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Genelabs Receives Confirmation of Orphan Drug Designation for Prestara (Prasterone) and Provides Update on Its Development

REDWOOD CITY, CA -- June 23, 2005 -- Genelabs Technologies, Inc. today provided an update on the development of Prestara(TM), its investigational drug for lupus.

The United States Food and Drug Administration (FDA) has confirmed to the company that the indication "prevention of loss of bone mineral density in systemic lupus erythematosus patients on glucocorticoids" qualifies for orphan drug exclusivity under the original orphan drug designation previously received by the company.

In October 2004, Genelabs announced that preliminary results of clinical trial GL02-01 in women with lupus did not show statistical significance for the primary endpoint, absolute change in bone mineral density (BMD) at the lumbar spine after six months of treatment. Genelabs subsequently completed its analysis of the clinical trial and provided the data to outside consultants for a separate analysis and report on the outcome.

Results of Study GL02-01 at the primary endpoint showed that patients on Prestara experienced a mean increase of 0.003 gm/cm(2) in BMD at the lumbar spine compared to a decrease of 0.005 gm/cm(2) for the patients on placebo.

Although these changes were in the desired direction, the magnitude of the difference was not large enough to reach statistical significance between groups (p=0.293). This compared with the results from the company's 12 month trial GL95-02, in which, using the same units of measurement, patients on Prestara experienced a mean increase of 0.015 gm/cm(2) in BMD at the lumbar spine compared to a decrease of 0.010 gm/cm(2) for the patients on placebo, and the difference was statistically significant (p=0.002).

The analyses of the trial results conducted by Genelabs and its consultants both indicated that several factors likely contributed to the failure of Study GL02-01 to demonstrate statistical significance. These analyses suggest that the shorter treatment duration of the study combined with higher BMD measurements of the patients at baseline and the concurrent use of calcium and vitamin D supplements were the most likely causes for the different outcome of Study GL02-01.

To obtain further information about the effect of Prestara on the bone mineral density of lupus patients, Genelabs currently is conducting an open label 12 month extension of the GL02-01 BMD study, which is designated Study GL03-01. This study is expected to be completed in August 2005, and some patients will have as much as 18 months of exposure to Prestara, comprised of six months under GL02-01 plus twelve months under GL03-01, with BMD measurements at six-month intervals.

While Study GL03-01 may provide useful data on the effect of Prestara on bone mineral density of women with lupus over a longer period of time, the FDA normally does not consider such open label studies to be sufficient to support approval of a new drug.

Genelabs and the FDA have scheduled a meeting to discuss the company's options with regard to the development of Prestara for lupus. Genelabs expects to determine its future development plans for Prestara after completing Study GL03-01 and meeting with the FDA.


SOURCE: Genelabs Technologies, Inc.

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