Redwood City, Calif. – June 22, 2005 – Genelabs Technologies, Inc. (Nasdaq:GNLB) today provided an update on the development of Prestara™, 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/cm² in BMD at the lumbar spine compared to a decrease of 0.005 gm/cm² 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/cm² in BMD at the lumbar spine compared to a decrease of 0.010 gm/cm² 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.

About Genelabs
Genelabs Technologies, Inc. is a biopharmaceutical company focused on the discovery and development of pharmaceutical products to improve human health. We have built drug discovery and clinical development capabilities that can support various research and development projects. Genelabs is currently concentrating its capabilities on developing a late-stage product for lupus, discovering novel compounds that selectively inhibit replication of the hepatitis C virus and advancing preclinical development of compounds from this hepatitis C virus drug discovery program. We believe that these high-risk, potentially high reward programs focus our research and development expertise in areas where we have the opportunity to generate either first-in-class or best-in-class products that will address diseases for which current therapies are inadequate.

Genelabs® and the Genelabs logo are registered trademarks and Prestara™ is a trademark of Genelabs Technologies, Inc.

NOTE ON FORWARD LOOKING STATEMENTS AND RISKS: This press release contains forward-looking statements including statements regarding the future development of Prestara™, continuation and conclusion of the open label study, potential meetings with the FDA, possible factors that could affect a future clinical trial, future orphan drug status and prospects for our HCV program. These forward-looking statements are based on Genelabs’ current expectations and are subject to uncertainties and risks that could cause actual results to differ materially from the statements made. Uncertainties and risks include, without limitation, further analysis of the data; adverse results from the open label study or Taiwan study; fluctuations in Genelabs’ stock price; regulatory problems or delays regarding Prestara; de-listing from the Nasdaq National Market; factors affecting our HCV drug discovery program; increases in expenses and Genelabs’ capital requirements and history of operating losses. Please see the information appearing in the Genelabs’ filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, under the captions “Risk Factors” and “Forward-Looking Statements” for more discussion regarding these uncertainties and risks and others associated with the company's research programs, early stage of development and other risks which may affect the company or cause actual results to differ from those included in the forward-looking statements. Genelabs does not undertake any obligation to update these forward-looking statements or risks to reflect events or circumstances after the date of this release.


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