- Excessive bleeding after childbirth
(postpartum haemorrhage or PPH) is the leading direct cause of
maternal mortality worldwide1
- The CHAMPION trial is assessing the
effectiveness and safety of heat-stable carbetocin vs. oxytocin,
the current standard of care, for preventing PPH after vaginal
birth2,3
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
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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* trial2,3
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.
Learn more at www.ferring.com and @Ferring, or connect with us
on Facebook, Instagram and LinkedIn.
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.
About MSD
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)
References
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.
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Ferring PharmaceuticalsBhavin VaidHead of Corporate
Communications+41 58 301 0952 (direct)+41 79 191 0632
(mobile)bhavin.vaid@ferring.comorLindsey RodgerSenior Manager,
Corporate Communications+41 58 451 4023 (direct)+41 79 191 0486
(mobile)lindsey.rodger@ferring.comorMSD for MothersClaire
Gillespie, +1 267-305-0932