Ferring Pharmaceuticals and MSD Announce Completion of Largest Clinical Trial Ever Conducted in Postpartum Haemorrhage
Ferring Pharmaceuticals and MSD, known as Merck & Co., Inc., Kenilworth, N.J., U.S.A., through its MSD for Mothers initiative, today announced the completion of CHAMPION (Carbetocin Haemorrhage Prevention), a global clinical trial conducted by the Human Reproduction Program (HRP) at the World Health Organization (WHO). CHAMPION is investigating whether Ferring’s proprietary and heat-stable carbetocin could offer a new solution to prevent excessive bleeding after childbirth (postpartum haemorrhage or PPH).2,3 Involving nearly 30,000 women in 10 countries, it is the largest clinical trial ever conducted in PPH.2,3
This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180221006496/en/
Each year, 14 million mothers are affected by PPH.4 As the leading direct cause of maternal mortality, 480,000 mothers died from PPH between 2003-09.1 Even when women survive, PPH can result in the need for serious medical interventions, including surgical removal of the uterus (hysterectomy) as well as blood transfusions to address severe anaemia.5 By preventing PPH from ever occurring, heat-stable carbetocin has the potential to both save lives and avoid severe, dangerous and costly long-term side effects.
“Despite progress towards the UN Sustainable Development Goal of reducing maternal mortality, every single day women across the world are dying unnecessarily from childbirth complications such as PPH. Timely administration of effective medicines can avoid the maternal deaths that occur due to excessive bleeding after childbirth,”6 said Mariana Widmer, Technical Officer, Maternal and Perinatal Health, WHO. “If the results of the trial for heat-stable carbetocin are favourable, this collaboration between private life sciences and the global public health community could help save women’s lives worldwide.”
The CHAMPION trial compares the effectiveness and safety of Ferring’s heat-stable carbetocin versus the current standard of care, oxytocin, for preventing PPH after vaginal birth.2,3 Heat-stable carbetocin could address a significant limitation associated with oxytocin – the need for refrigeration during shipping and storage to prevent degradation in temperatures above 8°C.3,7 Heat-stable carbetocin may remain active long-term in hot and humid climates,3 and could potentially reduce the incidence of PPH in areas where cold storage is difficult to achieve and maintain,3,4 and where 99% of maternal deaths due to PPH currently occur.4
“Using our established expertise in Reproductive Medicine and Women’s Health, we strive to find innovative treatments that will help to dramatically reduce the number of mothers dying as a result of childbirth,” said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. “Our heat-stable carbetocin is just one example of this research effort and forms part of our ongoing commitment to safeguarding the health of families worldwide. We are looking forward to seeing the results from the CHAMPION trial and hope that the learnings will usher in a new era in the prevention of PPH.”
If the results of the CHAMPION trial are favourable, Ferring will seek registration of heat-stable carbetocin on a broad basis around the world. If approved, Ferring would manufacture the product and it would be provided to the public sector of low- and lower-middle-income countries at an affordable and sustainable access price. Results from the trial are expected to be presented and published during the second half of 2018.
“The CHAMPION trial has the potential to change the paradigm in how we save more mothers from dying during childbirth,” said Julie L. Gerberding, M.D., M.P.H. Executive Vice President & Chief Patient Officer, Strategic Communications, Global Public Policy and Population Health at MSD. “Along with our partners, we recognised that heat-stable carbetocin could be a transformative solution to preventing PPH, which is the number one cause of maternal mortality. Through MSD for Mothers, we provided our company’s scientific expertise and financial resources to prove the concept and ultimately make a sustainable impact on the health of mothers, families and communities.”
About the CHAMPION* trial 2,3
CHAMPION (Carbetocin Haemorrhage Prevention), the world’s largest clinical trial in postpartum haemorrhage, is being undertaken to compare the effectiveness and safety of heat-stable carbetocin to oxytocin in the prevention of postpartum haemorrhage after vaginal births. The trial conducted by the Human Reproduction Program (HRP) at the World Health Organization enrolled nearly 30,000 women in 10 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.
About Ferring Pharmaceuticals:
Ferring Pharmaceuticals is a research-driven, specialty 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 specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative and personalised healthcare solutions to help mothers and babies, from conception to birth. Founded in 1950, Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.
About MSD for Mothers
Every day, approximately 830 women die from preventable causes related to pregnancy and childbirth.8 MSD for Mothers is a 10-year, $500 million initiative to create a world where no woman dies from complications of pregnancy and childbirth. Drawing on the company’s history of discovering innovative, life-saving medicines and vaccines, MSD for Mothers is applying the company’s scientific and business expertise – as well as its financial and human resources – to reduce maternal mortality around the world. Learn more at http://www.msdformothers.com/and @MSDforMothers.
For more than a century, MSD, a leading global biopharmaceutical company, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer's disease and infectious diseases including HIV and Ebola. For more information, visit http://www.msd.com/ and connect with us on Twitter, LinkedIn and YouTube.
Forward-Looking Statement of Merck & Co. Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2016 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov)
1 Say L. et al. Global causes of maternal death: a WHO
systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33.
2 Australian New Zealand Clinical Trial Registry. Available at: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366743 Last accessed: January 2018.
3 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. doi: 10.1186/s13063-016-1271-y.
4 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: January 2018.
5 El-Refaey H. and Rodeck C. Post-partum haemorrhage: definitions, medical and surgical management. A time for change. British Medical Bulletin. 2003;67:205–217.
6 Every Woman Every Child. The global strategy for women's, children's and adolescent's health (2016-2030) 2015. Available from: http://www.who.int/life-course/partners/global-strategy/ewec-globalstrategyreport-200915.pdf?ua=1 Last accessed: January 2018.
