Gates foundation gives $10M grant for Visceral Leishmaniasis research to OneWorld Health

Main Category: Tropical Diseases
Article Date: 15 Apr 2005 - 9:00 PDT

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The Institute for OneWorld Health, the first nonprofit pharmaceutical company in the US, today announced that it has received a grant of nearly US$10 million from the Bill & Melinda Gates Foundation to continue advancing its promising drug for Visceral Leishmaniasis (VL), paromomycin, through the approval and post-approval process. Specifically, the company will seek regulatory approval in India this year, execute a post-approval Phase IV study, and complete a clinical trial of shorter duration of administration to optimize the use of paromomycin. The grant will also support the company's work with partners to manufacture paromomycin at an affordable cost.

This announcement was made at the 3rd International Congress on Leishmaniasis held in Palermo, Sicily, this week, as OneWorld Health investigators were presenting positive results for paromomycin following the completion last November of the largest Phase III clinical trial ever conducted for VL.

VL, also known as kala azar ("black fever"), is a fatal disease transmitted by sand flies, which spread leishmania parasites that attack internal organs. An estimated 1.5 million people worldwide are currently infected; the number of new VL cases per year is estimated at 500,000; and as many as 200,000 people die annually. With the exception of malaria, VL kills more people than any other parasitic disease.

"Currently, VL devastates entire families for generations," said Victoria Hale, Ph.D., Founder and CEO of the Institute for OneWorld Health. "In addition to the death it brings, it also forces families to exhaust their assets to pay for treatment, and perpetuates cycles of poverty. We will help change that. Given the high safety levels and initial cure rates comparable to current hospital-based therapies, we believe paromomycin will help the Indian government to safely and affordably control VL. This grant allows us to realize the next steps required to deliver the drug to the people who need it most," Dr. Hale said.

Patients cured of VL develop life-long immunity to the disease. However, current treatments cost up to US$200, and can be toxic or ineffective. In response, OneWorld Health will be partnering with IDA Solutions to make paromomycin available for less than US$10 per treatment in the developing world. IDA Solutions is part of the International Dispensary Association (Amsterdam, Netherlands), the world's leading not-for-profit supplier of drugs to developing countries. IDA Solutions will manage Gland Pharma Ltd., a U.S. FDA-approved pharmaceutical company specializing in injectable drugs, based in Hyderabad, India, which will manufacture paromomycin.

OneWorld Health investigators at the 3rd International Congress on Leishmaniasis delivered presentations on the following: "Paromomycin as a new cure for visceral leishmaniasis: preliminary results of a Phase III randomized controlled trial of efficacy and safety" and "Paromomycin as a new cure for visceral leishmaniasis in pediatric patients: preliminary analysis of a Phase III randomized controlled clinical trial." See oneworldhealth.org/diseases/leishmaniasis_program.php for abstracts.

About The Institute for OneWorld Health

The Institute for OneWorld Health, the first U.S. nonprofit pharmaceutical company, develops new, affordable medicines for infectious diseases that disproportionately affect people in 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 (oneworldhealth.org). Media resources are available at oneworldhealth.org/media/index.php.

Contact: Angie Cecil
acecil@thehaloproject.com
516-455-7441
The Halo Project
http://www.thehaloproject.com

Joanne Hasegawa
jhasegawa@oneworldhealth.org
415-421-4700 ext. 322
Institute for OneWorld Health
http://www.oneworldhealth.org

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