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/
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.
# # #
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
Head of Corporate Communications
+41 58 301 0952 (direct)
+41 79 191 0632 (mobile)
Senior Manager, Corporate Communications
+41 58 451 4023 (direct)
+41 79 191 0486 (mobile)
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
FDA Approves OTEZLA® (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease19.7.2019 17:59:00 CEST | Press release
Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved OTEZLA® (apremilast) 30 mg twice daily (BID) for the treatment of adult patients with oral ulcers associated with Behçet’s Disease. OTEZLA, an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the first and only approved treatment option for oral ulcers associated with Behçet’s Disease, a rare, chronic, multisystem inflammatory disease that is difficult to treat. “Oral ulcers are a recurring and debilitating manifestation that affects nearly everyone living with Behçet’s Disease, and have an important negative impact on the quality of life for these patients,” said Yusuf Yazici, M.D., Clinical Associate Professor, Department of Medicine, New York University Langone Health. “In the clinical trial, OTEZLA demonstrated improvements in measures of oral ulcers at week 12. OTEZLA has the potential to be a needed treatment option for U.S. patients and their physicians, who
Abiraterone Acetate Included in World Health Organisation’s Essential Medicines List for the Treatment of Metastatic Castration-Resistant Prostate Cancer19.7.2019 13:05:00 CEST | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson is delighted with the recent announcement from the World Health Organisation (WHO) to include abiraterone acetate (ZYTIGA ® ) for the treatment of metastatic castration-resistant prostate cancer (mCRPC), in the updated Essential Medicines List, published on 9th July 2019.1,2 The WHO’s Essential Medicines List is a core guidance document that helps countries prioritise critical health products that are recommended to be widely available and affordable throughout health systems.1 “The inclusion of abiraterone acetate in the WHO Essential Medicines List highlights the critical role that this treatment can play in improving the lives of patients living with mCRPC and their families,” said Dr. Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. “I am proud that we are working hard to impact survival and quality of life by developing and providing innovative medicines which ar
Gilead Sciences Licenses Respiratory and Herpes Antiviral Research Programs From Novartis19.7.2019 12:30:00 CEST | Press release
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that it has licensed three preclinical antiviral programs from Novartis, including investigational agents with the potential to treat human rhinovirus, influenza and herpes viruses. Under the agreement, Gilead will acquire exclusive global rights to develop and commercialize novel small molecules against three undisclosed targets. Novartis will receive an upfront payment and is eligible to receive up to an additional $291 million in potential milestone payments upon achievement of certain development and commercial milestones, as well as royalties on annual net sales. “Today’s announcement builds on Gilead’s heritage in antiviral research and development. We look forward to applying this expertise to advance the development of potential new treatments for viruses with limited therapeutic options,” said John McHutchison AO, MD, Gilead’s Chief Scientific Officer and Head of Research and Development. Gilead’s antiviral portfolio include
Schlumberger Announces Second-Quarter 2019 Results19.7.2019 11:00:00 CEST | Press release
Schlumberger Limited (NYSE: SLB) today reported results for the second quarter of 2019. (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2019 Mar. 31, 2019 Jun. 30, 2018 Sequential Year-on-year Revenue $8,269 $7,879 $8,303 5% 0% Pretax segment operating income $968 $908 $1,094 7% -12% Pretax segment operating margin 11.7% 11.5% 13.2% 17 bps -148 bps Net income - GAAP basis $492 $421 $430 17% 14% Net income, excluding charges & credits* $492 $421 $594 17% -17% Diluted EPS - GAAP basis $0.35 $0.30 $0.31 17% 13% Diluted EPS, excluding charges & credits* $0.35 $0.30 $0.43 17% -19% North America revenue $2,801 $2,738 $3,139 2% -11% International revenue $5,463 $5,037 $5,065 8% 8% North America revenue, excluding Cameron $2,243 $2,178 $2,546 3% -12% International revenue, excluding Cameron $4,761 $4,469 $4,387 7% 9% *These are non-GAAP financial measures. See section titled "Charges & Credits" for details. Schlumberger Chairman and CEO Paal Kibsgaard commente
Schlumberger Appoints Olivier Le Peuch as CEO19.7.2019 10:46:00 CEST | Press release
Schlumberger Limited (NYSE: SLB) announced today that its Board of Directors has appointed Olivier Le Peuch as its Chief Executive Officer and member of the Schlumberger Board, effective August 1, 2019. Mr. Le Peuch succeeds Paal Kibsgaard, who will retire as Chief Executive Officer effective that same date. Also effective August 1, Mr. Kibsgaard will step down as Chairman of the Board and retire as a member of the Board of Directors. Mr. Kibsgaard will retire after more than 22 years of service to the Company, including eight years as CEO and four years as Chairman. Effective the same date, Mark G. Papa, a current non-independent director, will become non-executive Chairman of the Board. Peter Currie will continue to serve as the Board’s Lead Independent Director. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190719005161/en/ Olivier Le Peuch is appointed Chief Executive Officer and a member of the Schlumberger Board, effe
Fluke Corporation Acquires Industrial Reliability Leader PRÜFTECHNIK19.7.2019 10:00:00 CEST | Press release
Fluke Corp., the global leader in test and measurement instruments, has acquired Ismaning, Germany-based PRÜFTECHNIK, a market leader in precision laser shaft alignment, condition monitoring, and non-destructive testing. “Fluke’s acquisition of PRÜFTECHNIK reflects the growing importance our customers place on reliability systems to keep their equipment in optimum operating condition,” said Marc Tremblay, president of Fluke Corporation. “This business will help us usher in the next generation of solutions for our industrial customers.” Fluke Corporation For information on Fluke tools and applications, or to find the location of your nearest distributor, contact Fluke Corporation, P.O. Box 9090, Everett, WA USA 98206, call (800) 44-FLUKE (800-443-5853), fax (425) 446-5116, e-mail email@example.com or visit the Fluke Web site at http://www.fluke.com. About Fluke Founded in 1948, Fluke Corporation is the world leader in compact, professional electronic test tools and software for measu