Swissmedic approves Carbetocin Ferring for the prevention of postpartum haemorrhage in all births

• Excessive bleeding after birth, also known as postpartum haemorrhage (PPH), is the leading direct cause of maternal mortality worldwide,¹ causing approximately 70,000 deaths each year¹ – 99% of which occur in low- and lower-middle income countries²

• Carbetocin Ferring is the first medicine approved under the new Swissmedic and Marketing Authorisation for Global Health Products (MAGHP) procedure,³ which aims to build capacity and speed up access to essential medicines in low- and middle-income countries⁴

• Ferring developed this heat-stable formulation of carbetocin to specifically address limitations in refrigeration and cold-chain transport of PPH medications in low- and lower-middle income countries⁵

• Heat-stable carbetocin is recommended for PPH prevention in settings where oxytocin is unavailable or its quality cannot be guaranteed, and where its cost is comparable to other effective uterotonics⁶

Nigeria: Anita suffered from postpartum haemorrhage after the birth of her first child, and needed a blood transfusion to save her life.

Saint-Prex, Switzerland – 13 May, 2020 – Ferring Pharmaceuticals today welcomes the Swissmedic approval of Carbetocin Ferring, a heat-stable formulation of carbetocin, for the prevention of excessive bleeding after childbirth following all births, both vaginal and caesarean section.⁵

Every year, 14 million women experience excessive bleeding after birth, also known as postpartum haemorrhage (PPH),² which leads to approximately 70,000 deaths per year.¹ Although most deaths are preventable, PPH is the leading direct cause of maternal death worldwide,¹ 99% of which occur in low- and lower-middle income countries.²

Carbetocin Ferring is the first medicine approved under the new Swissmedic procedure for scientific advice and Marketing Authorisation for Global Health Products (MAGHP). The MAGHP procedure builds on the existing Swissmedic procedure for Marketing Authorisation and makes it accessible to representatives of regulatory authorities in low- and middle-income countries. The procedure’s objective is to make essential medicines, like Carbetocin Ferring, available faster for patients in low- and middle-income countries.⁴

“As the COVID-19 pandemic impacts healthcare systems, communities and families all over the world, protecting maternal health has never been so critical. This milestone approval marks the first step towards ensuring that this innovative medicine reaches the women who need it – and reducing the thousands of preventable deaths from PPH every year, said Per Falk, President and Chief Science Officer at Ferring Pharmaceuticals. It is thanks to the collaboration with the World Health Organization and MSD for Mothers that we can mark this milestone and work towards development goals in global health.”

This landmark approval in Switzerland paves the way as Ferring now seeks registrations for Carbetocin Ferring for the prevention of PPH following all births, in low- and lower-middle income countries, where the burden of maternal mortality is greatest. Ferring is initially working with governments and partners in India, Kenya and Nigeria to secure the approval and introduction of Carbetocin Ferring, so that patients who need it can access it as soon as possible.

“This regulatory milestone is testament to the potential that public-private partnerships hold to address public health challenges, said Dr Julie L. Gerberding, chief patient officer at MSD. Our ultimate goal through MSD for Mothers is to help create a world where no woman has to die while giving life. Today’s announcement brings us one step closer to realizing this vision by improving the response to prevent PPH.”

Carbetocin Ferring ampoules will be made available by Ferring at an affordable and sustainable price* to publicly controlled or publicly funded healthcare facilities and healthcare facilities operating on a not-for-profit basis, including through social marketing, in low- and lower-middle income countries. Ferring will supply Carbetocin Ferring from state-of-the-art manufacturing sites that have passed Good Practice Manufacturing inspections by stringent regulatory authorities.

“The loss of any woman during childbirth is a tragedy. Yet so many of the deaths caused by postpartum haemorrhage can be prevented, said Dr. Yeshita V Pujar, Consultant gynaecologist-obstetrician, Kles Prabhakar Kore Hospital & Medical Research Centre. This heat-stable formulation of carbetocin will play an important role in PPH prevention in countries which carry the greatest burden of maternal mortality, especially low- and lower-middle income countries. Many of these are in hotter parts of the world where cold-chain storage remains difficult to achieve and maintain. A heat-stable alternative for the prevention of PPH will be critical in saving maternal lives in settings where other effective uterotonics are unavailable or their quality cannot be guaranteed.”

