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/

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)

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

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

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(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

Vertex Confirms Wales Offer Accepted for Access to All Licensed Cystic Fibrosis Medicines13.11.2019 11:29:00 CETPress release

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today confirms that NHS Wales has accepted an offer for all currently licensed Vertex cystic fibrosis (CF) medicines and any future indications of these medicines under the same terms as the recently announced agreement with NHS England. This means that once the contract is finalized, patients with CF in Wales ages 2 years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene can access ORKAMBI ® (lumacaftor/ivacaftor) and CF patients ages 12 years and older who either have two copies of the F508del mutation or one copy of the F508del mutation and a copy of one of the other 14 licensed mutations can access SYMKEVI® (tezacaftor/ivacaftor) in combination with ivacaftor in the coming weeks. The agreement also offers expanded access to KALYDECO ® (ivacaftor) to include those patients ages 12 months and older who have one of the nine licensed gating mutations. “Today’s a

Software Testing and Digital Transformation Partners Recognized at 2019 Tricentis Partner Awards13.11.2019 11:00:00 CETPress release

Tricentis, the cloud’s #1 Continuous Testing Platform, today recognized top-performing partners from around the world during Tricentis Accelerate 2019 in Vienna, Austria. In its 5th year, the Tricentis Partner Awards recognize organizations for accelerating digital transformation across the enterprise. Award winners were selected from more than 300 different partners worldwide based on their collaboration with Tricentis, customers, and their advocacy for Tricentis’ automation methodologies. “Tricentis partners are leading the way for organizations to innovate faster, reduce business risk, and optimize cost,” said Alan Ota, Senior Vice President of Strategic Alliances, Tricentis. “Our partners are instrumental to our business and are focused on delivering the best in-class testing solutions to our joint customers. Our tremendous growth would not be possible without our global partners. We’re proud to acknowledge the achievements made by our partners in 2019 and look forward to continuin

Applicaster Appoints Jason Johns as Vice President of Sales, EMEA and APAC13.11.2019 10:00:00 CETPress release

Applicaster, the company simplifying the lifecycle management of direct-to-consumer media applications, today announced the appointment of Jason Johns as Vice President of Sales, EMEA and APAC. In his role, Johns will oversee Applicaster’s EMEA and APAC commercial and go-to-market strategies. “There is an incredible amount of opportunity in the media app market,” said Johns. “Because of our ability to enable frictionless growth for customers, we’re very well positioned to take advantage of this opportunity. Beyond the market opportunity, I was attracted to Applicaster because of the company’s customer-first culture plus its ability and desire to drive value lead engagements. Few businesses buy technology without a clear understanding of the business case and full transparency of the cost-of-ownership around their technology investments - Applicaster understands this and provides flexible commercial models that scale and can easily be upgraded and expanded as business requirements evolv

Clovis Oncology Announces Reimbursement for Rubraca® (rucaparib) Tablets for Women with Relapsed Ovarian Cancer in Italy13.11.2019 09:00:00 CETPress release

Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the Italian Medicines Agency (AIFA) has approved rucaparib for reimbursement in Italy. Rucaparib will soon be available as an option for monotherapy maintenance treatment for adults with relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy.3 Rucaparib is indicated for eligible patients regardless of BRCA status, which means it can be prescribed for women who harbor a BRCA mutation or who are BRCA wild-type.3 “We very much welcome the arrival of the PARP inhibitor rucaparib, which offers a new treatment option after surgery and two lines of chemotherapy to all eligible women affected by relapsed ovarian cancer,” declared Nicoletta Cerana, National President of Acto Onlus, the number one Italian network of patient associations involved in the fight against ovarian cancer and gynecological tumors. “Ovarian cancer is a highly lethal

Traxens Presents Solutions for Port Industry at Smart Ports Barcelona13.11.2019 07:30:00 CETPress release

Traxens, a company providing high-value data and services for the supply chain industry, announces today that it will present its smart asset tracking solutions at the Smart Ports Barcelona event, Smart Ports, Piers of the Future, November 19 to 21. Its tailored Industrial Internet of Things (IIoT) solutions are specifically designed to meet the needs of the port industry by providing near real-time insight into the end-to-end global supply chain. Traxens’ solution provides comprehensive, precise and timely data on cargo, through tracking logistic assets in transit anywhere in the world. Traxens’ patented breakthrough Internet of Things (IoT) technology brings improved efficiency and security, greater transparency and enhanced asset utilization whilst opening up new opportunities for all actors involved in the global supply chain. With Traxens’ solutions, ports can improve their efficiency and the interoperability of the systems with a trusted third party. For example, the Cargo Commun

PMC Group Announces Agreement to Acquire Lanxess’ Organotin Specialties Business13.11.2019 06:30:00 CETPress release

PMC Group N.A., Inc. ("PMC") and Lanxess Organometallics GmbH are pleased to announce that the parties have reached an agreement whereby PMC’s European subsidiary will acquire the organotin specialties product line (the “Business”) from Lanxess. The transaction is scheduled to close by year end, subject to customary closing conditions. The Business includes Lanxess’ global organotin catalyst, organotin specialties and intermediates product lines. The transaction includes a toll manufacturing agreement under which Lanxess will continue to manufacture certain products post-closing for PMC at its Bergkamen, Germany organometallics manufacturing facility. Mr. Debtosh Chakrabarti, President of PMC said, “This acquisition represents PMC’s continuing commitment to the organotin industry and is synergistic to our existing organometallics and catalyst businesses. We believe that the customer base of the Business as well as all of PMC’s customers will benefit significantly from combining the tec