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IMPACT OF LA JOLLA PHARMACEUTICAL'S
LUPUS DRUG CANDIDATE ON PATIENTS' HEALTH-RELATED
QUALITY OF LIFE PRESENTED AT NIH CONFERENCE
BETHESDA, Md., January 10, 2002 - Data
were presented today on La Jolla Pharmaceutical
Company's (Nasdaq: LJPC) drug candidate
for lupus renal disease, LJP 394, from
a previous Phase II/III clinical trial
which indicate that treatment with LJP
394 improved or sustained health-related
quality of life in patients with lupus
renal disease following 16 weeks of
treatment with LJP 394 and following
renal flares when compared to placebo.
Health-related quality of life is a
measure of a patient's sense of mental
and physical well-being or how they
feel and was measured by a standard
scoring instrument called the SF-36®
Health Survey.
Vibeke Strand, M.D., Clinical Professor
of Medicine, Division of Immunology,
Stanford University, and Bruce Crawford,
M.A. M.P.H., Mapi Values, presented
a paper titled "Improvement in
Health Related Quality of Life in 230
SLE Patients Enrolled in a Randomized
Controlled Trial Comparing LJP 394 Treatment
with Placebo" at the SLE: Targets
for New Therapeutics scientific conference
sponsored by the National Institutes
of Health and the SLE Foundation.
"Following 16 weekly treatments,
patients treated with LJP 394 reported
improved health-related quality of life
compared with placebo - a very short
time to show such a change," said
Dr. Strand. "The largest difference
between drug treatment and placebo treatment
occurred in the 'role emotional' domain,
indicating that patients felt better
when treated with LJP 394, despite a
renal flare. These improvements were
not determined to be due to differences
in the use of high-dose corticosteroids
and/or cytotoxic agents such as cyclophosphamide.
And, although this is the first health-related
quality of life evaluation of LJP 394,
the longitudinal improvement is consistent
with other reported benefits - the delay
of renal flares and the delay in treatments
with high-dose corticosteroids and/or
cyclophosphamide.
"Following a renal flare, patients
treated with LJP 394 demonstrated stabilization
or improvement in all SF-36 domains
while those receiving placebo reported
deterioration in all domains,"
added Dr. Strand. "In a patient
population with impaired health-related
quality of life at entry, this is an
important, new observation. Confirmation
of these results in the ongoing Phase
III clinical trial would provide additional
support for the potential value of this
new treatment for lupus patients."
Following 16 weeks of treatment with
100 mg of LJP 394: In 190 patients with
SF-36 measurements, LJP 394-treated
patients reported a positive trend in
their composite mental component score
of 1.3 compared with a worsening of
- 0.8 in patients treated with placebo,
a difference of 2.1. The largest mean
change occurred in the role emotional
score where the drug-treated patient
score improved by +7.7 points while
the placebo-treated patient score decreased
by - 8.1. This was a relative difference
of 15.8. The role-emotional assessment
represents the patient's perception
of limitations they experience in their
daily routine attributed to emotional
problems.
Following a renal flare: In 37 patients
with SF-36 measurements before and after
a renal flare, LJP 394-treated patients
experienced an improved or stable health-related
quality of life in all domains except
one, while placebo-treated patients
reported worsening in all domains. For
example, the mean change in role emotional
score for drug-treated patients improved
by +2.1 points compared with placebo-treated
patients where it decreased by - 20.6
points, a relative difference of 22.7
points. The changes in role emotional
and the mental component summary scores
are of a magnitude that would be considered
clinically meaningful.
As expected, at the beginning of the
study, the mean scores for all patients
were significantly lower in all domains
compared with normal individuals in
the U.S. of similar age and sex, indicating
that these lupus patients' perception
of their quality of life was poor.
The objective of the Phase II/III clinical
trial was to evaluate the ability of
LJP 394 to increase time to renal flare
in lupus patients with a history of
renal disease. The SF-36 assessment
was used to explore the potential improvement
in health-related quality of life in
lupus patients following treatment with
LJP 394. The trial enrolled 230 lupus
patients who were treated for up to
18 months. Patients were not randomized
at entry for SF-36.
The SF-36® Health Survey is a standardized
tool used in clinical research to measure
a patient's assessment of quality of
life outcomes related to disease and
disease treatment. It has been used
in a wide range of medical conditions
such as cardiovascular disease, pain,
diabetic foot ulcers, total knee replacement,
dialysis, rheumatoid arthritis, and
osteoarthritis.
The Survey asks 36 questions related
to how well a patient can perform day-to-day
activities and how they feel emotionally.
The answers are then reported as scores
in eight domains. These domains are
physical functioning, role-physical,
bodily pain, general health, vitality,
social functioning, role-emotional and
mental health
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.
Patients interested in the Phase III
lupus trial may call 1-888-30-LUPUS
for information.
Except for historical statements,
this press release contains forward-looking
statements, including, without limitation,
statements regarding the analysis of
results from pre-clinical and clinical
studies as well as La Jolla Pharmaceutical's
drug candidates and drug development
plans. These forward-looking statements
involve risks and uncertainties, and
a number of factors, both foreseen and
unforeseen, could cause actual results
to differ materially from those anticipated.
Clinical results for LJP 394 are derived
from a trial that was terminated prior
to completion, and certain data are
incomplete. The Company's blood test
to measure binding affinity for LJP
394 is experimental and has not been
validated by independent laboratories.
Tolerance, or the specific inactivation
of pathogenic B cells, is a new technology
that has not been proven. The Company's
ability to develop and sell its products
in the future may be affected by the
intellectual property rights of third
parties. Future clinical trials of the
Company's drug candidates may have negative
or inconclusive results. Future clinical
trials of the Company's drug candidates
may not support results of pre-clinical
or other prior trials and clinical trials
of LJP 394 for treating lupus or LJP
1082 for treating antibody-mediated
thrombosis may reveal a potential safety
issue requiring the development of a
new candidate. Any delays in testing
of the Company's drug candidates or
termination of development by the Company
would result in delays or lack of government
approval to market the compounds. The
development of drug candidates involves
many risks and uncertainties, including,
without limitation, whether the drug
can provide a meaningful clinical benefit,
and any positive results observed to
date may not be indicative of future
results. La Jolla Pharmaceutical's other
potential drug candidates involve comparable
risks. Interested parties are urged
to review the risks detailed from time
to time in La Jolla Pharmaceutical Company's
Securities and Exchange Commission filings,
including the report on Form 10-K for
the year ended December 31, 2000.

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