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). BJOG. 2016;123(13):2076-2086.
8 World Health Organization. Maternal Mortality Fact Sheet. Available at: http://www.who.int/mediacentre/factsheets/fs348/en/ Last accessed: January 2018.
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)
MSD for Mothers
Claire Gillespie, +1 267-305-0932
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 ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Bentley Advances Industrialization of Infrastructure Project Delivery Through ProjectWise Integration with Microsoft 36515.10.2018 12:16 | Tiedote
The Year in Infrastructure 2018 Conference - Bentley Systems, Incorporated announced the general availability of integration between ProjectWise 365 Services and Microsoft 365. The collaboration capabilities of Microsoft Teams and Microsoft Flow, alongside analytics from Microsoft SharePoint and Microsoft Power BI, can now be applied to mainstream automated digital workflows within ProjectWise. The integration will enable collaborative digital workflows that transcend system boundaries throughout infrastructure capital project delivery, ensuring standards and best practices are propagated across projects, and increasing repeatability, scalability, quality, and predictability—in effect, industrializing project delivery, so that project teams can widely replicate their best projects’ successes. Neil Lee, IT Director - Applications, Mott MacDonald, said, “The integration of ProjectWise and Microsoft Office 365 will be a significant enabler for our ongoing digital strategy for project deli
Siemens and Bentley Systems Announce Integrated Asset Performance Management (APM) Solution for Power Plants15.10.2018 12:12 | Tiedote
The Year in Infrastructure 2018 Conference – Siemens and Bentley Systems have announced a joint technology and service solution, consisting of their complementary offerings, to speed up the digitalization of power plants and provide intelligent analytics with a range of innovative offerings and managed services solutions. The new service, to be hosted on Siemens’ cloud-based open IoT operating system, MindSphere, will combine Bentley’s advanced asset performance software capabilities with Siemens’ complementary technology and service expertise to empower power plant owners to take full advantage of digitalization, which helps improve maintenance operations and planning. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005249/en/ APM for Power Plants combines Bentley's advanced asset performance software capabilities with Siemens' industry and domain expertise. (Photo: Business Wire) Siemens’ asset performance management
Bentley Systems Acquires LEGION, Leading Pedestrian Simulation Software15.10.2018 12:09 | Tiedote
The Year in Infrastructure 2018 Conference–– Bentley Systems, Incorporated, the leading global provider of comprehensive software solutions for advancing the design, construction, and operations of infrastructure, today announced the acquisition of leading pedestrian simulation software provider LEGION, based in London and supporting more than half of the world’s 40 largest transit agencies. The acquisition augments Bentley’s comprehensive modeling environment with collaborative digital workflows to explore and validate comparative simulations of pedestrian traffic scenarios. LEGION’s pedestrian simulation application offers modeling capabilities of people’s interactions with each other and physical obstacles, and activities, including circulation and evacuations, within public spaces like railway stations, airports, sports arenas, tall buildings, and street level with vehicle interactions. Using LEGION simulation tools in collaborative digital workflows with Bentley’s OpenBuildings De
Bentley Acquires Agency9 to Realize Digital Twins for Every City15.10.2018 12:07 | Tiedote
The Year in Infrastructure 2018 Conference–– Bentley Systems Incorporated, the leading global provider of comprehensive software solutions for advancing the design, construction, and operations of infrastructure, today announced the acquisition of Agency9, based in Stockholm. Agency9 has already provided nearly half of Sweden’s larger municipalities with city-scale digital twin cloud services for city planning and related web-based 3D visualization. Since 2012, Agency9 has taken advantage of reality meshes created by Bentley’s ContextCapture reality modeling software as the digital context for visualizing urban infrastructure assets represented in GIS data, terrain surveys, and BIM models. Bentley’s new iTwin™ cloud services, introduced at the conference, add digital alignment and change synchronization for infrastructure engineering digital twins, and will enable OpenCities Planner (formerly Agency9 CityPlanner) to uniquely serve urban planning requirements at fuller levels of detail.
Atos and Bentley Systems Announce Strategic Partnership to Create Digital Twins for Owner-operators of Industrial and Infrastructure Assets15.10.2018 12:04 | Tiedote
The Year in Infrastructure 2018 Conference – Atos, a global leader in digital transformation, and Bentley Systems, the leading global provider of comprehensive software solutions for advancing the design, construction, and operations of infrastructure, today announced a strategic partnership through which they will offer a complete solution to create and operate digital twins on behalf of industry and infrastructure asset owners. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005255/en/ Atos’ global experience and expertise in digital transformation together with Bentley’s infrastructure, engineering, reality modeling and asset performance software portfolio will enable businesses to take advantage of fully-integrated and managed digital twins as a cloud-based service. This new offering will support owner-operators meet their business KPIs through the following features and benefits: Full immersive visibility of assets
Siemens and Bentley Systems Announce PlantSight™ Digital Twin Cloud Services15.10.2018 12:01 | Tiedote
The Year in Infrastructure 2018 Conference – Siemens and Bentley Systems announced today the introduction of PlantSight, resulting from development together based on their highly complementary software portfolios. PlantSight is a digital solution to benefit customers through more efficient plant operations. PlantSight enables as-operated and up-to-date digital twins which synchronize with both physical reality and engineering data, creating a holistic digital context for consistently understood digital components across disparate data sources, for any operating plant. Plant operators benefit from high trustworthiness and quality of information for continuous operational readiness and more reliability. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005268/en/ PlantSight brings together data from multiple 3D models including reality meshes in one portal view, allowing rapid access to information that has previously been
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