8-K

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

June 10, 2003

(Date of earliest event reported)

GENELABS TECHNOLOGIES, INC.

(Exact name of Registrant as specified in its charter)

California	0-19222	94-3010150
(State of Incorporation)	(Commission File No.)	(IRS Employer Identification No.)

505 Penobscot Drive, Redwood City, California 94063

(Address of principal executive offices, including zip code)

(650) 369-9500

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

TABLE OF CONTENTS

	ITEM 5. OTHER INFORMATION
	ITEM 7. EXHIBITS
SIGNATURE
EXHIBIT INDEX
EXHIBIT 99.1

ITEM 5. OTHER INFORMATION

On June 10, 2003, Genelabs Technologies, Inc. issued a press release announcing and providing highlights from a corporate update to be presented at the Registrant’s annual meeting of shareholders.

ITEM 7. EXHIBITS

99.1 Press Release of Registrant, dated June 10, 2003, entitled “Genelabs to Provide Corporate Update at Annual Shareholder Meeting”

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereto duly authorized.

	GENELABS TECHNOLOGIES, INC.
	By:	/s/ Matthew M. Loar
	Name: Matthew M. Loar Title: Chief Financial Officer
Date: June 10, 2003

EXHIBIT INDEX

EXHIBIT NO.	DESCRIPTION
99.1	Press Release of Registrant, dated June 10, 2003, entitled “Genelabs to Provide Corporate Update at Annual Shareholder Meeting”

