News

Have you ever wondered what the letters and numbers stamped on the surface of a pill mean?

Amgen licenses AMG 634, an investigational treatment for tuberculosis and leprosy, to medicines development for global health...

The Mectizan (ivermectin) Expert Committee states that new in vitro data are not sufficient to indicate clinical benefit to reduce viral loads in COVID-19 patients...

January 30, 2020 marks the first ever World Neglected Tropical Disease Day. It is billed as 'A New Day in the Fight Against NTDs' and kicks off a decisive year in the fight against NTDs...

Mark Sullivan, Managing Director and Founder of Medicines for Global Health, was awarded one of EY Australia's "Entrepreneur of the YEar" awards in the social category for his work in establishing MDGH...

Significant portion of proceeds will be reinvested in neglected disease research and control efforts, fully realizing the original intent of this important public health funding mechanism‍...

Awarded annually, the Prix Galien Award recognizes outstanding achievements in improving the global human condition through the development of innovative drugs and other treatments...

The award is for his vision in establishing Medicines Development for Global Health to address health inequity, and the novel funding approach that was applied...

The sale of the Tropical Disease Priority Review Voucher follows the FDA’s approval of moxidectin, an oral treatment for river blindness...

Medicines Development for Global Health (MDGH) is delighted to announce that it has received the 2018 AusBiotech and Johnson & Johnson Innovation Industry Excellence Award in the “Established Company of the Year Award” category.

Medicines Development for Global Health Founder and Managing Director Mark Sullivan was named 2019 Victorian Australian of the Year this week for his vision for bringing urgently needed medicines into the fight against Neglected Tropical Diseases.‍

Mark Sullivan, the founder, Managing Director and Board Member of Medicines Development for Global Health, was interviewed by Dr. Norman Swan on today’s Health Report, broadcast nationally in Australia. The interview covers MDGH’s business model, the FDA’s approval of Moxidectin, and the medicine’s potential to help the fight against river blindness, which is a leading global cause of preventable blindness. Click anywhere to listen to a recording on the ABC’s website.

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 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.

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.

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.

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.

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.

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.

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.

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.

Based on a review of quality, safety and efficacy, the TGA approved the registration of ivermectin for the treatment of scabies. Ivermectin is an easy, effective oral treatment for scabies, and is now registered for this purpose in Australia.

LONDON – UK: The Global Health Investment Fund (GHIF) and Medicines Development for Global Health (Medicines Development) announced today a 10 million USD program for the registration of moxidectin for the treatment of river blindness (onchocerciasis). River blindness is a debilitating neglected tropical disease caused by the worm Onchocerca volvulus, which is transmitted through the bites of infected blackflies. The disease affects more than 37 million people, the majority of whom live in poor communities in sub-Saharan Africa. Medicines Development, an Australian not-for-profit biopharmaceutical company that licensed the moxidectin data from the World Health Organization (WHO), will undertake the registration process and, should it be successfully registered, will supply this potentially transformative new drug.

The Global Health Investment Fund (GHIF) has committed US$ 10 million to support completing the dossier for the registration of moxidectin for the treatment of onchocerciasis. Medicines Development for Global Health (MDGH), an Australian not-for-profit biopharmaceutical company, will be managing the work.

Medicines Development is working on the registration of a new game changing treatment for river blindness and scabies. According to the current legislation, with the registration of the new treatment MDL will be eligible for a Priority Review Voucher from the FDA.

Since August 2011 Medicines Development has been supporting the RV3 Rotavirus Vaccine team at the Murdoch Childrens Research Institute (MCRI) by helping to coordinate the development of MCRI’s novel vaccine to protect newborns from rotavirus infection.

The Department of Microbiology at Monash University and Medicines Development Limited, one of Australia’s specialist providers of development management services for the biotech and pharmaceutical industries, are joining forces to assess a new treatment for Clostridium difficile disease.

Medicines Development and Hatchtech are pleased to announce that Michael Wheatcroft has joined Hatchtech as Senior Development Manager under the Development Manager training and placement initiative supported by the Victorian Government’s Smart SME’s Innovation and Commercialisation Program.

Researchers at the Peter MacCallum Cancer Centre, The Auckland Cancer Society Research Centre, Monash University School of Biomedical Sciences and the Queensland Institute of Medical Research aim to develop a new class of immune-suppressive drugs that protect transplanted bone marrow stem cells against immune destruction.

Medicines Development and Immuron are pleased to announce that Gerhard Rank has joined Immuron as Development Manager under the Development Manager training and placement initiative supported by the Victorian Government’s Smart SME’s Innovation and Commercialisation Program.

Mark Sullivan joins six university vice-chancellors and TAFE bosses and representatives from more than 220 companies on the six day Super Trade Mission, the largest-ever Australian trade mission to India. Medicines Development is representing the Life Sciences sector for the mission, a major sector of the Victorian economy.

