New data highlight considerable burden of Nocturia

Chronic condition associated with disturbed sleep and notable loss of productivity and non-work related activity

Milan, Italy – Sunday 17 March 2013 –

New data presented today at the European Association of Urology (EAU) congress show that nocturia (waking up one or more times to void at night) is associated with significant reductions in work productivity and leisure activity in line with other common chronic disorders such as asthma, COPD (chronic obstructive pulmonary disease) and GERD (gastro-esophageal reflux disease).¹ Nocturia was found to reduce work productivity by almost 25% in the working population.¹

Further study results also show that sufferers consider disturbed sleep to be the most burdensome symptom, and around a third of people with nocturia are unable to get back to sleep after urinating, leading to insomnia.²

Fragmented sleep is a serious consequence of nocturia and has the potential to negatively affect daytime performance. An analysis of data collected from two, three-month, randomised, controlled clinical trials (n=646) was carried out as art of an economic evaluation to compare the effect of nocturia on productivity and activity with that of other chronic diseases.  Work productivity was assessed using the Work Productivity and Activity Impairment Questionnaire.³

A work productivity loss of 24% was observed with nocturia. This is higher than that reported for over active bladder (10-12%),⁴ and comparable to other non-urological chronic conditions such as GERD (25%)⁵ severe asthma (21%),⁶ COPD (19%)⁷ and constipation (34%).⁸ Furthermore, patients’ ability to conduct daytime activities was reduced by 34% with nocturia.¹

Commenting on the results of the study, Philip Van Kerrebroeck, MD, PhD, University of Maastricht said: “Nocturia is a common problem affecting around a third of adults, but its burden is underestimated and it is often dismissed as being less serious than other chronic conditions in terms of impact on quality of life and societal costs.  These data show that nocturia negatively affects both sleep and day time performance and its impact on work productivity is in line with many other chronic conditions. Patients with nocturia should seek specific treatment for this debilitating condition.”

The second data set presented at EAU was an analysis of subjective, patient-reported data on which nocturia symptoms they find most bothersome. The multiple negative effects on quality of life associated with nocturia have been reported previously, but no studies to date have asked patients to give their reasons why nocturia is so debilitating.

Men and women in two randomised controlled trials (n=786, women 273, men 513) were asked what bothers them most about having to get up at night to void and answers were
recorded verbatim.² Sleep disturbance as the most bothersome symptom associated with nocturia (57% of males and 42% of women).  The inability to go back to sleep was ranked as the second most bothersome symptom by 32% of men and 28% of women, and the third ranked symptom was feeling tired the next morning (17% of men and 15% of women). Self-reported signs and symptoms did not differ significantly with gender.  However, age was important as a small subgroup of older patients specifically mentioned fear of falling, especially due to dizziness and walking through a dark house to go to the toilet, as bothersome.

“I have started considering my sleep pattern as a series of naps”, explained one patient in the study. “I can’t ever fall back asleep. I start watching TV all night and I am miserable the next day”, said another.

– ENDS –

About Nocturia

Nocturia is a bothersome and highly prevalent condition defined by the International Continence Society as the need to wake one or more times nightly to void with each void preceded and followed by sleep.⁹

Studies of the relationship between QoL and nocturia suggest that the condition becomes clinically significant when 2 or more voids nightly are experienced. Among LUTS, nocturia is consistently reported to be one of the most bothersome symptoms by men as well as women and significantly compromises sleep and overall QoL.¹⁰ Often trivialised and assumed to be an inevitable part of the ageing process, nocturia is a serious condition with far-reaching social, health and economic implications for patients, their families and society.¹¹

About Ferring Pharmaceuticals

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

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

Moira Gitsham
Tonic Life Communications
+33 5 46 00 08 20
moira.gitsham@toniclc.com

