MISODEL™, Ferring’s removable misoprostol vaginal delivery system, approved for labour induction in European Decentralised Procedure

Saint-Prex, Switzerland – 17 October 2013 –

Ferring Pharmaceuticals announced today that its MISODEL^TM (misoprostol) removable, controlled-release vaginal delivery system for labour induction has successfully completed the European Decentralised Procedure involving 29 Member States¹ of the European Economic Area (EEA). Each involved Member State should now adopt the decision and grant the national marketing authorisation, which may take from one to several months. Ferring plans to launch the product in the various European countries beginning in 2014.  

MISODEL^TM (MYSODELLE^TM in some European countries) has been approved for induction of labour in women with an unfavourable cervix, from 36 weeks of gestation, in whom induction is clinically indicated. An unfavourable cervix is a cervix that has not yet softened and thinned so that dilation can take place.

The decentralised submission was based on the results of clinical studies in more than 3,000 pregnant women at term, including the EXPEDITE study², a phase III, double-blind, randomised, multicentre study of 1,358 patients with an unfavourable cervix. The study compared the 200 mcg MISODEL^TM controlled release vaginal delivery system with the 10-mg dinoprostone vaginal insert (DVI), in terms of efficacy and safety. The EXPEDITE study showed that MISODEL^TM significantly reduced the time to vaginal delivery compared to DVI.

“Clinically indicated labour induction, that is when labour is induced to avoid risks to the pregnant woman or her child, is becoming a more common need in our clinical practice,” said Professor Tim Draycott, Consultant Obstetrician and Senior Clinical Lecturer, University of Bristol, UK. “We welcome this new formulation of misoprostol for vaginal delivery, which has proved to be an effective labour inducer and will be an important option we can offer our patients”.

“We are very happy with the decision of the European Health Authorities to approve our new formulation of misoprostol for labour induction, which enables controlled-release delivery of the drug in the vagina,” said Dr. Pascal Danglas, Executive Vice President, Clinical and Product Development at Ferring Pharmaceuticals. “Ferring is committed to developing new and improved treatments in the area of reproductive health, where it has been active for decades. We look forward to making this new product available to obstetricians and the growing number of patients for whom labour induction is clinically indicated”.  

– ENDS –

About MISODEL^™

MISODEL^TM consists of a single application, removable controlled release vaginal delivery system with a reservoir of 200 mcg of misoprostol. Misoprostol is released at a mean rate of approximately 7 mcg/hour over a period of 24 hours. Drug release continues as long as MISODEL^TM is in the vagina. The product is equipped with a withdrawal tape that facilitates rapid removal when active labour begins.

Misoprostol is a synthetic prostaglandin E1 (PGE1) analogue. The World Health Organisation (WHO) recommends prostaglandins for labour induction³ and misoprostol is one of the compounds on the “WHO essential drug list” for labour induction. Most current clinical guidelines also recommend the use of prostaglandins for labour induction^2,4,5.

About the EXPEDITE study

The EXPEDITE study² was a phase III, randomized, double-blind, multicentre study, which compared 200 mcg MISODEL^TM (n=678) with the 10-mg dinoprostone vaginal insert (DVI) (n=680) in terms of efficacy and safety in the induction of labour in pregnant women with an unfavourable cervix. An unfavourable cervix is a cervix that has not yet softened and thinned so that dilation can take place.

Women treated with  MISODEL^TM (misoprostol) had significantly shorter median time to vaginal delivery (primary endpoint) than women treated with DVI (21.5 hours [95% CI: 20.0–23.4] versus 32.8 hours [95% CI: 30.2–34.9]; p<0.001, respectively). They also had significantly decreased overall median time to any delivery (18.3h versus 27.3h, p<0.001) and overall median time to onset of active labour (12.1h versus 18.6h p<0.001) compared with the women treated with DVI. Fewer women treated with MISODEL^TM received pre-delivery oxytocin (48.1% vs 74.1% p<0.001).

The rates of caesarean delivery, co-primary safety endpoint, were similar between MISODEL^TM and DVI (26.0% versus. 27.2%; p = 0.65).

About labour induction

Labour induction is defined as the artificial initiation of labour⁴. It is generally indicated when the risk to either the mother or the foetus outweighs the possible benefits of continuing to manage the pregnancy. In developed countries, the incidence of labour induction has increased to approximately 20% of all pregnancies^6,7. One possible explanation for this trend is the association between increased maternal age and complication rates⁸.

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

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

All trademarks mentioned above are property of Ferring B.V.

