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.

From the late 1990s, the WHO-based Special Programme for Research and Training in Tropical Diseases (WHO/TDR) has worked extensively with industry, patient and community groups to evaluate the use of moxidectin for the treatment of onchocerciasis. The compound is an anthelmintic medicine with activity against a broad range of parasitic worms and insects. The final stages of human studies in river blindness have now been completed and moxidectin has been shown to be well tolerated and effective against the disease.

The GHIF investment will be used to support the manufacture of moxidectin and the compilation of the regulatory dossier required for the registration process for use in humans. Should the drug be approved, Medicines Development will work towards ensuring a secure supply of moxidectin for onchocerciasis and, with GHIF, will continue to research other potential human uses of moxidectin for infectious diseases. An important part of the agreement between Medicines Development and GHIF is the contractual requirement to ensure accessibility of moxidectin for river blindness should the drug be approved, a goal consistent with the aims of each of the WHO, GHIF and Medicines Development.

“Moxidectin has the potential to be an important medicine for treating river blindness, and we are delighted to work with GHIF to achieve the goal of registering this drug for human use” said Mark Sullivan of Medicines Development. “GHIF’s strategy to invest in projects that impact health particularly in low- and middle-income countries could not be better matched with the reasons we established Medicines Development.”

“It is a privilege to be partnering with Medicines Development to bring moxidectin through its final stages of registration in humans. There has been no drug registered to fight river blindness since 1987. If successful, this will give health workers a new tool in their armoury in the effort to eliminate onchocerciasis.” said Julia Fan Li of the GHIF.

“We are delighted to see the continued progress in the development of moxidectin for treating river blindness” said John Reeder, Director of WHO/TDR. “Our vision for this drug being registered and made available to the communities affected by this debilitating disease has taken another important step forward.”

About River Blindness (Onchocerciasis): River blindness is widespread in sub-Saharan Africa, with pockets of infection in the Arabian Peninsula and in some parts of South America as well. The WHO estimates that over 100 million Africans are at risk of infection and some 37 million people are infected globally. This parasitic disease is caused by the worm Onchocerca volvulus, which is transmitted from person to person through the bite of black flies of the genus Simulium. Each adult female worm, which can live for up to 15 years in the human body, produces millions of microscopic offspring (microfilaria) that migrate through the skin, eyes, and lymph nodes. The microfilariae are the main cause of the symptoms, which include severe skin inflammation and intense itching, enlarged lymph nodes and, in some patients, visual impairment that can ultimately lead to blindness. Control and elimination of this disease currently relies on mass annual or biannual drug administration with CONFIDENTIAL – FOR RELEASE AT 8:00AM MELBOURNE TIME, 9 MARCH 2015

Confidential 2015-03-09 GHIF Moxidectin Press Release Page 2 of 2 9-Mar-15

ivermectin (through donations to the Mectizan Donation Program by Merck, known as MSD outside of the United States and Canada).

About the Global Health Investment Fund: The GHIF is a private investment fund structured by JPMorgan Chase & Co., the Bill & Melinda Gates Foundation and Lion’s Head Global Partners, which received anchor support from Grand Challenges Canada (funded by the Government of Canada), the German Ministry for Economic Cooperation and Development (acting through KfW), the Swedish International Development Cooperation Agency and the Children’s Investment Fund Foundation. The GHIF’s mission is to finance late-stage drugs, vaccines and diagnostics for diseases that disproportionately burden low-income populations. Public health challenges targeted by the GHIF include malaria, tuberculosis, HIV/AIDS, cholera, maternal and infant mortality and other neglected infectious diseases.

In addition to the anchor supporters listed above, the GHIF’s limited partners also include AXA, GlaxoSmithKline, the International Finance Corporation, JPMorgan Chase & Co., Merck, the Pfizer Foundation, Storebrand and a number of individual investors. The sponsors and partners of the GHIF believe that the Fund offers a novel opportunity to help bring about significant improvements in the treatment and prevention of disease and the reduction of maternal and child mortality, along with the prospect of a net financial return for investors.

LHGP Asset Management LLP, the London-based asset management arm of Lion’s Head Global Partners, authorized by the Financial Conduct Authority, serves as Investment Manager for the GHIF.

For additional information about GHIF, please visit http://www.ghif.com.
About Medicines Development for Global Health: Medicines Development is a not-for-profit biopharmaceutical company headquartered in Melbourne, Australia. This unique organisation was established in 2005 by a team of industry veterans to undertake the development and delivery of new medicines and vaccines for unmet medical needs prevalent in people in low- and middle-income countries. The company works on the development of a portfolio of products, including vaccines, small molecules and biological therapies, targeting predominantly infectious, immunologic and oncologic diseases.

For additional information about Medicines Development, please visit www.medicinesdevelopment.com

About TDR: The Special Programme for Research and Training in Tropical Diseases, is a global programme of scientific collaboration that helps facilitate, support and influence efforts to combat diseases of poverty. It is hosted at the WHO, and is sponsored by the United Nations Children’s Fund (UNICEF), the United Nations Development Programme (UNDP), the World Bank and WHO.

For additional information about WHO/TDR, please visit www.who.int/tdr.

 

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