[Ip-health] AP: Biotech company Gilead criticized for AIDS drug supply

[Sheila.SHETTLE@geneva.msf.org]

Posted on Tue, Feb. 07, 2006

Biotech company Gilead criticized for AIDS drug supply


PAUL ELIAS


Associated Press

SAN FRANCISCO - An international humanitarian group on Tuesday accused the
biotechnology company Gilead Sciences Inc. of breaking its promise to make
its effective AIDS drug widely available throughout the Third World.

Medecins Sans Frontieres, or Doctors Without Borders, said the Foster
City-based company's vow to make the virus-fighting pill Viread widely
available has turned out to be an "empty promise."

The company has touted its Gilead Access Program in several press releases
since it was unveiled nearly three years ago.
In April 2003, Gilead announced it would make the drug available in all of
Africa plus 15 other developing nations "at no profit."

The company has since announced it has expanded its access program to a
total of 97 countries. In August, Gilead slashed the price of Viread in
those countries to $208 per patient annually, compared to the nearly $5,000
annually the drug costs in the industrialized world.

Gilead chief executive John Martin said in April 2003 that because the drug
had fewer side effects than most AIDS treatments and needed to be taken
only once a day that "Viread will be a particularly important treatment
option for physicians and patients in these regions."

But the humanitarian group said Gilead has yet to garner regulatory
approval in 91 of those countries, making it nearly impossible to widely
distribute the drug in those regions. The group alleged that company
inaction is making it difficult for doctors to supply their patients with
the drug, which is used in two popular "cocktails" to treats AIDS
infections.

Gilead spokeswoman Amy Flood said Tuesday the company has applied for
regulatory approval in about half covered countries and expects to apply
for the rest sometime this year.

"The process for approval has been more time-consuming than we had
anticipated," Flood said. "This is a commitment that Gilead takes very
seriously."

Flood said Gilead had initially hoped to ship the drugs without winning
regulatory approval to the developing world on a "temporary import" basis,
but found that process too difficult.

Flood said Gilead has supplied the drug at the reduced cost to about 20,000
patients.

Doctors Without Borders said in a detailed press release issued Tuesday
that three other drug companies have won regulatory approvals to provide
inexpensive AIDS drugs in dozens of other Third World countries despite
often Byzantine bureaucratic process.

"Gilead has been extremely disingenuous," said Daniel Berman of Doctors
Without Borders in Paris. "Gilead's access program is a lie."

AIDS affects about 40 million people worldwide, with nearly 30 million
infections in Africa.

The U.S. Food and Drug Administration approved the drug in October 2001 and
European regulators approved it in February 2002. Viread accounted for $779
million in sales last year.

Gilead stock closed up 32 cents to $60.34 in trading on the Nasdaq Stock
Market.

+++++++++++++++++++++
Sheila Shettle
Communications Officer
M=E9decins Sans Fronti=E8res
Campaign for Access to Essential Medicines
Rue de Lausanne 78
1211 Geneva
Switzerland
+ 41.22.849.8403
sheila.shettle@geneva.msf.org
www.accessmed-msf.org