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LA JOLLA PHARMACEUTICAL TO COMPLETE
ENROLLMENT OF PHASE III LUPUS CLINICAL
TRIAL
SAN DIEGO, October 22, 2002 - La Jolla
Pharmaceutical Company (Nasdaq: LJPC)
announced today that it would complete
enrollment in its Phase III clinical
trial of LJP 394 for the treatment of
lupus renal disease by November 11,
2002. After the completion of enrollment,
study physicians will conduct final
patient visits during the next few weeks,
at which point the Phase III trial will
be finished. Then, the Company will
collect and audit final data from the
trial sites prior to unblinding and
analysis. The Company currently plans
to report initial results in early 2003.
Serum samples from approximately 90%
of the patients enrolled to date have
been analyzed. About 94% of the tested
patient samples have high-affinity antibodies
to LJP 394. In three previous clinical
trials, the percentage of patients who
had high-affinity antibodies to LJP
394 was 89%, 90% and 94%, respectively.
The Company believes that lupus patients
with high-affinity antibodies to LJP
394 are more likely to benefit from
treatment with LJP 394.
"As planned, we have reached the
targeted number of renal flares in high-affinity
patients," said Steven B. Engle,
Chairman and Chief Executive Officer.
The primary endpoint in the Phase III
trial is time to renal flare in patients
with high-affinity antibodies to LJP
394, and completion of the trial is
based on reaching a targeted number
of renal flares. In the samples tested
to date, the Company has observed that
approximately 90% of patients who experienced
a renal flare were high-affinity. Until
all patients have been fully evaluated
and the resulting data have been extensively
analyzed, conclusions should not be
drawn regarding the outcome of the study.
The Phase III trial is a randomized,
double-blind, placebo-controlled study
and is designed to confirm data observed
in the Phase II/III trial. In the Phase
II/III trial, LJP 394-treated patients
who had high-affinity antibodies to
the drug had fewer renal flares and
fewer treatments with high-dose corticosteroids
and/or cyclophosphamide than placebo-treated
patients.
Lupus is an autoimmune disease that
results in a wide variety of chronic,
progressive symptoms including episodes
of life-threatening kidney inflammation
known as "renal flares." The
current standard of care for lupus -
treatment with steroids and chemotherapy
drugs - can cause severe side effects
including diabetes, hypertension and
sterility, and may leave patients vulnerable
to lethal opportunistic infections.
LJP 394 is designed to specifically
prevent the production of antibodies
responsible for lupus kidney disease
without suppressing the normal functions
of the immune system.
La Jolla Pharmaceutical Company is
a biotechnology company leading the
development of therapeutics for antibody-mediated
autoimmune diseases afflicting several
million people in the United States
and Europe. The Company is conducting
a Phase III trial of LJP 394 in patients
with lupus kidney disease, a leading
cause of sickness and death in these
patients. The Company is also conducting
a Phase I/II trial of 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 our Web site: http://www.ljpc.com.
Except for historical statements, this
press release contains 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. Our analyses
of clinical results of 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 future analyses 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.
Our blood test to measure the binding
affinity for LJP 394 is experimental,
has not been validated by independent
laboratories, may require regulatory
approval and may be necessary for the
approval and the commercialization of
LJP 394. 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. Even if
results are promising, the U.S. Food
and Drug Administration ("FDA")
may require additional clinical trials.
The Company's ability to develop and
sell its products in the future may
be affected by the intellectual property
rights of third parties. Additional
risk factors include the uncertainty
of: obtaining required regulatory approvals;
successfully marketing products; receiving
future revenue from product sales or
other sources such as collaborative
relationships; future profitability;
the need for additional financing; our
dependence on patents and other proprietary
rights; FDA approval of our manufacturing
facilities; the increase in capacity
of our manufacturing capabilities for
possible commercialization; and our
lack of marketing experience. 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 other reports and registration
statements filed with the Securities
and Exchange Commission from time to
time, including the report on Form 10-K
for the year ended December 31, 2001.

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