Health

World's First Non-Profit Pharmaceutical Company Gears Up

"When the only available treatment for a fatal disease is both toxic and ineffectual, you have a potential crisis on your hands."

Although public-private partnerships exist to funnel needed drugs to developing nations, the Institute for OneWorld Health, a San-Francisco-based BAIDO member, may be the world's first non-profit pharmaceutical company. It was founded in July 2001 to provide drugs where corporations and governments have not.

A year on, the organization is preparing to launch clinical trials on a drug to cure visceral leishmaniasis, a disease which destroys the organs and is almost always fatal. India accounts for 80 percent of all infections (Brazil and the Sudan share most of the rest). Seventy percent of Indians with the disease are resistant to the only drug currently used: a tin-based, toxic substance dating from the 1930s.

"As any public-health expert can tell you, when the only available treatment for a fatal disease is both toxic and ineffectual, you have a potential crisis on your hands because the infection numbers can really take off," said Dr. Victoria Hale, iOWH's founder.

The first priority for iOWH's is to create new therapies where none exist, or where the available therapies are toxic or ineffectual. The second is to make sure they're affordable.

"That's why we undertook to revive paromomycin, a drug that is old and off-patent but promises to be very effective," Dr. Hale said. "It was really just sitting there because of its lack of profitability. The World Health Organization had the rights to it, but was unable to fund the necessary Phase III clinical trials. So we asked them if we could take it on. Their response was, 'you could probably do this quicker than we could, so yes, go ahead.'

Obstacles abound in providing drugs to developing countries. There are often no markets for treatments to diseases that affect the world's poorest people. Companies are not inclined to do research and development in such cases. Sometimes existing drugs are discontinued by the manufacturer because they are no longer desirable or profitable.

iOWH takes on the research and development costs, then license medicines to in-country manufacturers, many of which are capable of making high-quality oral medicines at a much lower price than a developed-world company could.

Th clinical trials on paromomycin will take two to three years. Then, the organization will seek regulatory permission from the WHO to license the drug's production in India.

"That may seem like a long time when people are suffering, but the alternative is for people to just enter the market holding a drug in their hand and to sell it and to wreak havoc." Dr. Hale said. "We especially have to be sure to get the dose right in children -- about half of leishmaniasis patients are under age 10."

Contact the Institute for OneWorld Health (iOWH) at (415) 379-3700, or email Dr. Victoria Hale at vhale@oneworldhealth.org.