Most new medicines are developed for diseases prevalent in high-income countries, where the potential returns offset the high cost and risk of their development. But this model disadvantages the world’s poorest populations and, according to the World Health Organization, two billion people don’t have access to even the most basic of essential medicines.
Addressing this health inequity is Australian biopharmaceutical not-for-profit, Medicines Development for Global Health (MDGH), which researches, develops and delivers new and improved medicines for diseases that disproportionately affect low- and middle-income countries.
MDGH is developing two highly impactful medicines, moxidectin and dovramilast, for the treatment of up to eight neglected diseases. And while its current focus is on infectious diseases, MDGH can work on any neglected diseases that don’t traditionally have a commercial market.
What makes MDGH different from similar ventures in the non-profit space is that MDGH mainly work on drugs in the clinical stage — those that are being tested on humans or later, whereas other groups primarily work on early stage development where chances of success are less than 1 in 10. At the stage MDGH acquires and develops medicines, the risk profile is lower with the key challenge is securing funding. MDGH is addressing this now.
MDGH employs a multi-pronged approach, with a unique impact investment mechanism central to its funding model.
To get a sense of what MDGH is currently trying to achieve, we should look at its past success.
A Proven Success: Moxidectin for River Blindness
In 2018, MDGH achieved a significant milestone, registering a new drug with the United States Food and Drug Administration (US FDA). The drug, moxidectin, was for the treatment of river blindness, and was the first new FDA-approved treatment for river blindness in the last 20 years.
MDGH had licensed the drug from the World Health Organization, who didn’t have the resources to get it registered, recognising it as a really promising molecule that may also be impactful in scabies, which is a big problem in Australia and the Pacific.
Interestingly, the work on river blindness was largely funded through an impact investment mechanism, including US$13 million from the Global Health Investment Fund (GHIF) — a Gates Foundation-underwritten social impact fund based in New York.
That funding enabled MDGH to finish the development of moxidectin for river blindness and get US FDA approval, which was followed by the award of a golden ticket, a FDA Priority Review Voucher.
Priority Review Vouchers incentivise companies to spend on neglected diseases. Those successful in registering a new drug receive the voucher which cuts the time the FDA takes to review a drug from a typical timeframe of around 1 year to just six months. The voucher can either be used for another drug, or can be sold to someone else to register their next drug.
This is very valuable to big pharma, where getting a new drug to market as soon as possible can be worth billions of dollars.
In MDGH’s case, it was the first non-profit to ever be awarded a Priority Review Voucher, which it then sold to Novo Nordisk who used it to accelerate access to one of their blockbuster drugs. This provided MDGH with the funds to continue the work it’s been doing since then.
Confident they would be awarded the voucher, MDGH had explained to impact investors that they were two years away from that milestone and investors would get a share of the proceeds of that voucher, which they did.
Global Health Investment Fund Managing Partner Curt LaBelle, MD said at the time, “The sale of this voucher is a prime example of our double bottom line model at work, as it not only enables us to provide substantial returns for our investors, but it also fulfils our mission of improving lives in low-income countries by greatly bolstering efforts to eliminate river blindness.”
The opportunity: Dovramilast for Leprosy
MDGH is now trying to do the same thing for their second molecule, dovramilast for leprosy. Dovramilast has the potential to improve the lives of tens of thousands of leprosy sufferers, where current treatments (thalidomide and corticosteroids) have significant side effects.
A novel compound with FDA orphan drug designation, dovramilast also has potential to treat various inflammatory conditions and tuberculosis.
Having defined a development and regulatory pathway, and if programs are successful, MDGH anticipates receiving a Priority Review Voucher — which currently sell for around US$100 million — in around five years time.
Series B Impact Investment Loan
MDGH is currently raising capital via an impact loan structure with a 5% coupon (paid annually or accrued) with an anticipated total investment return, upon receipt of FDA Priority Review Voucher, of 2x initial capital.
The investment is secured against the proceeds of a Priority Review Voucher which it expects to receive and sell in five years.
This raise, along with grants received, will take the program to Phase 3 ready.
Potential to Change Lives
MDGH Founder and CEO Mark Sullivan AO, credits social impact investment as a really important part of their capital raising needs, plus it presents opportunity for the investors.
“We see a multi-pronged approach to how we fund our work and social impact investment is really crucial to that.
“We already have some interested parties, both here and in the US, for the current raise, but are looking for people who are interested in investing in our programs, one of which has the potential to result in a Priority Review Voucher and improve people’s lives.
“We also have some interesting commercial opportunities with our portfolio with very substantial markets that we’re in Phase 2 for. So a lot of the derisking has already happened.
“Particularly in the Australian scene, this is a very unusual opportunity. In fact, I think it’s probably fair to say that globally, it’s a pretty unusual opportunity.
“The chance to have that impact, particularly on low- and middle-income country diseases, while getting a return which is appropriate, doesn’t come up that often, in our field at least.
“It is a long, painful and expensive process to introduce a new medicine. But once you get there you have a treatment for a disease that was previously untreatable or poorly managed — it transforms people’s lives.
“That’s the reason we do it, and it is a tremendous incentive to anyone who’s passionate about health.”
MDGH has so far raised around A$3 million through its impact investment mechanism, with 14 groups having come to the party. But it is still fund raising to get the right amount of money so it can do all the work needed to be successful.
Recent funding
MDGH has grants from the Australian Government, European and Developing Countries Clinical Trials Partnership, Helmsley Charitable Trust and the Gates Foundation.
The recently-received Australian Government’s $16 million grant award will advance the development and delivery of moxidectin for scabies and lymphatic filariasis and dovramilast for leprosy type 2 reaction. The grant from the government comes as “a very nice endorsement of the body of our work”, said Mark.
For more information on Medicines Development for Global Health and its Impact Investment Loan contact George Rugarabamu PhD, Principal, Corporate Development at george.rugarabamu@medicinesdevelopment.com, or see https://www.medicinesdevelopment.com/.