Prof. Paul Hertzog of the Monash Institute of Medical Research, in collaboration with Medicines Development, has been awarded a $422,418 Development Grant by the Australian National Health and Medical Research Council (NHMRC) to develop sublingual (oral) interferon alpha for the treatment of viral hepatitis. Ninety-seven Development Grant applications were reviewed, with only 16 (16.5%) being funded to commence in 2012.

Ivermectin is an easy, effective oral treatment for scabies, yet is currently not registered or “on-label” for this purpose in Australia.

Medicines Development is pleased to announce that Charlotte Mulder has completed its rigorous Development Manager Training Program and has been successfully placed at Virax Holdings Ltd as a Development Manager. Charlotte is Medicines Development’s first trainee and placement under its Development Manager training and placement initiative supported by the Victorian Government’s Smart SME’s Innovation and Commercialisation program.

Medicines Development is pleased to announce the appointment of Dr Gerhard Rank to support the RV3 Rotavirus Vaccine team at the Murdoch Childrens Research Institute (MCRI). Dr Rank will help coordinate the development of MCRI’s novel vaccine to protect newborns from rotavirus infection.

Dr Bruce Walker, director of the Ragon Institute of MGH, MIT and Harvard, professor of Medicine at Harvard University, and a Howard Hughes Medical Institute investigator is profiled in this edition of Nature. The article details how Dr Walker convinced philanthropist Terry Ragon and his wife to commit $100m over 10 years to create the Ragon Institute and highlights his continued efforts to transform HIV vaccine research.

Medicines Development is pleased to announce the appointment of Dr Charlotte Mulder to its Development Manager training and placement program. The program is supported by the Victorian Government’s Smart Small to Medium Size Enterprises (SME) Innovation Commercialisation Program (ICP) and aims, over three years, to co-fund the recruitment, training, placement and supervision of specialist product development managers. Each of these managers will be placed into a biotechnology company and receive ongoing mentorship from Medicines Development’s senior managers.

Bob Anderson (CEO Nexpep Pty Ltd), CSO ImmusanT Inc., discussed the results of phase 1 Nexvax2 study at the recent Digestive Diseases Week conference in Chicago, Illinois. For the study Medicines Development provided a full time Development Manager and a part time Project Leader to supplement Nexpep’s own internal resources.

Medicines Development announces that Mark Sullivan has joined the Investment Committee of Auckland UniServices. Auckland UniServices Limited is the largest research and development company of its kind in Australasia and a wholly owned company of The University of Auckland. UniServices manages The University’s intellectual property and is responsible for all research-based consultancy partnerships and commercialisation. Auckland UniServices has an annual turnover of NZ$125 million and over 700 employees.

Medicines Development is now an Approved Supplier for the Small Technology Industry Uptake Program. The STIUP program will gives Victorian businesses the opportunity to increase their competitiveness by using small technologies to explore, adopt and integrate into improved products, processes and services. The STIUP will allow Victoria’s innovative small technology companies to demonstrate and commercialise their goods and/or services to new customers. The Program will provide support through a voucher system which can be exchanged for access to facilities, goods, services, advice or expertise.

Melbourne-based Medicines Development has received backing to train up a handful of development managers to place in therapeutics companies on the commercialisation track. Chief executive and former GSK clinical program head Mark Sullivan spoke to BTN about the company’s approach to mentoring and finding project managers.

Medicines Development, a firm specialising in drug development and commercialisation, has been awarded a grant from the Victorian Government which will be used to expand its program for training and placement of skilled Development Managers within Victorian biotechnology companies

Opening the AusBiotech 2010 Conference in Melbourne today, Innovation Minister Gavin Jennings announced Victorian company Medicines Development has been engaged to provide specialist drug development expertise to biotechnology companies developing new pharmaceutical products.

Medicines Development, a leading provider of specialist development expertise to Australia’s biotechnology industry, will be attending the AusBiotech 2010 conference on 19-22 October 2010. The extensive international experience Medicines Development offers to meet the development needs of the industry, combined with its not-for-profit ethos, fits well with the conference theme of ‘Creating Global Solutions’ and the focus towards developing solutions that deliver a brighter future. Medicines Development is proud to participate in Australia’s premier biotechnology conference and extends an invitation to you to visit us at booth 105 in the Exhibition Hall. Alternatively, call Pete or Adelina on +61 3 9629 6111 or use the AusBiotech biopartnering service to arrange a meeting.

Medicines Development is currently coordinating an international collaboration between Opal Therapeutics Inc. (Opal) and Massachusetts General Hospital (MGH) to develop a novel immunotherapy to treat HIV. The collaboration involves the Ragon Institute of MGH, MIT and Harvard, Oxford University and the St Stephen’s AIDS Trust (Chelsea and Westminster Hospital). The first in human clinical trial is currently being conducted in London Sponsored by Medicines Development.