EX-99.1 3 f90787exv99w1.txt EXHIBIT 99.1 EXHIBIT 99.1 GENELABS TO PROVIDE CORPORATE UPDATE AT ANNUAL SHAREHOLDER MEETING Redwood City, Calif. - June 10, 2003 - Genelabs Technologies, Inc. (Nasdaq:GNLB) announced today that it will provide a corporate update at its annual shareholder meeting which will be held today at 10:00 am Pacific Daylight Time. The update to be provided to shareholders at the meeting highlights the following key areas of the company's business: Prestara(TM) for Systemic Lupus Erythematosus In August 2002, Genelabs received an approvable letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Prestara(TM) for systemic lupus erythematosus (SLE or lupus). FDA approval is contingent upon, among other things, the successful completion of an additional clinical trial providing sufficient evidence to confirm the positive effect of Prestara on the bone mineral density of women with lupus on glucocorticoids that was observed in a nested study within Genelabs' Study GL95-02. In January 2003, Genelabs announced the initiation of a multicenter, randomized, placebo-controlled, double-blind study, enrolling approximately 150 women with SLE receiving glucocorticoids. Based on current and projected enrollment trends, Genelabs is now targeting completion of patient enrollment in the clinical trial by the end of the third quarter 2003. With the six-month treatment duration specified in the clinical trial protocol, completion of enrollment by this target date would lead to completion of the clinical trial at the end of the first quarter of 2004. Separately, Genelabs announced the recent issuance of U.S. Patent No. 6,552,010, "Treatment of SLE with Dehydroepiandrosterone," adding to the Prestara intellectual property portfolio. At the end of 2002 Genelabs filed a Marketing Authorization Application (MAA) with the European Agency for the Evaluation of Medicinal Products (EMEA) under the centralized procedure, which provides for simultaneous consideration of the MAA in 17 European countries, with a single review and decision regarding the application. Genelabs is currently in active discussions with companies that are interested in licensing the European marketing rights for Prestara. In Japan, Genelabs plans to pursue approval of Prestara with a collaborator, and Genelabs is also in active discussions with companies that are interested in licensing the Japanese marketing rights for Prestara. Vice President, Drug Development Genelabs also announced that Mumtaz Ahmed, M.D., Ph.D., will join the company as Vice President, Drug Development. Dr. Ahmed has over twenty years experience in drug development and medical research, most recently as Vice President, Medical Affairs of Ascent Pediatrics. In addition to his tenure at Ascent, he previously held senior drug development and clinical research positions including Executive Director, Clinical Research at Ciba-Geigy (now Novartis) and Senior Research Investigator & Head, Development Biology at Pfizer. During his career, Dr. Ahmed has directed clinical and development activities for new drugs in the therapeutic areas of infectious diseases, cancer, endocrine, gastroenterology, analgesia and bone metabolism, including seven new drug applications that were approved by the FDA. He has authored numerous FDA submissions and related publications. "Dr. Ahmed's record of accomplishments in drug development is outstanding, and I am pleased to add him as a key member of our drug development and management teams," stated Irene A. Chow, Ph.D., chairman and chief executive officer. "I have seen first-hand how hard-working and thorough he is on his projects. His experience in bone metabolism will be a tremendous asset as we move forward with Prestara, and his experience in developing drugs for infectious disease will be an asset as our novel drug discovery compounds progress to more advanced stages of development." Hepatitis E Virus Vaccine A Phase II clinical trial of a vaccine designed to provide protection against disease caused by the hepatitis E virus was initiated in 2001 by the Walter Reed Army Institute of Research in collaboration with the Medical Department of the Royal Nepal Army, the U.S. National Institutes of Health and GlaxoSmithKline Biologicals. Genelabs has granted an exclusive worldwide license to GlaxoSmithKline Biologicials for vaccine applications under Genelabs' hepatitis E virus (HEV) patent portfolio. The agreement provides Genelabs with milestone payments when GlaxoSmithKline reaches certain development and regulatory goals and Genelabs would receive royalties should HEV vaccine products developed under this license be sold. As of February 28, 2003, there were 45 laboratory confirmed cases of HEV among the 2,000 volunteers enrolled in the clinical trial, which exceeded the number of cases pre-defined under the study analysis plan for unblinding of the clinical trial. A proposal to unblind the HEV cases to date, analyze them and consider the clinical trial as pivotal has been submitted by the HEV vaccine team to the FDA. Drug Discovery Research We advanced one of the antifungal lead compounds synthesized by our research scientists to preclinical development status, as it met our predefined criteria for such advancement. In 2002 we established a new research program seeking to discover orally active compounds for the treatment of hepatitis C virus (HCV) infection. Since initiating this program, we have developed assay systems; synthesized, acquired and tested compounds for activity against HCV; identified nucleoside and non-nucleoside lead compounds; begun optimization of selected lead compounds; and filed several patent applications claiming novel compounds with activity against the hepatitis C virus. We are now in active discussions with companies that may be interested in collaborating with us in drug discovery. Summary "Since our most recent shareholder meeting just one year ago we have made tremendous progress in all areas of our business - receiving the approvable letter from the FDA, filing our MAA in Europe, advancing our first novel compound to preclinical development status, and identifying lead compounds for our hepatitis C virus program," concluded Dr. Chow. "I look forward to sharing more information on further progress in the near future." About Genelabs Genelabs Technologies, Inc. is a biopharmaceutical company pioneering the discovery and development of novel pharmaceutical products to improve human health. We have built drug discovery and clinical development capabilities that can support various research and development projects. We are concentrating our capabilities on three core programs: developing a late-stage product for lupus, discovering novel antimicrobial lead compounds, and discovering novel lead compounds that selectively inhibit replication of the hepatitis C virus (HCV). Through our drug discovery efforts we have synthesized numerous antimicrobial lead compounds, one of which has been selected for preclinical development, and are using high-throughput methods for the discovery of novel lead compounds for HCV. Our clinical development efforts are concentrated on Prestara(TM) (prasterone; Anastar(TM) in Europe) for systemic lupus erythematosus, for which we have received an approvable letter from the U.S. Food and Drug Administration and for which we have submitted a Marketing Authorization Application in Europe. For more information about Genelabs, please visit www.genelabs.com. NOTE: This press release contains forward-looking statements including statements regarding our ongoing clinical trial for our investigational drug for systemic lupus erythematosus (SLE or lupus), our drug discovery programs, projected timelines and the status of discussions with potential licensees and collaborators. 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, the company's capital requirements and history of operating losses; whether the results of the company's clinical trials of Prestara(TM) and other supporting information will be sufficient to support the approval of Prestara(TM) by the FDA, the European Agency for Evaluation of Medicinal Products and other regulatory authorities; delays regarding the regulatory approval process including the timing and scope of approval received, if any; uncertainties and risks regarding market acceptance of Prestara(TM) as a treatment for lupus; uncertainties and risks regarding the company's ability to consummate strategic or corporate partner transactions on favorable terms or at all; the early stage of Genelabs' research programs and uncertainties associated with the preclinical development of compounds, including whether a compound will advance to preclinical testing, clinical trials, or ultimately become a product, and the uncertainty of the timing of any of these; and the validity, scope and enforceability of patents related to the company's technologies. The active ingredient in Prestara(TM) is prasterone, the synthetic equivalent of the androgenic hormone dehydroepiandrosterone (DHEA). Products containing DHEA are currently being marketed by others as dietary supplements. The company has not submitted applications for regulatory review of Prestara(TM) outside the U.S. and Europe. In addition, neither U.S. nor other regulatory authorities have made a determination as to the safety or efficacy of Prestara(TM) for SLE. Please see the information appearing in the company's filings with the Securities and Exchange Commission, including the most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K, under the captions "Risk Factors," "Business Risks" 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. -----END PRIVACY-ENHANCED MESSAGE-----