Heat-stable carbetocin is included on the World Health Organization (WHO) Model List of Essential Medicines (EML),⁸ and in the WHO recommendations on uterotonics for the prevention of postpartum haemorrhage. The EML identifies medicines essential for addressing the most important public health needs globally.⁷ The guidelines recommend heat-stable carbetocin for the prevention of PPH in settings where oxytocin is unavailable or its quality cannot be guaranteed, and where its cost is comparable to other effective uterotonics.**⁶

About the CHAMPION trial⁹

CHAMPION (Carbetocin Haemorrhage Prevention), the largest clinical trial in the prevention of PPH,*** was a double-blind, randomised, non-inferiority trial designed to compare the effectiveness and safety of investigational heat-stable carbetocin to oxytocin in the prevention of PPH after vaginal birth. The trial was funded by MSD for Mothers.**** Heat-stable carbetocin is a long-acting uterotonic developed by Ferring Pharmaceuticals.

* This price is a subsidised price of $0.31 +/- 10% per ampoule of 100 µg Carbetocin Ferring, Ex Works. This is comparable to the current United Nations Population Fund price for oxytocin of $0.32 per unit (10 I.U.).¹⁰

** The availability of Carbetocin Ferring is subject to regulatory review and approval in relevant countries.

*** Accurate as of trial closure in 2018

**** MSD for Mothers is an initiative of Merck & Co., Inc., Kenilworth, N.J., U.S.A.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, speciality biopharmaceutical group committed to helping people around the world build healthy families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned 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 79 191 0632 (mobile)
bhavin.vaid@ferring.com

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

References

1. 1. Say L, et al. Global causes of maternal death: a WHO systematic analysis. Lancet Global Health. 2014; 2(6):e323-e333. Available at: https://www.thelancet.com/pdfs/journals/langlo/PIIS2214-109X(14)70227-X.pdf Last accessed: May 2020
   2. WHO. Priority diseases and reasons for inclusion. Postpartum haemorrhage. Available at: http://www.who.int/medicines/areas/priority_medicines/Ch6_16PPH.pdf Last accessed: May 2020
   3. Swissmedic. First MAGHP approval in Switzerland. Available at: https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/authorisations/informationen/first-maghp-approval-inswitzerland.html Last accessed: May 2020
   4. Swissmedic. Swissmedic procedure for scientific advice and Marketing Authorisation for Global Health Products (MAGHP). Available at: https://www.swissmedic.ch/swissmedic/en/home/about-us/development-cooperation/marketing-authorisation-for-global-health-products.html Last accessed: May 2020
   5. World Bank. World Bank Country and Lending Groups. Published 2019. Available at: https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups Last accessed: May 2020
   6. WHO. WHO recommendations: Uterotonics for the prevention of postpartum haemorrhage. Available at: https://apps.who.int/iris/bitstream/handle/10665/277276/9789241550420-eng.pdf?ua=1 Last accessed: May 2020
   7. Data on file
   8. WHO Model List of Essential Medicines. Available at: https://apps.who.int/iris/handle/10665/325771 Last accessed: May 2020
   9. Widmer M, et al. Heat stable carbetocin vs oxytocin to prevent hemorrhage after vaginal birth. New England Journal of Medicine 2018;379:743-752
   10. UNFPA Procurement Services. Oxytocin 10 I.U./ml injection in 1ml ampoule. www.unfpaprocurement.org/products?id=OXYTOCIN_10IU/ML Last accessed: May 2020

Rebiotix and Ferring announce world’s first with positive preliminary pivotal Phase 3 data for investigational microbiome-based therapy RBX2660

• Rebiotix and Ferring are the first to announce positive preliminary results on primary efficacy endpoint from ongoing pivotal Phase 3 clinical trial for RBX2660

• RBX2660 is an investigational, non-antibiotic, microbiome-based therapy, developed to reduce Clostridioides difficile (C. diff) infection recurrences

