Ferring signs global agreement to commercialise novel gene therapy for bladder cancer patients

• rAd-IFN/Syn3, a novel gene therapy, is in Phase 3 development to treat high-grade non-muscle invasive bladder cancer patients, who are unresponsive to BCG therapy

• The US FDA has granted Fast Track and Breakthrough Therapy designations to rAd-IFN/Syn3

• Ferring US will create a new oncology division for the potential launch of rAd-IFN/Syn3

Saint-Prex, Switzerland – 3 May, 2018 –

Ferring Pharmaceuticals today announced the signing of an agreement giving the company the option to secure global commercialisation rights to nadofaragene firadenovec/Syn3 (rAd-IFN/Syn3), a novel gene therapy being developed by FKD Therapies Oy (FKD) as a treatment for patients with high-grade non-muscle invasive bladder cancer (NMIBC), who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy. This option is exercisable on marketing approval from the US FDA. Ferring will create a new US oncology division with the specialist knowledge and presence to introduce novel advanced therapies to the market.

rAd-IFN/Syn3 is currently undergoing Phase 3 development in the US under the sponsorship of Finnish gene therapy specialists FKD. The results of the earlier Phase 2 trial, published in the Journal of Clinical Oncology, reported 35% of BCG unresponsive NMIBC bladder cancer patients given one dose of rAd-IFN/Syn3 every three months, were free of high-grade disease at one year¹.  The ongoing Phase 3 study is designed to establish the efficacy and safety of the product. rAd-IFN/Syn3 has been awarded Fast Track and Breakthrough Therapy designations by the FDA.

“We are excited about the potential to commercialise rAd-IFN/Syn3, a novel gene therapy for bladder cancer patients,” said Michel Pettigrew, President of the Executive Board and Chief Operating Officer, Ferring Pharmaceuticals. “The gene therapy sector is growing rapidly and building a presence in this specialised area is a very positive opportunity for Ferring.”

Bladder cancer is one of the most frequently occurring cancers with an estimated 430,000 new cases being reported worldwide each year². It is the fourth most common cancer in men in the US³ and is the most expensive cancer to treat on a life-time basis, with a high burden on patients, their relatives and healthcare systems⁴. In high-grade NMIBC patients, BCG is the gold standard treatment and although effective, over 60% of cases eventually re-occur^5,6. The outcome for such patients is poor, with total cystectomy (complete removal of the bladder) to prevent the cancer spreading to other organs generally being the next treatment option. As such, the BCG unresponsive population is one of high unmet clinical need.

“Today, bladder cancer patients have very limited medical options and new treatments that delay or prevent total removal of the bladder and improve clinical outcomes are urgently needed for patients,” said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. “Phase 2 clinical results for rAd-IFN/Syn3 were very encouraging and we look forward to the Phase 3 data.”

Gene therapy is one of a new class of therapeutic treatments known as advanced therapy medicinal products. rAd-IFN/Syn3 is built on adenoviral vector technology, a non-integrating vector, and results in enhanced expression of the therapeutic protein interferon alfa 2b. To date, it has completed three clinical trials in the US.

About rAd-IFN/Syn3

rAd-IFN/Syn3 (nadofaragene firadenovec/Syn3) is an investigational gene therapy consisting of an adenovirus containing the gene interferon alfa-2b. It is administered by catheter into the bladder, where the virus enters the cells of the bladder wall. Inside the cells, the virus breaks down leaving the active gene to do its work. The internal gene/DNA machinery of the cells picks up the gene and translates its DNA sequence, resulting in the cells secreting high quantities of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This novel gene therapy approach turns the patient’s own bladder wall cells into multiple interferon microfactories, enhancing the body’s natural defences against the cancer. The Phase 3 trial for rAd-IFN/Syn3 opened in 2016 with up to 150 patients to be enrolled across 35 centers in the US.

About FKD Therapies Oy

FKD Therapies Oy is a gene therapy company, located in Kuopio, Finland and is the sponsor and developer of rAd-IFN/Syn3.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative and personalised healthcare solutions to help mothers and babies, from conception to birth. Founded in 1950, Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Learn more at www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.

