UNITED STATES
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
Date of Report (Date of earliest event reported) October 5, 2004
--------------------------
GENELABS TECHNOLOGIES, INC.
- ------------------------------------------------------------------------------
(Exact name of registrant as specified in its charter)
California 0-19222 94-3010150
- ------------------------------ --------------------- ----------------------
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
505 Penobscot Drive, Redwood City, California 94063
- ---------------------------------------------------- -----------------------
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (650) 369-9500
-----------------------
- ------------------------------------------------------------------------------
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligations of the registrant under any of
the following provisions (see General Instruction A.2. below):
|_| Written communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
|_| Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12)
|_| Pre-commencement communications pursuant
to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|_| Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
On October 5, 2004 Genelabs Technologies, Inc. (the
"Company") issued a press release announcing the preliminary results of its
Phase III clinical trial, Study GL02-01, for its investigational lupus drug
Prestara(TM) (prasterone). This double-blind, placebo controlled clinical
trial was designed to measure the effect of Prestara on the bone mineral
density of women with systemic lupus erythematosus (SLE or lupus) receiving
glucocorticoids. The preliminary analysis indicated that the study failed to
meet its primary endpoint. The Company stated that it plans to continue its
analysis of the data from Study GL02-01 and will seek to meet with the U.S.
Food and Drug Administration (FDA) to determine its next steps. A copy of the
press release announcing the results is attached as Exhibit 99.1 hereto.
Item 9.01 Financial Statements and Exhibits
(c) Exhibits
99.1 Press Release of Registrant, dated October 5, 2004, entitled
"Genelabs Announces Preliminary Results of Clinical Trial
GL02-01 in Women with Systemic Lupus Erythematosus -- Study
Fails to Meet Primary Endpoint."
SIGNATURES
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/ Adrian Arima
----------------------------
Name: Adrian Arima
Title: Vice President, General Counsel
Date: October 6 , 2004
EXHIBIT INDEX
EXHIBIT NO. DESCRIPTION
----------- -----------
99.1 Press Release of Registrant, dated October 5,
2004, entitled "Genelabs Announces
Preliminary Results of Clinical Trial GL02-01
in Women with Systemic Lupus Erythematosus --
Study Fails to Meet Primary Endpoint."
EXHIBIT 99.1
GENELABS ANNOUNCES PRELIMINARY RESULTS OF CLINICAL TRIAL GL02-01 IN WOMEN WITH
SYSTEMIC LUPUS ERYTHEMATOSUS
Study Fails to Meet Primary Endpoint
REDWOOD CITY, Calif. - October 5, 2004 - Genelabs Technologies, Inc.
(Nasdaq:GNLB) announced today that a preliminary analysis of its Phase III
clinical trial, Study GL02-01, for its investigational lupus drug Prestara(TM)
(prasterone) indicated that the study failed to meet its primary endpoint.
This double-blind, placebo controlled clinical trial was designed to measure
the effect of Prestara on the bone mineral density of women with systemic
lupus erythematosus (SLE or lupus) receiving glucocorticoids.
The company plans to continue its analysis of the data from Study GL02-01 and
will seek to meet with the U.S. Food and Drug Administration (FDA) to
determine its next steps.
"Although these preliminary results show that this study failed to reach
statistical significance, we are continuing to analyze the data in order to
gain further understanding of the results," stated James A.D. Smith, President
and Chief Executive Officer. "This process typically takes some time, and I
regret that we will likely not have further information to provide on Prestara
until we have completed these steps."
Genelabs previously completed a one-year Phase III clinical trial, designated
Study GL95-02, which included a nested study that indicated that the group of
patients receiving Prestara had increased bone mineral density, compared to a
decrease in bone density for the group of patients on placebo. Based on these
results, the FDA issued Genelabs an approvable letter, the key contingency of
which was a further clinical trial to confirm these results. Study GL02-01 was
designed to generate data to confirm the Study GL95-02 bone mineral density
results.
About Genelabs
Genelabs Technologies, Inc. is a biopharmaceutical company pioneering the
discovery and development of novel pharmaceutical products to improve human
health. We are concentrating our clinical development capabilities on
Prestara(TM), an investigational drug for women with systemic lupus
erythematosus. We are concentrating our drug discovery capabilities on novel
antiviral compounds for treatment of hepatitis C virus infections.
NOTE: This press release contains forward-looking statements including
statements regarding the preliminary results of our clinical trial for
Prestara, further analysis of the data from the clinical trial, future
discussions with the FDA and further actions which might be taken regarding
the clinical trial. 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, errors, omissions or
adverse events in the current Prestara(TM) clinical trials; 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 SLE; and
the company's capital requirements and history of operating losses. 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
currently does not have regulatory applications submitted for review of
Prestara(TM) outside the U.S. 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.