Genelabs Announces Positive Results of Pivotal Trial of Gl701 for Lupus / Company Intends to Submit New Drug Application to FDA

REDWOOD CITY, Calif. (PROTEXT) - Genelabs Technologies, Inc.(Nasdaq: GNLB) today announced positive results of its secondPhase III clinical trial of GL701, its investigational drug forsystemic lupus erythematosus (SLE). Based on the strength ofpreliminary data from this study and the results of the firstPhase III clinical trial, the company intends to submit a NewDrug Application (NDA). Genelabs has requested a pre-NDA meetingwith the Food and Drug Administration (FDA) and intends to beginthe submission process as soon as possible following thatmeeting. "Because of the current lack of effective therapies forpatients with SLE, we are delighted with these positive results,"stated James A.D. Smith, Genelabs President. "The favorableoutcome of this study is truly a milestone for both Genelabs andpeople with SLE as we work toward commercialization of the firstnew treatment for lupus in many decades." Marc Gurwith, M.D., Genelabs Vice President of DrugDevelopment and Chief Medical Officer commented, "I wish to thankall of the patients, physicians and their medical teams whoparticipated in this groundbreaking clinical trial. We lookforward to submitting the results of this study to the FDA andpresenting the data in an appropriate scientific forum." Study Design The study enrolled 381 women with SLE randomized to receiveeither an oral dose of 200 mg of GL701 or placebo once a day for12 months. The study was designed to determine whether GL701 canimprove or stabilize clinical outcome and disease symptoms inpeople with SLE. Efficacy was measured by the response of thepatients to the treatment (disease activity was stable orimproved) utilizing measurement tools including Systemic LupusErythematosus Disease Activity Index (SLEDAI), Systemic LupusActivity Measure (SLAM), Krupp Fatigue Severity Score (KFSS), andPatient Global Assessment. Systemic Lupus Erythematosus (SLE) SLE is a life-long, devastating autoimmune disease thatprimarily affects women, many of whom experience the initialonset of disease in their late teens and early twenties. Thereare approximately 200,000 people with SLE in the United Statesand more than one million worldwide, according to variousgovernment and private sector statistics. SLE causes the immunesystem to attack the body's own tissue, which can lead toinflammation, pain and injury to tissues and major organs. Peoplewith SLE can develop different combinations of symptoms and organinvolvement. Common signs and symptoms include severe fatigue,arthritis, facial rash and unusual sensitivity to sunlight aswell as inflammation of the lungs and heart. More serious, life-threatening organ damage, which involves inflammation of thebrain tissue and kidney failure, can lead to poor quality of lifeand ultimately death. There is no cure for SLE. The multi-facetedmanifestations and unknown etiology of the disease have made SLEdifficult to study and to treat. No drug has been approved forthe treatment of SLE in the US in the past 40 years. Currenttreatment is primarily limited to inflammation suppression, mostcommonly through chronic use of steroids such as prednisone.Long-term use of steroids has many serious adverse consequencesincluding premature osteoporosis, atherosclerosis and diabetes. GL701 Genelabs' therapeutic approach with GL701, through anexclusive license from Stanford University, is to increase levelsof dehydroepiandrosterone (DHEA) in patients with SLE. GL701 is apharmaceutical preparation that contains prasterone, thepharmaceutical generic designation for DHEA, as the activeingredient. DHEA is a naturally occurring hormone that isproduced by the adrenal glands. People with SLE generally haveabnormally low levels of DHEA and studies have shown thathormonal influences may play a role in the development andprogression of SLE. Genelabs completed its first Phase III trial with GL701 in1997. In the first study, steroid-dependent SLE patients had ahigher rate of response to treatment with GL701 than patients onplacebo, demonstrated by sustained reduction of their prednisonedose to physiologic levels. Data from this study were presentedat the American College of Rheumatology National ScientificMeeting in November 1997 and showed that, compared to the placebogroup, a greater percentage of patients who received daily dosesof 200 mg of GL701 achieved the primary endpoint of a sustainedreduction of their steroid dose to 