FDA Asks Genelabs Technologies, Inc. For Additional Trial Of Lupus Drug

REDWOOD CITY, Calif., Jan. 13 /PRNewswire-FirstCall/ -- Genelabs Technologies, Inc. (Nasdaq: GNLB; GNLBD) today updated the future development options for Prestara(TM) for women with systemic lupus erythematosus (SLE or lupus) after the company's meeting with the U.S. Food and Drug Administration (FDA). The FDA indicated that an additional, adequate, well-controlled phase III clinical trial would be necessary to support an indication for the treatment of the signs and symptoms of lupus, and the FDA recommended that Genelabs refer to the FDA's draft guidance for developing drugs for SLE (issued March 2005) when designing this trial.

The company also discussed with the FDA its options for pursuing an indication of prevention of loss of bone mineral density (BMD) in women with lupus. Genelabs has pursued a BMD indication since receiving an approvable letter for its Prestara New Drug Application (NDA) in 2002. The FDA stated that additional positive prospective phase III clinical trial data would be necessary before the FDA would consider reviewing an NDA for BMD in lupus. Based on the recent FDA interaction, Genelabs believes that pursuit of an indication for treating the signs and symptoms of lupus is a more viable route forward for Prestara than an indication for prevention of BMD loss in lupus.

"I am pleased that the FDA has provided guidance on their requirements for approval of Prestara for the treatment of lupus signs and symptoms," stated James A.D. Smith, President and Chief Executive Officer. "I believe the FDA recognizes the need for new drugs for lupus, but at the same time they also must adhere to their established standards for approval. They are indicating that they will require one additional pivotal trial in order to approve our NDA for the treatment of lupus. I am encouraged that the agency has acknowledged the positive outcome from our previous study evaluating Prestara's overall impact on women suffering from lupus. Genelabs is potentially only one positive clinical trial from approval for a difficult and debilitating disease that has very limited and inadequate treatment options. To get there, our next step is to determine the specifics of a new clinical trial evaluating the impact of Prestara on the overall signs and symptoms of lupus."

Genelabs is presently in process of designing an additional clinical trial for Prestara(TM) for the treatment of lupus utilizing the FDA guidance document published in 2005. The company plans to work with the FDA in the development of the protocol, as suggested by the FDA in the recent meeting, and plans to formally meet with the agency again regarding the prospective clinical trial design. Because the company currently does not have sufficient funds to conduct another clinical study of Prestara on its own, if an additional clinical trial is conducted it would likely be in conjunction with a new or existing collaborator, or, alternatively, Genelabs may have to delay or discontinue future development of Prestara.

Regarding approval for the treatment of lupus based on a single clinical trial, the FDA indicated that robust demonstration of efficacy would be required to be considered adequate evidence of efficacy.

Background of Prestara for Disease Activity in Women with Lupus

Genelabs' first double-blind, placebo-controlled clinical trial of Prestara for lupus, designated Study GL94-01, enrolled 191 patients and evaluated Prestara's ability to reduce the glucocorticoid dose in steroid-dependent women with mild to moderate lupus while maintaining stable or improved SLE disease activity. The primary endpoint was sustained reduction in glucocorticoid dose to levels approximately equivalent to those normally produced by the adrenal glands. Results showed that patients who received the 200 mg daily doses of Prestara had a higher response rate than patients who received placebo, particularly for those patients with active disease at baseline. The results of this study were published in the July 2002 issue of Arthritis and Rheumatism.

Genelabs also completed a second double-blind, placebo-controlled clinical trial, designated Study GL95-02, which enrolled 381 patients and evaluated the ability of Prestara to improve or stabilize clinical outcome and disease symptoms in women with mild to moderate lupus. The primary endpoint was stabilization or improvement in two lupus disease activity measures, two health-related quality of life measures and no clinical deterioration. There was a statistically significant greater rate of response for Prestara patients than for those on placebo, and in late 2002 the FDA advised Genelabs that it considers Study GL95-02 to be positive, adequate and well-controlled. The results of this clinical trial were published in the September 2004 issue of Arthritis and Rheumatism.

Background of Prestara for Bone Mineral Density in Lupus and FDA Approvable Letter

Nested within Genelabs' clinical trial GL95-02 was a separate study of 55 patients to assess the effect of Prestara on the BMD of women with lupus who were taking glucocorticoids. An analysis of the patients who had pre- and post-treatment bone mineral density measurements showed that the group of patients receiving Prestara had a statistically significant increase in bone mineral density, compared to a decrease in bone density for the group of patients on placebo. The results of this study were published in the April 2005 issue of The Journal of Rheumatology.

In August 2002, the FDA issued an approvable letter to Genelabs regarding the company's NDA for Prestara. In the approvable letter, the FDA indicated that the approval of the NDA would require the successful completion of an additional clinical trial providing sufficient evidence to confirm the positive effect of Prestara on the patients' bone mineral density. To address this requirement, Genelabs conducted a double-blind clinical trial, designated Study GL02-01, which was designed to satisfy FDA's requirement if the results were positive. The results of Study GL02-01 were not statistically significant in favor of Prestara.

The patients who completed Study GL02-01 were eligible to enroll in Study GL03-01, an open-label one-year follow-on clinical trial which treated all patients with Prestara. Study GL03-01 met its primary endpoint of maintaining the BMD of women with lupus taking 200 mg per day of Prestara and receiving glucocorticoids. Also in that study, patients taking 200 mg per day of Prestara for 12 to 18 months increased their BMD.

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 capabilities that can support various research and development projects. Genelabs is currently concentrating these capabilities on 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, while also developing a late-stage product for lupus. 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. For more information, please visit www.genelabs.com.

NOTE: Genelabs® and the Genelabs logo are registered trademarks and Prestara(TM) 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(TM), designing a clinical trial protocol, future meetings with the FDA, possible factors that could affect a future clinical trial, and the future of the company's research and development programs. 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, that Genelabs may not be able to raise sufficient funds to continue operations; a determination to discontinue development of Prestara; an adverse response from the FDA; regulatory problems or delays regarding Prestara; potential de-listing from the Nasdaq Capital Market; fluctuations in Genelabs' stock price; failures or setbacks in our HCV research programs or in our collaboration with Gilead; progress and announcements by competitors regarding their HCV programs; 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.

Contact: Matthew M. Loar

Chief Financial Officer Phone: 650-562-1424

Source: Genelabs Technologies, Inc.