• CDC defines C. diff as a major burden to patients and doctors and an urgent healthcare threat causing an estimated half a million illnesses and thousands of deaths annually in the US alone ^{1, 2}

Roseville, Minnesota and Saint-Prex, Switzerland – 6 May, 2020, 07:00 EST – Today, Rebiotix and Ferring Pharmaceuticals announced positive preliminary findings from their ongoing pivotal Phase 3 trial of the investigational microbiome-based treatment, RBX2660. These preliminary positive efficacy findings mark an important milestone, advancing RBX2660 in its clinical development program with a goal of bringing a US FDA approved therapy to patients. The clinical development program for RBX2660 is the most advanced in the world in evaluating the safety and efficacy of a standardized, non-antibiotic microbiome-based therapy.

RBX2660 is being developed to reduce C. diff infection recurrences, an urgent unmet need for patients and healthcare providers worldwide. Antibiotics, the current standard of care, have been shown to disrupt the microbiome and increase the risk of C. diff recurrence.³ C. diff causes nearly 30,000 deaths each year in the US; in Europe, the incidence of C. diff is increasing, with recurrent bouts of infection representing 10-15% of all healthcare-related infections in hospitals annually.^{4, 5} As a live biotherapeutic, aiming to help restore the gut microbiome community, RBX2660 may bring an innovative therapeutic option to patients suffering from this potentially deadly infection.

“C. diff infection is a significant public health threat that has limited treatment options. These positive preliminary findings represent a major step forward towards bringing an innovative, non-antibiotic option to patients that may help restore their gut microbiome, said Per Falk, Ferring’s President and Chief Science Officer. With health systems under increasing pressure due to viruses like COVID-19 and the rising threat of antimicrobial resistance, the need for new therapies is greater than ever. We believe the power of the microbiome has great potential and we look forward to bringing RBX2660 to patients soon.”

“Since founding Rebiotix in 2011, our mission has been to harness the power of the microbiome to treat complex diseases. Our first goal was to address C. diff, which poses a significant health threat to thousands worldwide every year,” said Lee Jones, CEO and founder of Rebiotix, a Ferring company. The positive preliminary data on the primary efficacy endpoint are a major stepping stone for the RBX2660 development program, bringing us closer to an approved microbiome therapy available for healthcare providers to help patients. As a first-in-class, potentially paradigm-changing technology, we look forward to discussing our final data with the FDA in the latter part of this year.”

The ongoing Phase 3 trial is a randomized, multicenter, double-blinded, placebo-controlled study. The trial also incorporates a safety assessment intended to follow patients for several months after receiving the investigational drug. The safety data will provide insight into the potential of using microbes as a therapeutic intervention. The full data package is anticipated in the second half of 2020.

This trial builds on nearly a decade of research and evaluation of the formulation, with robust clinical and microbiome data collected over multiple controlled trials under the proprietary MRT™ drug platform.

Notes to editors

About Clostridioides difficile infection (C. diff)

C. diff is a bacterium that causes diarrhea and colitis (an inflammation of the colon). It is estimated to cause up to half a million illnesses in the US alone every year and is considered an urgent threat to public health by the CDC, and can lead to severe complications, including hospitalization, surgery, and death.² While antibiotics are the standard of care to address the infection, they are also the primary risk factor for disease recurrence.³ Recurrence of C. diff occurs in approximately 15-50% of patients.⁷

About the microbiome

The human microbiome is a complex community of microorganisms which live on every surface of the body. The microbiome aids in the maintenance and development of the immune system, metabolism, and other functions essential to human life.⁸ The gastrointestinal tract houses the most dense and complex population of microbiota, which has an incredible influence over daily health – from aiding in food digestion to fighting disease. Clinical and scientific studies indicate antibiotics, viruses, stress and other factors can disturb the gut microbiota. This disruption, often referred to as “dysbiosis,” may have negative health impacts, and promote conditions for infections like C. diff infection to take hold.⁹ Rebiotix and Ferring believe there is tremendous potential in microbiota-based therapies to address such illnesses, and are evaluating this therapeutic option through their pioneering microbiota-based MRT™ drug platform, beginning with recurrent C. diff infection.

