Company on track to file for drug approval in India
San Francisco, Calif. –April 14, 2005 – The Institute for OneWorld Health, the first nonprofit pharmaceutical company in the U.S., 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.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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