Business Wire

Ferring’s Heat-Stable Carbetocin Could Save Thousands of Women’s Lives by Preventing Excessive Bleeding after Childbirth

Jaa

Ferring Pharmaceuticals today announced new data demonstrating that its heat-stable formulation of carbetocin is as effective as the current standard of care, oxytocin, for the prevention of excessive bleeding, also known as postpartum haemorrhage (PPH), after vaginal birth.1

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180627005996/en/

Heat-barrier infographic (Graphic: Business Wire)

Heat-barrier infographic (Graphic: Business Wire)

Results from the CHAMPION clinical trial, conducted by the World Health Organization (WHO) as part of a collaboration with Ferring and MSD for Mothers ** , were published in the New England Journal of Medicine (NEJM).1 This is the largest study conducted in the prevention of PPH with nearly 30,000 women in ten countries.1

Every year, 14 million women are affected by PPH.2 Although most deaths are preventable,3 PPH is the leading direct cause of maternal death worldwide,4 causing approximately 70,000 deaths per year.4

This is an important step forwards in PPH prevention and these results pave the way for heat-stable carbetocin to potentially save the lives of thousands of women, especially in areas where cold-chain transport and storage is not feasible,” said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. “We will now work with the WHO and MSD for Mothers to make heat-stable carbetocin available in countries where it is needed most, protecting women and families around the world.”

Researched and developed by Ferring as a solution to address unmet needs in women’s health, heat-stable carbetocin remains effective at high temperatures,5 addressing a significant limitation of oxytocin which must be stored and transported at 2 – 8°C. 6,7 Studies in low- and lower-middle income countries have revealed degradation and loss of efficacy in oxytocin ampoules, which could be due to inadequate storage and distribution conditions.7,8 Data show that heat-stable carbetocin maintains effectiveness for at least three years at 30°C and six months at 40°C.5 Heat-stable carbetocin has the potential to save thousands of women’s lives in low- and lower-middle income countries, where 99% of PPH-related deaths occur2 and where the refrigeration of medicines can be difficult to achieve and maintain.6

The CHAMPION trial was 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), using Ferring’s heat-stable carbetocin, and funded by MSD for Mothers.1,6 Ferring will now seek registrations and manufacture heat-stable carbetocin. The parties will work together with the aim of making heat-stable carbetocin available at an affordable and sustainable price in the public sector of low- and lower-middle income countries that have a high burden of maternal mortality.

* The availability of heat-stable carbetocin is subject to regulatory review and approval in relevant countries.

** Known as Merck & Co., Inc., Kenilworth, N.J., U.S.A.

About the CHAMPION trial 1
CHAMPION, (Carbetocin Haemorhage 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, 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 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 was researched and developed by Ferring Pharmaceuticals and the CHAMPION trial was funded by MSD for Mothers.

Results demonstrated that heat-stable carbetocin is clinically non-inferior to oxytocin for the primary outcome of ≥500 ml blood loss or additional uterotonic use. The frequency of blood loss of ≥500 ml or additional uterotonic use was 14.5% in the carbetocin group and 14.4% in the oxytocin group (Relative Risk (RR): 1.01 95% confidence interval (CI) 0.95 to 1.06), consistent with non-inferiority.

Non-inferiority was not demonstrated for the second primary outcome of blood loss of ≥ 1,000 ml (1.51% carbetocin group vs 1.45% in the oxytocin group, RR: 1.04, CI: 0.87 to 1.25); however, the trial was underpowered for this outcome. There were no significant differences between groups in other measures of bleeding or in adverse effects.

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 Widmer M, et al. Heat stable carbetocin vs oxytocin to prevent hemorrhage after vaginal birth. New England Journal of Medicine 2018;in press.
2 World Health Organization. Priority diseases and reasons for inclusion. Postpartum haemorrhage. Available at: http://www.who.int/medicines/areas/priority_medicines/Ch6_16PPH.pdf Last accessed: May 2018.
3 World Health Organization. WHO recommendations for the prevention and treatment of postpartum haemorrhage. Published 2012. Available at: http://apps.who.int/irisbitstream/10665/75411/1/9789241548502_eng.pdf Last accessed: May 2018.
4 Say L, et al. Global causes of maternal death: a WHO systematic analysis. The Lancet Global Health. 2014; 2(6):e323-33. Available at: https://www.thelancet.com/pdfs/journals/langlo/PIIS2214-109X(14)70227-X.pdf Last accessed: May 2018.
5 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.
6 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.
7 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). An International Journal of Obstetrics and Gynaecology 2016;123(13):2076-2086.
8 Anyakora, et al. Quality medicines in maternal health: results of oxytocin, misoprostol, magnesium sulfate and calcium gluconate quality audits. BMC Pregnancy and Childbirth 2018;18:44.

