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

July 9, 2019

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July 9, 2019

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

Heat-stable carbetocin has been added to the WHO Essential Medicines List of uterotonics for the prevention of excessive bleeding after childbirth ¹

Excessive bleeding after birth, also known as postpartum haemorrhage (PPH), is the leading direct cause of maternal mortality worldwide ²

WHO guidelines recommend heat-stable carbetocin for PPH prevention in settings where oxytocin is unavailable or its quality cannot be guaranteed, and where its cost is comparable to other effective uterotonics ³*

Heat-stable carbetocin was developed by Ferring Pharmaceuticals to address limitations in refrigeration and cold-chain transport of medicines in low- and lower-middle income countries ⁴

Saint-Prex, Switzerland – Tuesday, 09 July 2019 –

Ferring Pharmaceuticalstoday 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.

Nepal: Dinesh felt helpless as his wife Tulasi was rushed to have emergency blood transfusions after experiencing postpartum haemorrhaging (PPH) following the birth of their first child. His mind raced, imagining raising their new born on his own and without a mother. Tulasi recovered and Dinesh is thankful for this every day.

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.³The 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 EML

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 trial

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.

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

WHO Model List of Essential Medicines. Available at: https://apps.who.int/iris/handle/10665/325771 Last accessed: July 2019
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
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
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
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.
WHO. Maternal mortality – Fact sheets. Published 2018. Available at: www.who.int/news-room/fact-sheets/detail/maternal-mortality Last accessed: July 2019
Widmer M, et al. Heat stable carbetocin vs oxytocin to prevent hemorrhage after vaginal birth. New England Journal of Medicine 2018;379:743-752
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
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
Torloni MR, et al. Quality of Oxytocin Available in Low and Middle-Income Coun
Ferring Pharmaceuticals. Data on file. 2019
UNFPA Procurement Services. Oxytocin 10 I.U./ml injection in 1ml ampoule. www.unfpaprocurement.org/products?id=OXYTOCIN_10IU/ML Last accessed: July 2019

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Nepal: Yamuna, 18, experienced postpartum haemorrhage (PPH) following the birth of her first child. Due to the lack of facilities in her local health centre she was forced to walk for hours to reach the nearest hospital, adding to her risk of death. Luckily Yamuna survived and is on the road to recovery, however the experience has placed a financial strain on her and her family.

Nepal: Dr Khadka is a General Practice and Emergency Medicine doctor in Nepal. Although transportation in his local area is improving every day, women still struggle to access hospitals from more remote places. This leaves them at greater risk for complications, such as postpartum haemorrhage (PPH), potentially leading to death.

Nepal: Dr Vaidya is an OBGYN consultant in Bhaktapur Hospital, Nepal. Although she is surrounded by a skilled team, in her eyes all women that come into hospitals in her region to give birth are at risk of complications, such as postpartum haemorrhage (PPH). This is especially true at night-time when access to anaesthesiology and intensive care facilities is limited.

Uganda: Joan’s pregnancy was without complications, but when she gave birth, she suffered from excessive bleeding (PPH) and had to be transferred to a hospital. Thanks to blood transfusions she survived, but she stills feels dizzy sometimes.

Uganda: Ruth is a midwife. Her daughter suffered from postpartum haemorrhage (PPH) when giving birth in a clinic. She was transferred to a hospital for treatment but tragically died. Ruth’s clinic has integrated services and 24hour care, but unfortunately the one her daughter attended did not. Ruth now cares for her grandson with her surviving daughter.

Uganda: Stella is a health-worker supporting HIV communities. She had a traumatic birth with her third child, suffering from excessive bleeding (PPH) and uterine prolapse. Thankfully she survived due to the care she received in the healthcare centre, but the experience has enforced her decision not to have another child.

India: Radha experienced excessive bleeding (PPH) after giving birth. She received blood transfusions and treatment, and after three days she regained consciousness. Thankfully she survived but the experience impacted both her and her family; she was scared for her baby’s wellbeing, and her older children feared she would die.

India: This hospital caters for nine districts, and sees around 70,000 births every year. Many of Dr Deshpande’s patients suffer from postpartum haemorrhage (PPH) and hypertensive disorders. She emphasises the need for antenatal care to ensure that women don’t die after giving birth, and is passionate about protecting women’s rights in maternal care.

India: The head of this hospital’s OBGYN department is Dr Gaddappa. In his hospital, he says that active management of third stage labour is often enough to prevent postpartum haemorrhage. However, women who give birth remotely often don’t have access to effective medication – and by the time they arrive at the hospital it can be too late.

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