7.5 mg per day or less whileimproving or maintaining stable disease activity. This beneficialeffect was most evident in the group of SLE patients with activedisease (SLEDAI >2) at baseline. The ability to reduce steroiduse among people with SLE has been a major goal in lupus clinicalresearch because long-term use of steroids is responsible formany serious and life-threatening toxicities. Earlier this year the FDA granted Fast Track designation toGL701 for SLE, which means that the FDA has determined that GL701is intended to treat a serious or life-threatening condition forwhich there is no adequate therapy currently available. Thisdesignation also means that the FDA can take actions to expeditethe review of the NDA including assigning priority review status.In 1994, GL701 received Orphan Drug designation from the FDA forthe treatment of SLE. Orphan Drug designation provides sevenyears of marketing exclusivity from the date of a drug'sapproval. Genelabs intends to retain the right to market GL701 in theUnited States and is seeking partners for development andmarketing of GL701 outside of the U.S. The company is theexclusive licensee of two issued U.S. patents from StanfordUniversity which cover the use of GL701 in lupus patients toreduce concomitant steroid dosage and for the treatment of lupuswith or without additional drug therapies. Genelabs Technologies, Inc. is a biopharmaceutical companyengaged in the discovery of small molecule drugs that bind to DNAor RNA to regulate gene expression or inactivate pathogens. Thecompany's drug discovery program is based on an integratedplatform of technologies that encompasses genomics, transcriptionbiology, structure-biased combinatorial chemistry, high-throughput screening and several proprietary validation andcharacterization assays. The company's development efforts arefocused on its drug candidate, GL701, which has completed twoPhase III clinical trials as a new therapy for systemic lupuserythematosus. NOTE Except for historical information, the statements in this newsrelease are forward-looking and are subject to uncertainties andrisks that could cause actual results to differ materially fromthe statements made. Uncertainties and risks include, withoutlimitation, the adequacy of the company's GL701 clinical trialprocesses and whether the results of those clinical trials andother supporting information will be sufficient to supportregulatory submissions and/or approvals; delays regarding theregulatory approval process including the timing and scope ofapproval received, if any; uncertainties and risks regardingmarket acceptance of GL701 as a treatment for SLE; the company'slimited manufacturing and marketing experience; the validity,scope and enforceability of patents related to GL701; thecompany's capital requirements and history of operating losses;and uncertainties and risks regarding the company's ability toraise needed additional capital or consummate strategic orcorporate partner transactions on favorable terms or at all. Thecompany has not submitted applications for regulatory review inthe US or other countries, and the regulatory authorities havenot yet made a determination as to the safety or efficacy ofGL701 for SLE. Please see the information appearing in thecompany's filings with the Securities and Exchange Commission, inparticular information under the caption "Risk Factors" in thecompany's 1998 Form 10-K, for more discussion regarding theseuncertainties and risks and those associated with the company'sresearch programs, early stage of development and other riskswhich may affect the company. The company does not undertake anyobligation to update these forward-looking statements to reflectevents or circumstances after the date of this release. Genelabs' press releases are available by fax 24 hours a dayat no charge by calling PR Newswire's Company News On-Call at800-758-5804, extension 115419. They are also posted on theInternet at http://www.genelabs.com and http://www.prnewswire.com. CONTACT: investors, Debra Catz Bannister of GenelabsTechnologies, Inc., 650-562-1424; or media, Kathy Lauri of PorterNovelli, 212-601-8121, for Genelabs Technologies, Inc. otsOriginal Text Service: Genelabs Technologies, Inc. Internet:http://www.newsaktuell.de Contact: investors, Debra CatzBannister of Genelabs Technologies, Inc., 650-562-1424; or media,Kathy Lauri of Porter Novelli, 212-601-8121, for GenelabsTechnologies, Inc. Web site: http://www.genelabs.com

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