Project Lead(s): Michelle McIntosh
An international group of public and private organizations is collaborating to accelerate development of an innovative heat-stable and low-cost, inhaled form of oxytocin to manage postpartum hemorrhage in resource-poor settings.
The technology, originally developed at the Monash Institute of Pharmaceutical Sciences, is being licensed to GSK as part of a collaborative agreement to co-develop, register and distribute the product in regions of high maternal mortality. A US $16.6M early phase development program will be delivered, combining financial support and R&D expertise from GSK with funding from The McCall MacBain Foundation, Grand Challenges Canada, which is funded by the Government of Canada, and Planet Wheeler Foundation.
The alliance brings together innovative science, development capability of inhaled medicines and specialist philanthropic commitment, in a collaborative effort to accelerate progress towards potential implementation of an affordable product in those countries with greatest need.
Every year, nearly 300,000 women die due to pregnancy-related causes, with the risk of a woman in a developing country dying from a maternal-related cause during her lifetime being around 23 times higher than a woman living in a developed country. The single biggest cause of death is excessive bleeding during or after birth, a condition that is effectively managed in developed countries using the gold standard therapy, oxytocin, a manufactured form of a natural hormone. However, accessibility to quality oxytocin in resource-poor settings is limited, as current products are only available in an injectable form requiring supply and storage under refrigerated conditions and trained personnel to administer the product safely.
This new collaboration aims to address these issues through the development of a heat-stable, affordable and easy-to-administer inhaled form of oxytocin. Formulated as a dry powder, inhaled oxytocin eliminates the need for refrigerated storage conditions, while delivering oxytocin via a powder inhaler could facilitate its administration by health workers, birth attendants and mothers themselves. Combined, this novel approach has the potential to support women in low-resource settings or who give birth outside of medical facilities.
The alliance’s funding will enable Monash to complete its commitments in an early phase development program being conducted by collaborative teams at Monash and GSK. This comprehensive program over the next few years comprises preclinical and early stage clinical trials, product optimization, development of manufacturing processes, and research into local markets.
McCall MacBain has provided a AUD $1.5 million (US $1.35 million) matching grant to Monash University to assist in the development of a medicine aimed at greatly reducing maternal mortality in the developing world, one of the key goals of the McCall MacBain Foundation. Grand Challenges Canada is contributing CA $1M (US $910,000). This is Grand Challenges Canada’s second investment under a new partnership with Foreign Affairs, Trade and Development Canada (DFATD), whose goal is to accelerate scale-up of promising global health innovations. In 2011, the inhaled oxytocin innovation was awarded a seed grant by Saving Lives at Birth, a partnership between Grand Challenges Canada, the U.S. Agency for International Development, the U.K. Department for International Development, the Government of Norway and the Bill & Melinda Gates Foundation. The Planet Wheeler Foundation is also contributing AUD $500,000 (US $450,000) to this project.
For more details, read the full News Release.