jueves, 22 de febrero de 2018

MSD and Ferring Pharmaceuticals Complete Largest Ever Clinical Trial in Postpartum Haemorrhage

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February 22, 2018

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 birth.

Ferring Pharmaceuticals and MSD, known as Merck & Co, 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). Involving nearly 30,000 women in 10 countries, it is the largest clinical trial ever conducted in PPH. 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.

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. 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,”
Mariana Widmer, 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. 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.

Heat-stable carbetocin may remain active long-term in hot and humid climates, and could potentially reduce the incidence of PPH in areas where cold storage is difficult to achieve and maintain, and where 99% of maternal deaths due to PPH currently occur.

“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 heatstable 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

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.

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
the exposure to litigation, including patent litigation, and/or regulatory actions.

References

Say L. et al. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33.
Australian New Zealand Clinical Trial Registry. Available at: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366743 Last accessed: January 2018.
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.
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.
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.
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.
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.
World Health Organization. Maternal Mortality Fact Sheet. Available at: http://www.who.int/mediacentre/factsheets/fs348/en/