For more information, please contact

Antonella Di Fatta
MSL GROUP EMEA  HC Practice
Tel: +39 02 773361
Mobile: +39 3347151318
antonella.difatta@mslgroup.com

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

References

1. Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Latvia, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom
2. Wing DA, Brown R, Plante LA, Miller H, Rugarn O, Powers BL.  Misoprostol vaginal insert and time to vaginal delivery: a randomized controlled trial.  Obstet Gynecol 2013; 122 (2 Pt 1): 201-9
3. World Health Organization. Managing complications in pregnancy and childbirth. A guide for midwives and doctors (2007). Available from: http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/9241545879/en/index.html. Accessed April 2013.
4. RCOG & NICE. Induction of Labour Clinical Guideline (2008).  Available at: http://www.nice.org.uk/nicemedia/live/12012/41255/41255.pdf. Accessed May 2013.
5. ACOG. Obstet Gynecol 2009;114:386–97.
6. Blondel B, Kermarrec M. Les NAISSANCES en 2010 et leur évolution depuis 2003. Unité de recherche épidémiologique en santé périnatale et santé des femmes et des enfants. INSERM 2011;U.953.
7. RCOG & NICE. Induction of Labour Clinical Guideline (2008).  Available at: http://www.nice.org.uk/nicemedia/live/12012/41255/41255.pdf. Accessed September 2013.
8. Carolan M, Davey MA, Biro MA, Kealy M. Older Maternal Age and Intervention in Labor: A Population-Based Study Comparing Older and Younger First-Time Mothers in Victoria, Australia. Birth 2011;38:24–9. Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Carolan+M%2C+Davey+MA%2C+Biro+MA%2C+Kealy+M.+Older+Maternal+Age+and+Intervention+in+Labor%3A+A+Population-Based+Study+Comparing+Older+and+Younger+First-Time+Mothers+in+Victoria%2C+Australia.+Birth. Accessed September 2013.

Ferring announces second $3 million donation to the Royal Textile Academy of Bhutan

Saint-Prex, Switzerland – June 05, 2013 –

Ferring Pharmaceuticals has announced a second $3 million donation to the Royal Textile Academy of Bhutan to support its mission to preserve and promote Bhutanese textiles and improve the livelihoods of the weavers who make them.

Today, at the opening of the new Royal Textile Academy facilities in Thimphu, Bhutan, Michel Pettigrew, President of the Ferring Executive Board, said “We are very keen that this major cultural initiative of preserving Bhutan’s traditional skills and heritage continues, and that the commercial momentum which will enhance the quality of life and economic prospects of the weavers be able to grow over the next few years. This is of great importance to all of us at Ferring as we conduct our business under the Philosophy of “People Come First”.

In 2009, Ferring donated $3 million to the Academy to fund the creation of a new cultural centre in the Bhutanese capital of Thimphu. The new grant will be used to support the continued development of the academy, which includes a state-of-the-art museum, a textile weaving school and conservation centre.

On behalf of Her Majesty, Gyalyum Sangay Choden Wangchuck, Mrs. Rinzin O. Dorji, Executive Director of the Academy, thanked Ferring and said “This grant will not only benefit the weavers of Bhutan, through the academy it will contribute to economic
development in the region.”

– 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 gastroenterology, reproductive health, urology 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

Helen Gallagher
+41 (0)58 301 00 51
helen.gallagher@ferring.com

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

Ferring presents phase III data for a controlled release misoprostol vaginal delivery system for labour induction at the First European Congress on Intrapartum Care

Saint-Prex, Switzerland – 24 May, 2013 –

Data from the EXPEDITE study presented today at the First European Congress on Intrapartum Care (ECIC) demonstrated that use of a controlled release misoprostol vaginal insert significantly reduced time to vaginal delivery compared to a dinoprostone vaginal insert.¹

“The increased incidence of labour induction has prompted the need for safe and more efficacious techniques and induction agents”, said Dr. Deborah Wing, University of California, Irvine. “These results point toward significant efficacy advantages for the misoprostol vaginal delivery system”.

Misoprostol is a synthetic prostaglandin E1 (PGE1) analogue. The World Health Organisation (WHO)² recommends prostaglandins for cervical ripening and labour induction and misoprostol is one of the compounds on the “WHO essential drug list” for labour induction. Many current clinical guidelines also recommend the use of prostaglandins for the induction of labour ^3,4.