For more information, please contact

Bhavin Vaid
Head of Corporate Communications
+41 58 301 09 52 (direct)
+41 79 191 06 32 (mobile)
bhavin.vaid@ferring.com

Lindsey Rodger
Senior Manager, Corporate Communications
+41 58 451 40 23 (direct)
+41 79 191 04 86 (mobile)
lindsey.rodger@ferring.com

References

1. Shore ND, Boorjian AS, Canter KD, Ogan K, Karsh IL, Downs MT, et al. Intravesical rAd–IFNα/Syn3 for Patients With High-Grade, Bacillus Calmette-Guerin–Refractory or Relapsed Non–Muscle-Invasive Bladder Cancer: A Phase II Randomized Study. J Clin Oncol [Internet]. 2017 October [cited 2018 Mar 19]; 35(30):3410-3416. Available from http://ascopubs.org/doi/full/10.1200/JCO.2017.72.3064
2. Antoni S, Ferlay J, Soerjomataram I, Znaor A, Ahmedin J, Bray F. Bladder Cancer Incidence and Mortality: A Global Overview and Recent Trends. Eur Urol [Internet]. 2017 Jan [cited 2018 Mar 19]; 71(1):96-108. Available from: http://www.europeanurology.com/article/S0302-2838(16)30280-9/fulltext
3. Colorectal cancer can be prevented. Get screened [Internet]. United States: American Cancer Society; 2018. Key Statistics for Bladder Cancer; 2018 Jan 4 [cited 2018 March 19]. Available from: https://www.cancer.org/cancer/bladder-cancer/about/key-statistics.html
4. Sievert KD, Amend B, Nagele U, Schilling D, Bedke J, Horstmann M, et al. Economic aspects of bladder cancer: what are the benefits and costs?. World J Urol [Internet]. 2009 Mar [cited 2018 Mar 19]; 27(3): 295-300. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2694315/
5. Maruf M, Brancato S, Agarwal P. Non invasive bladder cancer: a primer on immunotherapy. Cancer Biol Med [Internet]. 2016 Jun [cited 2018 March 19]; 13(2): 194–205. Available from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4944546/
6. Derré L, Cesson V, Lucca I, Cerantola Y, Valerio M 1, Fritschi U, et al. Intravesical Bacillus Calmette Guerin Combined with a Cancer Vaccine Increases Local T-Cell Responses in Non-muscle-Invasive Bladder Cancer Patients. Clin Cancer Res [Internet]. 2017 Feb [cited 2018 Mar 19]; 23(3): 717-725. Available from: https://www.ncbi.nlm.nih.gov/pubmed/27521445

Feature
Bladder cancer infographic

Ferring acquires innovative biotechnology company and microbiome pioneer Rebiotix Inc.

• Rebiotix’s RBX2660 is a non-antibiotic treatment in Phase 3 development for the prevention of recurrent Clostridium difficile infection (CDI) and has the potential to be the world’s first approved human microbiome product

• CDI is one of the most common healthcare-associated infections in the US, affecting more than 500,000 people and causing approximately 29,000 deaths each year.¹

• Ferring’s global capabilities ensure broader patient access to any future approved human microbiome treatments derived from Rebiotix’s Microbiota Restoration Therapy™ (MRT™) drug platform

Saint-Prex, Switzerland & Roseville, MN, US – 05 April, 2018 –

Ferring Pharmaceuticals* and Rebiotix Inc. today announce that they have agreed to the acquisition of Rebiotix by Ferring. This acquisition brings together two innovative healthcare companies that share a common commitment to exploring and understanding the human microbiome to develop new solutions for patients.

The most advanced investigational microbiome treatment from Rebiotix is RBX2660, a non-antibiotic treatment currently in Phase 3 development for the prevention of recurrent CDI. RBX2660 has the potential to be the first human microbiome product approved anywhere in the world. In the US, RBX2660 has received FDA Fast Track, Breakthrough Therapy and Orphan Drug Designations, which means the FDA considers it eligible for Expedited Review, once the submission has been made.

“The scientific advances Rebiotix has made add significant strategic value to Ferring’s leadership in gastroenterology,” said Michel Pettigrew, President of the Executive Board and Chief Operating Officer, Ferring Pharmaceuticals.  “Therapies targeted towards the microbiome have the potential to transform healthcare. Together, we have a unique opportunity to help people living with debilitating and life-threatening conditions like Clostridium difficile infection.”

Rebiotix’s proprietary MRT drug platform delivers healthy, live, human-derived microbes into the gastrointestinal tract. It provides a standardised, stabilised product that is ready-to-use in an easy-to-administer format. The MRT pipeline consists of a number of investigational treatments including RBX7455, a non-frozen, lyophilised oral capsule formulation, in development for the prevention of recurrent CDI.

