$30 million grant to create disease control program

January 2006

The Institute for OneWorld Health, the first nonprofit pharmaceutical company in the United States, received a $30 million grant from the Bill & Melinda Gates Foundation to initiate and evaluate the effect of a pilot program to dramatically reduce morbidity and mortality from visceral leishmaniasis (VL) in the rural communities of India, Bangladesh and Nepal.

VL, also known as “black fever,” is a fatal disease transmitted by sand flies, which spread Leishmania parasites that attack internal organs. It is endemic in 62 countries and the number of new cases per year is estimated at 500,000. More than 90% of VL cases occur in five countries: India, which bears the greatest disease burden, Bangladesh, Nepal, Sudan and Brazil.

With the exception of malaria, VL kills more people than any other parasitic disease.

OneWorld Health completed phase-3 clinical testing last year of paromomycin, an off-patent aminoglycoside antibiotic, for the treatment of VL in Bihar, India. Findings demonstrated that paromomycin is safe and effective. OneWorld Health plans to submit an application for 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,” said Victoria Hale, PhD, founder and chief executive officer 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.”

Where the funds will go

The main activities of the grant, which is designed to lay the foundation for a long-term VL control program, include the following:

• A phase-4 demonstration study: To construct an effective and sustainable delivery strategy, OneWorld Health will formalize partnerships with local governments, primary health care centers and nongovernmental organizations. The partners will conduct a study to demonstrate the feasibility of administering paromomycin in rural field conditions and provide further data on the safety and efficacy of the drug.
• A clinical trial in children: To extend the benefits of this drug to a larger population, a new clinical trial will include children younger than 5 years.
• Drug approval: Although OneWorld Health will seek regulatory approval in India first, it also plans a regulatory submission to the FDA and the European Agency for the Evaluation of Medicinal Products (EMEA). In 2005, the FDA and EMEA granted orphan drug status to paromomycin for the treatment of VL. The U.S. Orphan Drug Act provides for formal protocol assistance when requested by the sponsors of drugs for rare diseases or conditions. The EMEA regulations are similar, and have the added advantage of applying to all 25 members of the European Union.
• Local drug manufacture to standards: Ensure that paromomycin is manufactured in India using the FDA’s Good Manufacturing Practices at an affordable price and ensure scalability for subsequent countrywide distribution.

To secure high-quality, affordable local manufacturing, OneWorld Health partnered with International Dispensary Association (IDA) Solutions. IDA Solutions has contracted with Gland Pharma Ltd., an FDA-approved pharmaceutical company specializing in injectable drugs based in Hyderabad, India. Gland 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.

“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,” said Bill Gates, co-founder of the Gates Foundation.

For more information:

• For more information, visit the Institute for OneWorld Health’s Web site at www.oneworldhealth.org