Similar remission results shown between once-daily 4g dose and twice-daily 2g doses of mesalazine (PENTASA®) in active ulcerative colitis

Stockholm, Sweden – 24 October 2011 –

Results of a new study ¹ presented today at the United European Gastroenterology Week (UEGW) congress in Stockholm demonstrate that a single daily 4g dose of mesalazine (PENTASA granules) is non-inferior to the standard, twice-daily 2g dose in inducing remission in patients with active ulcerative colitis.

The objective of the study was to show non-inferiority of once daily mesalazine (PENTASA) versus the standard twice-daily dosing for the induction of remission in active 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). The primary endpoint was met. The study found similar clinical and endoscopic remission rates for the once-daily 4g dose and twice-daily 2g doses (52.1% and 41.8% respectively, p=0.1402). With regard to secondary endpoints, clinical remission at weeks 4, 8 and 12 were similar between the once-daily 4g dose and twice-daily 2g doses at 39.8% versus 27.6% (p=0.07), 45.1% versus 40.8% (p=0.53), 92.4% versus 79.4% (p=0.13); mucosal healing at week 8 by UC-DAI sub-score ≤1: 87.5% versus 71.1% (p=0.007).

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. ²

“We’ve known for some time that once-daily dosing can effectively maintain remission in patients suffering from mild to moderate ulcerative colitis. This new study suggests that the benefits of once-daily dosing can be extended to patients with active ulcerative colitis,” 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 IBD

Inflammatory Bowel Disease (IBD) describes a range of chronic diseases of the gastrointestinal system, encompassing Ulcerative Colitis (UC) and Crohn’s Disease (CD). IBD is characterised by intermittent flares with debilitating symptoms (such as diarrhea, abdominal pain and weight loss) that can result both in a significant worsening of the patient’s quality of life as well as causing emotional distress and social isolation. In addition, patients can also suffer from a number of serious complications of the disease and may require life-long treatment and often surgery.

Both CD and UC are ongoing diseases and, although symptoms may disappear with treatment, they tend to come back over time. Thus, patients are at risk of future attacks unless they continue to take their medication to keep them in remission.

During the acute, active phase of IBD doctors may prescribe stronger therapies to control the inflammation, despite their potential harmful effects, if they will help the patient get better. However, side effects from a treatment being used for maintenance therapy are far less acceptable. Since patients will most probably have to take these medications over their entire lifetime, they must be both effective and safe. Mesalazine fulfils these requirements, as well as being convenient for the patient.

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

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

References

1. Flourie, B., Once-Daily versus Twice-daily Mesalazine (PENTASA®) for Active Ulcerative Colitis: Efficacy Results from MOTUS, a Multicentre, Controlled, Randomised, Investigator-Blinded Study, UEGW Abstract number 0P95
2. Kane, S., Am J Med. 2003; 114:39-43

Ferring Pharmaceuticals acquires Cytokine PharmaSciences Inc.

Saint-Prex, Switzerland – 20 October 2011 –

Ferring Pharmaceuticals (Ferring) announced today that it has completed the purchase of Cytokine PharmaSciences Inc. (CPSI) and its UK subsidiary Controlled Therapeutics (Scotland) Ltd. (CTS), a global biopharmaceutical company with a particular focus in obstetrics.

Ferring is already well-established in the field of reproductive health and believes that the acquisition of CPSI/CTS will strengthen its position over the next few years. It is Ferring’s second major investment in the therapeutic field in two years, having purchased the global marketing rights for LYSTEDA® (tranexamic acid) for the treatment of heavy menstrual bleeding, in May 2010.

“This acquisition advances our vision to become the global scientific and commercial leader in reproductive health, and perfectly complements our already strong portfolio of obstetrics products including TRACTOCILE® (atosiban) and PABAL® (carbetocin). In addition, the acquisition includes the manufacturing assets for dinoprostone marketed by Forest Laboratories, Inc. as CERVIDIL® in the US and Canada, and by Ferring as PROPESS® elsewhere. This acquisition gives us the opportunity to integrate the product portfolio into Ferring on a global basis and to extend our presence in this important field,” commented Michel Pettigrew, President of the Executive Board and COO at Ferring.