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

References

1. Andersson F et al. Nocturia has a strong impact on productivity – a comparison with different chronic diseases. EAU 2013: presented at poster session ‘Nocturia, OAB, metabolic syndrome – towards a new management’, abstract number #406.
2. Holm-Larsen T et al. “My sleep pattern is a series of naps.” Subjective patient-reported data on what is most bothersome about nocturia. EAU 2013: presented at poster session ‘Nocturia, OAB, metabolic syndrome – towards a new management’, abstract number #405.
3. Reilly MC et al. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993;4:353-365. doi: 10.2165/00019053-199304050-00006.
4. Coyne KS et al. The prevalence of lower urinary tract symptoms (LUTS) and overactive bladder (OAB) by racial/ethnic group and age: Results from OAB-POLL. Neurourol Urodyn 2012 Jul 27. doi: 10.1002/nau.22295.
5. Wahlqvist P et al. Validity of a Work Productivity and Activity Impairment questionnaire for patients with symptoms of gastro-esophageal reflux disease (WPAI-GERD) – results from a cross-sectional study. Value Health 2002;5:106-113.
6. Chen E et al. Chronic traffic-related air pollution and stress interact to predict biologic and clinical outcomes in asthma. Environ Health Perspect 2008;116:970-975.
7. Di Bonaventura M et al. The burden of chronic obstructive pulmonary disease among employed adults. Int J Chron Obstruct Pulmon Dis 2012;7:211-219.
8. Sun SX et al. Impact of chronic constipation on health-related quality of life, work productivity, and healthcare resource use: an analysis of the National Health and Wellness
   Survey. Dig Dis Sci 2011;56:2688–2695.
9. van Kerrebroeck P et al. The standardization of terminology in nocturia: report from the Standardisation Sub-committee of the International Continence Society. Neurol UroL Urodyn 2002;21:179-83.
10. van Dijk MM et al: The role of nocturia in the quality of life of men with lower urinary tract symptoms. BJU Int 2010;105:1141.
11. Asplund R. Nocturia: consequences for sleep and daytime activities and associated risks. European Urology Supplements 2005;3:24-32.

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]

In patients with active, left-sided ulcerative colitis, study shows once-daily dose of mesalazine granules provided similar results to twice-daily dose

Vienna, Austria – February 14, 2013 –

Results of a recent sub analysis¹ of data from the MOTUS study² presented today at the Congress of European Crohn’s and Colitis Organisation showed that a once-daily 4g dose of mesalazine (Pentasa® granules) was non-inferior to the twice-daily 2g dose for such formulation in inducing remission in patients with left-sided active ulcerative colitis.

The objective of the MOTUS study was to show non-inferiority of once-daily mesalazine versus twice-daily dosing for the induction of remission in active ulcerative colitis. As many patients with ulcerative colitis experience left-sided disease, the aim of the new sub analysis was to assess specifically the efficacy in patients with left-sided ulcerative colitis.

Patients with active mild-to-moderate ulcerative colitis were randomised to 4g mesalazine once-daily or 2g mesalazine twice-daily. All patients also received mesalazine enema (1g/day) for 4 weeks. The primary endpoint was clinical and endoscopic remission at week 8 (UC-DAI score ≤1). Secondary endpoints were clinical remission at weeks 4, 8, 12 (normal stool frequency, no bloody stools, no active disease by physician’s global assessment); mucosal healing at week 8 (UC-DAI endoscopic mucosal appearance score ≤1). Subgroup analyses of the primary endpoint were carried out by disease location (left-sided disease versus overall study population). Statistical data were based on intent-to-treat (ITT) analyses. If the lower limit of the 95% CI was between -15% and 0%, then the once-daily regimen was declared non-inferior to the twice-daily regimen.

206 patients were enrolled (once-daily n=102, twice-daily n=104). Of the overall population, 83% had left-sided or distal ulcerative colitis and 17% had pancolitis or extensive ulcerative colitis. Patients with left-sided/distal ulcerative colitis comprised 81.4% of the once-daily arm (n=82) and 84.6% of the twice-daily arm (n=86). The primary endpoint of clinical and endoscopic remission at week 8 (UC-DAI score ≤1) was achieved by 52.9% and 41.5% of patients with left-sided/distal ulcerative colitis in the once-daily arm and the twice-daily arm, respectively (lower 95% CI limit -3.7%). These remission rates are comparable to those of the overall study population (once-daily 52.1%, twice-daily 41.8%). For patients with left-sided/distal ulcerative colitis, non-inferiority was also demonstrated for the secondary endpoints of complete remission (UC-DAI=0; once-daily 28.0%, twice-daily 24.4%, lower 95% CI limit -9.9%) and mucosal healing (endoscopic sub score UC-DAI ≤1; once-daily 86.6%, twice-daily 68.2%, lower 95% CI limit -5.0%) at week 8.