The EXPEDITE study compared the efficacy and safety of a controlled release vaginal insert containing a reservoir of 200 µg of misoprostol (MVDS) versus a reservoir of 10 mg dinoprostone in a vaginal insert (DVI) when used for labour induction in a randomised phase III double-blinded study.

The research was done at over 30 sites across the USA where a total of 1,358 women were randomly assigned to receive either a single dose of MVDS (n=678) or dinoprostone vaginal insert (DVI) (n=680).

The co-primary efficacy endpoint of median time to vaginal delivery was found to be significantly shorter for women treated with MVDS compared with DVI (MVDS: 21.5 hours [95% CI: 20.0–23.4], DVI: 32.8 hours [95% CI: 30.2–34.9]; p<0.001). MVDS also decreased time to any delivery, time to active labour and pre-delivery oxytocin administration, compared with DVI.

The rates of caesarean delivery, co-primary safety endpoint, were not significantly different between MVDS and DVI (26.0% vs. 27.2%; p = 0.65). Furthermore, no significant differences between groups were observed in overall rates of neonatal treatment-emergent adverse events.

About labour induction

Labour induction has been increasingly used in obstetric practice over the last three decades. In Europe, the incidence of labour induction has risen from 10.4% to 20.5% (1981-1998)⁵. One explanation for the constantly rising rates of labour induction could be the increasing average maternal age at delivery across Europe. Induction of labour in older mothers is widely practiced as an intervention perceived to reduce the risk of late stillbirth⁶. For example, in the UK, the mean maternal age has increased dramatically over the past two decades, with statistics showing that between 1987 and 2008 pregnancies in women aged 35 and over rose from 8% to 20% and pregnancies in women aged 40 years and older trebled from 1.2% to 3.6%⁷. However, labour induction rates differ widely across Europe and the rise is not linear.

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.

– ENDS –

For more information, please contact

Antonella Di Fatta
MSLGROUP Emea  HC Practice
Tel: +39 02 773361
Mobile: +39 3347151318
antonella.difatta@mslgroup.com

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

References

1. 1^st European Congress of Intrapartum Care. Amsterdam, May 2013. Abstract 303. Lead Author: Hugh Miller – Coauthor(s): Hugh Miller; Deborah A Wing; Lauren A Plante; Olof Rugarn; Barbara L Powers – Misoprostol Vaginal Insert Significantly reduced time to vaginal delivery Compared with Dinoprostone Vaginal Insert when used for Labor INDUCTION.
2. World Health Organization. Managing complications in pregnancy and childbirth. A guide for midwives and doctors (2007). Accessed April 2013. Available from: http://www.who.int/reproductivehealth/publications/maternal
   _perinatal_health/9241545879/en/index.html.
3. RCOG & NICE. Induction of Labour Clinical Guideline (2008).  Available at: http://www.nice.org.uk/nicemedia/live/12012/41255/41255.pdf (Last accessed May 2013).
4. ACOG. Obstet Gynecol 2009;114:386–97.
5. EURO-PERISTAT, SCPE, EUROCAT & EURONEOSTAT. European perinatal health report: better statistics for better health for pregnant women and their babies (2008). Accessed March 2013. Available from: www.sante.public.lu/publications/sante-fil-vie/petite-enfance/european-perinatal-health-report/european-perinatal-health-report.pdf, accessed May, 15^th, 2013, 14:00 pm.
6. Carolan M, Davey MA, Biro MA, Kealy M. Older Maternal Age and Intervention in Labor: A Population-Based Study Comparing Older and Younger First-Time Mothers in Victoria, Australia. Birth 2011;38:24–9. Available at http://www.ncbi.nlm.nih.gov/pubmed/?term=Carolan+M%2C+Davey+MA%2C+Biro+MA%2C+Kealy+M.+Older+Maternal+Age+and+Intervention+in+Labor%3A+A+Population-Based+Study+Comparing+Older+and+Younger+First-Time+Mothers+in+Victoria%2C+Australia.+Birth
7. RCOG. Induction of labour at Term in Older Mothers (2013). Available at: http://www.rcog.org.uk/files/rcog-corp/1.2.13%20SIP34%20IOL.pdf

Ferring Pharmaceuticals begins phase III trials of elobixibat, new compound with novel mechanism of action for chronic idiopathic constipation

Saint-Prex, Switzerland – May 2, 2013 –

Ferring Pharmaceuticals today announced it has initiated enrolment of patients in two phase III clinical trials of elobixibat for the treatment of chronic idiopathic constipation (CIC), a common gastrointestinal disorder affecting approximately 14% of the general population¹. The two studies, Echo 1 and Echo 2, will be conducted at close to 200 sites worldwide and will enrol nearly 1700 patients. The studies aim to demonstrate the efficacy and safety of repeated daily doses of elobixibat against placebo over a period of up to 26 weeks.