EX-99.1

                                                                    EXHIBIT 99.1

GENELABS TO PROVIDE CORPORATE UPDATE AT ANNUAL SHAREHOLDER MEETING


Redwood City, Calif. - June 10, 2003 - Genelabs Technologies, Inc. (Nasdaq:GNLB)
announced today that it will provide a corporate update at its annual
shareholder meeting which will be held today at 10:00 am Pacific Daylight Time.
The update to be provided to shareholders at the meeting highlights the
following key areas of the company's business:

Prestara(TM) for Systemic Lupus Erythematosus

In August 2002, Genelabs received an approvable letter from the U.S. Food and
Drug Administration (FDA) for its New Drug Application (NDA) for Prestara(TM)
for systemic lupus erythematosus (SLE or lupus). FDA approval is contingent
upon, among other things, the successful completion of an additional clinical
trial providing sufficient evidence to confirm the positive effect of Prestara
on the bone mineral density of women with lupus on glucocorticoids that was
observed in a nested study within Genelabs' Study GL95-02. In January 2003,
Genelabs announced the initiation of a multicenter, randomized,
placebo-controlled, double-blind study, enrolling approximately 150 women with
SLE receiving glucocorticoids.

Based on current and projected enrollment trends, Genelabs is now targeting
completion of patient enrollment in the clinical trial by the end of the third
quarter 2003. With the six-month treatment duration specified in the clinical
trial protocol, completion of enrollment by this target date would lead to
completion of the clinical trial at the end of the first quarter of 2004.

Separately, Genelabs announced the recent issuance of U.S. Patent No. 6,552,010,
"Treatment of SLE with Dehydroepiandrosterone," adding to the Prestara
intellectual property portfolio.

At the end of 2002 Genelabs filed a Marketing Authorization Application (MAA)
with the European Agency for the Evaluation of Medicinal Products (EMEA) under
the centralized procedure, which provides for simultaneous consideration of the
MAA in 17 European countries, with a single review and decision regarding the
application. Genelabs is currently in active discussions with companies that are
interested in licensing the European marketing rights for Prestara. In Japan,
Genelabs plans to pursue approval of Prestara with a collaborator, and Genelabs
is also in active discussions with companies that are interested in licensing
the Japanese marketing rights for Prestara.

Vice President, Drug Development

Genelabs also announced that Mumtaz Ahmed, M.D., Ph.D., will join the company as
Vice President, Drug Development. Dr. Ahmed has over twenty years experience in
drug development and medical research, most recently as Vice President, Medical
Affairs of Ascent Pediatrics. In addition to his tenure at Ascent, he previously
held senior drug development and clinical research positions including Executive
Director, Clinical Research at Ciba-Geigy (now Novartis) and Senior Research
Investigator & Head, Development Biology at Pfizer. During his career, Dr. Ahmed
has directed clinical and development activities for new drugs in the
therapeutic areas of infectious diseases, cancer, endocrine, gastroenterology,
analgesia and bone metabolism, including seven new drug applications that were
approved by the FDA. He has authored numerous FDA submissions and related
publications.




"Dr. Ahmed's record of accomplishments in drug development is outstanding, and I
am pleased to add him as a key member of our drug development and management
teams," stated Irene A. Chow, Ph.D., chairman and chief executive officer. "I
have seen first-hand how hard-working and thorough he is on his projects. His
experience in bone metabolism will be a tremendous asset as we move forward with
Prestara, and his experience in developing drugs for infectious disease will be
an asset as our novel drug discovery compounds progress to more advanced stages
of development."