“Ferring shares our passion for understanding the role the microbiome plays in human health and has global capabilities that offer huge potential for the investigational therapies that we have in development,” said Lee Jones, Founder, President and Chief Executive Officer, Rebiotix, Inc. “Rebiotix was founded to revolutionise healthcare by harnessing the power of the human microbiome and this is a significant milestone in achieving that goal.”

“This acquisition strengthens our innovation pipeline and complements our own ongoing microbiome research as well as our partnerships with world-leading organisations in this area,” said Per Falk, Chief Science Officer, Ferring Pharmaceuticals. “Rebiotix’s culture and passion for high quality, innovative research fits with our own and complements our existing R&D capabilities.”

In addition to the acquisition of Rebiotix, Ferring, as a leader in gastroenterology, is supported by ongoing partnerships with world-leading research organisations in the field of microbiome research including the Karolinska Institutet and Science for Life Laboratory, the Centre for Translational Microbiome Research, Intralytix, The Institut Pasteur, the University of Lille, MyBiotics Pharma, March of Dimes and Metabogen.

– ENDS –

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative and personalised healthcare solutions to help mothers and babies, from conception to birth. Founded in 1950, Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Learn more at www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.

About Rebiotix Inc.

Rebiotix Inc. is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionise the treatment of challenging diseases. Rebiotix possesses a deep and diverse clinical pipeline targeting several other disease states with drug products built on its pioneering MRT platform. The MRT platform is a standardised, stabilised drug technology that is designed to rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com.

About RBX2660

RBX2660 is the most advanced product utilising Rebiotix’s proprietary MRT drug platform. RBX2660 is in Phase 3 development for the prevention of recurrent CDI and has the potential to be the first human microbiome product approved anywhere in the world. It consists of a microbiota suspension of intestinal microbes and is administered via enema.

*Ferring Holding Inc. signed the agreement as part of Ferring Pharmaceuticals Group

For more information, please contact:

Bhavin Vaid
Head of Corporate Communications
+41 58 301 0952 (direct)
+41 79 191 0632 (mobile)
bhavin.vaid@ferring.com

Jason Rando (for Rebiotix)
Tiberend Strategic Advisors
+1 212 375 2665 (direct)
+1 917 930 6346 (mobile)
jrando@tiberend.com

References

1. Centers for Disease Control and Prevention. Nearly half a million Americans suffered from Clostridium difficile infections in a single year. Press release. February 25, 2015. Available online at: https://www.cdc.gov/media/releases/2015/p0225-clostridium-difficile.html. Last accessed April 2018.

Nocturia: the most common cause of a poor night’s sleep, say experts on World Sleep Day

• Nocturia, the need to wake to urinate more than once in the night, is the most common cause of sleep disruption in adults of all ages.^1,2

• The condition is associated with loss of deep sleep, disruption of daytime functioning and reduced productivity and alertness.^3,4,5

• In rare cases, nocturia may also be a symptom of a serious health condition, such as high blood pressure, diabetes or cardiovascular disease.²

Saint-Prex, Switzerland – 16 March, 2018 –

On World Sleep Day, scientists are highlighting the number one reason that people are waking up at night – nocturia (otherwise known as the need to get up and urinate more than once during the night).^1,2 It often has one or more contributing factors such as an overproduction of urine, reduced bladder capacity; certain illnesses and medications are also potential contributors.^2,6 Although it is most common in older adults, nocturia can affect people of all ages and frequent sleep disturbances significantly impact daily living and can be a sign of more serious health conditions.^2,3,4,5

“Nocturia’s disruption to deep sleep results in reduced productivity and alertness that can affect multiple areas of an individual’s life during the day,” said Jens-Peter Nørgaard, Medical Director of Ferring Pharmaceuticals and Professor of Urology at Ghent University, Belgium. “From making it difficult to manage a busy daily schedule to negatively impacting productivity at work, sleep disruption has significant impact far beyond fatigue or night-time inconvenience.”

The effect that sleep disruption can have was measured recently in a study by Nokia Health, which designs smart health devices and apps. In the study sleep patterns were measured using Nokia sleep sensors and compared to self-reported quality of sleep. Of the over 19,000 people surveyed it was shown that frequency of nightly awakenings was the most important factor in getting a good night’s sleep – more than the total duration of sleep or the time people went to bed.⁷

Lack of sleep from nocturia can lead to impaired daytime functioning, as well as reduced productivity and alertness.^3,4,5 These frequent sleep interruptions are important as uninterrupted sleep is needed to sustain physical (including the immune system), mental and emotional health.⁸

“People often ignore sleep disturbance from nocturia, but this can produce significant disruption to daytime functioning,” said Dr. Andrew Krystal, Professor of Psychiatry and Behavioral Science at University of California, San Francisco. “It is important this is discussed with a healthcare professional, as this disruption is not just harmful in itself but can also be an indicator of more serious health conditions.”