Elobixibat is a first-in-class compound with a novel physiological mechanism of action. It acts locally in the gut with minimal systemic exposure to enhance the amount of luminal bile acids in the colon by a partial inhibition of the Ileal Bile Acid Transporter (IBAT). This increases colonic fluid secretion and motility. Phase II clinical trials with elobixibat in patients with CIC have demonstrated clinically meaningful, statistically significant and dose-dependent improvement on key constipation symptoms such as bowel movement frequency, straining and stool consistency². Ferring acquired the global marketing rights for elobixibat, excluding Japan and a small number of Asian markets, from Albireo AB in 2012.

“We are pleased to begin Phase III studies on elobixibat for the treatment of chronic idiopathic constipation,” said Pascal Danglas, Executive Vice President, Clinical and Product Development at Ferring. “CIC causes significant discomfort to sufferers and seriously impacts their quality of life. Studies have shown that patients are not satisfied with current treatments. With its novel mechanism of action, we believe that elobixibat has the potential to improve medical treatment of CIC sufferers.”

– ENDS –

About chronic idiopathic constipation

Chronic idiopathic constipation (CIC) is among the most common diseases throughout the world, affecting approximately 14% of the general population particularly women and the elderly¹. Patients with CIC often experience hard and lumpy stools, straining during defecation and a sensation of incomplete evacuation, as well as discomfort and bloating. CIC adversely affects a person’s quality of life and is associated with significant health care expenditure³. Studies show that nearly 50% of CIC sufferers are not satisfied with available treatments⁴ underscoring the unmet medical need in this area.

About the Elobixibat Research in Constipation (Echo) phase III trials

For further information on the Echo 1 trial, please visit: http://www.clinicaltrials.gov/ct2/show/NCT01827592?term=elobixibat&rank=1

For further information on the Echo 2 trial please visit: http://www.clinicaltrials.gov/ct2/show/NCT01833065?term=elobixibat&rank=2

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 gastroenterology, reproductive health, urology 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

Helen Gallagher
+41 (0) 58 301 00 51
helen.gallagher@ferring.com

References

1. Suares NC, Ford AC. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis. Am J Gastroenterol. 2011 Sep;106(9):1582-91
2. Chey WD, et al. A Randomized Placebo-Controlled Phase IIb Trial of A3309, A Bile Acid Transporter Inhibitor, for Chronic Idiopathic Constipation. Am J Gastroenterol 2011; 106:1803–1812
3. 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 Sep;56(9):2688-95
4. Johanson JF, Kralstein J. Chronic constipation: a survey of the patient perspective . Aliment Pharmacol Ther 2007 ; 25 : 599 – 608

Ferring to Present Safety Analysis for FIRMAGON® (degarelix) at the American Urological Association Annual Meeting

San Diego, CA, USA – May 1, 2013 –

The following data will be presented at the annual meeting of the American Urological Association (AUA) in San Diego, CA:

Androgen deprivation therapy by a gonadotropin releasing hormone antagonist, degarelix, lowers the risk of cardiovascular events or death when compared to luteinising hormone-releasing agonists
(Abstract 781)

Date: Monday, May 6, 2013; 8:00-10:00 AM
Session/Type: Prostate Cancer: Advanced (II); Moderated Poster
Location: San Diego Convention Center, Room 7
Authors: Peter Albertsen; Bertrand Tombal; Thomas Wiegel; Egbert van der Meulen; Bo-Eric Persson; Tine Kold Olesen; Joshua Beckman

Analysis of disease control-related outcomes from six comparative randomised clinical trials of degarelix versus luteinising hormone-releasing hormone agonists
(Abstract 716)

Date: Sunday, May 5, 2013; 3:30-5:30 PM
Session/Type: Prostate Cancer: Advanced (I); Podium Presentation
Location: San Diego Convention Center, Room 1
Authors: Neal Shore; Kurt Miller; Bertrand Tombal; E. David Crawford; Cathrina Karup; Egbert van der Meulen; Bo-Eric Persson

Per AUA media embargo policy, coverage of research being presented is prohibited before the date and time of presentation.

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

Molly Wilson
Tonic Life Communications
+1 (215) 928-2357
molly.wilson@toniclc.com

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

© 2013 Ferring B.V.
FIRMAGON^® is a registered trademark of Ferring B.V.