International collaboration seeks to make childbirth safer in developing countries

A global alliance led by GSK and Monash University promises to fast-track delivery of oxytocin to mothers in developing countries

Every year, thousands of mothers die from a preventable cause of death: post-partum haemorrhaging, the excessive loss of blood after childbirth. Despite advances in maternal health, haemorrhage remains the leading direct cause of maternal death worldwide. Between 2003 and 2009, haemorrhage accounted for about 661,000 reported maternal deaths. Over 99% of those deaths occurred in developing countries

Post-partum haemorrhage can be treated by a simple injection of oxytocin immediately after childbirth. Oxytocin has long been considered the gold standard therapy; the World Health Organization recommends that the hormone should be considered the “first choice” treatment of medical practitioners in preventing haemorrhaging during labour.

While synthetic oxytocin is readily available in birthing clinics in developed nations including Australia, it is a different story elsewhere. In developing countries, access to the medicine is impeded by logistics and the fact that many women give birth at home: oxytocin requires refrigerated transport and storage, as well as skilled health workers to administer the injection. The conditions in these often under-resourced countries make it difficult for mothers to receive oxytocin injections in a safe and timely manner.

A new global collaboration involving GSK, the Monash Institute of Pharmaceutical Sciences (MIPS), the McCall MacBain Foundation, the Planet Wheeler Foundation and Grand Challenges Canada may soon offer a solution. With GSK and the MIPS at the helm, these organisations have committed to accelerating the development of a new dry-powder inhaled form of oxytocin.

The technology was first developed by Dr Michelle McIntosh and her team at the MIPS, and is now being co-developed with GSK. Dr McIntosh explains the marriage: "At Monash, we bring the product concept, pre-clinical research and scientific development to the table but we don't bring manufacturing, commercialisation and distribution – that's why we needed to form a partnership."

The new formulation will allow mothers to inhale oxytocin immediately after delivery. Importantly, it will be heat-stable and not require costly and logistically complicated cold-chain transport systems. The inhaler device would facilitate administration by minimally-skilled birthing attendants.

"At Monash, we bring the product concept, pre-clinical research and scientific development to the table but we don't bring manufacturing, commercialisation and distribution – that's why we needed to form a partnership."

Dr Michelle McIntosh, Monash Institute of Pharmaceutical Sciences

As part of the collaborative agreement, GSK has been licensed to co-develop, register and distribute the product in regions of high maternal mortality. McCall McBain has provided $1.5m, a figure matched by other donors. Grand Challenges Canada has contributed roughly $1m in partnership with the Canadian Government’s Department of Foreign Affairs, Trade and Development. A further $500,000 has been provided by the Planet Wheeler Foundation, and GSK has contributed funds and in-kind contributions valued at $16m. The pooling will enable collaborative teams from Monash and GSK to conduct an early-phase development programme over the next few years. The programme will be comprehensive, spanning across pre-clinical research, early-stage clinical trials, product optimisation, manufacturing and research into local markets.

Allan Pamba, Vice-President for GSK in East Africa 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.”

Pre-clinical trials have so far shown that the hormone is effectively taken up by inhalation. According to Dr McIntosh, in the best-case scenario, the product could be ready for use in 2019. Thanks to the alliance, the global vision to improve maternal mortality rates in the developing world may soon become a reality.

There are no plans to market inhaled oxytocin in Australia in the foreseeable future.

This article first appeared in grassROOTS Winter 2015,  Research Australia’s quarterly publication:

Dr Michelle McIntosh (front, fifth from left) and her team at the Monash Institute of Pharmaceutical Sciences are developing inhaled oxytocin with the help of an international collaboration.

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