Business Wire

FERRING-PHARMACEUTICALS

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

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/

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 (C arbetocin Ha em orrhage P revention ), 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

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Barilla Launches 7th Edition of Good Food Makers to Shape the Future of Food2.7.2025 14:20:00 CEST | Press release

Barilla officially opens applications for Good Food Makers 2025, its open innovation program dedicated to startups and innovative companies focused on creating a more sustainable and connected food system. Now in its seventh edition, the program welcomes a new format — Good Food Makers – ECOSYSTEM — developed in collaboration with Almacube, the innovation hub of the University of Bologna and Confindustria Emilia. This year’s goal is to build a true innovation ecosystem by involving Barilla’s value chain partners and accelerating the adoption of emerging technologies. Three selected startups will join a four-week co-development journey with Barilla professionals and partner companies, working side-by-side to create impactful solutions across the entire food chain — from field to fork. Applications are open until the end of July, with the program running from September to January 2026, concluding with the Innovation Day. “Good Food Makers reflects our commitment to open innovation that g

SE Labs Award Reinforces NetApp Status as the Most Secure Storage on the Planet2.7.2025 14:00:00 CEST | Press release

NetApp wins 2025 SE Labs Award for Enterprise Data Protection NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced that it was recognized as a standout performer in cybersecurity in the SE LABS ® Awards 2025. NetApp won the 2025 SE Labs Award for Enterprise Data Protection, validating NetApp’s status as the most secure storage on the planet. This recognition as a winner of a 2025 SE Labs Award is a result of NetApp’s exceptional innovation in cyber resiliency to deliver NetApp ONTAP® Autonomous Ransomware Protection with Artificial Intelligence (ARP/AI), which was tested and validated by SE Labs. NetApp ARP/AI demonstrated 99 percent detection of tested, advanced full-file encryption ransomware attacks with zero false positives, indicating a strong ability to operate in a business context without contributing to alert fatigue. “Great security doesn’t just happen—it’s built, tested and proven,” says Simon Edwards, Founder and CEO of SE Labs. “Behind every

CroíValve Announces Funding from Horizon Europe EIC Accelerator2.7.2025 14:00:00 CEST | Press release

CroíValve, a pioneering medical device company innovating a better way to help more patients suffering from Tricuspid Regurgitation (TR), was awarded funding from Horizon Europe’s European Innovation Council (EIC) Accelerator Programme. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702306192/en/ DUO™ Transcatheter Tricuspid System Part of the EU’s Horizon Europe 2021-2027 Research and Innovation Programme, the EIC Accelerator Programme provides transformational funding to high-potential, high-risk start-ups, scale-ups and subject matter experts. This award includes grant funding of €2.5 million, combined with an equity investment of €10 million in CroiValve’s next financing. The latest competition included 959 applications, with only 40 awards across 16 countries. Almost one third of the selected companies are led by a woman and CroiValve are incredibly proud to be one of this group. “Securing European Innovation Council

EUMETSAT: Europe’s First Geostationary Sounder Satellite Is Launched2.7.2025 13:20:00 CEST | Press release

Europe has taken a major step forward in strengthening its resilience to extreme weather events with the successful launch of the Meteosat Third Generation Sounder 1 (MTG-S1) satellite. MTG-S1 will deliver new streams of atmospheric data, enabling earlier, more accurate warnings that protect lives, property and infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702002782/en/ MTG-S1 is part of the Meteosat Third Generation programme, Europe’s new fleet of geostationary meteorological satellites. Image: EUMETSAT Extreme weather events like storms, flooding, and heatwaves have caused hundreds of billions of euros in damage and claimed tens of thousands of lives across Europe in the past decades. Launched on 1 July 2025, MTG-S1 will provide Europe’s national meteorological services with high-frequency data on temperature, humidity and trace gases throughout the atmosphere – enabling forecasters to detect the earli

HCLTech and Equinor Expand Digital Collaboration2.7.2025 13:08:00 CEST | Press release

HCLTech, a global technology leader, and Equinor, Europe's largest energy supplier and a pioneer in renewables and low-carbon solutions, have expanded their IT collaboration to support the next phase of Equinor’s digital transformation. This expanded relationship will cover Equinor’s IT landscape across several key strategic areas. HCLTech will support Equinor as it accelerates its digital transformation by: Accelerating its cloud migration and standardizing services across operations Enhancing its cyber resilience and network performance Improving workplace experience through automation Enabling advanced user experiences with technologies like augmented reality (AR) "We’re pleased to continue our long-standing collaboration with Equinor," said Sandeep Kumar Saxena, Executive Vice President, HCLTech. "This collaboration reflects our shared commitment to innovation and sustainability.” Over the past decade, HCLTech has been a trusted advisor to Equinor, supporting the company’s global e

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