VL, also known as kala azar ("black fever"), is a fatal disease transmitted by sand flies, which spread leishmania parasites that attack internal organs. VL is endemic in 62 countries, and the number of new VL cases per year is estimated at 500,000. With the exception of malaria, VL kills more people than any other parasitic disease. OneWorld Health completed phase III clinical testing last year with paromomycin, an off-patent antibiotic, for the treatment of VL in India. This large-scale clinical trial in Bihar, India, demonstrated that paromomycin is both safe and effective. OneWorld Health is submitting an application for drug approval to the Indian regulatory agency in early 2006.
"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 energized about the prospect of controlling a deadly disease in India and beyond."
"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 the Indian government 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:
- Phase 4 demonstration study: To construct an effective and sustainable delivery strategy, OneWorld Health will formalize partnerships with local government, primary healthcare centers and nongovernmental organizations (NGOs). The partners will conduct a study todemonstrate the feasibility of administering paromomycin in rural field conditions, and to provide further data on the safety and efficacy of the drug.
- Clinical trial in children: To extend the benefits of this safe drug to a larger population, a new clinical trial will include children under five years of age.
- U.S. FDA or EMEA approval: Although OneWorld Health will seek regulatory approval in India first, it also plans a regulatory submission to the FDA or the European Agency for the Evaluation of Medicinal Products (EMEA). In 2005, the FDA and the EMEA each granted orphan drug status to OneWorld Health for paromomycin for the treatment of VL.
- Local drug manufacture to GMP standards: OneWorld Health will ensure that paromomycin is manufactured in India using FDA Good Manufacturing Practices, the highest international standards, at an affordable price, and will also ensure scalability for subsequent countrywide distribution.
To secure high quality, affordable local manufacturing, OneWorld Health has partnered with IDA Solutions, part of the International Dispensary Association (Amsterdam, Netherlands), the world's leading not-for-profit supplier of drugs to developing countries. IDA Solutions has contracted with Gland Pharma Ltd., a U.S. FDA-approved pharmaceutical company specializing in injectable drugs based in Hyderabad, India. Gland has agreed to 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.
At the World Health Assembly in May 2005, the governments of India, Bangladesh, and Nepal committed to eliminate VL in their countries. Paromomycin may provide a critical tool to help these countries achieve their goal.
About The Institute for OneWorld Health
The Institute for OneWorld Health, the first U.S. nonprofit pharmaceutical company, develops safe, effective, affordable new medicines for people with diseases of the developing world, including visceral leishmaniasis, malaria, diarrhea and Chagas disease. OneWorld Health applies its entrepreneurial business model with a staff of experienced pharmaceutical scientists that identifies promising leads and drives development from pre-clinical studies to clinical trials through regulatory approval. The Institute for OneWorld Health, headquartered in San Francisco, Calif., is a tax-exempt 501(c) (3) U.S. corporation (http://www.