Merck and Ferring Pharmaceuticals announced that they have entered into collaboration with the World Health Organization (WHO) to develop carbetocin for post-partum hemorrhage in women after childbirth.
The collaboration aims to advance a new, proprietary formulation of carbetocin that is designed to be stable at room temperature even in tropical climates, such as those in the ICH climatic zone IV. Merck said the development of such a drug can significantly improve management of excessive bleeding after childbirth and help reduce maternal deaths, especially in areas where cold storage is difficult to achieve and maintain.
Kenneth C. Frazier, chairman and CEO of Merck, said, “Mothers hold the future in their hands. That’s why Merck has taken on our 10-year, $500 million fight against maternal mortality. 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.”
Standard treatment for prophylaxis of post-partum hemorrhage is oxytocin. Oxytocin is temperature-sensitive and requires maintained cold distribution and storage in hot climates. The WHO will hold a multi-country clinical study to assess the efficacy of room-temperature stable carbetocin against oxytocin. Carbetocin is currently not available in the U.S.
The study will be conducted in 12 countries involving an estimated 29,000 women. If study results are positive, the collaboration will move on to development with the aim of providing the drug in developing countries which have a high burden of maternal mortality. Merck said the partnership intends to supply the drug at an affordable and sustainable public-sector price.
Michel L. Pettigrew, Ferring’s President of the Executive Board and COO, said, “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. Ferring originally developed carbetocin and received the indication for the prevention of post-partum hemorrhage more than a decade ago. Ferring is delighted to join with the WHO and Merck in this project that aims to make the benefits of carbetocin available in areas of the world where cold storage is not readily available.”
WHO will conduct the study assessing room temperature stable carbetocin in Egypt, South Africa, India, Thailand, Kenya, Uganda, Nigeria, Argentina, Pakistan, Brazil, Singapore, and the UK.