News

Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved moxidectin 8 mg oral for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older. The FDA has also awarded MDGH a priority review voucher ....

The Rotavirus Vaccine Program at the Murdoch Children’s Research Institute has published results from their study evaluating the efficacy of an oral human neonatal rotavirus vaccine (RV3-BB) in preventing rotavirus gastroenteritis. Amanda Handley, Director at Medicines Development, has been providing project management services on this program since January 2013. Congratulations to all the program team...

Medicines Development for Global Health is delighted to announce the publication of the moxidectin Phase III study in the Lancet. The paper’s authors, coordinated by the previous Sponsor of moxidectin, the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, concluded that “Moxidectin would therefore be expected to reduce parasite transmission between treatment...

The February 2018 edition of Clinical Researcher’s Q & A with Mark Sullivan and Craig Rayner on good management practice. Please click here to read the Q&A.

Medicines Development for Global Health is pleased to announce the submission of a New Drug Application for moxidectin as an oral treatment for river blindness to the US Food and Drug Administration (FDA). The FDA have also confirmed that moxidectin has qualified for priority review.

Medicines Development is pleased to announce that it has been accepted as a member of the Neglected Tropical Disease NGO Network (NNN), a global forum for nongovernmental organizations working together on NTDs. The NNN was established in October 2009 to create a global forum for nongovernmental organizations working to control onchocerciasis, lymphatic filariasis, schistosomiasis, soil transmitted helminths and trachoma. There is a long list of esteemed members in this network.

There are two bills on FDA reauthorization in the US Congress aimed at improving the FDA Priority Review Program for Neglected Tropical Diseases. The neglected tropical diseases world is benefiting from this prescient legislation to address the market failure in neglected tropical diseases. However, in reviewing the proposed legislation, there are some unexpected and potentially undesirable consequences to the proposed changes.

The Cancer Therapeutics CRC has received the Australian CRC Association’s (CRCA) Award for Excellence in Innovation at the annual awards dinner in Canberra on May 2017. As Participant Partner of the Cancer Therapeutics CRC, Medicines Development is proud to be involved with the ground breaking research targeted to the treatment of various cancers.

MDGH has played a central role in the establishment of the Global Health Alliance Melbourne (GLHAM) which aims to capitalize on Victoria’s strengths and capabilities in global health expertise.

Neglected tropical diseases (NTDs) remain important sources of morbidity, mortality and disadvantage in low and middle-income countries, and yet the development and registration of new treatments for these diseases is rare. Funding to support the research and development of new medicines for these diseases is directly correlated with their low potential for return on investment, and remains insufficient to consistently meet regulatory standards. To drive this drug development, in 2007 the United States Congress created the priority review voucher (PRV) to reward sponsors who successfully register medicines to treat specified NTDs. The PRV is saleable to any company wishing to gain priority review of their new treatment, regardless of indication, creating a market that has yielded up to US$350 million per PRV. Although three new NTD treatments have been approved under the scheme, concerns have been expressed that sponsors benefitting from PRV sale are not bound to ensure treatment access and that the program does little to drive new NTD drug development.

Sally Kinrade of MDGH will be presenting at ICTMM on repurposing as a strategy to address unmet medical needs: developing the veterinary endectocide moxidectin to treat human neglected tropical diseases.

Mark Sullivan, Managing Director at MDGH, will be presenting on capital raising for a pre-NDA PRV candidate: moxidectin for onchocerciasis. During his presentation he will discuss the development pathway of moxidectin and the unmet medical need being addressed. He will also give an overview of the capital raising activities and time frames and review the global health impact obligations contained within the funding agreements. Further, Mark will share his vision on the post PRV plans to build a sustainable NFP global health biotechnology company.

Medicines Development for Global Health has received AU$1.5 million from the Australian Tropical Medicines Commercialisation fund with matching funding from the Global Health Investment Fund for a total of AU$3 million to used to run a pivotal Phase II dose finding trial for moxidectin for scabies elimination.

Medicines Development is pleased to be involved with the Cancer CRC’s poster presentation at the 14th International Congress on Targeted Anticancer Therapies which was recently held in Washington DC on 21-23 March 2016.

Kate E. Mounsey et al discuss the true global health burden of scabies, the inadequacy of current treatments and the new hope that moxidectin brings to show that improved control of scabies in endemic communities is achievable.

In a study published today in the New England Journal of Medicine, Romani and colleagues, notably Andrew C. Steer, report the results of the Skin Health Intervention Fiji Trial (SHIFT), evaluating the efficacy of mass drug administration (MDA) of topical permethrin cream and oral ivermectin in the treatment of scabies. The elegantly conducted randomised study, undertaken in Fijian island communities, demonstrated that oral ivermectin MDA was superior to permethrin cream MDA in reducing the prevalence of scabies infection. Medicines Development for Global Health congratulates Andrew for publishing such a compelling study supporting the use of oral therapy in treating this important communicable disease.

In the editorial accompanying the NEJM publication of Romani, L., et al. (2015). “Mass Drug Administration for Scabies Control in a Population with Endemic Disease”, Professor Bart Currie highlights the inclusion of scabies on the World Health Organization’s list of Neglected Tropical Diseases (NTDs) noting that at any given time approximately 130 million people are affected globally by scabies infection.

Medicines Development for Global Health has retained the services of d3 Medicine to provide strategic advice on the regulatory strategy to support the registration of moxidectin for onchocerciasis. The services of d3 Medicine have been retained through an innovative risk-share agreement for the benefit of both companies.

Three scientists were jointly awarded the Nobel Prize in Physiology or Medicine 2015 earlier this month for their pioneering work to develop novel therapies for treating some of the world’s most devastating parasitic diseases. The prize recognises the work of William C. Campbell, Satoshi Ōmura and Youyou Tu, whose research provided new treatments for parasitic roundworm and malaria infections.

An interesting article that provides the history and examines the success of the Priority Review Voucher program. The author notes that though the value of the voucher has increased from $67.5 million to $350 million, the prospect of payment of this size may be insufficient for large pharmaceutical manufacturers accustomed to substantially higher revenues. Medicines Development however, as a not for profit drug development company dedicated to the development of affordable medicines and vaccines, views this as a significant amount of funding.