Business Wire

Heat-stable carbetocin has been added to the WHO Essential Medicines List for the prevention of excessive bleeding after childbirth

Share

Ferring Pharmaceuticals today welcomes the World Health Organization’s (WHO) addition of heat-stable carbetocin to the WHO Model List of Essential Medicines (EML) of uterotonics for the prevention of excessive bleeding after birth.1 The EML identifies medicines the WHO deems essential for addressing the most important public health needs globally.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190709005661/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

Nepal: Due to postpartum haemorrhage (PPH), Tulasi was rushed to have emergency blood transfusions after childbirth. Her husband Dinesh felt helpless, but thankfully she recovered. (Photo: Business Wire)

Every year, 14 million women are affected by excessive bleeding after birth, also known as postpartum haemorrhage (PPH).5 Although most deaths are preventable,6 PPH is the leading direct cause of maternal death worldwide,2 causing approximately 70,000 deaths per year,2 99% of which occur in low- and lower-middle income countries.5

“The WHO’s addition of heat-stable carbetocin to the Essential Medicines List brings us one step closer to tackling this life-threatening condition that impacts thousands of women and their families,” said Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. “This milestone is thanks to collaboration from stakeholders around the world, and demonstrates how work across both the public and private sectors can help achieve development goals in global health. As the manufacturer, Ferring is now seeking registrations for heat-stable carbetocin and, once approved, our priority is to make heat-stable carbetocin available at an affordable and sustainable price** in public sector healthcare facilities in low- and lower-middle income countries where cold-chain transport and refrigeration of medicines is often difficult to achieve or maintain.”

This addition to the EML follows the 2018 update to the WHO’s recommendations on uterotonics for the prevention of PPH.3 The guidelines recommend heat-stable carbetocin for the prevention of excessive bleeding after all births in settings where oxytocin is unavailable or its quality cannot be guaranteed, and where its cost is comparable to other effective uterotonics. 3 The CHAMPION trial, the largest clinical trial in PPH prevention, showed that heat-stable carbetocin is non-inferior to current standard of care oxytocin, for the primary outcome of ≥500 ml blood loss or additional uterotonic use, after vaginal birth.7 Heat-stable carbetocin remains effective at high temperatures,8 addressing a significant limitation of oxytocin, which must be stored and transported at 2 – 8°C.9,10

Carbetocin is currently registered in more than 80 countries worldwide for the prevention of PPH due to uterine atony following caesarean section.11 Ferring is now seeking registrations for heat-stable carbetocin for the prevention of PPH following all births. Once approved, the heat-stable formulation of carbetocin will be available at an affordable and sustainable price** to publicly controlled or publicly funded healthcare facilities and healthcare facilities operating on a social marketing basis in low- and lower-middle income countries.

About the EML1
The WHO Model List of Essential Medicines (EML) serves as a guide for the development of national and institutional essential medicine lists and is updated and revised every two years by the WHO Expert Committee on Selection and Use of Medicines.

About the CHAMPION trial7
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, funded by MSD for Mothers*** and conducted by the WHO Department of Reproductive Health and Research including the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), enrolled nearly 30,000 women in ten countries including Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the UK. Heat-stable carbetocin is a long-acting uterotonic developed by Ferring Pharmaceuticals. The results demonstrated that heat-stable carbetocin is non-inferior to the standard of care, oxytocin, for the primary outcome of > 500 ml blood loss or additional uterotonic use. Non-inferiority was not demonstrated for the secondary primary outcome of blood loss of 1000 ml or more, however, the trial was underpowered for this outcome. There were no significant differences between groups in other measures of bleeding or in adverse effects.

* The availability of heat-stable carbetocin is subject to regulatory review and approval in relevant countries.
** This price is a subsidised price of $0.31 +/- 10% per ampoule of 100 µg heat-stable carbetocin. This is comparable to the current United Nations Population Fund price for oxytocin of $0.33 per unit (10 I.U.).12
*** 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 families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women’s health, and in speciality 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.

# # #

References


1 WHO Model List of Essential Medicines. Available at: https://apps.who.int/iris/handle/10665/325771 Last accessed: July 2019

2 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: July 2019

3 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: July 2019

4 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: July 2019

5 WHO. Priority diseases and reasons for inclusion. Postpartum haemorrhage. Available at: http://www.who.int/medicines/areas/priority_medicines/Ch6_16PPH.pdf Last accessed: July 2019.