“These results show that patients with active, left-sided ulcerative colitis may benefit from the convenience of once-daily dosing of mesalazine granules”, said Prof. Bernard Flourié, Lyon Sud Hospital, France.

– ENDS –

About Pentasa^® (mesalazine)

Pentasa belongs to a class of anti-inflammatory drugs called the aminosalicylates. It is used to treat and control the symptoms of inflammatory bowel disease (IBD) – both ulcerative colitis (UC) and Crohn’s disease (CD). Approved indications vary by country.

About Ulcerative colitis

Ulcerative colitis is a form of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and may also strongly affect quality of life. It is believed that as many as 800,000 people in the U.S. and as many as 900,000 people in the EU have ulcerative colitis.

Mesalazine is approved in many countries for the treatment of mild to moderate ulcerative colitis. Patients with active colitis are commonly prescribed multiple doses daily. However, non-compliance, failure of patients to take the medication as often as prescribed, significantly increases the risk of symptom persistence and recurrence.³

About Ferring Pharmaceuticals

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

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

References

1. Flourié, B., Comparing the efficacy of once-daily or twice-daily mesalazine dosing in the treatment of left-sided ulcerative colitis versus the overall MOTUS study population, ECCO 2013 abstract number P562
2. Flourié, B., Once-Daily versus Twice-daily Mesalazine (PENTASA®) for Active Ulcerative Colitis: Efficacy Results from MOTUS, a Multicentre, Controlled, Randomised, Investigator-Blinded Study, UEGW 2011 abstract number 0P95
3. Kane, S., Am J Med. 2003; 114:39-43

Ferring’s European Marketing Authorisation Application for controlled release misoprostol vaginal delivery system for the induction of labour accepted for review

Saint-Prex, Switzerland – 5 November 2012 –

Ferring Pharmaceuticals announced today that it has received confirmation from European health authorities that the Marketing Authorisation Application (MAA) for its controlled release, removable misoprostol vaginal delivery system (MVDS) has been accepted for review under the decentralised procedure. Ferring is seeking approval for the MVDS for induction of labour in women with an unfavourable cervix, from 36 weeks gestation, in whom induction is clinically indicated.

The submission was based on the results of clinical studies in more than 3,000 pregnant women at term including the EXPEDITE Study*, a Phase 3, double blind, randomized, multicenter study of 1,358 patients at 35 U.S. study sites. The study evaluated the efficacy and safety of Ferring’s controlled release removable MVDS versus CERVIDIL®** (dinoprostone) and the results showed that MVDS decreased the time to vaginal delivery in women with an unfavourable cervix compared to CERVIDIL. An unfavourable cervix is a cervix that has not yet softened and thinned so that dilation can take place.

“We are pleased by the action of European authorities in accepting the Marketing Authorisation Application for review for Ferring’s controlled release, removable misoprostol vaginal delivery system,” said Pascal Danglas, Executive Vice President, Clinical and Product Development, Ferring Pharmaceuticals. “Among expectant mothers, labour induction is an increasingly common clinical indication. Ferring is committed to developing new and improved treatments in the area of reproductive health. We look forward to cooperating with the review process.”

– ENDS –

About Labour Induction

Labour induction is an increasingly common obstetric intervention, with more than 20 percent of births now being induced.

The need for labour induction occurs when delivery of the baby is necessary, for a variety of reasons, prior to the start of a natural labour. The induction process requires the uterus to be stimulated to contract in an effort to have a vaginal birth. Additionally, it can involve the need for cervical ripening which is when the cervix is deemed as being “unfavourable” or when the tissue needs to soften, thin and dilate. This can be achieved through either pharmacological or mechanical means.

