FDA Approves Gilead AIDS Drug for Hepatitis B

By pdimaso

Originally published on Advocate.com August 12 2008 11:00 PM ET

Gilead Sciences
Inc. prepared to expand its reach further beyond AIDS
drugs Monday after federal regulators approved the biotech
drug maker's signature anti-HIV therapy as a hepatitis
B treatment.

Gilead announced
that the Food and Drug Administration is joining
regulators in Europe, Turkey, Australia and New Zealand by
allowing the company to market Viread as a tool for
suppressing the chronic liver disease.

Sales of Viread
as a stand-alone pill have declined in recent years
following Gilead's launch of Truvada and Atripla, which
combine Viread with other drugs and currently dominate
the market.

Viread debuted in
2001 and quickly became a top-selling anti-HIV
treatment. Sales peaked at nearly $783 million in 2004
before Gilead's own competing drugs began chipping
away at Viread's share of the AIDS drug market.

Viread had about
$613 million in sales last year on total company
revenues of $3.73 billion.

Wall Street
analysts anticipating Viread's approval Monday have called
the market for hepatitis B drugs significant, since only a
small fraction of more than 1 million in the U.S.
estimated to be infected with the virus have been
diagnosed.

The Foster
City-based company sells another hepatitis B treatment,
Hepsera, which reported sales of $303 million last year.

The FDA's
approval was based on two clinical trials that showed Viread
was more effective than Hepsera at combatting liver
inflammation and scarring caused by hepatitis B, the
company said.

The infectious
disease is blamed as a major cause of liver cancer and is
especially common in the U.S. among Asian-Americans owing to
the prevalence of hepatitis in Asian countries.

Also Monday, the
9th U.S. Circuit Court of Appeals in San Francisco
reinstated a lawsuit against Gilead claiming the company
cost shareholders money by allegedly marketing Viread
for unapproved or "off-label" uses.

The appeals court
reversed a lower court's decision dismissing the suit
filed by disgruntled shareholders in November 2003. Gilead
declined to comment on the court's decision Monday.

Gilead shares
rose 57 cents or about 1 percent in after-hours trading
Monday to $57.00. (AP)