[Ip-health] AP: Gilead Faces Criticism Over Drug Access

[Mike Palmedo]

http://www.cbsnews.com/stories/2006/06/04/ap/health/mainD8I1GVVO0.shtml

Gilead Faces Criticism Over Drug Access - Critics say Gilead Sciences
isn't doing enough to bring its HIV treatment to Third World nations

June 4, 2006

(AP) 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."

But medical and AIDS advocacy groups say the access program is little
more than an empty promise. 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."