Merck and Ferring Pharmaceuticals are collaborating with the World Health Organization (WHO) to advance a new, proprietary formulation of carbetocin, used to prevent excessive bleeding (post-partum hemorrhage) in women after childbirth, which is designed to be stable at room temperature, even in hot and tropical climates (ICH climatic zone IV).
Currently, oxytocin, the standard medicine administered for the prevention of excessive bleeding, is temperature-sensitive and requires sustained cold distribution and storage in hot climates. WHO will conduct a multi-country clinical study to evaluate the effectiveness of room-temperature-stable carbetocin as compared to oxytocin. The development of a medicine that can be stored at room temperature has the potential to significantly improve management of bleeding following childbirth in the many areas of the world where cold storage is difficult to achieve and maintain, helping reduce maternal deaths in those areas.
Starting this year, the study will enroll approximately 29,000 women in 12 countries around the world. If the results of the study are positive, the organizations will work together with the aim of making the medicine available in developing countries that have a high burden of maternal mortality, at an affordable and sustainable public-sector price.
Through its Merck for Mothers initiative, Merck is applying its scientific and business expertise—as well as its financial resources—to reduce maternal mortality around the world. “Mothers hold the future in their hands. That’s why Merck has taken on our 10-year, $500 million fight against maternal mortality,” said Kenneth C. Frazier, chairman and CEO, Merck. “Working with our partners, we can help make a better solution a reality. It would be a real breakthrough to help prevent the number-one cause of women dying in childbirth in the most vulnerable parts of the globe.”
“Few tragedies compare to the death of a mother during childbirth. Obstetric treatments that benefit mother and baby are a key focus of our efforts at Ferring,” said Michel L. Pettigrew, president of the executive board and chief operating officer, Ferring Group. “Ferring originally developed carbetocin and received the indication for the prevention of post-partum hemorrhage more than a decade ago.”
Carbetocin is not available in the U.S. The WHO study of room-temperature-stable carbetocin will take place in Argentina, Brazil, Egypt, India, Kenya, Nigeria, Pakistan, Singapore, South Africa, Thailand, Uganda and the U.K.