Gilead Faces Criticism Over Drug Access

Close-up of Gilead Sciences Inc.'s Truvada pill in their lab in Foster City, Calif., Monday, May 2006. Truvada is one of the most popular HIV treatments in the world. (AP Photo/Paul Sakuma) (Paul Sakuma - AP)

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 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. The onerous dosing regimen and often nasty side effects dissuaded many patients from taking their medication.

"Truvada is revolutionary because simplicity leads to better outcomes," said Gilead Chief Financial Officer John Milligan, a former Gilead scientist who has been with the company for 16 years.

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.

"The drug clearly dominates its class," said Sharon Seiler, an analyst at Punk, Ziegel who sent a note to her clients Tuesday advising them to buy the company's stock. "The company has a lot of credibility."

The Foster City company is expected to get an even bigger boost when the Food and Drug Administration approves a new, three-drug combination of Truvada and Bristol-Myers Squibb Co.'s popular Sustiva. Because all three drugs are already on the market, FDA approval is widely expected this year.

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. Nearly 25 million of those are in Africa south of the Sahara.

Gilead acknowledges a responsibility to make its drugs available to the developing world and has touted its Gilead Access Program in several press 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."