6 WHO. Maternal mortality – Fact sheets. Published 2018. Available at: www.who.int/news-room/fact-sheets/detail/maternal-mortality Last accessed: July 2019

7 Widmer M, et al. Heat stable carbetocin vs oxytocin to prevent hemorrhage after vaginal birth. New England Journal of Medicine 2018;379:743-752

8 Malm M, et al. Development and stability of a heat-stable formulation of carbetocin for the prevention of postpartum haemorrhage for use in low and middle-income countries. Journal of Peptide Science 2018;e3082

9 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

10 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

11 Ferring Pharmaceuticals. Data on file. 2019

12 UNFPA Procurement Services. Oxytocin 10 I.U./ml injection in 1ml ampoule. www.unfpaprocurement.org/products?id=OXYTOCIN_10IU/ML Last accessed: July 2019

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

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

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Pioneering Impact Strategy, Record EM Sustainable Finance (EMSF), Celebrates Its Fourth Anniversary With Strong Outperformance Since Inception1.7.2025 09:00:00 EEST | Press release

Record Currency Management, in partnership with UBS Wealth Management, is proud to celebrate the fourth anniversary of its pioneering Emerging Market Sustainable Finance (EMSF) Strategy. Operating at the intersection of impact investing, Emerging and Frontier Market currencies and private placements, the strategy offers investors an opportunity to achieve financial returns, alongside measurable impact. Since inception, EMSF has grown to over U$1 billion in AUM and delivered positive returns of +18.7% since inception. The strategy has significantly outperformed both USD and local currency EM Debt benchmarks with around 30% lower volatility - reaffirming that investors need not compromise between financial returns and measurable impact. By taking currency risk across a wide universe of emerging and frontier currencies, EMSF helps MDBs and DFIs raise local currency funding. This allows borrowers in Emerging Markets to receive funding in local currency, eliminating FX risk. Simultaneously,

Lazard Welcomes Klaus H. Hessberger as Managing Director and Global Co-Head of Financial Sponsors Group1.7.2025 08:50:00 EEST | Press release

Lazard, Inc. (NYSE: LAZ) today announced that Klaus H. Hessberger has been appointed to the firm as Managing Director, Global Co-Head, and Head of Europe for Lazard’s Financial Sponsors Group, based in London. Adam Cady, previously Lazard’s Head of Large-Cap Financial Sponsor Coverage North America in New York, has also been named Global Co-Head of the Global Financial Sponsors Group, running the team together with Klaus. These appointments reflect Lazard’s expanding connectivity and partnership with alternative asset managers, which continues to be a principal area of focus and a major source of future growth for the firm globally. Lazard’s recruiting efforts are also a key contributor to the firm’s long-term growth goals, with ongoing success in attracting top tier talent globally. “Klaus is a recognised leader in the global financial sponsor community with an impressive track record of advising global alternative asset managers and leading teams of highly experienced industry profes

Usercentrics Report Reveals: As Concern Over Data Use Grows, Transparency Becomes the Number One Driver for Building Trust1.7.2025 08:28:00 EEST | Press release

59% of consumers are uncomfortable with their data being used to train AI systems, according to a new report from privacy tech leader Usercentrics. But it isn’t AI itself that worries consumers - it’s the lack of clarity around how their data is used. Rather than rejecting innovation, people are demanding greater transparency and control. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630843237/en/ How much do consumers trust companies in various industries when it comes to data collection and use? According to the State of Digital Trust 2025report, based on insights from 10,000 frequent internet users across Europe and the United States, digital privacy has become a strategic imperative. “We’re not witnessing a breakdown in trust, but a reset in expectations,” says Adelina Peltea, CMO at Usercentrics. “In the age of AI, giving users real control over their data isn’t just about compliance - it’s how brands build loyalty.

Galderma Announces Departure of Its Chief Financial Officer1.7.2025 08:00:00 EEST | Press release

Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced that Thomas Dittrich, Chief Financial Officer, will be leaving the company to pursue another senior executive opportunity outside the organization. “We thank Thomas for his financial leadership and many contributions during his time at Galderma. He played a key role in establishing the financial discipline, operational readiness, and strategic clarity that will continue to guide us forward. We wish him every success in his next role and remain focused on further accelerating Galderma’s strong growth – from category leadership to becoming a true powerhouse in dermatology.” FLEMMING ØRNSKOV, M.D., MPH CHIEF EXECUTIVE OFFICER GALDERMA Thomas Dittrich will remain with the company as Chief Financial Officer through Q2 2026 to ensure a seamless transition through the close of the 2025 fiscal year. A successor will be announced in due course. “I want to thank Flemming, our Board of Directors, our investor

Transition Industries Signs Strategic Agreements for the Pacifico Mexinol Project, the Largest Standalone Ultra-Low Carbon Chemical Production Facility in the World30.6.2025 21:30:00 EEST | Press release

Transition Industries LLC, a developer of world-scale, net-zero carbon emissions methanol and green hydrogen projects in North America, held a signing event for an Engineering, Procurement, and Construction (EPC) contract with the consortium of Samsung E&A Co., Ltd. (Samsung E&A), Grupo Samsung E&A Mexico, S.A. de C.V., and Techint Engineering and Construction for the Pacifico Mexinol project located in Ahome, Sinaloa, Mexico, which is contingent upon the fulfillment of customary conditions precedent and obtainment of all required approvals. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630940954/en/ MAIRE group’s technology division NextChem, through its subsidiary KT TECH SpA, also signed a Basic Engineering, Critical and Proprietary Equipment Supply Agreement with Samsung E&A in connection with its proprietary NX AdWinMethanol®Zero technology supply to the project. Transition Industries is jointly developing the Pacif

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye