MDGH timeline
MDGH is developing two medicines: moxidectin and CC-11050 (AMG 634). Together, these medicines are targeting seven different diseases that collectively have a global prevalence of three billion cases.
2005
MDGH founded as Medicines Development Limited
2006
Phase II study in Ghana begins for Moxidectin in river blindness driven by the WHO, Wyeth and partners
2007
Discussions with EMA on Phase III moxidectin in river blindness
2009
Phase II study in Ghana is completed
Pfizer acquires Wyeth
2010
Orphan drug designation granted by US FDA moxidectin for river blindness
2011
Pfizer withdraws from WHO/TDR collaboration. New partner sought
2013
MDGH approaches WHO/TDR for scabies
2014
Moxidectin licence transferred to MDGH
2015
MDGH affiliate office in the UK is established
GHIF commits US$13M in initial funding to support the manufacture of moxidectin
2016
Pre-NDA meeting with FDA
2017
cQT study and CMC finalised
NDA filed with FDA
Receipt of $0.45M impact investment loan to bridge cash flow constraints
2018
FDA approval of moxidectin for river blindness and PRV received
Founder and Managing Director Mark Sullivan is named 2019 Victorian Australian of the year
MDGH awarded the 2018 AusBiotech and J&J Innovation Industry Excellence Award
2019
MDGH named one of Fast Company’s ‘World’s Most Innovative Companies’ for 2019
MDGH sells its PRV to Novo Nordisk, with funds raised going towards additional moxidectin clinical trials and field implementation
Euro 4.6M awarded by EDCTP to a consortium for a paediatric dose finding project that includes MDGH in a key role
Mark Sullivan recognised as EV’s ‘Entrepreneur of the Year’ in the category of Australian Social Entrepreneur.
Atticus Medical Pty Ltd established as the commercialisation entity to develop moxidectin for indications with large market potential
2020
MDGH initiates a Phase IIa moxidectin dose-finding study in people with scabies in Australia and France
2020 Mitchell Humanitarian Award presented to Mark Sullivan and John Reeder
MDGH and GHIF sign a ‘Development Commercialisation Agreement’ and an ‘IP Management Agreement’
Results of a Phase II clinical trial show that moxidectin is effective and well-tolerated for the treatment of whipworm in adolescents
Mark Sullivan recognised by the Australian Academy of Technology and Engineering with the Clunies Ross Entrepreneur of the Year award
Moxidectin nominated in ‘Best Pharmaceutical Product’ category for the 2020 Prix Galien USA Awards
MDGH licences a new molecule, CC-11050 (AMG 634), from Amgen to advance development as a potential treatment for tuberculosis and leprosy
2021
A project partially funded by an EDCTP award of Euro 2.8M grant to a consortium starts. The project’s aim is to develop a paediatric formulation of moxidectin for neglected diseases
An article in The Lancet Respiratory Medicine is published by Aurum Institute and partners and suggests that combination therapy with CC-11050 might enhance the recovery of FEV1, a key measure of lung function
2022
2023
2024
