Ferring Pharmaceuticals acquires global rights to MILPROSA (progesterone vaginal ring)

Saint-Prex, Switzerland – September 28, 2015 –

Ferring Pharmaceuticals announced today that it has acquired the global rights to MILPROSA^TM (progesterone vaginal ring) from Teva Women’s Health, Inc. MILPROSA has the potential to be the first once-weekly progesterone treatment for luteal phase support in women undergoing Assisted Reproductive Technology (ART) treatment if approved by regulatory authorities in the United States.

MILPROSA is a soft, flexible silicone-based vaginal ring designed to deliver a daily 11 mg dose of progesterone over the course of one week.¹

“Ferring is a leader in infertility and MILPROSA, if approved, would enhance our broad treatment portfolio in this area. Equally important to Ferring is that MILPROSA would offer a weekly treatment regimen for patients and a new treatment option for doctors,” said Michel Pettigrew, President of the Ferring Executive Board and COO.

– ENDS –

About Ferring Pharmaceuticals

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.

MILPROSA and FERRING are trademarks of Ferring B.V.

For more information, please contact

Nicole Barraud-Estoppey
+41 (0) 58 301 00 53
Nicole.Barraud-Estoppey@ferring.com

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

References

1. Stadtmauer, L. et al. Fertil Steril 2013;99:1543–9

Ferring Pharmaceuticals begins Phase 2b/3 trial of selepressin for treatment of septic shock

Saint-Prex, Switzerland – 17 August 2015 –

Ferring Pharmaceuticals announced initiation of patient enrollment in a phase 2b/3 clinical trial of selepressin for the treatment of septic shock, a life-threatening complication of infection affecting millions of people worldwide annually¹. The trial, SEPSIS-ACT, will be conducted at 50-60 sites in Europe and the United States and will enroll 1800 patients.

Selepressin is a selective vasopressin type 1a receptor agonist which increases arterial pressure and has the potential to reduce vascular leakage and pulmonary oedema.

“Despite progress in identifying and treating septic shock, its impact upon patients and their families remains high, as does the burden it places on healthcare systems,” said Per Falk, Executive VP and Chief Scientific Officer at Ferring. “Ferring is investigating whether selepressin can provide an improved treatment option for patients suffering from septic shock.”

SEPSIS-ACT (Selepressin Evaluation Programme for Sepsis Induced Shock – Adaptive Clinical Trial) is a double blind, randomised, placebo controlled phase 2b/3 adaptive trial that aims to demonstrate efficacy and safety in patients with vasopressor-dependent septic shock. Its primary endpoint is the number of vasopressor and mechanical ventilator-free days up to day 30 following initiation of treatment. The intent is for the endpoint to reflect the speed of recovery from septic shock and respiratory failure.

“SEPSIS-ACT has the potential to be a landmark trial that could change the way patients are treated in the ICU,” said Dr. Derek Angus, Chair of the Department of Critical Care Medicine and Director of CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illnesses) Center at the University of Pittsburgh. “It stands out for its innovative adaptive design, including a newly defined primary endpoint.”

– ENDS –

About septic shock

Severe sepsis and septic shock are major healthcare problems, affecting millions of people around the world each year, killing one in four (and often more), and are increasing in incidence.¹ Septic shock occurs when sepsis, a potentially life-threatening complication of infection is complicated by low blood pressure that does not respond to standard treatment (fluid administration) and leads to problems in one or more of the vital organs. Septic shock patients require rapid emergency care in hospital intensive care units (ICU). Despite active treatment in the ICU, the death rate remains high.^2,3

For further information on the SEPSIS-ACT trial, please visit

https://www.clinicaltrialsregister.eu/ctr-search/search?query=selepressin, or https://clinicaltrials.gov/ct2/show/NCT02508649?term=selepressin&rank=1

About Ferring Pharmaceuticals

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in a range of therapy areas. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

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

For more information, please contact

Nicole Barraud-Estoppey
+41 (0) 58 301 00 53
Nicole.Barraud-Estoppey@ferring.com

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

References

1. Dellinger RP, et al., Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637
2. International Sepsis Forum, “Promoting a better understanding of SEPSIS,” Second Edition, Nov. 2003.
3. Stevenson, EK, et al. Two Decades of Mortality Trends among Patients with Severe Sepsis: A Comparative Meta-analysis. Crit Care Med. 2014 March ; 42(3): 625–631.