Nocturia can also be a symptom of more serious health problems such as high blood pressure, diabetes and heart disease.² The impact of sleep disturbances can also lead to greater risk of serious health conditions such as increased risk of diabetes, weakened immune systems and heart disease.⁹ Similarly, individuals who suffer from chronic sleep disturbances experience reduced cognitive functioning, which can impact productivity, relationships and careers.⁸

About World Sleep Day

World Sleep Day is an annual event intended to be a celebration of sleep and a call to action on important issues related to sleep. It is organised by the World Sleep Day Committee of the World Sleep Society (founded by World Association of Sleep Medicine and the World Sleep Federation) and will take place on Friday 16^th March 2018.¹⁰

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative and personalised healthcare solutions to help mothers and babies, from conception to birth. Founded in 1950, Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Learn more at www.ferring.com and @Ferring, or connect with us on Facebook, Instagram and LinkedIn.

Ferring is a proud supporter of World Sleep Day

For more information, please contact

Lindsey Rodger
Senior Manager, Corporate Communications
+41 58 451 40 23 (direct)
+41 79 191 0486 (mobile)
lindsey.rodger@ferring.com

Bhavin Vaid
Head of Corporate Communications
+41 58 301 09 52 (direct)
+41 79 191 06 32 (mobile)
bhavin.vaid@ferring.com

References

1. Benefield LE. Facilitating Aging in Place: Safe, Sound, and Secure, An Issue of Nursing Clinics. 2014
2. National Association for Continence. Nocturia web page. Last accessed 2017.
3. Bliwise DL et al. J Clin Sleep Med 2015;11:53–5.
4. Bliwise DL et al. Eur Urol Suppl 2014;13:e591–e591a.
5. Kobelt G, Borgstrom F, Mattiasson A. Productivity, vitality and utility in a group of healthy professionally active individuals with nocturia. BJU Int. 2003;91(3):190–5
6. Park, H.K and Kim, H.G., Current Evaluation and Treatment of Nocturia, Korean J Urol. Aug 2013; 54(8): 492–498. page 492
7. Roitmann, E., O. Bellahsen, and A. Chieh. “Perceived sleep quality of sleep profiles derived from connected sleep detector data.” Sleep Medicine 40 (2017): e281-e282.
8. Laureanno, P. Ellsworth, P., Demystifying Nocturia: Identifying the Cause and Tailoring the Treatment. Urol Nurs. 2010;30(5):276-287.
9. Orzel-Gryglewska, J. Consequences of Sleep Deprivation. International Journal of Occupational Medicine and Environmental Health 2010; 23(1): 95-114. doi:10.2478/v10001-010-0004-9.
10. World Sleep Day website. Homepage. [Last accessed February 2017] Available at: www.worldsleepday.org

Ferring announces positive outcome of European Decentralised Procedure (DCP) for Testavan®, a treatment for men with hypogonadism

• Testavan® expands treatment options for men with hypogonadism, a condition which causes low levels of testosterone and which may adversely affect quality of life and sexual function^1,3

• Men treated with Testavan achieved normalised testosterone levels after three months, with improvements in quality of life and fatigue scores, and an increase in erectile function^4,6

• Testavan is a topical gel with a fast-drying formulation that is designed to enhance bioavailability. It is administered with a convenient hands-free applicator⁷

Saint Prex, Switzerland – 15 March 2018 –

Ferring Pharmaceuticals today announced the positive outcome of the European Decentralised Procedure (DCP) for Testavan^® (transdermal testosterone gel 2%), a testosterone replacement therapy for adult male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. The Netherlands acted as Reference Member State (RMS) on behalf of all 31 European Economic Areas (EEA) countries.¹

“Men suffering from hypogonadism symptoms, including erectile dysfunction and fatigue, often remain untreated due to barriers that delay diagnosis and lack of treatment options,” said Per Falk, Executive Vice President and Chief Science Officer, Ferring Pharmaceuticals. “Ferring is committed to delivering innovative healthcare solutions to treat a number of male urologic conditions. With the positive outcome of the DCP, hypogonadal patients in many European countries will soon have access to a convenient treatment to normalise testosterone and relieve symptoms.”