About RBX2660

The investigational RBX2660 formulation is the first-in-class microbiota-based therapy to achieve positive preliminary Phase 3 study results. RBX2660 is being developed to help break the cycle of recurrent C. diff infection. The therapy has been granted Fast Track, Orphan, and Breakthrough Therapy designations from the US FDA. The RBX2660 ongoing pivotal Phase 3 trial, PUNCH CD3, is a randomized, multicenter, double-blinded, placebo-controlled study. For more information about the RBX2660 Phase 3 study, visit www.clinicaltrials.gov (NCT03244644).

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 maternal health, and in specialty areas within gastroenterology and urology. Founded in 1950, privately-owned 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

Rebiotix Inc, part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRT™ drug platform. The platform consists of investigational drug technologies designed to potentially rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract. For more information on Rebiotix and its pipeline of human microbiome-directed therapies for diverse disease states, visit www.rebiotix.com, or connect with us on Twitter, Facebook, LinkedIn and YouTube.

For more information, please contact

Courtney Jones
Marketing Manager
Rebiotix Inc., a Ferring Company
+1 651 705 8774 (direct)
courtney.jones@ferring.com

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

References

1. Centers for Disease Control and Prevention. What Is C. Diff?17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html

    

2. Centers for Disease Control and Prevention. Biggest Threats and Data, 14 Nov. 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html

    

3. Theriot CM, Young VB. Microbial and metabolic interactions between the gastrointestinal tract and Clostridium difficile infection. Gut Microbes. 2013;5(1):86-95. doi:10.4161/gmic.27131.

    

4. Lessa FC, Mu Y, Bamberg WM, et al., Burden of Clostridium difficile Infection in the United States. New England Journal of Medicine. 2015;372(9):825-834. doi:10.1056/nejmoa1408913.

    

5. DRG Report 2016 Clostridium Difficile.

    

6. Centers for Disease Control and Prevention. Clostridioides difficile Fact Sheet. Available at: https://www.cdc.gov/cdiff/pdf/Cdiff-Factsheet-P.pdf

    

7. Stevens VW, Nelson RE, Schwab-Daugherty EM, et al., Comparative Effectiveness of Vancomycin and Metronidazole for the Prevention of Recurrence and Death in Patients with Clostridium difficile Infection. JAMA Intern Med. 2017;177(4):546–553. doi:10.1001/jamainternmed.2016.9045.

    

8. Mohajeri MH, Brummer RJM, Rastall RA, et al., The role of the microbiome for human health: from basic science to clinical applications. Eur J Nutr. 2018;57(Suppl 1):1–14. doi:10.1007/s00394-018-1703-4.

    

9. Quigley EM. Gut bacteria in health and disease. Gastroenterol Hepatol (N Y). 2013;9(9):560–569.

Rebiotix, a Ferring Company, Completes Enrollment for First-Ever, Pivotal Phase 3 Clinical Trial of Microbiota-based RBX2660

• Enrollment completion for the first Phase 3 clinical trial in microbiome industry

• Largest randomized, double-blinded study, with over 300 patients enrolled aimed to demonstrate the potential benefit of RBX2660 in reducing rates of recurrent Clostridioides difficile (C. diff) infection

• Rebiotix intends to use the results from the Phase 3 trial to serve as the basis for licensure application to the US FDA

Saint-Prex, Switzerland – February 4, 2020 –

Rebiotix, a Ferring company, announced today that it has completed enrollment of the pivotal Phase 3 clinical trial for RBX2660, an investigational therapy aimed at breaking the cycle of recurrent Clostridioides difficile (C. diff) infection, which is responsible for the deaths of thousands of people in the US alone. The Centers for Disease Control and Prevention (CDC) has classified C. diff as an urgent public health threat, with limited options for treatment.

RBX2660 was developed under Rebiotix’s investigational microbiota-based MRT™ drug platform with the goal of delivering standardized, stabilized formulations to meet unmet medical needs. Conducted in the US and Canada, this is the first Phase 3 trial of its kind to be completed using a broad consortia microbiota-based formulation.

