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Women in India are the first in the world to receive new heat-stable carbetocin formulation to prevent excessive bleeding after childbirth

July 26, 2021 Off By BusinessWire

Excessive bleeding after birth (postpartum haemorrhage or PPH) is preventable yet is a leading direct cause of maternal mortality worldwide, causing around 70,000 deaths each year¹

New formulation of carbetocin is heat-stable – meaning it doesn’t need to be refrigerated, often a challenge in low- and lower-middle income countries

Heat-stable carbetocin is now being used in clinical practice for the first time in healthcare settings in India – more countries to follow

SAINT-PREX, Switzerland–(BUSINESS WIRE)–After nearly a decade of public-private collaboration, Ferring Pharmaceuticals today announces the first use of heat-stable carbetocin (Carbetocin Ferring) for the prevention of excessive bleeding after birth, known as postpartum haemorrhage (PPH). Heat-stable carbetocin is now available for use in healthcare facilities across India, in the prevention of excessive bleeding following vaginal and caesarean section births.

This major maternal health milestone has been eagerly awaited since the publication of the CHAMPION (Carbetocin HAeMorrhage PreventION) trial results in 2018² – a study led by the World Health Organization (WHO) as part of a collaboration with MSD for Mothers* and Ferring Pharmaceuticals. These data contributed to heat-stable carbetocin being added to the WHO Model List of Essential Medicines (EML),³ as well as an update in the WHO’s recommendations on uterotonics for the prevention of excessive bleeding after birth.⁴

“Today is an unforgettable milestone for maternal health in India. Every 5 minutes a woman dies during pregnancy or childbirth across India and excessive bleeding after childbirth is responsible for 30% of these deaths,” said Dr Shivaprasad Goudar, Professor of Physiology, J N Medical College & Director-Research, KLE Academy of Higher Education and Research, Belagavi, India and Principal Investigator (India) for the CHAMPION clinical trial. “It is truly traumatic to see a mother die due to a preventable cause, and the impact this has on the family goes beyond the initial loss. Because this new formulation is not dependent on being stored or transported in refrigerators, it is a real step forward to ensuring women, especially in remote areas, can access high quality maternity care. The last few months have been an incredibly challenging time for India as we tackle the COVID-19 pandemic but it remains vital to prioritise maternal health to ensure the safety of expectant mothers at risk of excessive bleeding after childbirth.”

Until now, the first-choice drug for preventing excessive bleeding after birth required storage and transportation at 2–8°C, typically in a refrigerator to maintain its effectiveness. This is often difficult in low- and lower-middle income countries, many of which have hot climates and unpredictable power sources. As a result, many women are deprived of access to a lifesaving drug or the drug being less predictable and potentially being less effective because of exposure to heat. Carbetocin Ferring is a heat-stable formulation with predictable quality offering an additional option for healthcare professionals in preventing excessive bleeding after childbirth.

“At Ferring, we believe that every woman giving birth should have access to quality care and medicines to help them build families, regardless of where they live. Reaching the moment where the first woman receives heat-stable carbetocin is a landmark achievement for Ferring, which would not have been possible without collaboration, and we would like to thank all those involved, especially the patients in the clinical trial,” said Per Falk, President of Ferring Pharmaceuticals. “While we are hugely proud of achieving this milestone, our work will not stop here. Ferring is committed to supporting access to heat-stable carbetocin across the world in other low- and lower-middle income countries, so that we are closer to the vision that no woman dies giving life.”

Carbetocin Ferring was first approved in 2020, under the Swissmedic procedure for scientific advice and Marketing Authorisation for Global Health Products (MAGHP), aimed to make essential medicines available faster for patients in low- and middle-income countries.^5,6 Since then, besides India, Carbetocin Ferring has been approved in South Sudan, Sierra Leone – the countries with the first and third highest rates of maternal mortality in the world respectively, and Tanzania.⁷ Ferring and key partners are working to secure additional national registrations, to bring heat-stable carbetocin to the public sector of all low- and lower-middle income countries, where the burden of maternal mortality and cases of PPH are greatest.

Alongside it’s listing in the WHO Essential Medicines List, heat-stable carbetocin has been included in the UNFPA Product Catalogue for “quality-assured commodities related to reproductive health, census and humanitarian response”.^8,9

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

ENDS

Notes to Editors

About Carbetocin Ferring

Globally, PPH causes approximately 70,000 deaths each year¹ – with over 90% of deaths from PPH occurring in low- and lower-middle income countries.⁷ Carbetocin Ferring is a heat-stable formulation of carbetocin, a uterotonic medicine for the prevention of PPH in all births.³ It is administered in a single dose. Carbetocin Ferring was developed by Ferring Pharmaceuticals to address limitations in refrigeration and cold-chain transport of medicines in low- and lower-middle income countries. Heat-stable carbetocin is recommended by the World Health Organization in settings where oxytocin is unavailable or its quality cannot be guaranteed, and where its cost is comparable to other effective uterotonics.¹⁰ It is licensed for the prevention of postpartum haemorrhage due to uterine atony after childbirth, following all births. Carbetocin Ferring is available at a sustainable access price for use in public-sector healthcare facilities in low- and lower-middle income countries.¹¹ The availability of Carbetocin Ferring is subject to regulatory review and approval in relevant countries.

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.

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References

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: July 2021

² Widmer M, et al. Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth. N Engl J Med 2018; 379:743-752

DOI: 10.1056/NEJMoa1805489

³ WHO Model List of Essential Medicines. Available at: https://apps.who.int/iris/handle/10665/325771 Last accessed: July 2021

⁴ 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 2021

⁵ 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: July 2021

⁶ 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: July 2021

⁷ World Health Organization. Trends in maternal mortality 2000 to 2017. 2019. Available at: https://apps.who.int/iris/bitstream/handle/10665/327596/WHO-RHR-19.23-eng.pdf Last accessed: July 2021

⁸ WHO Model List of Essential Medicines. Available at: https://apps.who.int/iris/handle/10665/325771 Last accessed: July 2021

⁹ UNFPA.UNFPA Product Catalog. Available at https://www.unfpaprocurement.org/products Last accessed: July 2021

¹⁰ 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 2021

¹¹ Ferring. 2019. Ferring statement on subsidised pricing of heat-stable carbetocin for the prevention of postpartum haemorrhage in low- and lower-middle income countries. Available at: https://www.ferring.com/ferring-statement-on-subsidised-pricing-of-heat-stable-carbetocin-for-the-prevention-of-postpartum-haemorrhage-in-low-and-lower-middle-income-countries/ Last accessed July 2021