Testavan’s fast-drying gel formulation is based on Ferring’s Advanced Skin Technology (F.A.S.T.), a proprietary transdermal gel technology, which enhances bioavailability of testosterone through the skin. Testavan’s low dose and volume, in addition to its unique hands-free applicator, were designed to ensure patient convenience. The hands-free applicator may lower the risk of transference of testosterone skin residue from the patient to others.^8,10

In phase III trials, men treated with Testavan achieved normalised testosterone levels by month three, with improvements in quality of life and fatigue scores over three months, and early and sustained increase in erectile function score at one and three months. Assessment measures included testosterone responder rate, defined as the percentage of subjects achieving normalised levels of testosterone (300-1050 ng/dL); the Multidimensional Assessment of Fatigue (MAF); general well-being assessment (Short Form 12 Health Survey, SF-12); International Index of Erectile Function (IIEF).

About male hypogonadism

Male hypogonadism is a condition characterised by low levels or absence of testosterone due to certain medical conditions, and signs and symptoms of testosterone deficiency. Male hypogonadism is reported to have an incidence of 2-6% in men aged 40-79 years and becomes more common with age.³ There is a substantial quality of life and clinical burden associated with hypogonadism in men, and can be associated with comorbidities such as diabetes, metabolic syndrome, cardiovascular diseases, and adverse bone health. ^3,11,14

About Testavan

Testavan, the new 2% testosterone gel, uses a proprietary hydroalcoholic and highly viscous topical formulation. The product is homogeneous, transparent and nonstaining, and comes in a metered dose dispenser that includes a hands-free cap applicator for precise dispensing and application. The starting dose is 23 mg testosterone, delivered by one pump actuation, contained in 1.15 g of gel, and the highest dose is 3.45 g of gel containing 69 mg testosterone (delivered by 3 pump actuations).¹

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative and personalised healthcare solutions to help mothers and babies, from conception to birth. Founded in 1950, Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Learn more at www.ferring.com and @Ferring, or connect with us on Facebook, Instagram and LinkedIn.

For more information, please contact

Bhavin Vaid
Head of Corporate Communications
+41 58 301 09 52 (direct)
+41 79 191 06 32 (mobile)
bhavin.vaid@ferring.com

Lindsey Rodger
Senior Manager, Corporate Communications
+41 58 451 40 23 (direct)
+41 79 191 0486 (mobile)
lindsey.rodger@ferring.com

References

1. Ferring Pharmaceuticals. Data on file 2018.
2. Nieschlag E, Behre HM (eds). Andrology: male reproductive health and dysfunction. 3rd edn. Heidelberg: Springer, 2010.
3. Dohle G. et al. Guidelines on Male Hypogonadism. EAU guidelines 2017. Available at: http://uroweb.org/guideline/male-hypogonadism/#note_4 Last accessed: March 2018
4. Belkoff L. et al. Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open label studies. Andrologia 2018 Feb;50(1). doi: 10.1111/and.12801. Epub 2017 Mar 10.
5. Arver S. et al. A new 2% testosterone gel formulation: A comparison with currently available topical preparations. In Press. Andrology 2018.
6. Cunningham G et al. Efficacy and safety of a new topical testosterone replacement gel therapy for the treatment of male hypogonadism. Endocr Pract 2017;23(5):557-565.
7. Testavan Summary of Product Characteristics. Ferring Pharmaceuticals.
8. Alberti I. et al. Pharmaceutical development and clinical effectiveness of a novel gel technology for transdermal drug delivery. Expert Opin Drug Deliv 2005;2:935-950.
9. Olsson H. et al. Pharmacokinetics and Bioavailability of a New Testosterone Gel Formulation in Comparison to Testogel in Healthy Men. Clin Pharmacol Drug Dev 2014;3(5):358-64.
10. Efros M., Carrara D., Neijber A. The efficacy, bioavailability and safety of a novel hydroalcoholic testosterone gel 2% in hypogonadal men: results from phase II open-label studies. Andrologia 2016;48(6):637-645.
11. Kalyani RR, Dobs AS. Androgen deficiency, diabetes, and the metabolic syndrome in men. Curr Opin Endocrinol Diabetes Obes 2007;14(3):226-234.
12. García-Cruz E. et al. Metabolic syndrome in men with low testosterone levels: relationship with cardiovascular risk factors and comorbidities and with erectile dysfunction. J Sex Med 2013;10(10);2529-2538.
13. Rodriguez-Tolrà J. et al. Effects of testosterone treatment on bone mineral density in men with testosterone deficiency syndrome. Andrology 2013;1(4):570-575.
14. Zarotsky V. et al. Systematic literature review of the risk factors, comorbidities, and consequences of hypogonadism in men. Andrology 2014;2(6):819-834.