CTS has also developed a strong pipeline of women’s healthcare products, including the misoprostol vaginal insert which is intended to be marketed in the US and Canada as MISODEL® and in Europe and the rest of the world as MISOPESS®. It is anticipated that the new treatment will be filed for FDA approval in 2012.

It is estimated that there are 130 million babies born globally each year and, depending on the country, that labour induction rates range from 15% to 30% of all births. Treatments for cervical ripening are set to play an increasingly prominent role in the delivery process.

– ENDS –

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 more than 50 countries and markets its products in more than 70 countries.

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

About Cytokine PharmaSciences

Cytokine PharmaSciences, Inc. is a specialty pharmaceutical company engaged in developing anti-inflammatory and autoimmune therapeutics. The Company is headquartered in King of Prussia (near Philadelphia), Pennsylvania. A wholly owned subsidiary, Controlled Therapeutics (Scotland) Limited (CTS), is located in East Kilbride (near Glasgow). CTS develops and manufactures controlled-release drug delivery products and has a strong focus in the area of women’s health.

For more information, please visit the company’s websites at www.cytokinepharmasciences.com and www.ctscotland.com.

Note: Trademarks are either registered or pending and property of their respective owners.

For more information, please contact

Helen Gallagher
Ferring Pharmaceuticals
+41 58 301 00 51
helen.gallagher@ferring.com

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

The untold impact of childhood bedwetting in later life

Glasgow, Switzerland – 2 September 2011 –

New data, presented today at the International Continence Society (ICS) congress in Glasgow¹, suggest that bedwetting in children could be an indicator of future nocturia, the medical term for the complaint of needing to wake one or more times to pass urine at night, and bedwetting in adulthood.

The new survey conducted by a German study group, set out to establish the extent to which there is a relationship between nocturia and a history of childhood bedwetting.

Questionnaires were answered by 1,201 adult subjects, and grouped according to those currently experiencing nocturia (53.4%), those reporting current symptoms of bedwetting (18.1%), and a control group (28.5%).

In comparison with the control group, it was demonstrated that bedwetting in childhood was a strong indicator for future bedwetting in adults (p<0.0001; odds ratio 9.841). Bedwetting in children was also demonstrated to be an indicator for symptoms of nocturia in later life (p=0.0747; odds ratio 1.351).

These results reinforce calls for the prompt and targeted treatment of bedwetting in children, not only to reduce the number of patients who continue bedwetting into adulthood, but also the number of people who go on to develop nocturia in later life.

Bedwetting adversely affects children’s general well-being and quality of life and, if left untreated, can persist into adulthood. Without treatment at least one in ten children will wet the bed for life.² Indeed, these new results suggest as many as 18% may continue bedwetting into their adult life.¹

Not treating bedwetting can also have a negative impact on a child’s mental health and lead to troubled social development.³

Across Europe, it is estimated that more than five million children wet the bed.⁴
In the UK, it is the most common chronic condition in children after asthma, affecting more than half a million five to 16 year-olds.⁵ As such, today’s data presents a stark warning about the potential for the condition to progress into adulthood, manifesting itself as either continued adult bedwetting or nocturia.

The importance of these findings are reinforced by additional research, also presented at this year’s ICS meeting. The Boston Area Community Health Survey questioned 5,503 adults, aiming to investigate the impact of nocturia on quality of life.⁶

Worryingly, the study revealed the condition to have a comparable impact to other chronic conditions such as hypertension, diabetes and arthritis. It also suggests the impact of repeated night time trips to the toilet significantly increases the likelihood of patients experiencing depression, especially among younger men and women.

“As many parents prepare for their children to go back to school after the summer holidays, bedwetting is often front of mind. It’s really important to remember that in most cases it is a treatable medical condition and that it’s not your child’s fault. The first step to helping your child and preventing future problems is to talk to your child’s clinician about the problem,” said Dr. Daniela Marschall-Kehrel, German Enuresis Academy. “As this data shows, it is really important to seek treatment – both with regards to a child’s general well-being but also with an eye on reducing future health issues in later life”.

