This is the first non-profit pharmaceutical company in the US that works towards reducing morbidity and mortality from visceral leishmaniasis (VL) in the rural communities of India, Bangladesh and Nepal.
The generous donation is meant for initiation and evaluation of the impact of an innovative pilot programme which involved clinical testing with paromomycin, an off-patent antibiotic, for the treatment of VL in India.
The large-scale clinical trial in Bihar demonstrated that paromomycin is both safe and effective. OneWorld Health will now submit an application for drug approval to the Indian authorities.
"The elements for a sustainable public health solution for VL in India, created and managed by Indians, are coming closer together," stated Victoria Hale, PhD, founder and CEO of OneWorld Health.
"Our role is to fortify the arsenal of public health tools. The Gates Foundation funds are the catalyst for us to partner with some remarkable researchers, government officials and manufacturers in India, and other nations in the future, to create a local solution that meets the highest international quality standards. We are energised about the prospect of controlling a deadly disease in India and beyond," she added.
"The development of this new drug is a terrific global health success story. By developing a low-cost, off-patent drug for a neglected disease, OneWorld Health and its partners have given the world a more effective cure with a good safety profile at a fraction of the cost," stated Bill Gates, co-founder of the Gates Foundation.
"I am also very pleased that India has been a key partner in this effort, and has committed to eliminating the threat of visceral leishmaniasis for all Indians."
The main activities of the grant, which is designed to lay the foundation for a long-term VL control program, include a phase four demonstration study to construct an effective and sustainable delivery strategy.
To do this, OneWorld Health will have partnerships with local governments, primary healthcare centres and NGOs. The partners will conduct a study to demonstrate the feasibility of administering paromomycin in rural field conditions, and to provide further data on the safety and efficacy of the drug.
Clinical trials will also be carried out on children under five so as to make sure that the benefits of this safe drug extend to a larger population.
Although OneWorld Health will seek regulatory approval in India first, it also plans to seek approvals from the FDA and the (EMEA). In 2005, the FDA and the EMEA had each granted orphan drug status to OneWorld Health for paromomycin.
OneWorld will also ensure that paromomycin is manufactured in India using manufacturing practices approved by the FDA at an affordable price.
To secure high quality and affordable local manufacturing, OneWorld Health has partnered with IDA Solutions, part of the International Dispensary Association of Amsterdam, Netherlands, the world's leading non-profit supplier of drugs to developing countries.
IDA Solutions has contracted with Gland Pharma Ltd, an FDA-approved pharmaceutical company specialising in injectable drugs based in Hyderabad.
Gland Pharma Ltd will manufacture paromomycin and make it available at a fraction of the cost of other VL drugs, which range in price from several hundred to thousands of dollars per cure. IDA Solutions and Gland have agreed to restrict sales of paromomycin to the government sector only, reducing the risk of drug resistance resulting from improper use of the drug.
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