“Rebiotix was founded to harness the power of the human microbiome to treat debilitating diseases,” said Lee Jones, Rebiotix Founder and CEO. “Microbiota-based therapies have shown tremendous potential as an innovative, non-antibiotic therapy, starting with C. diff. The completion of enrollment of this trial is a critical next step in making microbiota-based products accessible to patients – we are excited about this important milestone and look forward to sharing results later this year.”

The Phase 3 trial builds on the company’s extensive history with the formulation, including several hundred participants previously enrolled in multiple Phase 2 clinical trials. The robust data collected over the course of the company’s multi-year clinical development program will be eventually presented to the US FDA as part of a Biological License Application (BLA).

Ferring Pharmaceuticals, also with a rich and vast history of microbiome research of its own, led the industry by becoming the first major pharmaceutical company to acquire a microbiome therapeutics company in April 2018. Headquartered in Saint-Prex, Switzerland, Ferring is expected to have the first regulatory approved microbiota-based therapeutic in the world through the potential approval of the RBX2660 in the US.

About Clostridioides difficile Infection

Clostridioides difficile (also known as C. diff) is a bacterium that causes diarrhea and colitis (an inflammation of the colon). C. diff, impacts nearly a half a million people each year in the United States; of those impacted, up to one in five patients will experience a recurrent episode.¹ In 2019, the U.S. Centers for Disease Control listed C. diff as an urgent threat to public health.²

About RBX2660

RBX2660 is currently in Phase 3 clinical development for the reduction of recurrent Clostridioides difficile (C. diff) infection. RBX2660 has been granted Fast Track, Orphan, and Breakthrough Therapy Status designations from the US FDA.

For more information about the RBX2660 Phase 3 study, visit www.clinicaltrials.gov (NCT03244644).

About Rebiotix

Rebiotix Inc., part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRT™ drug platform. The platform consists of investigational drug technologies designed to potentially rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract.

For more information on Rebiotix and its pipeline of human microbiome-directed therapies for diverse disease states, visit www.rebiotix.com.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build healthy families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned 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

References

1. Centers for Disease Control and Prevention. What Is C. Diff?,17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html.
2. Centers for Disease Control and Prevention. Biggest Threats and Data, 14 Nov. 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html.

Ferring’s Propess® is the first pharmacological treatment for cervical ripening to be approved in Japan for over 20 years

• Ferring announces that the Minister of Health, Labour and Welfare (MHLW) in Japan has approved Propess® (dinoprostone) for the initiation of cervical ripening

• Propess, developed in Scotland, UK, and marketed in over 60 countries, was approved following close collaboration with the patient community in Japan

• This approval provides women in Japan with greater choice and is part of Ferring’s commitment to advancing Reproductive Medicine and Maternal Health worldwide

Saint-Prex, Switzerland – 23rd January, 2020 –

Ferring Pharmaceuticals today announced that Propess^® (dinoprostone) has been approved by the Minister of Health, Labour and Welfare (MHLW) in Japan for initiation of cervical ripening in patients at term (from 37 completed weeks of gestation).¹

This is the first time in over 20 years that a pharmacological therapy for cervical ripening has been approved in the country.²

Around 10 per cent of births globally require induction of labour, which may be required if the health of the mother or baby is at risk3 ^3,4 Cervical ripening is carried out prior to induction to prepare the cervix for birth. This approval offers women requiring an induction in Japan greater choice of alternatives to mechanical methods of cervical ripening.

“The approval of Propess in Japan is a big step forward in offering women more choice when it comes to cervical ripening,” said Per Falk, President and Chief Science Officer, Ferring Pharmaceuticals. “There is a lack of research and development of treatment options for women who are pregnant or giving birth, which is why it is important for Ferring to continue to invest and advance the field of Reproductive Medicine and Maternal Health and continue with our purpose of building families worldwide.”

The announcement today follows a close collaboration between Ferring Pharmaceuticals and a local patient advocacy group to ensure the needs and safety of women in labour are addressed in Japan.

“For women giving birth, mechanical methods may not always be the right option and it is important that a woman’s safety and comfort is paramount,” said Mikiya Kitamura, Vice President, Ferring Japan R&D. “Ensuring that a treatment is safe and effective is a priority for us, and we are pleased to have been able to work together with our local patient advocacy group on this significant milestone.”

