International collaboration to develop inhaled form of oxytocin

An international group of public and private organisations 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.

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 $16.6 million 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 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,1 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 programme being conducted by collaborative teams at Monash and GSK. This comprehensive programme over the next few years comprises preclinical and early stage clinical trials; product optimisation; development of manufacturing processes; and research into local markets.

McCall MacBain has provided a $A 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.

John and Marcy McCall MacBain noted: "The cold-chain, sanitary and expertise barriers of the current oxytocin formulations will be greatly ameliorated by this development. We are proud to work with the world-leading Monash Institute of Pharmaceutical Sciences, our fellow donors and GSK to bring this new product to the urgent need of birthing mothers in the developing world."

Grand Challenges Canada is contributing CA $1 million (US $910,000). This is Grand Challenges Canada’s second investment under a new partnership with the Department of 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 US Agency for International Development, the UK Department for International Development, the Government of Norway and the Bill & Melinda Gates Foundation.

Allan Pamba, vice-president for East Africa at GSK and co-chair of the UN Every Woman, Every Child Innovation Working Group, said: "Pregnancy and childbirth should be an incredible time. But for thousands of women, often in the world’s poorest countries, it puts their life in jeopardy. For the sake of new mums and their babies – a child’s health and prospects are better if they have their mother – this needs to change.

"In GSK’s Maternal and Neonatal Health Unit, R&D, we are constantly challenging ourselves to find new interventions that improve the life chances of mothers and their newborns. Collaborating with others is fundamental to these efforts and we are delighted to partner with Monash. By combining their technical expertise with our experience in drug development and respiratory know-how, we have the potential to give new mothers a fighting chance."

The Honourable Christian Paradis, Canada’s Minister of International Development and La Francophonie, said: "Canada has made maternal, newborn and child health its top development priority. If we are to end the needless and preventable deaths of mothers, newborns and children across the developing world within a generation, we need to make sure that women, children and healthcare workers have access to low-cost, easy-to-use healthcare products. A ground-breaking, heat-stable oxytocin dry powder inhaler has the potential to save the lives of many women facing post-partum hemorrhage, which is a leading cause of maternal deaths in the developing world."

Director of the Monash Institute of Pharmaceutical Sciences (MIPS) at Monash University, Professor Bill Charman, said the collaboration future proofs major research.

"Thanks to the generosity and support of our partners, turning our research into a new medicine that has the potential to save lives globally is now within our grasp," he said.

"This is an exciting and impactful time, not only for MIPS, but for all the organisations in this collaboration to make a significant impact in improving maternal mortality rates in the developing world," Professor Charman said.

Tashi Wheeler, Grants Manager at the Planet Wheeler Foundation – which is contributing $A 500,000 (US $450,000) – said: "Our Foundation does a lot of work in the area of maternal mortality and when we were approached by the Monash Institute of Pharmaceutical Science to support their oxytocin research our answer was an almost immediate and resounding yes. What an effective and affordable way to prevent a problem that can take the lives of thousands of mothers every year. This is exactly the kind of thing we want to get behind."