Bedwetting is the involuntary release of urine during sleep, occurring in children over the age of five and in the absence of any central nervous system defect.⁷ It is a common condition with similar prevalence rates worldwide.⁷

Bedwetting is more common in boys than girls and, if untreated, 16% of all seven year-olds will still be affected.⁷ A misconception is that children will grow out of bedwetting but there is adult data to the contrary. Studies from Hong Kong indicate that 2.5% up to age 40 are still suffering from the disease, of which over 50% are having bedwetting three times or more every week.⁸ Today’s data add to the growing evidence base underlining the importance of treating bedwetting.¹

Many parents lack awareness and understanding of bedwetting despite it being a chronic medical condition. Almost half of parents ignore the problem, whilst nearly a third delay action until the child is wetting the bed at least five times a week.⁹ Furthermore, 80% mistakenly believe stress and worry are the major causes of child bedwetting.⁹

The reality is that, in the majority of cases, bedwetting is a disease which can be treated effectively and permanently.

– ENDS –

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

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

Laura Craggs
Tonic Life Communications
+44 207 798 9260
laura.craggs@toniclc.com

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

References

1. Nykturie. Are today’s nocturia patients the former bedwetters? An internet based national epidemiological survey, ICS 2011, Abstract (ABSTRACT NUMBER 241)
2. Hjälmås K. Pathophysiology and impact of nocturnal enuresis. Acta Paediatr. 1997 Sep;86(9):919-22.
3. Schulpen TW. The burden of nocturnal enuresis. Acta Paediatr. 1997 Sep;86(9):981-4.
4. https://www.ferring.com.pl/en/therapeutic-areas/urology/about-bedwetting.aspx. Date Accessed 18th August 2011
5. ERIC 2001. A compilation from the Europa World Year Book 1998 using the statistics from surveys in Great Britain, Holland, new Zealand and Ireland (Butler 1998)
6. ICS Abstract 543. Nocturia and Quality of Life. Results from the Boston Area Community Health (BACH) Survey. September 2011.
7. Butler et al. Alspac, 2005, BJU; 96: 404-410
8. Yeung CK, Sreedhar B, Sihoe JD, Sit FK, Lau J. Differences in characteristics of nocturnal enuresis between children and adolescents: a critical appraisal from a large epidemiological study. BJU Int 2006; 97(5):1069-1073.
9. BRMB International Survey, 2002

New research reveals night-time toilet trips are not a trivial problem

Glasgow – 2 September 2011 –

New data, presented at the International Continence Society (ICS) Congress, highlight the significant detrimental impact of nocturia on the quality of life of patients who suffer from this under-reported and often misunderstood condition.¹

Nocturia – the medical term for the complaint of needing to wake one or more times to pass urine at night – is commonly trivialized and often thought of as being a natural and inevitable part of growing older. As such, many patients suffer in silence without discussing their problem with their clinician.

The new research¹ involved 5,503 men and women, aged 30-79 years from the city of Boston. Quality of life, from both a mental and physical health perspective, was measured using the internationally recognized SF-12 questionnaire.

Results from the study reveal the extent to which nocturia is associated with a decrease in overall quality of life, comparable to other chronic conditions such as hypertension, diabetes and arthritis. Nocturia was associated with a significant decrease in quality of life indicators, including sleep disturbance, and both the physical and mental health component scores of the SF12 (p-value<0.05).¹

The data also suggest that repeated night time trips to the toilet significantly increase the likelihood of patients experiencing depression, especially among younger men and women.¹

“This data sheds light on the real impact nocturia can have on the mental well-being and overall quality of life of patients with this under-reported condition” explained Dr Varant Kupelian, New England Research Institutes. “It is important that healthcare professionals engage with their patients to understand if they are experiencing nocturia related sleep disruption, and to discuss how best to manage their condition” he continued.

Results of a separate study² also presented at ICS showed that nocturia is a problem for shift workers who sleep through the day and work during the evening. The study, involving more than 1,000 men and women aged 18-65, suggests that an increase in the number of night shifts undertaken over the course of a week correlates to a higher prevalence of nocturia.

Investigators concluded the survey results warranted a deeper investigation into the extent to which nocturia is more of a problem in people working night shifts due to a disturbance in their circadian clock which results in a disruption of vasopressin (anti-diuretic hormone) production.

Whilst many other studies have focused on the impact of distributed sleep patterns, the authors believe this is the first time a possible relationship between changes in circadian rhythm due to night time work and nocturia have been examined.

