Prescription for the developing world

SAN FRANCISCO -- Victoria Hale is chief executive of the ultimate oxymoron: a nonprofit drug company. From her office in San Francisco's financial district, she hopes to wipe out diseases that plague developing nations but are ignored by Western drug companies for lack of profit possibilities.

Hale's prescription is to gain marketing rights to promising drug candidates that are owned by drug companies but sit undeveloped in labs.

The drug industry spent $32 billion on research and development in 2002, which yielded millions of possible drug compounds, many of which could fight diseases endemic to the developing world.

But with profit pressures, the companies largely focus on lucrative therapies for widespread diseases such as cancer and diabetes and distinctly Western worries such as penile dysfunction, baldness, and other "lifestyle" afflictions.

There's simply no money in fighting the "black fever" in India or the exotic Chagas disease in Latin America.

"Every company discovers many, many more candidates than they can pursue," Hale said. "These are clear opportunities that just sit and collect dust."

So the former government drug regulator and Genentech Inc. scientist launched the Institute for OneWorld Health three years ago when she turned 40 -- "Looking in the mirror, I asked, `Let's be honest, what have you really done?' "

OneWorld is now gobbling up rights to drug candidates sitting on companies' shelves that could treat illnesses caused by parasites, such as kala azar -- Hindi for "black fever" -- and infant diarrhea, a leading cause of infant mortality around the world.

"When she first told me of her plans, I didn't believe it would work," said Alan Taylor, an executive with biotech firm Gilead Sciences Inc. and a OneWorld adviser. "But OneWorld has created a buzz throughout the industry."

Several similar private-public partnerships have emerged in recent years, including the Swiss giant Novartis' nonprofit Institute for Tropical Diseases and the New York-based Global Alliance for Tuberculosis Drug Development.

"We are in the midst of a huge change in how these groups can work together," said Dr. Regina Rabinovich, infectious diseases director of the Bill and Melinda Gates Foundation, which funds many of these partnerships. The drug and biotechnology industries, notoriously secretive and guarded about their patent portfolios, are starting to realize the altruistic and public relations benefits such arrangements can have. Companies can also get tax write-

offs if they donate patents. Recently, Chiron Corp. donated most commercial rights to the drug compound dubbed PA-824 to the tuberculosis alliance. The drug was being developed to treat cancer but was also found to be effective against tuberculosis in preliminary experiments.

"Chiron doesn't have any reason to move this forward and our goal is to get that drug developed," said alliance spokeswoman Gwynne Oosterbaan. "Chiron has every incentive to hand it over to us."

Oosterbaan said the alliance hopes to start human experiments sometime next year.

Two years ago, gene-mapping pioneer Celera Genomics donated the rights to a compound to treat Chagas disease, a Latin American affliction transmitted by an insect dubbed the "assassin bug" that causes heart failure.

Some 18 million people are infected with the disease and 45,000 die annually. Usually the disease doesn't show symptoms for up to 20 years, but the disease ultimately damages the heart and other organs.

More recently, armed with a little more than $10 million from the Gates Foundation, OneWorld has just started a large and pivotal human experiment in Bihar, India, that's testing a drug to treat kala azar. Known medically as leishmaniasis, kala azar is carried by the sand fly and kills an estimated 200,000 people annually. Twelve million people are thought to be infected, mostly in India.

The compound being tested, paromomycin, was developed by a company now owned by Pfizer Inc., which donated it to the World Health Organization. The drug showed promise in earlier experiments but WHO shelved it anyway because of budget constraints. Now OneWorld has taken over. "If this experiment works and this trial becomes successful I think it I will attract the attention of many more companies and trust funds," said Dr. Shyam Sundar, director of the Kala-Azar Free and Charitable Medical Clinic in Bihar.