Contact information

Ferring Pharmaceuticals
Bhavin Vaid
Head of Corporate Communications
+41 58 301 0952 (direct)
+41 79 191 0632 (mobile)
bhavin.vaid@ferring.com
or
Lindsey Rodger
Senior Manager, Corporate Communications
+41 58 451 4023 (direct)
+41 79 191 0486 (mobile)
lindsey.rodger@ferring.com
or
Patrick Gorman
Director, Ferring Pharmaceuticals USA
+1 862 286 5035 (direct)
patrick.gorman@ferring.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Loxam Announces a Conditional Agreement to Acquire UK Platforms20.7.2018 17:51Tiedote

Loxam Group (“Loxam”) announces that its wholly-owned subsidiary Nationwide Platforms Limited (“Nationwide”) has entered into a conditional agreement with HSS Hire Group plc (“HSS”) with respect to the acquisition of UK Platforms Limited (“UKP”). UKP specializes in renting powered access equipment from its 12 branches located throughout the United Kingdom. The company has approximately 130 employees and operates a fleet of 3,000 units. UKP is controlled by HSS since 2013. As part of this transaction, Nationwide has entered into a commercial agreement with HSS to provide powered access equipment to complement HSS’ existing fleet. The closing of the transaction is subject to the approval by HSS’ shareholders and the confirmation that it will not be referred to the Competition and Mergers Authority. The transaction is expected to close before year end 2018. Don Kenny, CEO of Loxam’s Powered Access Division states: “I am delighted with the acquisition of UKP which will further reinforce NW

Schlumberger Announces Second-Quarter 2018 Results20.7.2018 14:00Tiedote

Schlumberger Limited (NYSE: SLB) today reported results for the second quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2018 Mar. 31, 2018 Jun. 30, 2017 Sequential Year-on-year Revenue $8,303 $7,829 $7,462 6% 11% Pretax operating income $1,094 $974 $950 12% 15% Pretax operating margin 13.2% 12.4% 12.7% 75 bps 45 bps Net income - GAAP basis $430 $525 $(74) -18% n/m Net income, excluding charges & credits* $594 $525 $488 13% 22% Diluted EPS - GAAP basis $0.31 $0.38 $(0.05) -18% n/m Diluted EPS, excluding charges & credits* $0.43 $0.38 $0.35 13% 23% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Schlumberger Chairman and CEO Paal Kibsgaard commented, “The second quarter was both busy and exciting for Schlumberger as we completed a number of major milestones in preparation for the broad-based global activity upturn that is now emerging. We delivered solid top-line gro

H.I.G. Capital Announces the Sale of KidsFoundation19.7.2018 22:50Tiedote

H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €21 billion of equity capital under management, announced today that one of its affiliates has entered a definitive agreement to sell the KidsFoundation Group (“KidsFoundation”), the Dutch market leader in childcare services, to Onex Corporation (“Onex”)(TSX:ONEX). Terms were not disclosed. Headquartered in Almere, the Netherlands, KidsFoundation provides high-quality childcare to nearly 30,000 children between the ages of six weeks and 12 years. H.I.G. created KidsFoundation in 2014 through the acquisition of assets from the estate of Estro Group. During H.I.G.’s ownership, the company has developed strongly with significant capital invested by H.I.G. to create a high-quality childcare offering. H.I.G. worked with KidsFoundation management to optimise the footprint of the company by exiting loss-making locations, introduce new IT systems to drive operational improvement and develop an internal M&

SIG Combibloc Group Holdings S.à r.l.: 2018 Second Quarter Results19.7.2018 19:01Tiedote

We are pleased to announce our quarterly conference call to discuss the results of SIG Combibloc Group Holdings S.à r.l. for the second quarter ended June 30, 2018. Date: Monday, July 23, 2018 Time: 15.00 CEST / 14.00 BST / 9.00 EDT The call information will be distributed on our secure site. If you would like access to our call, please contact investor.relations@sig.biz . Regards, SIG Combibloc Group Holdings S.à r.l. View source version on businesswire.com: https://www.businesswire.com/news/home/20180719005634/en/ Contact information SIG Combibloc Group Holdings S.à r.l. Jennifer Gough investor.relations@sig.biz

NEORIS Announces Creation of Innovation Labs Worldwide to Create a Smarter Future19.7.2018 18:32Tiedote

NEORIS, a global digital consulting services company, announced today it is consolidating the most innovative solutions it has developed in different geographies and allocating unprecedented resources to deploy a network of Innovation Labs worldwide. The main objective is to lay the foundation for the continuous development of disruptive solutions for its four core industries: Manufacturing, Financial Services, Healthcare and Telecommunications. Due to its disruptive nature, NEORIS decided that its first Innovation Lab should be housed in the Monterrey Digital Hub, which today is the first-of-its-kind as it is a space where entrepreneurs, companies, universities and investors converge to foster an ecosystem for Digital Transformation. The lab inaugurated in Monterrey, Mexico is the first of a series of Innovation Labs that will open in the different countries that NEORIS operates, and is a space where customers can experience emerging technologies through real-life scenarios. One such

CORRECTING and REPLACING Albar Capital Deploys FlexNOW19.7.2018 18:29Tiedote

Subhead of release should read: Out-of-the-Box Multi-Asset Execution Management System (instead of Easy-to-Install Multi-Asset Execution Management System). The corrected release reads: ALBAR CAPITAL DEPLOYS FLEXNOW Out-of-the-Box Multi-Asset Execution Management System FlexTrade (@FlexTrade) today announced that Albar Capital Ltd., a new hedge fund led by Javier Velazquez (formerly of Millennium Capital Partners LLP), is now trading equities and futures using FlexNOW, FlexTrade’s new execution management system. “The FlexNOW team was instrumental in solving several of our problems,” said Jason Ruder, Trader at Albar Capital. “Not only are they helping us with our compliance requirements, they are also responsive to requests that improve my workflow.” According to Rhyd Lewis, FlexNOW Product Manager, FlexNOW’s quick onboarding and easy installation process was critical for Albar Capital’s launch on 2 July. “We had no problem integrating FlexNOW with Albar’s portfolio and risk managemen

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme