Wall Street darling is target of Third World critics

~ Gilead Sciences' stock price has nearly doubled because of its AIDS drug.

FOSTER CITY, Calif. -- The 25-year fight against AIDS has been good to Gilead Sciences Inc., a Bay Area biotechnology company that makes the world's hottest-selling HIV treatment.

The popularity of the treatment, Truvada, is soaring because it has almost no side effects and requires patients to take only a single pill once a day. With close to two dozen AIDS drugs on the market, the company that once had Defense Secretary Donald H. Rumsfeld as its chairman is an industry leader. Its stock price has nearly doubled since Truvada was approved on Aug. 2, 2004.

But success on Wall Street hasn't insulated Gilead from complaints that it isn't doing enough to combat the disease where it hits hardest: in the Third World.

"For a company that prides itself on their access program, they have been irresponsible in getting the drug out," said David Bryden of the Global Aids Alliance, a Washington-based advocacy group that organized a small protest outside Gilead's annual shareholders meeting in May.

Truvada's chief asset is that it includes two drugs -- known generically as tenofovir and emtricitabine -- in a single pill.

That's a dramatic departure from a few years ago, when HIV-positive patients carried small alarm clocks to remind them to take their myriad pills at the right time.

"Truvada is revolutionary because simplicity leads to better outcomes," said Gilead chief financial officer John Milligan.

Doctors now prescribe Truvada to 60 percent of all newly diagnosed HIV cases in the United States. The two drugs in Truvada will ring up close to $2 billion in sales this year individually or combined in the blue, teardrop shaped pill. That's about half the estimated global AIDS market of about $4 billion.

But the 1 million Americans estimated to be infected with HIV are a fraction of the 40 million people worldwide living with the AIDS virus.

Gilead has touted its Gilead Access Program in several news releases since it was unveiled nearly three years ago. In April 2003, Gilead said it would make tenofovir available in all of Africa plus dozens of other developing nations "at no profit."

In February, the international humanitarian group Doctors Without Borders issued a scathing report that concluded the company has failed to gain regulatory approval in nearly all the impoverished countries it promised to serve.

On the same day in New Delhi, activists protested Gilead's plans to patent tenofovir in India, which has the most AIDS cases of any country. Close to 6 million people are living with the AIDS virus in India. Tenofovir has been available generically in India since last year and activists fear the cheaper drugs will disappear if Gilead is granted a patent.

"We certainly believe in intellectual property around the world," Gilead chief executive John Martin said. "On principal we believe that our product should be patented."

What's more, Martin said, critics should give Gilead a chance to get its drugs approved by government regulators in each of the poor countries where it has promised access. Several countries having been reviewing the company's applications for two years, he said.

"We are one small company in a big world where billions of dollars are being put at the problem of AIDS," Martin said. "I am proud of what we have been able to accomplish and look forward to what we'll do in the future."