http://www.genelabs.com/pressReleases/020904.html

EXTRACT

Redwood City, Calif. – February 9, 2004

Genelabs Technologies, Inc. (Nasdaq: GNLB) announced today that it has
completed patient enrollment in its confirmatory Phase III clinical
trial of Prestara™ (prasterone), Genelabs’ investigational drug for
women with systemic lupus erythematosus (SLE or lupus). A total of 155
women with lupus are enrolled in the study among 26 study centers
located in the United States and Mexico. The primary endpoint of this
clinical trial is bone mineral density at the lumbar spine, and the
treatment duration is six months with either 200 mg per day of Prestara
or placebo.

Genelabs is developing Prestara as a proposed treatment to limit bone
loss in women with SLE who are taking glucocorticoids. Because loss of
bone mineral density is a common manifestation of SLE, patients with the
disease are at greater risk of osteoporosis and other complications of
bone loss. In addition, the use of glucocorticoids such as prednisone,
one of the most commonly used medications to treat SLE, can cause
further damage to bone health.

In August 2002, the U.S. Food and Drug Administration (FDA) completed
its review of Genelabs’ New Drug Application for Prestara for women with
SLE and issued an approvable letter to Genelabs. Approval is contingent
upon, among other things, the successful completion of a clinical trial
providing sufficient evidence to confirm the positive effect of Prestara
on bone mineral density that was observed in Genelabs’ previous Phase
III Study GL95-02. The current clinical trial, Study GL02-01, is
designed to generate data that, if positive, would satisfy the FDA’s
requirement for confirmation of the Study GL95-02 bone mineral density
results.

“Completing enrollment of all patients into our confirmatory clinical
trial is a major milestone that I am thrilled we have now accomplished.
Our drug development team and outside clinical investigators have done
an outstanding job in recruiting patients while holding to the highest
quality standards,” stated Irene A. Chow, Ph.D., chairman and chief
executive officer. “Because patients will receive either Prestara or
placebo for six months, the last patients will finish treatment in
August 2004. Afterwards, we will unblind and analyze the data following
a standard review for completeness and accuracy. I expect that we will
have the results of this clinical trial in the fourth quarter of this year."