Ferring Pharmaceuticals moves forward with early stage development of bacteriophage therapy for inflammatory bowel disease

Saint-Prex, Switzerland – 13 July 2015 –

Ferring Pharmaceuticals announced today that it will collaborate with Baltimore-based Intralytix, Inc. in the latest phase of its early stage development programme for a bacteriophage-based therapy for inflammatory bowel disease (IBD).

Bacteriophages are viruses that infect bacteria. They were isolated for the first time a century ago and discovered to be antibacterial agents. More recently, researchers linked a specific strain of bacteria, adherent and invasive Escherichia coli (AIEC), to Crohn’s disease¹, a chronic IBD condition. To explore the possibility that bacteriophages could be used to combat AIEC in IBD patients, Ferring first collaborated with the University of Lille, University of Auvergne and DigestScience, a foundation dedicated to research on digestive diseases, to better understand AIEC. Then, together with the Institut Pasteur and Intralytix, Ferring developed a combination of bacteriophages specifically designed to target AIEC strains found in Crohn’s disease patients.

In the collaboration announced today, Intralytix will assist Ferring in formulating and manufacturing the bacteriophages for use in clinical trials, which are expected to begin as soon as 2016.

“Crohn’s disease is a painful and debilitating condition with limited treatment options,” said Per Falk, Executive VP and Chief Scientific Officer at Ferring. “Our development program to bring relief to CD patients with our bacteriophage treatment directed against AIEC bacteria is ongoing.”

– ENDS –

About Ferring Pharmaceuticals

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

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

For more information, please contact

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. Barnich N, Boudeau J, Claret L, Darfeuille-Michaud A. Regulatory and functional co-operation of flagella and type 1 pili in adhesive and invasive abilities of AIEC strain LF82 isolated from a patient with Crohn’s disease. Mol Microbiol. 2003;48(3):781–794.; Barnich N, et al. CEACAM6 acts as a receptor for adherent-invasive E. coli, supporting ileal mucosacolonization in Crohn disease. J Clin Invest.2007;117(6):1566–1574; Chassaing B, et al. Crohn disease–associated adherent-invasive E. coli bacteria target mouse and human Peyer’s patches via long polar fimbriae.J Clin Invest. 2011;121(3):966–975

Inflammatory Bowel Disease Treatment Gets Boost From New Educational Resource

Elsevier, the journal Digestive Inflammatory and Ferring Pharmaceuticals announce the launch of the Inflammatory Bowel Disease Resource Centre.

Saint-Prex, Switzerland / Amsterdam, The Netherlands – 22 April 2015 –

A new educational resource for doctors and healthcare professionals will help improve knowledge and treatment of Inflammatory Bowel Disease (IBD). The Inflammatory Bowel Disease Resource Centre (www.IBD-RC.com) was developed by Elsevier, the journal Digestive and Liver Disease, and was made possible through an educational grant from Ferring Pharmaceuticals. The Inflammatory Bowel Disease is a free online platform designed to increase healthcare professionals’ knowledge of IBD.

The new IBD Resource Centre aims to give healthcare professionals the latest research and opinions on IBD, helping them treat patients more effectively. It is a unique source of peer-reviewed information, bringing together the latest research on IBD with insights and opinions from key thought leaders.

“IBD can really affect people’s lives, and as healthcare professionals we can help limit the impact the disease has on them by treating it as effectively as possible,” said Dr. Alessandro Armuzzi, editor of the Inflammatory Bowel Disease Resource Centre and leader of the IBD Unit at Complesso Integrato Columbus Catholic University, Rome, Italy. “We hope that this new resource will give healthcare professionals the information and guidance they need to help people with the disease.”

As Resource Centre editor, Dr Alessandro Armuzzi selects, reviews and approves all the featured content. Healthcare professionals have free access to the peer-reviewed research featured on IBD Resource Centre, and can read articles and watch videos about IBD, increasing their understanding of the disease, and knowledge about its treatment.

“At Ferring, we think it’s important that healthcare professionals have access to the latest peer-reviewed information,” commented Pascal Danglas, MD, Executive Vice President and Chief Medical Officer, Ferring Pharmaceuticals. “We are pleased to add the Inflammatory Bowel Disease Resource Centre to the many educational resources Ferring sponsors.”

