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LA JOLLA PHARMACEUTICAL COMPANY PRESENTS RESULTS LINKING ANTIBODIES
TO dsDNA WITH RENAL FLARES
Four Posters Presented at American Society of Nephrology Annual
Meeting
SAN DIEGO, November 17, 2003 -- La Jolla Pharmaceutical Company
(Nasdaq: LJPC) today presented analyses showing statistically
significant associations between changes from baseline in levels
of antibodies to double-stranded DNA (dsDNA) and the relative
risk of renal flare in both the Phase 2/3 and Phase 3 clinical
trials of Riquent. These results, in studies of approximately
500 patients, were presented at the American Society of Nephrology
Annual Meeting being held November 14-17, 2003 in San Diego, CA.
Analyses of data using Coxs Proportional Hazards Regression
Model predict that a 50% reduction in antibodies to dsDNA from
baseline is associated with a 52% lower risk of renal flare in
the Phase 2/3 trial (p=0.0007) and a 53% lower risk in the Phase
3 trial (p<0.0001). These findings are consistent with previously
released data showing that patients with sustained reductions
in antibodies to dsDNA had fewer renal flares. These results will
be submitted as part of the Companys planned regulatory
filings regarding Riquent.
Summary of four poster presentations at the American Society
of Nephrology:
James Tumlin, M.D., Associate Professor of Medicine, Emory University
School of Medicine, presented a poster entitled, "Efficacy
Results from a Randomized Controlled Trial of LJP 394 in Systemic
Lupus Erythematosus (SLE) Patients with a History of Renal Disease."
The poster summarized data from the Phase 3 trial of Riquent in
which 298 lupus patients with high affinity antibodies to Riquent
at baseline were treated with Riquent or a placebo for up to 22
months.
Dr. Tumlin also presented a poster entitled, "Renal Flare
in SLE Patients with Impaired Renal Function in a Randomized Controlled
Trial of LJP 394." This poster summarized data from a subpopulation
of patients in the Phase 3 and Phase 2/3 trials with impaired
renal function.
Matthew Linnik, Ph.D., Chief Scientific Officer and Executive
Vice President of Research at La Jolla Pharmaceutical, presented
a poster entitled, "Reductions in Anti-dsDNA Antibodies and
Reduced Risk of SLE Renal Flare and Major SLE Flare." This
poster presented Cox regression analyses and sustained reduction
analyses on data from the Phase 2/3 and Phase 3 trials.
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 an abstract entitled, "Safety
Results from a Randomized Controlled Trial of LJP 394 in SLE Patients
with a History of Renal Disease." The abstract summarized
safety data from the Phase 3 trial of Riquent that showed that
Riquent was well tolerated for the duration of the trial in which
patients were treated for periods of up to 22 months.
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 RiquentTM,
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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