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LA JOLLA PHARMACEUTICAL COMPANY PRESENTS FIVE POSTERS AT AMERICAN
COLLEGE OF RHEUMATOLOGY
SAN DIEGO, October 27, 2003 -- La Jolla Pharmaceutical Company
(Nasdaq: LJPC) announced today that the Company and several of
its clinical investigators presented five posters at the American
College of Rheumatology 67th Annual Scientific Meeting in Orlando,
FL. The posters included previously released data from several
of the Company’s clinical trials of Riquent™ (formerly
LJP 394) for the treatment of lupus renal disease and data regarding
LJP 1082, the Company’s drug candidate for the treatment
of antibody-mediated thrombosis.
Mario Cardiel, M.D., Department of Immunology and Rheumatology,
Instituto Nacional de la Nutricion Salvador Zubiran, Mexico City,
presented a poster entitled "Clinical Efficacy Results from
a Randomized Clinical Trial of LJP 394 in SLE Patients with History
of Renal Disease." The poster reviewed data from the Phase
3 clinical trial of Riquent, in which 298 lupus patients were
treated with Riquent or a placebo for up to 22 months. Treatment
with Riquent resulted in 25% fewer renal flares and 21% fewer
Major SLE flares compared with placebo, although as previously
announced, these findings were not statistically significant.
Treatment with Riquent also resulted in a statistically significant
reduction in antibodies to double-stranded DNA (dsDNA) that are
believed to cause lupus renal disease. Renal flares are significant
increases in kidney inflammation that can lead to a loss of kidney
function, kidney failure, and the need for long-term dialysis.
A Major SLE flare is a composite endpoint of treatments for lupus,
including the initiation or increased use of immunosuppressive
agents, hospitalization or death due to lupus.
Matthew Linnik, Ph.D., La Jolla Pharmaceutical Company’s
Chief Scientific Officer and Executive Vice President of Research,
presented a poster entitled "SLE Patients with Sustained
Reductions in Anti-dsDNA Antibodies Have a Reduced Risk of Renal
Flare and Major SLE Flare." This poster reviewed data from
both the Phase 3 and Phase 2/3 clinical trials of Riquent, where
lupus patients with sustained reductions in antibodies to dsDNA
had a lower incidence of both renal flare and Major SLE flare.
Treatment with Riquent resulted in a two- and four-fold increase,
respectively, in the number of patients with sustained reductions
in antibodies to dsDNA compared with placebo.
Daniel Wallace, M.D., F.A.C.P., F.A.C.R., Clinical Chief of Rheumatology,
Cedars-Sinai Medical Center, Los Angeles, and Clinical Professor,
UCLA School of Medicine, presented a poster entitled "Safety
Results from a Randomized Controlled Trial (RCT) of LJP 394 in
Systemic Lupus Erythematosus (SLE) Patients with a History of
Renal Disease." The poster reviewed safety data from the
Phase 3 trial of Riquent, which showed no differences in the overall
incidence of serious adverse events or adverse events between
Riquent-treated patients and placebo-treated patients.
Based on the data from the Phase 3 and 2/3 clinical studies, as
well as additional data, La Jolla Pharmaceutical Company currently
plans to submit a New Drug Application for Riquent with the United
States Food and Drug Administration (FDA) in December 2003 or
January 2004.
Additionally, La Jolla Pharmaceutical presented two posters regarding
LJP 1082, the Company’s drug candidate designed to treat
antibody-mediated thrombosis, also known as Antiphospholipid Syndrome.
Arash Horizon, M.D., Division of Rheumatology, Cedars-Sinai Medical
Center, and Assistant Clinical Director, UCLA, presented a poster
entitled "Results of a Randomized, Placebo Controlled, Double
Blind Phase 1/2 Clinical Trial (RCT) to Assess the Safety and
Tolerability of LJP 1082 in Patients with Antiphospholipid Syndrome."
The poster reviewed previously announced and additional data from
the Phase 1/2 clinical trial of LJP 1082 in which 20 patients
received placebo or doses of LJP 1082 ranging from 1 to 200 mg.
There were no significant safety differences between drug-treated
and placebo-treated patients, and there were no serious adverse
events reported. Trial data also demonstrated that circulating
antibodies from treated patients bound to LJP 1082 in a dose-dependent
manner. Patients in the trial treated with 200 mg showed the highest
level of reactivity with LJP 1082.