March of Dimes and Ferring announce new Prematurity Research Center at Imperial College London

White Plains, N.Y., USA and Saint-Prex, Switzerland, 7 March 2018 –

March of Dimes and Ferring Pharmaceuticals today announced that March of Dimes has selected Imperial College London as the first European partner to join its network of Prematurity Research Centers working to find the unknown causes of preterm birth and new ways to prevent it.

This March of Dimes Prematurity Research Center at Imperial College London is supported by a grant from Ferring Pharmaceuticals. Both Ferring and March of Dimes are committed to advancing research to help prevent the 15 million preterm births each year worldwide. Preterm birth is responsible for 1.1 million infant deaths each year.¹

“We’re delighted that the talented scientists at Imperial College London will join as the sixth March of Dimes Prematurity Research Center to help us get closer to a world in which all babies are born healthy,” said Stacey D. Stewart, president of March of Dimes. “It’s vital that our team is able to share information and findings with colleagues outside of the U.S., in order to accelerate the discovery of solutions to the serious problem of premature birth.”

“Globally, too many babies are being born too soon, and too many families are suffering the consequences,” said Per Falk, Executive Vice President and Chief Science Officer, Ferring Pharmaceuticals.  “Ferring is committed to addressing unmet patient needs in reproductive medicine and women’s health, including the growing rates of preterm birth worldwide. We believe that this new center will accelerate the development of new healthcare solutions that are urgently needed to help babies that are born earlier than expected.”

Phillip Bennett, Professor of Obstetrics and Gynaecology at Imperial College London, and the principal investigator of the new Center, said, “We are proud to have been selected to join the March of Dimes Prematurity Research Center family. Imperial College London and its partner hospitals have renowned clinics for supporting women who deliver preterm, as well as a long tradition of ground-breaking research in this area. As London is a truly global city, we are also fortunate to encompass a large and diverse patient population.”

“Our teams of world-class scientists will be using the latest technologies, some unique to Imperial, to study how the body recognises and interacts with bacteria and other microbes in the birth canal. This will enable us to develop methods for predicting–and ultimately preventing–preterm birth.”

The March of Dimes European Prematurity Research Center at Imperial College London will be a partnership between the College and three major London hospitals: Queen Charlotte’s and Chelsea, St. Mary’s Hospital, and Chelsea and Westminster. Each of these hospitals deliver around 5,000 babies a year.

The network of March of Dimes Prematurity Research Centers encompasses approximately 200 scientists in numerous fields, including obstetrics, neonatology, genetics and genomics, immunology, engineering, informatics, and social sciences. (NOTE: See below for a complete list of the Prematurity Research Centers).

Each March of Dimes Prematurity Research Center is assigned a theme or research target. The theme selected for Imperial College London is entitled, “Microbe-Host Interactions.” This team of scientists will identify and characterise these complex processes in order to obtain insight into why some women are at higher risk for preterm birth.

About Preterm Birth

Preterm birth (before 37 weeks of pregnancy) and its consequences are the leading cause of death among children under age five worldwide. Babies who survive an early birth often face lifelong health challenges, such as breathing problems, cerebral palsy, and learning disabilities. The preterm birth rate is on the rise in the United States, climbing for a second year in a row in 2016.

Quick viewable link for B-roll footage on preterm birth: https://www.youtube.com/watch?v=FbFhPnJy3B0

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative and personalised healthcare solutions to help mothers and babies, from conception to birth. Founded in 1950, Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Learn more at www.ferring.com and @Ferring, or connect with us on Facebook, Instagram and LinkedIn.

About Imperial College London

Imperial College London is one of the world’s leading universities. The College’s 17,000 students and 8,000 staff are expanding the frontiers of knowledge in science, medicine, engineering and business, and translating their discoveries into benefits for our society.

Imperial is the UK’s most international university, according to Times Higher Education, with academic ties to more than 150 countries. Reuters named the College as the UK’s most innovative university because of its exceptional entrepreneurial culture and ties to industry.

About March of Dimes

March of Dimes leads the fight for the health of all moms and babies. We support research, lead programs and provide education and advocacy so that every family can have the best possible start. Building on a successful 80-year legacy of impact and innovation, we stand up for every mom and every baby. Visit marchofdimes.org or nacersano.org for more information. Visit shareyourstory.org for comfort and support. Find us on Facebook and follow us on Instagram and Twitter.

