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We address health inequity by researching, developing and delivering new and improved medicines for diseases disproportionately affecting low- and middle-income countries.
MDGH was founded by Mark Sullivan in 2005. Since then, we have demonstrated that we can assemble the resources, collaborators and financing required to develop and register new medicines for infectious diseases.
A significant milestone for our company was the FDA approval of moxidectin for the treatment of river blindness in 2018, making it the first medicine approved to treat river blindness (onchocerciasis) in 20 years. In 2020, we secured the global rights to CC-11050 (AMG 634) from Amgen, an investigational treatment that holds promise in tackling two challenging diseases: tuberculosis and leprosy type 2 reactions.
The majority of new medicines are developed for diseases that are prevalent in high-income countries as the potential returns on an approved medicine offset the high cost and risk of development. This model disadvantages the world’s poorest populations – according to the World Health Organization, an estimated two billion people do not have access to even the most basic of essential medicines.
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The MDGH development model is resource-efficient and cost-effective, and is intended to reduce the time and expense of bringing medicines through development. It is built on identifying and integrating the necessary expertise from each part of the development pathway at the time that expertise is needed. We undertake product development under the strictest of global regulatory standards to achieve and maintain regulatory approval, and we work with partners to ensure delivery of medicines to those who need them most.
In our model, the strongest elements of product development partnerships (PDPs) and traditional biopharmaceutical industry are combined, allowing us to focus on developing and delivering medicines to those most in need while maintaining self-determination as a not-for-profit company. While we engage academia and industry partners in our work, we do not require a pharmaceutical company partner because we can undertake all phases of product development in-house.
MDGH is a not-for-profit company registered with the Australian Charities and Not-for-profits Commission (ACNC) and is endorsed as a Deductible Gift Recipient (DGR, type 1). MDGH has been self-funded from the outset and, as such, has been independent of major philanthropic funders, governments and companies. We have therefore preserved the right to self-determine our projects of interest.
When taking on the sponsorship of moxidectin in 2014, we leveraged the potential value of the US Food and Drug Administration (FDA) priority review voucher (PRV) to obtain an investment from the Global Health Investment Fund (GHIF). Furthermore, in 2017, funding for moxidectin as a potential treatment for scabies was raised from Australian social impact investors. After receiving a PRV, we sold it to Novo Nordisk and repaid our investors. The excess of these funds continues to support paediatric and field use studies, manufacturing requirements and development in relation to another disease, scabies. As part of the investment from GHIF, both parties agreed to pricing, quality and supply obligations for moxidectin, and also to establish and co-fund a jointly owned company called Atticus Medical Pty Ltd. Atticus Medical is providing MDGH with some of the financial support for further development and delivery of moxidectin in river blindness and scabies.
We were also successful in receiving two substantial grants from the European and Developing Countries Clinical Trial Partnership in 2019 and 2021, which support additional work on the use of moxidectin in the field and development of a new formulation for very young children, respectively.
As the scope of our work and the potential for impact increases, so does the need for capital. We aim to remain innovative in the approach to fundraising and while we continue to use our financial resources and seek grants, the coming years will see us diversifying funding sources to include philanthropic support. We will be reaching out to supporters to raise funds for ongoing and new programs.
We are deeply grateful to the following people, foundations and organisations for their investment of time and resources, and their commitment to improving public health.
In 2014, MDGH licensed from the WHO the world-wide rights to moxidectin for all human health applications. The company also assumed full responsibility for moxidectin’s registration for onchocerciasis as well as its development for other neglected tropical diseases. The close collaboration between WHO/TDR and MDGH has been critical in this process, with the input of Dr John Reeder and Dr Annette C. Kuesel being particularly significant.
The GHIF invested US$13M in 2015 to support MDGH’s work for completing the US FDA dossier for the registration of moxidectin for the treatment of onchocerciasis.
In 2016, MDGH was awarded AU$1.5M grant from The Australian Trade Commission to support the clinical development of moxidectin for scabies treatment and elimination via the Australian Tropical Medicines Commercialisation Program. Matching funding was provided by GHIF.
In 2019 and 2021, EDCTP provided two substantial grants to MDGH and partners: €4.6M for additional clinical trials comparing efficacy and safety of single or annual and biannual moxidectin or ivermectin treatment, and €2.8M for the development of a paediatric formulation of moxidectin.
In 2020, The Bill and Melinda Gates Foundation funded our work in scoping options for the sustainable manufacture and supply of moxidectin and the broader work on a case study for changing the supply paradigm for global health medicines.
In 2020, MDGH licensed CC-11050 (AMG 634) from Amgen. MDGH acknowledges the generosity of Amgen to make it possible for MDGH to take on the CC-11050 program and for their continued support to the two Phase 2 clinical trials in tuberculosis and leprosy type 2 reactions, by generously providing CC-11050 to both studies and funding the leprosy study.
Additionally, MDGH has received support from private foundations and impact investors for the moxidectin in scabies program:
MDGH develops and maintains strong relationships and collaborations that generate both trust and respect among our global public health colleagues. We are open to partnerships with biopharmaceutical companies, PDPs, civil society organisations, and manufacturers.
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If you would like more information about the work we do and how your organisation could collaborate with MDGH, please contact us here:
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MDGH respectfully acknowledges the Traditional Owners of the land on which our office is located, the Wurundjeri people of the Kulin Nation, and pay our respect to their Elders past, present and emerging.