Hepatitis E Virus Vaccine

A Phase II clinical trial of a vaccine designed to provide protection against
disease caused by the hepatitis E virus was initiated in 2001 by the Walter Reed
Army Institute of Research in collaboration with the Medical Department of the
Royal Nepal Army, the U.S. National Institutes of Health and GlaxoSmithKline
Biologicals. Genelabs has granted an exclusive worldwide license to
GlaxoSmithKline Biologicials for vaccine applications under Genelabs' hepatitis
E virus (HEV) patent portfolio. The agreement provides Genelabs with milestone
payments when GlaxoSmithKline reaches certain development and regulatory goals
and Genelabs would receive royalties should HEV vaccine products developed under
this license be sold.

As of February 28, 2003, there were 45 laboratory confirmed cases of HEV among
the 2,000 volunteers enrolled in the clinical trial, which exceeded the number
of cases pre-defined under the study analysis plan for unblinding of the
clinical trial. A proposal to unblind the HEV cases to date, analyze them and
consider the clinical trial as pivotal has been submitted by the HEV vaccine
team to the FDA.

Drug Discovery Research

We advanced one of the antifungal lead compounds synthesized by our research
scientists to preclinical development status, as it met our predefined criteria
for such advancement. In 2002 we established a new research program seeking to
discover orally active compounds for the treatment of hepatitis C virus (HCV)
infection. Since initiating this program, we have developed assay systems;
synthesized, acquired and tested compounds for activity against HCV; identified
nucleoside and non-nucleoside lead compounds; begun optimization of selected
lead compounds; and filed several patent applications claiming novel compounds
with activity against the hepatitis C virus. We are now in active discussions
with companies that may be interested in collaborating with us in drug
discovery.

Summary

"Since our most recent shareholder meeting just one year ago we have made
tremendous progress in all areas of our business - receiving the approvable
letter from the FDA, filing our MAA in Europe, advancing our first novel
compound to preclinical development status, and identifying lead compounds for
our hepatitis C virus program," concluded Dr. Chow. "I look forward to sharing
more information on further progress in the near future."



About Genelabs

Genelabs Technologies, Inc. is a biopharmaceutical company pioneering the
discovery and development of novel pharmaceutical products to improve human
health. We have built drug discovery and clinical development capabilities that
can support various research and development projects. We are concentrating our
capabilities on three core programs: developing a late-stage product for lupus,
discovering novel antimicrobial lead compounds, and discovering novel lead
compounds that selectively inhibit replication of the hepatitis C virus (HCV).
Through our drug discovery efforts we have synthesized numerous antimicrobial
lead compounds, one of which has been selected for preclinical development, and
are using high-throughput methods for the discovery of novel lead compounds for
HCV. Our clinical development efforts are concentrated on Prestara(TM)
(prasterone; Anastar(TM) in Europe) for systemic lupus erythematosus, for which
we have received an approvable letter from the U.S. Food and Drug Administration
and for which we have submitted a Marketing Authorization Application in Europe.
For more information about Genelabs, please visit www.genelabs.com.

NOTE: This press release contains forward-looking statements including
statements regarding our ongoing clinical trial for our investigational drug for
systemic lupus erythematosus (SLE or lupus), our drug discovery programs,
projected timelines and the status of discussions with potential licensees and
collaborators. 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, the company's capital requirements and history of
operating losses; whether the results of the company's clinical trials of
Prestara(TM) and other supporting information will be sufficient to support the
approval of Prestara(TM) by the FDA, the European Agency for Evaluation of
Medicinal Products and other regulatory authorities; delays regarding the
regulatory approval process including the timing and scope of approval received,
if any; uncertainties and risks regarding market acceptance of Prestara(TM) as a
treatment for lupus; uncertainties and risks regarding the company's ability to
consummate strategic or corporate partner transactions on favorable terms or at
all; the early stage of Genelabs' research programs and uncertainties associated
with the preclinical development of compounds, including whether a compound will
advance to preclinical testing, clinical trials, or ultimately become a product,
and the uncertainty of the timing of any of these; and the validity, scope and
enforceability of patents related to the company's technologies. The active
ingredient in Prestara(TM) is prasterone, the synthetic equivalent of the
androgenic hormone dehydroepiandrosterone (DHEA). Products containing DHEA are
currently being marketed by others as dietary supplements. The company has not
submitted applications for regulatory review of Prestara(TM) outside the U.S.
and Europe. In addition, neither U.S. nor other regulatory authorities have made
a determination as to the safety or efficacy of Prestara(TM) for SLE. Please see
the information appearing in the company's filings with the Securities and
Exchange Commission, including the most recent Quarterly Report on Form 10-Q and
Annual Report on Form 10-K, under the captions "Risk Factors," "Business Risks"
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.