Because premature birth is such a complex problem, with multiple causes, March of Dimes has chosen Prematurity Research Centers and partners who can use different tools and methods to examine the factors involved in different ways. Each center’s work informs and amplifies the work the other centers are pursuing.

The other five March of Dimes Prematurity Research Centers are located at (with date of launch):

• Stanford University School of Medicine (2011);
• Ohio Collaborative (2013);
• Washington University in St. Louis (2014);
• University of Pennsylvania Perelman School of Medicine (2014);
• University of Chicago-Northwestern University-Duke University (2015).

For more information, please contact

Ferring Pharmaceuticals

Bhavin Vaid
Head of Corporate Communications
+41 58 301 0952 (direct)
+41 79 191 0632 (mobile)
bhavin.vaid@ferring.com

Lindsey Rodger
Senior Manager, Corporate Communications
+41 58 451 4023 (direct)
+41 79 191 0486 (mobile)
lindsey.rodger@ferring.com

Imperial College London

Hannah MacLachlan
Head of Communications
+44 (0) 207 594 6704
h.maclachlan@imperial.ac.uk

Kate Wighton
Research Media Officer – Medicine
+44 (0) 207 594 2409
k.wighton@imperial.ac.uk

March of Dimes

Michele Kling
Director of Media Relations
+1 (914) 997 4613
mkling@marchofdimes.org

References

1. Born Too Soon: The Global Action Report on Preterm Birth. (WHO, March of Dimes) 2012.

Ferring Pharmaceuticals and MSD Announce Completion of Largest Clinical Trial Ever Conducted in Postpartum Haemorrhage

• Excessive bleeding after childbirth (postpartum haemorrhage or PPH) is the leading direct cause of maternal mortality worldwide

• The CHAMPION trial is assessing the effectiveness and safety of heat-stable carbetocin vs. oxytocin, the current standard of care, for preventing PPH after vaginal birth,

Saint-Prex, Switzerland, & Kenilworth, N.J., February 22, 2018

Ferring Pharmaceuticals and MSD, known as Merck & Co., Inc., Kenilworth, N.J., U.S.A., through its MSD for Mothers initiative, today announced the completion of CHAMPION (Carbetocin Haemorrhage Prevention), a global clinical trial conducted by the Human Reproduction Program (HRP) at the World Health Organization (WHO). CHAMPION is investigating whether Ferring’s proprietary and heat-stable carbetocin could offer a new solution to prevent excessive bleeding after childbirth (postpartum haemorrhage or PPH).^2,3 Involving nearly 30,000 women in 10 countries, it is the largest clinical trial ever conducted in PPH.^2,3

Each year, 14 million mothers are affected by PPH.¹ As the leading direct cause of maternal mortality, 480,000 mothers died from PPH between 2003-09.¹ Even when women survive, PPH can result in the need for serious medical interventions, including surgical removal of the uterus (hysterectomy) as well as blood transfusions to address severe anemia.² By preventing PPH from ever occurring, heat-stable carbetocin has the potential to both save lives and avoid severe, dangerous and costly long-term side effects.

“Despite progress towards the UN Sustainable Development Goal of reducing maternal mortality, every single day women across the world are dying unnecessarily from childbirth complications such as PPH. Timely administration of effective medicines can avoid the maternal deaths that occur due to excessive bleeding after childbirth,”³ said Mariana Widmer, Technical Officer, Maternal and Perinatal Health, WHO. “If the results of the trial for heat-stable carbetocin are favourable, this collaboration between private life sciences and the global public health community could help save women’s lives worldwide.”

The CHAMPION trial compares the effectiveness and safety of Ferring’s heat-stable carbetocin versus the current standard of care, oxytocin, for preventing PPH after vaginal birth.^2,3 Heat-stable carbetocin could  address a significant limitation associated with oxytocin – the need for refrigeration during shipping and storage to prevent degradation in temperatures above 8°C.^3,4 Heat-stable carbetocin may remain active long-term in hot and humid climates,³ and could potentially reduce the incidence of PPH in areas where cold storage is difficult to achieve and maintain,^3,4 and where 99% of maternal deaths due to PPH currently occur.⁴

“Using our established expertise in Reproductive Medicine and Women’s Health, we strive to find innovative treatments that will help to dramatically reduce the number of mothers dying as a result of childbirth,” said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. “Our heat-stable carbetocin is just one example of this research effort and forms part of our ongoing commitment to safeguarding the health of families worldwide. We are looking forward to seeing the results from the CHAMPION trial and hope that the learnings will usher in a new era in the prevention of PPH.”

