Thousands of pet owners already know the drug that is set to transform the lives of millions of people, many of them living in Africa’s sub-Sahara region. Its scientific name is moxidectin and veterinarians use it to treat parasites that infect domestic pets and farm animals.
Now, thanks to an innovative approach to drug development and impact investment financing, an Australian company is poised to release a new treatment for the scourge of river blindness, and potentially scabies.
The path to this remarkable outcome started five years ago at the not-for-profit, Medicines Development for Global Health, in Melbourne and culminated in the US Food and Drug Administration issuing its first Priority Review Voucher to an Australian company. The voucher has great commercial value because it cuts down the FDA drug approval process from 10 months to six months.
MDGH was able to sell that voucher to one of the world’s top 30 pharmaceutical companies (yet to be named for commercial confidentiality reasons) for a price estimated to between $US 80 to $120 million. With more trials to come (in Ghana and Democratic Republic of Congo), MDGH is confident that the drug will be widely distributed within five years. It is expected to accelerate the eradication of River Blindness, a disease that currently debilitates an estimated 20 million people in Africa. MDGH also believes the drug will have other uses including tackling scabies in remote Australian indigenous communities while generating significant sales revenue in the developed world.
So how did this remarkable story come about? In a tale of “firsts’’, what were the key elements that enabled this medical breakthrough to occur?
The World Health Organisation had done considerable initial work on the drug, but it took the MDGH development expertise and the FDA’s Priority Review Voucher program to accelerate moxidectin’s commercial appeal and complete the development journey. For MDGH vice-president Dr Larry Ward one of the important elements was the capacity of the MDGH team under founder and managing director Mark Sullivan to bring together a high-level drug development team with detailed knowledge of the FDA’s regulatory regime. “It was highly virtual,’’ Dr Ward explained. “They pulled in expertise from across the globe with the core team managing the process from Melbourne.’’
Mark’s role was recognised with his nomination as Victoria’s representative for the 2019 Australian of The Year. The honour came just months after the FDA had rubber-stamped moxidectin’s efficacy and suitability for human use and issued the voucher. The voucher was not only a huge endorsement of the drug but also meant that MDGH could ‘’trade’’ the voucher to a pharmaceutical company who could use it to expedite FDA review of one of their own drugs.
But that outcome had been through some perilous moments with innovative funding mechanisms being required, including ensuring there was enough funding to support the drug’s application for other uses.
The critical player became the Global Health Investment Fund, a social impact investment vehicle set up by the Bill & Melinda Gates Foundation and JPMorgan Chase and Co, that specialises in financing medical treatments for diseases in low-income populations. The Fund committed US$13 million to MDGH’s moxidectin submission to the FDA.
But there was, in the interim, a funding shortfall for the scabies program.
Enter Ronan Lehane, an impact driven entrepreneur and part of Philanthropy Australia’s Next Gen cohort. Ronan admitted that the initial response from potential Australian funders to the proposed drug development was not promising. “Everyone said it was going to be too hard. Australian impact investors couldn’t wrap their heads around it,’’ he says. That meant Lehane turned to his trusted relationships to devise what turned out to be unique funding arrangement that raised a crucial $450,000 to ensure the scabies research work continued.
Ronan admits that because this was drug development, the approach was still perceived as “high risk’’, but this did not consider the late stage of the project. His success reflected his personal relationship with some of the funding families and the strength and experience of the MDGH team to execute. The consequence was that those funders expressed a strong interest in staying involved as MDGH pushes forward with the scabies’ treatment. Scabies is a significant problem in indigenous communities where up to 70 per cent of babies have been affected by the scabies mite in their first year.
Ronan believes that the MDGH success story is a powerful incentive for new investors to get on board. “People now know MDGH and its amazing development story,’’ he says. “A local bio-tech company targeting a significant impact on Australian issues is absolutely more appealing to local investors.’’ Ronan’s inspired approach was a vital element in the mix, according to Dr Ward. “Drug development is incredibly expensive, so to raise money around any global health product is difficult so you do need innovative funding approaches,’’ he explains.
The FDA voucher sale enables the creation of a new US$20 million company co-owned by GHIF and MDGH. It has the rights to develop the drug for all of its proposed applications including scabies and even head lice. “Its aim will be to make money but…any of our share of profits will flow back to MDGH, which is a not-for-profit with charitable status,’’ Dr Ward says, ‘this is a great model for funding global health projects.’’