Institute for OneWorld Health receives multimillion do...( ile at a fraction of the cost stated...),Health

ile, 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 com
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Contact: Angie Cecil
acecil@thehaloproject.com
Institute for OneWorld Health
1-Dec-2005

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