“The new Resource Centre is a smart and innovative way of bringing the latest breakthroughs in IBD research from the journal Digestive and Liver Disease to a broad, international audience. It’s an absolute privilege to work with Dr. Armuzzi on this endeavour. We greatly value the strong commitment from Ferring to this type of educational outreach,” said Sybrand Boer Iwema, Elsevier Publisher for journal Digestive and Liver Disease.

For more information: www.IBD-RC.com

– ENDS –

About Digestive and Liver Disease

Digestive and Liver Disease is an International Journal of Gastroenterology and Hepatology, publishing papers on basic and clinical research in the field of gastroenterology and hepatology.
www.journals.elsevier.com/digestive-and-liver-disease

About Ferring Pharmaceuticals

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

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

About Elsevier

Elsevier is a world-leading provider of information solutions that enhance the performance of science, health, and technology professionals, empowering them to make better decisions, deliver better care, and sometimes make groundbreaking discoveries that advance the boundaries of knowledge and human progress. Elsevier provides web-based, digital solutions — among them ScienceDirect, Scopus, Elsevier Research Intelligence and ClinicalKey — and publishes over 2,500 journals, including The Lancet and Cell, and more than 33,000 book titles, including a number of iconic reference works. Elsevier is part of RELX Group plc, a world-leading provider of information solutions for professional customers across industries.

www.elsevier.com

For more information, please contact

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

Mareille Prevo
Elsevier
+31 204853783
m.prevo@elsevier.com

Ferring and the Institut Pasteur collaborate in novel IBD drug development project

Paris, France/Saint-Prex, Switzerland – 16 April 2015 –

Ferring Pharmaceuticals a research-driven, specialty biopharmaceutical group and the Institut Pasteur, a non-profit international biomedical research center in Paris (France) today announced a collaboration aimed at identifying and developing bacteriophages to treat patients suffering from inflammatory bowel disease (IBD).

Bacteriophages are viruses that infect bacteria. They were isolated for the first time a century ago at the Institut Pasteur and discovered to be antibacterial agents. With the development of antibiotics, their use declined, but today interest is growing as overuse of antibiotics is blamed for increased bacterial resistance.

Following a recent finding linking infection to the onset and severity of Crohn’s Disease, a chronic IBD condition, Ferring and the Institut Pasteur have agreed to work together to develop a proprietary and well defined set of bacteriophages specifically designed to treat IBD. The new programme aims to test the feasibility and efficacy of these bacteriophages in controlled clinical trials in the coming years.

“Data generated in our collaboration with the Institut Pasteur and the fact that many patients with IBD are colonized by bacteria known to cause aggressive infections, show us that bacteriophages have an important role to play in the treatment of IBD,” said Per Falk, Executive VP and Chief Scientific Officer. “A dedicated programme will now start to develop a Ferring medicine from these research findings.”

Isabelle Buckle, Executive Vice President, Technology Transfer & Industrial Partnerships, Institut Pasteur said, “It is very exciting to see bacteriophages, discovered many years ago, return to bring a real advantages to patients today. The collaboration with Ferring is a very good example of a successful academic/industry partnership. We believe that IBD patients will benefit from it.”

– ENDS –

About Ferring Pharmaceuticals

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

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

About the Institut Pasteur

The Institut Pasteur, a private foundation with officially recognized charitable status set up by Louis Pasteur in 1887, is today an internationally renowned center for biomedical research with a network of 32 institutes worldwide. In the pursuit of its mission to prevent and fight against diseases in France and throughout the world, the Institut Pasteur operates in four main areas: scientific and medical research, public health and health monitoring, teaching, and business development and technology transfer.

More than 2,400 people work on its Paris campus. The Institut Pasteur is a globally recognized leader in infectious diseases, microbiology, and immunology. Its 130 units also focus their research on certain cancers, genetic and neurodegenerative diseases, genomics and developmental biology. This research aims to expand our knowledge of living organisms in a bid to lay the foundation for new prevention strategies and novel therapeutics. Since its inception, 10 Institut Pasteur scientists have been awarded the Nobel Prize for Medicine, including two in 2008 for the 1983 discovery of the human immunodeficiency virus (HIV) that causes AIDS.

www.pasteur.fr

For more information, please contact

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

Institut Pasteur Press Office
Myriam Rebeyrotte
+33 1 45 68 81 01
presse@pasteur.fr

Ferring announces European approval of new room temperature stable formulation of PABAL® (carbetocin)

Saint-Prex, Switzerland – 7 April 2015 –

Ferring announced today that its new room-temperature-stable* formulation of PABAL® (carbetocin) for intravenous (IV) administration has been approved through the EU Mutual Recognition Procedure. PABAL is a long-acting synthetic analogue of human oxytocin with a half-life of approximately 40 minutes¹ and is indicated for the prevention of uterine atony following delivery of the infant by caesarean section under epidural or spinal anaesthesia.² The new formulation of PABAL is the first long-acting, room-temperature-stable oxytocic agent to be approved for this condition. Room-temperature-stable PABAL is expected to become available in Europe during the second quarter of 2015.

