.⁶ Interrupted sleep, caused by nocturia, not only affects the patient and their partners but can also affect society through reduced productivity and job performance.^7,8,9

“The current lack of awareness about and understanding of nocturia means this major problem often remains undiagnosed or inappropriately treated,” comments Professor Philip Van Kerrebroeck from the University Hospital Maastricht, The Netherlands.

“In many cases, it is wrongly thought to be only a bladder or prostate problem, when nocturia may actually be a kidney problem. We need a two-pronged approach. Physicians need to recognise the signs and symptoms of the condition and treat it appropriately, but patients also need to be aware of the signs so they can go to their doctor as soon as they have any concerns. It is important for patients to understand that their condition can be treated and there is no need for them to suffer in silence”.

Further investigative study will be required to establish whether appropriate treatment of nocturia will help reduce the link between the condition and other chronic diseases.

In an effort to raise awareness of nocturia as a condition in its own right, it has newly been included within the official EAU guidelines. The new chapter on non-neurogenic lower urinary tract symptoms (LUTS), including nocturia, incorporates information on a variety of LUTS treatment options including α-blockers and 5α-reductase inhibitors. The chapter also highlights the role of desmopressin as the only therapy specifically addressing nocturia and its main cause nocturnal polyuria and awards a Level 1 Grade A recommendation.¹⁰

– ENDS –

About the studies

Association between nocturia and mortality in a community-dwelling elderly population aged 70 years and over: results of a 3-year prospective cohort study in Japan (Nakagawa et al)

The authors conducted a Comprehensive Geriatric Assessment of all residents aged ≥70 years in 2003 in an urban district of north Japan. The population-based cross-sectional survey was conducted using an extensive health interview for each participant. Mortality over 3 years was investigated using data from the national health insurance system. Differences in survival stratified by presence/absence of nocturia (≥2 voids/night) were assessed with Kaplan-Meier curves, and statistical significance was calculated with the log-rank test. The risk of mortality with or without nocturia was compared using a time varying multivariate Cox proportional hazard model.

Lower urinary tract symptoms increase the risk of falls in older men (Parsons et al)

The authors evaluated 5872 participants in the Osteoporotic Fractures in Men, a prospective cohort study of risk factors for falls and osteoporotic fractures among community-dwelling men aged > or =65 years. The primary outcome was the 1-year cumulative incidence of falls in men with moderate or severe, vs mild LUTS at baseline, as measured by the American Urological Association Symptom Index. They used Poisson regression models and considered multiple variables as potential confounders.

For more information, please contact

Natalie Fairbank
Senior Account Executive, Tonic Life Communications
+44 207 798 9999
natalie.fairbank@toniclc.com

Jens-Peter Norgaard
Chief Scientific Officer, Medical Science Urology, Ferring Pharmaceuticals
+45 2878 7547
jenspeter.norgaard@ferring.com

References

1. Nakagawa et al. J Urol 2009;181(Suppl):8.
2. Parsons et al. BJU Int 2009;104:63-68.
3. Irwin DE, Milsom I, Hunskaar S et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol 2006; 50: 1306-1315.
4. Yoshimura K, Terada N, Matsui Y, Terai A, Kinukawa N, Arai Y. Prevalence of and risk factors for nocturia: Analysis of a health screening program. Int J Urol 2004; 11: 282-287.
5. Brieger GM, Yip SK, Hin LY, Chung TK. The prevalence of urinary dysfunction in Hong Kong Chinese women. Obstet Gynecol 1996; 88: 1041-1044.
6. Asplund R. Nocturia in relation to sleep, somatic diseases and medical treatment in the elderly 5. BJU Int 2002; 90: 533-536.
7. Bolge SC, Doan JF, Kannan H, Baran RW. Association of insomnia with quality of life, work productivity, and activity impairment. Qual Life Res 2009; 18: 415-422.
8. Bolge SC, Balkrishnan R, Kannan H, Seal B, Drake CL. Burden associated with chronic sleep maintenance insomnia characterized by nighttime awakenings among women with menopausal symptoms. Menopause 2010; 17: 80-86.
9. Kobelt G. Health-economic issues in nocturia. BJU Int 1999; 84 Suppl 1: 29-32.
10. European Association of Urology Guidelines – 2010 edition.

