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.
December 16, 2017
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.
November 22, 2017
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.
July 11, 2017
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.
May 29, 2017
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.
April 3, 2017
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.
November 10, 2016
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.
September 14, 2016
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.
September 14, 2016
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.
June 18, 2016
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.
April 22, 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.
April 4, 2016
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.
December 10, 2015
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.
December 10, 2015
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.
November 25, 2015
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.
October 21, 2015
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.
October 1, 2015
Mark Sullivan will be attending the Northern Australia Investment Forum in Darwin from 8 to 10 November 2015. The forum is a high-level, invitation-only event that will bring together senior executives of leading international and Australian companies keen to pursue investment opportunities.
October 1, 2015
The development of a neonatal rotavirus vaccine has taken a step forward through the joint efforts of Australian and New Zealand researchers, with the publication of a phase 2a clinical trial demonstrating safety and immunogenicity of the RV3-BB human neonatal rotavirus vaccine. The study was published online on the 27th August in the journal Lancet Infectious Diseases. Medicines Development has been working with the RV3 Rotavirus Vaccine team at the Murdoch Childrens Research Institute (MCRI), with support from Medicines Development’s Director of Development Management Amanda Handley and CEO Mark Sullivan.
August 31, 2015
A new record has been set for the price of Priority Review Vouchers (PRVs) awarded by the US Food and Drug Administration (FDA), with the sale of United Therapeutics’ PRV to AbbVie for US$350 million (News coverage). The acquisition of the voucher by AbbVie gives the company the opportunity to reduce the FDA review period from ten to six months. AbbVie has not yet disclosed which late-stage drug will benefit from the PRV, although speculation is mounting that they may use it to accelerate the approval of venetoclax, an anti-leukemia drug developed in partnership with Roche.
August 25, 2015
The PRV program was initially adopted by the FDA in 2007 to incentivise the development of drugs to treat neglected tropical diseases (NTDs) (see list below), which would ordinarily attract little, if any, pharmaceutical development interest. Under the scheme, companies with any newly approved drug intended to treat a designated NTD become eligible to receive a Tropical Disease Priority Review Voucher. In 2012, the program was expanded to cover rare pediatric diseases, with the creation of Rare Pediatric Disease Priority Review Vouchers awarded upon registration of therapies targeting diseases affecting fewer than 200,000 children in the US. To date, six priority review vouchers, three of each type, have been awarded by the FDA to be redeemed by the recipient or sold on to another company.
August 25, 2015