Uterine atony, or lack of muscle tone in the uterus, is responsible for approximately 80% of postpartum haemorrhage (PPH) cases.^3,4 PPH is defined as a bleed of 500 mL or more in vaginal deliveries and in excess of 1000 mL in abdominal deliveries.⁵ International and national guidelines agree that active management of the third stage of labour is a key factor in preventing PPH.^5–10 This is often achieved with uterotonic agents like oxytocin, ergometrine, syntometrine and the other formulations of carbetocin,^2,11–13 all of which require refrigeration from manufacture, through distribution, storage and eventual use.^10,14,15

“Preventing uterine atony saves lives,” said Pascal Danglas, MD, Executive Vice President and Chief Medical Officer at Ferring Pharmaceuticals. “By removing the necessity of refrigeration, Ferring aims to make PABAL more easily accessible. Expanding access to such medications is central to our commitment to women’s health globally.”

Based on the results obtained in stability studies, the new formulation has a recommended storage and shelf-life of 24 months at 30ºC and 75% humidity,¹⁶ which may be helpful in low-income countries where cold-chain storage and transport may not be available.¹⁷

Ferring, MSD (known as Merck in the United States and Canada) and the World Health Organization (WHO) are working together with the aim of making the room-temperature-stable formulation of carbetocin for intramuscular administration available in the public sector of developing countries that have a high burden of maternal morbidity and mortality, at an affordable and sustainable price. As part of this collaboration, WHO will conduct a multi-country clinical trial to evaluate the effectiveness of this formulation (as compared to oxytocin) in preventing uterine atony in the third stage of labour in women who have delivered vaginally. The study will take place in 11 countries around the world and enrol approximately 30,000 women.

*Keep vials in the outer carton, in order to protect from light. Store below 30°C. Do not freeze.²

– ENDS –

Notes to the editor

Carbetocin 100 micrograms/mL solution for injection is marketed by Ferring B.V. and/or one of its affiliates, dependent on country, with one of the following registered trademarks: PABAL®, DURATOCIN®, LONACTENE®, LONACTENE® RT and DURATOBAL®.

About PABAL®

Since its introduction in 1999, PABAL has been approved for the prevention of uterine atony in over 70 countries. With a single 100mcg IV dose, it stimulates uterine contractility within two minutes, and sustains rhythmic contractions for one hour.¹⁸ In women undergoing caesarean section, PABAL significantly reduces the need for additional uterotonics and additional uterine massage compared with oxytocin.¹⁹ Carbetocin may also be associated with lower levels of perceived post-operative pain following caesarean delivery than oxytocin.²⁰ Room temperature stable PABAL is available in vials containing 1ml and can be stored at up to 30^oC.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 reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

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

Pregnancy and childbirth pose significant health risks even in the developed world and more so in the developing world. This is reflected by global initiatives to significantly improve maternal and neonatal health by 2015 via the Millennium Development Goals.²¹ It has been estimated that 40% of women experience pregnancy-related health problems during or after pregnancy and childbirth, with 15% suffering serious or long-term complications.²² The management of such risks necessitates continued research and development in obstetrics. Ferring is dedicated to improving obstetric therapies, from the management of preterm labour and induction of labour to prevention of PPH, to reduce undesirable maternal and neonatal risks during pregnancy.