Propess is currently marketed in over 60 countries and was developed in the 1980s in Scotland where it continues to be manufactured. As leaders in Reproductive Medicine and Maternal Health, this approval demonstrates Ferring’s continued commitment to helping people around the world to build healthy families.

About Propess⁵

Propess is a vaginal delivery system containing the active substance dinoprostone 10 mg used for the initiation of cervical ripening in women at term (from 37 completed weeks of gestation). The dinoprostone softens and opens the part of the birth canal known as the cervix, to start the process of labour.

About labour⁶

Labour is initiated or induced by obstetricians in situations where it is considered safer, for the mother or the unborn child, to be delivered. This could be due to pre-eclampsia (sudden, severe rise in blood pressure and kidney impairment), poor growth in the baby, unexplained bleeding in the last phase of pregnancy or a prolonged pregnancy (the most common reason). The success of induction of labour is related to the condition of the cervix prior to the induction. If during examination of the cervix length, positioning and softening, it is deemed unfavourable, then cervical ripening will be initiated.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build healthy families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned 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 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

References

1. Minister of Health, Labour and Welfare (MHLW). Approval of Propess (dinoprostone). January 2020. Japan New Drug Application (NDA) approval document.
2. Ferring Pharmaceuticals. Data on file. January 2020.
3. World Health Organization. WHO Recommendations for Induction of Labour. Geneva: World Health Organization; 2011. Available at: https://www.who.int/reproductivehealth/publications/maternal_perinatal_health/9789241501156/en/ Last accessed: January 2020.
4. The American College of Obstetricians and Gynecologists. Frequently asked questions: Labor delivery and postpartum care. Available at: https://www.acog.org/Patients/FAQs/Labor-Induction?IsMobileSet=false Last accessed: January 2020.
5. Propess summary of product characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/135/smpc. Last accessed: January 2020.
6. World Health Organization. Managing complications in pregnancy and childbirth: a guide for midwives and doctors – 2nd ed. Geneva: World Health Organization; 2017. Available at: https://www.who.int/maternal_child_adolescent/documents/managing-complications-pregnancy-childbirth/en/. Last accessed: January 2020.

FerGene Appoints David Meek Chief Executive Officer

CAMBRIDGE, Mass. – December 19, 2019 –

FerGene, a new gene therapy company launched by Ferring Pharmaceuticals and Blackstone Life Sciences in November, today announced the appointment of David Meek as President and Chief Executive Officer, effective January 14, 2020.

Mr. Meek has 30 years of industry experience. Most recently, he has served as CEO of Ipsen, a leading global biopharmaceutical company focused on innovation and specialty care and dedicated to improving lives through the discovery of new medicines in oncology, neuroscience and rare diseases.

“I’m honored to lead FerGene in this exciting role and spearhead the effort to develop and commercialize this critical and innovative therapy and advance its clinical development. We will build a committed, patient-centric team and with the support from Ferring and Blackstone Life Sciences, I am confident we can efficiently and effectively bring this life changing therapy to patients in need,” said Mr. Meek.

Jean Duvall, Co-Chair of FerGene and Executive Committee member of Ferring Pharmaceuticals, said, “We are extremely confident in David and his ability to lead and build FerGene as it seeks to bring a promising therapy to market for bladder cancer patients and improve the standard of care. With an impressive track record of corporate leadership experience, David is poised to excel in this role.”

Paris Panayiotopoulos, Co-Chair of FerGene and Blackstone Life Sciences Managing Director, said, “We are thrilled to welcome David as FerGene’s new CEO. David’s proven track record of growing businesses across both Biotech and Pharma, as well as his deep knowledge of the US Oncology market, make him the ideal fit to lead FerGene. David’s experience will be instrumental as we advance a breakthrough investigational gene therapy that offers the potential to meaningfully improve the standard of care for a patient population which has seen little innovation over the past twenty years.”

FerGene was launched in November 2019 with a focus on US commercialization of nadofaragene firadenovec (rAd-IFN/Syn3), an investigational novel gene therapy in late stage development for patients with high-grade, Bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC).

