Ferring Pharmaceuticals and MSD Announce Completion of Largest Clinical Trial Ever Conducted in Postpartum Haemorrhage

22-Feb-2018 Intellasia | BusinessWire | 1:00 PM Print This Post
  • Excessive bleeding after childbirth (postpartum haemorrhage or PPH)
    is the leading direct cause of maternal mortality worldwide
    1
  • 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 birth
    2,3

SAINT-PREX, Switzerland, & KENILWORTH, N.J.–(BUSINESS WIRE)–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


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 TwitterLinkedIn 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.

Contacts

Ferring Pharmaceuticals
Bhavin Vaid
Head of Corporate
Communications
+41 58 301 0952 (direct)
+41 79 191 0632
(mobile)
[email protected]
or
Lindsey
Rodger
Senior Manager, Corporate Communications
+41 58 451
4023 (direct)
+41 79 191 0486 (mobile)
[email protected]
or
MSD
for Mothers

Claire Gillespie, +1 267-305-0932

 


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