CHAMPION trial is completed of carbetocin to prevent excessive bleeding after childbirth.- Ferring + Merck Inc.

Ferring Pharmaceuticals and Merck Inc., through its Merck for Mothers initiative, 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). The CHAMPION trial is studying whether Ferring�s investigational proprietary heat-stable formulation of carbetocin could offer a new solution to prevent excessive bleeding after childbirth (postpartum hemorrhage or PPH). Involving nearly 30,000 women in 10 countries, it is the largest clinical trial ever conducted in PPH. These 10 countries include Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the United Kingdom. Each year, 14 million mothers are affected by PPH. As the leading direct cause of maternal mortality, 480,000 mothers died from PPH between 2003-2009. 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 anemia.

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. Oxytocin requires 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 in many low- and lower-middle-income countries, cold storage is difficult to achieve and maintain. If the results of the CHAMPION trial are favorable, Ferring plans to seek registration of heat-stable carbetocin on a broad basis. 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.

Heat-stable carbetocin was researched and developed by Ferring Pharmaceuticals and the CHAMPION trial was funded by Merck for Mothers..