About Ferring’s Controlled Release Misoprostol Vaginal Delivery System (MVDS)

Ferring’s controlled release removable misoprostol vaginal insert is an investigational vaginal delivery system containing misoprostol. In the EXPEDITE Study, the MVDS was given as a single dose, with continuous, controlled release of misoprostol for up to 24 hours. The U.S. Food and Drug Administration (FDA) has also accepted for review Ferring’s New Drug Application (NDA) for the MVDS. The MVDS was developed by Ferring Controlled Therapeutics Ltd. a wholly-owned member of the Ferring Group based in East Kilbride, Scotland.

About Ferring Pharmaceuticals

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.

*The EXPEDITE Study: A phase III, double blind, randomized, multicenter study of EXogenous Prostaglandin comparing the Efficacy and safety of the Misoprostol Vaginal Insert (MVI) 200 mcg to the Dinoprostone vaginal Insert for reducing Time to vaginal delivery in pregnant women at tErm
**CERVIDIL® (dinoprostone) is a registered trademark of Ferring, except in the U.S. where it is a trademark of Forest Laboratories, Inc.

For more information, please contact

Ferring Announces FDA Acceptance of NDA Filing for Controlled Release Misoprostol Vaginal Insert for Decreasing Time to Vaginal Delivery in Women

Parsippany, NJ, USA – 23 October 2012 –

Ferring Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for its controlled release misoprostol vaginal insert (MVI). Ferring is seeking approval for the MVI for decreasing time to vaginal delivery in women with an unfavorable cervix (a cervix that has not yet softened and thinned so that dilation can take place) when used in sequential regimen with oxytocin augmentation, if needed.

The NDA submission was based on the results of clinical studies in more than 3,000 pregnant women at term including the EXPEDITE Study*, a Phase 3, double blind, randomized, multicenter study of 1,358 patients at 35 U.S. study sites. The study evaluated the efficacy and safety of Ferring’s controlled release removable MVI versus CERVIDIL®** (dinoprostone) and determined that the study reported MVI decreased the time to vaginal delivery in women with an unfavorable cervix compared to CERVIDIL.

“We are pleased with the FDA’s acceptance of the NDA submission for Ferring’s controlled release misoprostol vaginal insert,” said Aaron Graff, President and COO of Ferring Pharmaceuticals Inc. “We are dedicated to advancing new treatments in the field of women’s health and obstetrics and are proud to bring one of the first new advancements in obstetrics in over 15 years.  We look forward to collaborating with the FDA on its review of our NDA.”

– ENDS –

About Labor Induction

Labor induction is an increasingly common obstetric intervention, with more than 20 percent of births now being induced.

The need for labor induction occurs when delivery of the baby is necessary, for a variety of reasons, prior to the start of a natural labor. The induction process requires the uterus to be stimulated to contract in an effort to have a vaginal birth. Additionally, it can involve the need for cervical ripening which is when the cervix is deemed as being “unfavorable” or when the tissue needs to soften, thin and dilate. This can be achieved through either pharmacological or mechanical means.

About Ferring’s Controlled Release Misoprostol Vaginal Insert

Ferring’s controlled release removable misoprostol vaginal insert (MVI) is an investigational vaginal delivery system containing misoprostol.  In the EXPEDITE Study, the MVI was given as a single dose, with continuous, controlled release of misoprostol for up to 24 hours. Marketing Authorisation Application for the MVI has also been submitted in the EU.

About Ferring Pharmaceuticals Inc.

Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, gastroenterology, infertility, obstetrics/gynecology, orthopaedics and urology. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com.

*The EXPEDITE Study: A phase III, double blind, randomized, multicenter study of EXogenous Prostaglandin comparing the Efficacy and safety of the Misoprostol Vaginal Insert (MVI) 200 mcg to the Dinoprostone vaginal Insert for reducing Time to vaginal delivery in pregnant women at tErm
**CERVIDIL® (dinoprostone) is a registered trademark of Forest Laboratories, Inc.