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

For more information, please contact

Sarah Herbert
MSLGROUP London
sarah.herbert@mslgroup.com
+44 (0) 20 3219 8708

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

References

1. Sweeney G, Holbrook AM, Levine M, et al. Pharmacokinetics of carbetocin, a long acting oxytocin analogue, in nonpregnant women. Curr Ther Res 1990;47:528–540.
2. PABAL Summary of Product Characteristcs (SmPC): Available at: https://www.medicines.org.uk/emc/medicine/17274 (Last accessed February 2015)
3. Callaghan WM, Kuklina EV, Berg CJ. Trends in postpartum hemorrhage: United States,1994–2006. Am J Obstet Gynecol 2010;202:353 e351–356.
4. Mehrabadi A, Liu S, Bartholomew S, et al. Temporal trends in postpartum hemorrhage and severe postpartum hemorrhage in Canada from 2003 to 2010. J Obstet Gynaecol Can 2014;36:21–33.)
5. World Health Organization. WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage 2012. Available at http://apps.who.int/iris/bitstream/10665/75411/1/9789241548502_eng.pdf (Last accessed February 2015).
6. Lalonde A; International Federation of Gynecology Obstetrics. Prevention and treatment of postpartum hemorrhage in low-resource settings. Int J Gynaecol Obstet 2012;117:108–118.
7. Leduc D, Balleman C, Biringer A, et al. Society of Obstetricians and Gynaecologists of Canada. Active management of the third stage of labour: prevention and treatment of postpartum hemorrhage. Int J Gynaecol Obstet 2010;108:258–267
8. ACOG Committee on Practice Bulletins – Obstetrics. ACOG Practice Bulletin No. 76. Postpartum haemorrhage. Obstet Gynecol 2006; 108: 1039-1047
9. Royal College of Obstetricians and Gynaecologists. RCOG Green-top Guieline No. 52: Prevention and Management of Postpartum Haemorrhage 2009. Available at: http://www.rcog.org.uk/en/guidelines-research-services/guidelines/gtg52/ (Last accessed February 2015)
10. Queensland Maternity and Neonatal Clinical Guidelines Program. Maternity and Neonatal Clinical Guideline: Primary postpartum haemorrhage 2012. Available at: http://www.health.qld.gov.au/qcg/documents/g_pph.pdf. (Last accessed February 2015).
11. Mayne Pharmaceuticals. Oxytocin Summary of Product Characteristics (SPC) 2010. Available at: http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con079194.pdf (Last Accessed March 2015).
12. Hameln Pharmaceuticals LTD. Ergometrine Injection BP 0.05% w/v 2015. Available at: https://www.medicines.org.uk/emc/medicine/20884 (Last Accessed March 2015).
13. Alliance Pharmaceuticals. Syntometrine Ampoules Summary of Product Characteristics (SPC) (eMC) 2014. Available at: https://www.medicines.org.uk/emc/medicine/135 (Last Accessed March 2015).
14. Centro Nacional de Excelencia Tecnológia en Salud: CENETEC. Prevención y manejo de la hemorragia postparto en el primero y segundo nivel de atención. 2008. Available at: http://www.isssteags.gob.mx/guias_praticas_medicas/gpc/docs/SSA-103-08-ER.pdf. (Last accessed February 2015).
15. Poręba R, Oszukowski P, Oleszczuk J, et al. Extended position statement by the Expert Group of the Polish Gynaecological Society on the use of carbetocin in the prevention of postpartum haemorrhage. GinPolMedProject 2013;1:41–57.
16. Ferring Pharmaceuticals. Data on file. eCTD document Q-3.2.P.8.1 Stability Summary and Conclusion-9203 section 3.2.P.8.1.2. 2014.
17. World Health Organization. Priority Medicines for Europe and the World Update Report. 2013. Available at: http://www.who.int/medicines/areas/priority_medicines/Ch6_0Intro.pdf (Last accessed February 2015).
18. Hunter DJ, et al. Effect of carbetocin, a long-acting oxytocin analog on the postpartum uterus. Clin Pharmacol Ther 1992;52:60–7.
19. Su LL, Chong YS, Samuel M. Carbetocin for preventing postpartum haemorrhage. Cochrane Database Syst Rev 2012; 4:CD005457
20. De Bonis M, Torricelli M, Leoni L, et al. Carbetocin versus oxytocin after caesarean section: similar efficacy but reduced pain perception in women with high risk of postpartum haemorrhage. J Matern Fetal Neonatal Med 2012;25:732–735.
21. United Nations. Goal 5: Improve Maternal Health Fact Sheet. 2010. Available at: http://www.un.org/millenniumgoals/pdf/MDG_FS_5_EN_new.pdf (Last accessed February 2015).
22. United Nations. Press release: UN Agencies Issue Joint Statement for Reducing Maternal Mortality. 1999. Available at: http://www.unicef.org/newsline/mmstat.htm. (Last accessed February 2015).