Dr. Linnik also presented a poster relating to LJP 1082, entitled
"Domain Specificity of Autoantibodies to Beta 2-Glycoprotein
1 in Patients with Antiphospholipid Syndrome Enrolled in a Phase
1/2 Trial with LJP 1082." The poster summarized laboratory
analyses demonstrating that the antibodies from most of the 15
patients studied were highly specific for domain 1 of beta-2 glycoprotein
1. These antibodies are believed to contribute to the increased
risk of thrombotic events in Antiphospholipid Syndrome. This study
further supports the development of a domain 1 Toleragen®
as a treatment for this disease.
La Jolla Pharmaceutical Company is a biotechnology company developing
therapeutics for antibody-mediated autoimmune diseases afflicting
several million people in the United States and Europe. The Company
is developing Riquent™, formerly known as LJP 394, for the
treatment of lupus kidney disease, a leading cause of sickness
and death in patients with lupus. The Company is also developing
LJP 1082 for the treatment of antibody-mediated thrombosis, a
condition in which patients suffer from recurrent stroke, deep-vein
thrombosis and other thrombotic events. The Company's common stock
is traded on The Nasdaq Stock Market under the symbol LJPC. For
more information about the Company, visit its Web site: http://www.ljpc.com.
Except for historical statements, this press release contains,
and the presentations referred to above contained, forward-looking
statements involving significant risks and uncertainties, and
a number of factors, both foreseen and unforeseen, could cause
actual results to differ materially from our current expectations.
Forward-looking statements include those which express a plan,
belief, expectation, estimation, anticipation, intent, contingency,
future development or similar expression. Although we plan to
submit a New Drug Application ("NDA") for Riquent™,
there is no guarantee that regulatory authorities will approve
Riquent in a timely manner, or at all. Our analyses of clinical
results of Riquent, previously known as LJP 394, our drug candidate
for the treatment of systemic lupus erythematosus ("lupus"),
and LJP 1082, our drug candidate for the treatment of antibody-mediated
thrombosis ("thrombosis"), are ongoing and could result
in a finding that these drug candidates are not effective in large
patient populations, do not provide a meaningful clinical benefit,
or may reveal a potential safety issue requiring us to develop
new candidates. The analysis of the data from our Phase 3 trial
of Riquent has shown that the trial did not reach statistical
significance with respect to its primary endpoint, time to renal
flare. Although we plan to submit an NDA for Riquent, the results
from our clinical trials of Riquent may not ultimately be sufficient
to obtain regulatory clearance to market Riquent either in the
U.S. or Europe, and we may be required to conduct additional clinical
studies to demonstrate the safety and efficacy of Riquent in order
to obtain marketing approval. There is no guarantee, however,
that we will have the necessary resources to complete any additional
trial, that we will elect to conduct an additional trial, or that
any additional trial will sufficiently demonstrate the safety
and efficacy of Riquent. Our blood test to measure the binding
affinity for Riquent is experimental, has not been validated by
independent laboratories, may require regulatory approval, and
will likely be necessary for the approval and the commercialization
of Riquent. Our other potential drug candidates are at earlier
stages of development and involve comparable risks. Analysis of
our clinical trials could have negative or inconclusive results.
Any positive results observed to date may not be indicative of
future results. In any event, regulatory authorities may require
additional clinical trials, or may not approve our drugs. Our
ability to develop and sell our products in the future may be
affected by the intellectual property rights of third parties.
Additional risk factors include the uncertainty and timing of:
obtaining required regulatory approvals, including delays associated
with any approvals that we may obtain; the clear need for additional
financing; FDA approval of our manufacturing facilities and processes;
the increase in capacity of our manufacturing capabilities for
possible commercialization; successfully marketing and selling
our products; our lack of manufacturing, marketing, and sales
experience; generating future revenue from product sales or other
sources such as collaborative relationships; future profitability;
and our dependence on patents and other proprietary rights. Readers
are cautioned to not place undue reliance upon forward-looking
statements, which speak only as of the date hereof, and we undertake
no obligation to update forward-looking statements to reflect
events or circumstances occurring after the date hereof. Interested
parties are urged to review the risks described in our Annual
Report on Form 10-K for the year ended December 31, 2002, and
in other reports and registration statements that we file with
the Securities and Exchange Commission from time to time.
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