For more information, please contact

Katie Silverwood
+1 (645) 500-7765
katie.silverwood@mslgroup.com

New study showed desmopressin melt reduced sleep disruption in bedwetting children

London, UK – 12 October 2012 –

Preliminary results from a new, prospective study presented today at the first Joint Congress of the International Children’s Continence Society (ICCS), Education and Resources for Improving Childhood Continence (ERIC), and the British Association of Paediatric Urology (BAPU) show that treatment with melt-in-the-mouth desmopressin (MINIRIN® Melt)*, an orally disintegrating tablet, reduced periodic limb movements (PLMS) in children with nocturnal enuresis (bedwetting).¹ Periodic limb movements in sleep are repetitive movements, most typically in the lower limbs, that are associated with the disruption of normal sleep patterns².

The preliminary results from the study of 30 children aged 6 – 16 years reveal that the antidiuretic effect of desmopressin melt correlates strongly with reduced PLMS in children with nocturnal enuresis, as 90% of the children in the study experienced reduced PLMS.

This prospective study is on-going and has set out to evaluate the beneficial impact of desmopressin melt on sleep, cognition, quality of life and self-esteem, and other items. Full results are expected in 2013.

The children in the study had a diagnosis of nocturnal enuresis as identified by the ICCS criteria and had experienced at least four out of seven wet days with proven nocturnal polyuria (defined as nocturnal diuresis >100% bladder volume for age).

At initial screening, 87% of children were recorded as having disrupted sleep as measured by polysomnography (a recording of the biophysiological changes that occur during sleep). These children experienced more than 5 periodic limb movements per sleep hour (PLMS index). The overall PLMS index for those children involved in the study ranged between 3.6 and 23.3 (with a mean 10.8 +/- 5.0).

The six-month results show a significant improvement in the incidence of nocturnal enuresis (p<0.001) with 12 children recorded as being full responders to desmopressin melt treatment, 11 partial responders and only 5 non-responders. A reduction of the PLMS index was reported in 26 of 29 patients (90%, p<0.001) and a reduction of the nocturnal diuresis in 16 of 21 patients (76%, p=0.001).

Commenting on the results of the study, Johan Vande Walle, head of the Department of Pediatric Nephrology, University Hospital Ghent, Belgium explained: “This preliminary data suggests that by effectively treating bedwetting we can improve the quality of sleep, which is so important for a child’s development. As the study continues, we will explore the impact this brings to quality of life and daily functioning.”

– ENDS –

* Desmopressin melt is indicated for the treatment of bedwetting in 72 countries across the world and it is marketed under several names, including MINIRIN® Melt and DESMOMELT®

About desmopressin

In bedwetting, studies have shown that long-term treatment with desmopressin is effective, well tolerated and can aid long term improvements in nocturnal dryness.^3,4 Therapy with the antidiuretic agent MINIRIN is a recommended first-line treatment for bedwetting with a level 1, grade A recommendation from the ICI and EAU/ESPU^5,6. In addition, UK NICE guidelines, which are based on a review of evidence, suggest that treatment with desmopressin should be considered if rapid onset and/or short-term improvement in bedwetting is the priority of treatment or if an alarm is inappropriate or undesirable.⁷

When desmopressin is prescribed, patients should be instructed to avoid high fluid intake, not to ingest a higher than recommended dose and to promptly discontinue the medication and seek medical assessment if headache, nausea or vomiting develops.^8,9

About Ferring Pharmaceuticals

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

Moira Gitsham
Tonic Life Communications
+33 5 46 00 08 20
moira.gitsham@toniclc.com

Alice Greenslade
Tonic Life Communications
+44 (0) 207 798 9918
alice.greenslade@toniclc.com

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

References

1. Herzeele et al. Desmopressin improves sleep patterns in patients with nocturnal enuresis. ICCS 2012 Abstract (Poster Number 21)
2. Birgit Högl. Periodic Limb Movements are Associated With Disturbed Sleep. Journal of Clinical Sleep Medicine, Vol. 3, No. 1, 2007
3. Lottmann H, Baydala L, Eggert P, Klein BM, Evans J, Norgaard JP. Long-term desmopressin response in primary nocturnal enuresis: open-label, multinational study. Int J Clin Pract 2009;63(1):35-45
4. Evans J, Malmsten B, Maddocks A, Popli HS, Lottmann H; on behalf of the UK study group. Randomized comparison of long-term desmopressin and alarm treatment for bedwetting. J Pediatr Urol. 2011 Feb;7(1):21-9. Epub 2010 Jun 25.
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