If the results of the CHAMPION trial are favourable, Ferring will seek registration of heat-stable carbetocin on a broad basis around the world. If approved, Ferring would manufacture the product and it would be provided to the public sector of low- and lower-middle-income countries at an affordable and sustainable access price. Results from the trial are expected to be presented and published during the second half of 2018.

“The CHAMPION trial has the potential to change the paradigm in how we save more mothers from dying during childbirth,” said Julie L. Gerberding, M.D., M.P.H. Executive Vice President & Chief Patient Officer, Strategic Communications, Global Public Policy and Population Health at MSD. “Along with our partners, we recognized that heat-stable carbetocin could be a transformative solution to preventing PPH, which is the number one cause of maternal mortality.  Through MSD for Mothers, we provided our company’s scientific expertise and financial resources to prove the concept and ultimately make a sustainable impact on the health of mothers, families and communities.”

About the CHAMPION* trial

CHAMPION (Carbetocin Haemorrhage Prevention), the world’s largest clinical trial in postpartum haemorrhage, is being undertaken to compare the effectiveness and safety of heat-stable carbetocin to oxytocin in the prevention of postpartum haemorrhage after vaginal births. The trial conducted by the Human Reproduction Program (HRP) at the World Health Organization enrolled nearly 30,000 women in 10 countries including Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the UK. Heat-stable carbetocin was researched and developed by Ferring Pharmaceuticals and the CHAMPION trial was funded by MSD for Mothers.

About Ferring Pharmaceuticals:

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative and personalised healthcare solutions to help mothers and babies, from conception to birth. Founded in 1950, Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Learn more at www.ferring.com and @Ferring, or connect with us on Facebook, Instagram and LinkedIn.

About MSD for Mothers

Every day, approximately 830 women die from preventable causes related to pregnancy and childbirth.⁵  MSD for Mothers is a 10-year, $500 million initiative to create a world where no woman dies from complications of pregnancy and childbirth. Drawing on the company’s history of discovering innovative, life-saving medicines and vaccines, MSD for Mothers is applying the company’s scientific and business expertise – as well as its financial and human resources – to reduce maternal mortality around the world. Learn more at http://www.msdformothers.com/and @MSDforMothers.

About MSD

For more than a century, MSD, a leading global biopharmaceutical company, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit http://www.msd.com/ and connect with us on Twitter, LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co. Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2016 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov)

For more information, please contact

Ferring Pharmaceuticals

Bhavin Vaid
Head of Corporate Communications
+41 58 301 0952 (direct)
+41 79 191 0632 (mobile)
bhavin.vaid@ferring.com

Lindsey Rodger
Senior Manager, Corporate Communications
+41 58 451 4023 (direct)
+41 79 191 0486 (mobile)
lindsey.rodger@ferring.com

MSD for Mothers

Claire Gillespie
+1 267-305-0932

References

1. Say L. et al. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33.
2. Australian New Zealand Clinical Trial Registry. Available at: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366743 Last accessed: January 2018.
3. Widmer M. et al. Room temperature stable carbetocin for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally: study protocol for a randomized controlled trial. Trials. 2016;17(1):143. doi: 10.1186/s13063-016-1271-y.
4. World Health Organization. Priority diseases and reasons for inclusion. Postpartum haemorrhage. Available at: http://www.who.int/medicines/areas/priority_medicines/Ch6_16PPH.pdf Last accessed: January 2018.
5. El-Refaey H. and Rodeck C. Post-partum haemorrhage: definitions, medical and surgical management. A time for change. British Medical Bulletin. 2003;67:205–217.
6. Every Woman Every Child. The global strategy for women’s, children’s and adolescent’s health (2016-2030) 2015. Available from: http://www.who.int/life-course/partners/global-strategy/ewec-globalstrategyreport-200915.pdf?ua=1  Last accessed: January 2018.
7. Torloni MR. et al. Quality of Oxytocin Available in Low and Middle-Income Countries: A Systematic Review of the Literature (Systematic Review on Quality of Oxytocin). BJOG. 2016;123(13):2076-2086.
8. World Health Organization. Maternal Mortality Fact Sheet. Available at: http://www.who.int/mediacentre/factsheets/fs348/en/  Last accessed: January 2018.