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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): November 22, 1999
GENELABS TECHNOLOGIES, INC.
(Exact Name of Registrant as Specified in Charter)
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<S> <C> <C>
California 0-19222 94-3010150
(State or Other Jurisdiction (Commission File No.) (IRS Employer
of Incorporation) Identification No.)
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505 Penobscot Drive
Redwood City, CA 94063
(Address of Principal Executive Offices)
Registrant's telephone number, including area code: (650) 369-9500
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ITEM 5. OTHER EVENTS
On November 22, 1999, Genelabs Technologies, Inc. ("Genelabs") announced that
GL701, its investigational drug for systemic lupus erythematosus, demonstrated a
statistically significant advantage over placebo according to some analyses in
patients with active disease. In a recent pre-NDA-meeting with the Food and Drug
Administration ("FDA"), the FDA agreed that Genelabs' New Drug Application
("NDA") proposal appears adequate for submission; however, approval will be
based on a complete review. The NDA will be based on the results of two pivotal
Phase III clinical trials.
The Registrant hereby incorporates by reference the press release attached
hereto as Exhibit 99.1, and made a part of this Item 5.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS
(c) EXHIBITS
99.1 Press Release, dated November 22, 1999
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 hereunto duly authorized.
Genelabs Technologies, Inc.
Dated: November 22, 1999 By: /s/ JAMES A.D. SMITH
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James A.D. Smith
President
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EXHIBIT INDEX
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Exhibit
Number Description
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99.1 Press Release dated November 22, 1999
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EXHIBIT 99.1
PRESS RELEASE DATED NOVEMBER 22, 1999
GENELABS MEETS WITH FDA - WILL SUBMIT NDA FOR GL701 FOR SLE
Genelabs Technologies, Inc. (Nasdaq:GNLB) today announced that GL701, its
investigational drug for systemic lupus erythematosus (SLE), demonstrated a
statistically significant advantage over placebo according to some analyses in
patients with active disease. In a recent pre-NDA meeting with the Food and Drug
Administration (FDA), the FDA agreed that Genelabs' New Drug Application (NDA)
proposal appears adequate for submission; however, approvability will be based
on a complete review. The NDA will be based on the results of two pivotal Phase
III clinical trials.
Genelabs Vice President, Drug Development and Chief Medical Officer, Marc
Gurwith, M.D., said, "The preliminary data from our second Phase III clinical
trial of GL701 for SLE were provided to the FDA prior to our pre-NDA meeting. We
are pleased with the outcome of that meeting and will now proceed with our NDA
submission. SLE is a difficult disease to study and, if approved, GL701 will be
the first new drug approved for people with SLE in the past 40 years."
SECOND PHASE III CLINICAL TRIAL RESULTS
SLE is a chronic, progressive disease that primarily affects women. This
study was designed to determine whether GL701 can improve or stabilize clinical
outcome and disease symptoms in people with SLE. The 381 women with SLE enrolled
in this double-blind, placebo-controlled trial were randomized to receive either
an oral dose of 200 mg of GL701 or placebo once a day for 12 months. In one
analysis, the proportion of patients with active disease who responded to
treatment with GL701 was 66% compared to 49% for such patients receiving
placebo, which represents a 35% higher rate of response for GL701. This
improvement in response rate was statistically significant (p=0.005). Response,
the protocol-specified primary endpoint, was defined as improvement or
stabilization as measured by each of four scoring instruments in the absence of
clinical deterioration. Because of the inherent variability in the scoring
instruments, the classification of a patient as a responder allowed for a slight
deterioration in any of the four scores from baseline. The scoring instruments
were Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), Systemic
Lupus Activity Measure (SLAM), Krupp Fatigue Severity Score (KFSS), and Patient
Global Assessment. In addition, the advantage of GL701 over placebo was
consistent among secondary efficacy variables. GL701 was well tolerated and the
safety and tolerability profile was similar to that in the previous Phase III
study. The company will present the full results from the second Phase III
clinical trial in an appropriate scientific forum.
FIRST PHASE III CLINICAL TRIAL RESULTS
In the first Phase III study, SLE patients treated with GL701 had a greater
response to treatment than those on placebo, demonstrated by sustained reduction
of their prednisone dose to physiologic levels. The study enrolled 191 women
with mild to moderate SLE who were receiving daily doses of 10 to 30 mg of
prednisone. Patients were randomized to receive either placebo or 100 mg or 200
mg of GL701 daily for seven to nine months. At enrollment, baseline SLEDAI
scores were recorded for all patients. During the study, according to the study
protocol, steroid doses were required to be reduced at each visit provided a
patient's SLEDAI score had not increased. The study results, presented in
November 1997 at the American College of Rheumatology National Scientific
Meeting showed that, compared to the
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placebo group, a greater percentage of patients in the GL701 200 mg group
achieved the primary endpoint of a sustained reduction of their steroid dose to
7.5 mg per day or less (i.e., physiologic levels equivalent to those normally
produced by their own adrenal glands). This beneficial effect was most evident
in the group of 137 SLE patients with active disease at baseline, defined as a
SLEDAI score greater than 2. Among these patients, response rates were 51% for
the group who received daily doses of 200 mg of GL701, 38% for the group who
received 100 mg of GL701 and 29% for the group who received placebo.
