Merck Announces Findings from WHO-led Study of Investigational Heat-Stable Carbetocin for Preventing Excessive Bleeding After Childbirth

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June 27, 2018 4:00 pm EDT

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
through its Merck for Mothers initiative announced study results
on an investigational heat-stable formulation of carbetocin for the
prevention of excessive bleeding after childbirth, also known as
postpartum haemorrhage (PPH). The results demonstrated that heat-stable
carbetocin is clinically non-inferior to the standard of care, oxytocin,
for the primary outcome of ≥500 ml blood loss or additional uterotonic
use.1 Non-inferiority was not demonstrated for the second
primary outcome of blood loss of ≥1,000 ml or more.1

Results from the CHAMPION (Carbetocin Haemorhage Prevention)
clinical trial, led by the World Health Organization (WHO) and conducted
as part of a public-private collaboration with Ferring and Merck for
Mothers
, were published in the New England Journal of Medicine
(NEJM).1 CHAMPION is the largest study conducted in PPH
prevention, with nearly 30,000 women from 10 countries.1 The
CHAMPION trial of investigational heat-stable carbetocin 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), with
scientific and financial support provided by Merck for Mothers.1

The current standard of care for the prevention of PPH, oxytocin, is
temperature sensitive.2,3,4 Multiple studies in low- and
lower-middle-income countries have consistently revealed degradation and
potential loss of efficacy of oxytocin, which could be due to inadequate
storage and distribution.4,5 Because of its heat-stability,
this investigational formulation of carbetocin has the potential to be
used in low- and lower-middle income countries, where the refrigeration
of medicines can be difficult to achieve and maintain.3

Every year, 14 million mothers are affected by PPH.6 Although
most deaths due to PPH are preventable,7 it contributes to
the leading direct cause of maternal mortality worldwide,8
causing approximately 70,000 deaths every year.8

“No woman should die giving life, and our mission is to give mothers
around the world access to affordable, life-saving medical
interventions,” said Julie L. Gerberding, Chief Patient Officer at
Merck. “Prevention is key, which is why we are collaborating on the
CHAMPION project. The collaboration has brought innovation developed in
the private sector into the public sector in an effort to address unmet
needs in countries where the majority of maternal deaths occur.”

The collaboration began when Merck for Mothers first approached
Ferring and the WHO about studying the investigational heat-stable
carbetocin in an effort to increase public sector access, given the
organizations’ shared goals of PPH prevention. Ferring will now seek
registrations and manufacture heat-stable carbetocin for low- and
lower-middle income countries. The parties will work together with the
aim of making heat-stable carbetocin available at an affordable and
sustainable price for appropriate cases 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.

About the CHAMPION trial

1

CHAMPION, (Carbetocin Haemorhage Prevention),
the world’s largest clinical trial in the prevention of PPH, was a
double-blind, randomized, 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 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 was researched and developed by
Ferring Pharmaceuticals and the CHAMPION trial was funded by Merck
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 ≥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 Merck for Mothers

Every day, approximately 830 women die from preventable causes related
to pregnancy and childbirth. Merck 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, Merck
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 www.merckformothers.com
and @MerckforMothers.

About Merck

For more than a century, Merck, a leading global biopharmaceutical
company known as MSD outside of the United States and Canada, has been
inventing for life, bringing forward medicines and vaccines for many of
the world’s most challenging diseases. 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, Merck 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 www.merck.com
and connect with us on TwitterFacebookInstagram,
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and LinkedIn.

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For Merck & Co., Inc.
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Doris Li, 908-246-5701
or
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or
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