Xanodyne and Ferring announce co-promote for ZIPSOR™

Newport, KY and Parsippany, NJ, USA – 1 April 2010 –

Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women’s healthcare and pain management, today announced that it has signed a co-promotion agreement for Zipsor™ (diclofenac potassium) Liquid Filled Capsules with Ferring Pharmaceuticals Inc., a global bio-pharmaceutical company, headquartered in Switzerland. Zipsor, a non-steroidal anti-inflammatory drug (NSAID) indicated for the treatment of mild to moderate acute pain in adults received FDA approval in June 2009, and diclofenac, the active ingredient in Zipsor, is one of the most widely prescribed NSAIDs in the world.

Under the agreement, Ferring’s orthopaedic sales force will promote Zipsor to certain orthopaedic surgeons, rheumatologists, sports medicine physicians and physiatrists in the United States. Ferring will receive a royalty on Zipsor sales generated by a pre-defined target prescriber base. Co-promotion efforts will begin on May 3, 2010.

“Zipsor represents an exciting addition to our current orthopaedic product portfolio”, said William N. Garbarini, Vice President, Orthopaedics / Urology Business Unit, Ferring Pharmaceuticals. “Ferring has successfully commercialized Euflexxa in the United States and welcomes the opportunity to expand our offering to the orthopaedic community by helping orthopaedic surgeons and rheumatologists treat patients with acute pain.”

Commenting on the agreement, Natasha Giordano, Xanodyne’s Chief Operating Officer said, “We are pleased to partner with a quality company such as Ferring to help us extend the reach of Zipsor in the United States beyond pain specialists and other selected physicians who are the primary focus of our current sales efforts. We look forward to working together to leverage the early market success of Zipsor and to reach considerably more practitioners who attend to the needs of patients with acute pain.”

# # #

Source: Ferring Pharmaceutical Inc. and Xanodyne Pharmaceuticals, Inc.

– ENDS –

About Zipsor

ZIPSOR (diclofenac potassium) Liquid Filled Capsules, is a new treatment option for relief of mild to moderate acute pain in adults (18 years of age or older).

Important Safety Information

Cardiovascular Risk

Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.  Zipsor is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

NSAIDs increase the risk of serious gastrointestinal (GI) adverse reactions including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

See full Prescribing information for Zipsor at www.Zipsor.com.

About Xanodyne Pharmaceuticals, Inc.

Xanodyne, which commenced operations in 2001, is an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women’s healthcare and pain management. Xanodyne markets a portfolio of products consisting of prescription pharmaceuticals and a line of prenatal vitamins. Additionally, Xanodyne is advancing a late stage pipeline of product candidates targeted at significant potential markets in Xanodyne’s focus areas. For more information visit www.Xanodyne.com.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of products in the U.S. market.  They include: BRAVELLE®, MENOPUR® and REPRONEX® (menotropins for injection, USP), NOVAREL® (chorionic gonadotropin for injection, USP), ENDOMETRIN® (progesterone) Vaginal Insert, 100 mg, FIRMAGON® (degarelix for injection), PROSED® DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA® (1% sodium hyaluronate).

Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, orthopaedics, gastroenterology, obstetrics/gynecology, and infertility. For more information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.

For more information, please contact

Dina Ramon (Ferring Pharmaceuticals)
Kovak-Likly Communications
+1 (203) 762-8833
dramon@klcpr.com

Janet M. Barth (Xanodyne)
JMB Consulting
+1 (973) 727-7654
jbarth@njexecutives.com

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.