GL701
Genelabs' therapeutic approach with GL701, through an exclusive license
from Stanford University, is to increase levels of dehydroepiandrosterone (DHEA)
in patients with SLE. GL701 is a pharmaceutical preparation that contains
prasterone, the pharmaceutical generic designation for DHEA, as the active
ingredient. DHEA is a naturally occurring hormone that is produced by the
adrenal glands. People with SLE generally have abnormally low levels of DHEA and
studies have shown that hormonal influences may play a role in the development
and progression of SLE.
Earlier this year the FDA granted Fast Track designation to GL701 for SLE,
which means that the FDA has determined that GL701 is intended to treat a
serious or life-threatening condition for which there is no adequate therapy
currently available. This designation also means that the FDA can take actions
to expedite the review of the NDA including assigning priority review status. In
1994, GL701 received Orphan Drug designation from the FDA for the treatment of
SLE. Orphan Drug designation provides seven years of marketing exclusivity from
the date of a drug's approval.
Genelabs intends to retain the right to market GL701 in the United States
and is seeking partners for development and marketing of GL701 outside of the
US. The company is the exclusive licensee of two issued US patents from Stanford
University which cover the use of DHEA in lupus patients to reduce concomitant
steroid dosage and for the treatment of lupus with or without additional drug
therapies.
SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
SLE is a life-long, devastating autoimmune disease that primarily affects
women, many of whom experience the initial onset of disease in their late teens
and early twenties. There are approximately 200,000 people with SLE in the
United States and more than one million worldwide, according to various
government and private sector statistics. SLE causes the immune system to attack
the body's own tissue, which can lead to inflammation, pain and injury to
tissues and major organs. People with SLE can develop different combinations of
symptoms and organ involvement. Common signs and symptoms include severe
fatigue, arthritis, facial rash and unusual sensitivity to sunlight as well as
inflammation of the lungs and heart. More serious, life-threatening organ
damage, which involves inflammation of the brain tissue and kidney failure, can
lead to poor quality of life and ultimately death. There is no cure for SLE. The
multi-faceted manifestations and unknown etiology of the disease have made SLE
difficult to study and to treat. No drug has been approved for the treatment of
SLE in the US in the past 40 years. Current treatment is primarily limited to
inflammation suppression, most commonly through chronic use of steroids such as
prednisone. Long-term use of steroids has many serious adverse consequences
including premature osteoporosis, atherosclerosis and diabetes.
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Genelabs Technologies, Inc. is a biopharmaceutical company engaged in the
discovery of small molecule drugs that bind to DNA or RNA to regulate gene
expression or inactivate pathogens. The company's drug discovery program is
based on an integrated platform of technologies that encompasses genomics,
transcription biology, structure-biased combinatorial chemistry, high-throughput
screening and several proprietary validation and characterization assays. The
company's development efforts are focused on its drug candidate, GL701, which
has completed two Phase III clinical trials as a new therapy for systemic lupus
erythematosus.
NOTE
Except for historical information, the statements in this news release are
forward-looking 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 adequacy of the company's GL701 clinical
trial processes, whether the results of those clinical trials and other
supporting information will be sufficient to support regulatory approvals and
whether or not this NDA will be approved by the FDA; delays regarding the
regulatory approval process including the timing and scope of approval received,
if any; uncertainties and risks regarding market acceptance of GL701 as a
treatment for SLE; the company's limited manufacturing and marketing experience;
the validity, scope and enforceability of patents related to GL701; the
company's capital requirements and history of operating losses; and
uncertainties and risks regarding the company's ability to raise needed
additional capital or consummate strategic or corporate partner transactions on
favorable terms or at all. The company has not submitted applications for
regulatory review in the US or other countries, and the regulatory authorities
have not yet made a determination as to the safety or efficacy of GL701 for SLE.
Please see the information appearing in the company's filings with the
Securities and Exchange Commission, in particular information under the caption
"Risk Factors" in the company's 1998 Form 10-K, for more discussion regarding
these uncertainties and risks and those associated with the company's research
programs, early stage of development and other risks which may affect the
company. The company does not undertake any obligation to update these
forward-looking statements to reflect events or circumstances after the date of
this release.
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