This finding is especially relevant as an estimated 17% of the European workforce are thought to be shift workers.³

Nocturia is the complaint that an individual has to wake and pass urine one or more times at night. The condition is equally common in men and women,⁴ and although it increases with age, it affects a significant proportion of younger, as well as, older people.⁵ On average, up to around 20% of adults aged 40-59 years have ≥ two toilet visits per night,^6, 7 this increases to around 35% in those over 60 years.⁵

Nocturia is the leading cause of sleep disruption in older adults.⁸ Sleep is crucial for well-being, health, vitality and essential biological rhythms;⁹ disrupted sleep impairs all of these and studies show that insufficient or disrupted sleep can lead to physical and mental problems including depression and mood alteration.^{10, 11} Indeed, poor sleep is associated with disrupted endocrine and immune functioning, reduced health, and increased mortality.^{12, 13, 14, 15}

Nocturia is a treatable condition and people making repeated night-time visits to the toilet are urged to seek help. Nocturnal polyuria – the production of an abnormally large volume of urine during sleep – is present in the majority of patients with nocturia (60-80%).^{16, 17, 18, 19, 20, 21}

– ENDS –

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

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

Laura Craggs
Tonic Life Communications
+44 207 798 9260
laura.craggs@toniclc.com

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

References

1. ICS Abstract 543. Nocturia and Quality of Life. Results from the Boston Area Community Health (BACH) Survey. September 2011.
2. ICS Abstract 360. An explorative epidemiological patient-reported survet investigating a potential relation between night time work and nocturia.
3. Agnès Parent-Thirion et al. Fourth European Working Conditions Survey. The European Foundation for the Improvement of Living and Working Conditions, 2007 http://www.eurofound.europa.eu/pubdocs/2006/98/en/2/ef0698en.pdf Date Accessed 18th August 2011
4. Schatzl G, Temml C, Schmidbauer J, Dolezal B, Haidinger G, Madersbacher S. Cross-sectional study of nocturia in both sexes: analysis of a voluntary health screening project. Urology 2000; 56: 71-75
5. 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
6. 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
7. Brieger GM, Yip SK, Hin LY, Chung TK. The prevalence of urinary dysfunction in Hong Kong Chinese women. Obstet Gynecol 1996; 88: 1041-1044
8. Bliwise DL, Foley DJ, Vitiello MV, et al. Nocturia and disturbed sleep in the elderly. Sleep Med 2009; 10:540-548.
9. Hunter. To sleep, perchance to live. EMBO Rep 2008;9:1070-1073
10. Naitoh P, Kelly TL, Englund C. Health effects of sleep deprivation. Occup Med 1990; 5: 209-237
11. Hetta J, Rimon R, Almqvist M. Mood alterations and sleep. Ann Clin Res 1985; 17: 252-256
12. Cohen S, Doyle WJ, Alper CM, Janicki-Deverts D, Turner RB. Sleep habits and susceptibility to the common cold. Arch Intern Med 2009; 169: 62-67
13. Dew MA, Hoch CC, Buysse DJ et al. Healthy older adults’ sleep predicts all-cause mortality at 4 to 19 years of follow-up. Psychosom Med 2003; 65: 63-73
14. Tasali E, Leproult R, Ehrmann DA, Van CE. Slow-wave sleep and the risk of type 2 diabetes in humans. Proc Natl Acad Sci U S A 2008; 105: 1044-1049
15. Gottlieb DJ, Punjabi NM, Newman AB et al. Association of sleep time with diabetes mellitus and impaired glucose tolerance. Arch Intern Med 2005; 165: 863-867
16. van Kerrobroeck P, Abrams P, Chaikin D, et al. The standardisation of terminology in nocturia: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21:179-183.
17. Weiss J. Prevalence of nocturnal polyuria in nocturia. J Urol 2009; 181: 538
18. Chang SC, Lin AT, Chen KK, Chang LS. Multifactorial nature of male nocturia. Urology 2006; 67: 541-544
19. Swithinbank LV, Vestey S, Abrams P. Nocturnal polyuria in community-dwelling women. BJU Int 2004; 93: 523-527
20. Yoong HF, Sundaram MB, Aida Z. Prevalence of nocturnal polyuria in patients with benign prostatic hyperplasia Med J Malaysia 2005; 60: 294-296
21. Klingler HC, Heidler H, Madersbacher H, Primus G. Nocturia: an austrian study on the multifactorial etiology of this symptom. Neurourol Urodyn 2009; 28: 427-431