Merck and Ferring Pharmaceuticals have entered into collaboration with the World Health Organization (WHO) to advance a new, proprietary formulation of carbetocin, used to prevent excessive bleeding (post-partum haemorrhage) in women after childbirth.
Carbetocin is designed to be stable at room temperature, even in hot and tropical climates (ICH climatic zone IV).
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At present, oxytocin is administered as a standard medicine to prevent excessive bleeding and it requires sustained cold distribution and storage in hot climates.
As part of the companies’ efforts to develop new drug to prevent excessive bleeding in women after childbirth, the WHO will carry out a multi-country clinical trial to evaluate the effectiveness of room-temperature-stable carbetocin, as compared with oxytocin.
The trial will include about 29,000 women in Argentina, Brazil, Egypt, India, Kenya, Nigeria, Pakistan, Singapore, South Africa, Thailand, Uganda and the UK.
If the trial results are positive, the organisations will work together to make the new medicine available in developing countries.
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By GlobalDataThe trial will test the effectiveness of a new medicine, which can be stored at room temperature in hot and tropical locations.
Merck chairman and chief executive officer Kenneth Frazier said: "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."
Merck for Mothers initiative is intended to prevent any woman dying from complications of pregnancy and childbirth.
Ferring Group president of the Executive Board and COO Michel Pettigrew said few tragedies compare with the death of a mother during childbirth.
"Obstetric treatments that benefit mother and baby are a key focus of our efforts at Ferring," Pettigrew said. "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."
Switzerland-based Ferring Pharmaceuticals identifies, develops and markets new products in the areas of reproductive health, urology, gastroenterology and endocrinology.