FerGene also recently announced Phase 3 study results of nadofaragene firadenovec, which FerGene reports met its primary endpoint with more than half of patients with high-grade, BCG unresponsive non-muscle invasive bladder cancer (cis ± ta/t1) achieving a complete response at three months.

While at Ipsen, Mr. Meek has led a growth strategy of financial results and pipeline advancement. He has also transformed Ipsen into a global biopharma growth leader with initiatives to transform external innovation, Ipsen’s R&D operations and build out the company’s footprint in countries like the U.S. and China. In addition to his time as CEO of Ipsen, Mr. Meek’s prior leadership roles have included serving as Executive Vice President & President of Oncology at Baxalta from 2014 – 2016, following its spin-off from Baxter. He was also Chief Commercial Officer of Endocyte from 2012 – 2014. Prior to that, Mr. Meek served in various executive leadership roles at Novartis Pharma and Novartis Oncology after beginning his career at Johnson & Johnson and Janssen from 1989 – 2004.

About nadofaragene firadenovec

Nadofaragene firadenovec (rAd-IFN/Syn3) is an investigational gene therapy being developed as a treatment for patients with high-grade, BCG unresponsive, NMIBC. It is an adenovirus vector-based gene therapy containing the gene interferon alfa-2b, administered by catheter into the bladder every three months. The vector enters the cells of the bladder wall, where, it breaks down, releasing 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 thereby turns the patient’s own bladder wall cells into multiple interferon microfactories, enhancing the body’s natural defenses against the cancer.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

NMIBC is an early form of bladder cancer which is present in the superficial layer of the bladder and has not invaded deeper into the bladder or spread to other parts of the body.¹ It is estimated that there will be 80,000 new cases of bladder cancer in the U.S. in 2019; more than 70% of these cases present as NMIBC.^2,3 In patients with high-grade NMIBC, intravesical BCG is the recommended treatment; however, between 30% and 50% cases with high-grade disease will recur.⁴ The outcome for BCG unresponsive patients is poor, with total cystectomy (complete removal of the bladder) often being the next treatment option.⁵

About FerGene

FerGene, a new gene therapy company and Ferring subsidiary, has been created to potentially commercialize nadofaragene firadenovec in the U.S. and to advance the global clinical development. FerGene’s goal is to bring this promising therapy to a patient population which has seen little improvement in their standard of care over the past twenty years. Blackstone Life Sciences will invest $400 million USD and Ferring will invest up to $170 million USD in FerGene.

About Blackstone Life Sciences

Blackstone Life Sciences is a private investment platform with capabilities to invest across the life-cycle of companies and products within the key life science sectors. By combining scale investments and hands-on operational leadership, Blackstone Life Sciences helps bring to market promising new medicines that improve patients’ lives.

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 maternal health, and in specialty areas within gastroenterology and urology. 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 and Public Affairs
Ferring Pharmaceuticals
+41 79 191 0632
bhavin.vaid@ferring.com

References

1. Anastasiadis A, de Reijke TM. Best practice in the Treatment of Nonmuscle Invasive Bladder Cancer. Ther Adv Urol. 2012;4(1):13-32
2. Maruf, M et al., Non invasive bladder cancer: a primer on immunotherapy. Cancer Biol Med. 2016;13(2):194-205.
3. Ghatalia, Pooja et al. “Approved checkpoint inhibitors in bladder cancer: which drug should be used when?.” Therapeutic advances in medical oncology vol. 10 1758835918788310. 30 Jul. 2018, doi:10.1177/1758835918788310.
4. Cambier S et al. EORTC Nomograms and Risk Groups for Predicting Recurrence, Progression, and Disease-specific and Overall Survival in Non–Muscle-invasive Stage Ta–T1 Urothelial Bladder Cancer Patients Treated with 1–3 Years of Maintenance Bacillus Calmette-Guérin. European Urolology. 2016, Vol. 69(1): 60-69.
5. Cookson, M et al.,Use of intravesical valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma in situ of the bladder. Therapeutic Advances in Urology. 2014, Vol. 5(5):181-191.