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LA JOLLA PHARMACEUTICAL COMPANY PRESENTS AT AMERICAN COLLEGE
OF RHEUMATOLOGY AND AMERICAN SOCIETY OF NEPHROLOGY ANNUAL MEETINGS
SAN DIEGO, October 29, 2004 -- La Jolla Pharmaceutical Company
(Nasdaq: LJPC) announced that it presented additional and previously
released results from its Phase 2/3 and Phase 3 clinical trials
of Riquent® (abetimus sodium, formerly LJP 394) for the treatment
of lupus renal disease. Posters were presented today at the American
Society of Nephrology Annual Meeting being held in St. Louis,
MO and last week at the American College of Rheumatology Annual
Meeting held in San Antonio, TX.
At the American College of Rheumatology meeting, Kenneth R. Heilbrunn,
M.D., Vice President of Clinical Development at La Jolla Pharmaceutical
Company, presented new data in a poster entitled "The Effect
of LJP 394 and Concomitant Immunosuppressive Agents on Levels
of Anti-dsDNA Antibodies in SLE Patients."
The poster summarized additional data from a Phase 3 clinical
trial comparing changes in levels of antibodies to double-stranded
DNA (dsDNA) in patients on Riquent or placebo who were receiving
either mycophenolate mofetil (MMF) or azathioprine (AZA) at baseline.
Patients treated with Riquent who were on MMF at baseline had
a greater reduction in levels of antibodies to dsDNA compared
with patients treated with placebo who were on MMF at baseline.
Similarly, patients treated with Riquent who were on AZA at baseline
had a greater reduction in levels of antibodies to dsDNA than
patients treated with placebo who were on AZA at baseline.
By week 24, Riquent-treated patients on MMF experienced a median
reduction in levels of antibodies to dsDNA of 55% compared with
a median reduction of 6% for placebo-treated patients. Riquent-treated
patients on AZA experienced a median reduction in levels of antibodies
to dsDNA of 28% compared with a median reduction of 1% for placebo-treated
patients. Forty-two patients were receiving MMF at baseline (20
Riquent and 22 placebo). Seventy-four patients were receiving
AZA at baseline (38 Riquent and 36 placebo). Baseline characteristics
were similar between treatment groups.
Also, Vibeke Strand, M.D., Stanford University Medical Center,
presented a poster entitled "Improved Health-Related Quality
of Life (HRQOL) Following Sustained Reductions in Anti-dsDNA Antibody
Levels in Patients with Systemic Lupus Erythematosus (SLE) After
Treatment with LJP 394."
At the American Society of Nephrology meeting, James A. Tumlin,
M.D., Emory University, presented a poster entitled "Reductions
in 24-hour Urine Protein Levels Associated with Treatment of SLE
Patients with LJP394 in Two Randomized, Placebo-controlled Clinical
Trials." A second poster, presented by Claudia Hura, M.D.,
San Antonio Kidney Disease Center, was entitled "Integrated
Safety Results from Studies of LJP 394 in SLE Patients."
La Jolla Pharmaceutical Company is a biotechnology company developing
therapeutics for antibody-mediated autoimmune diseases and inflammation
afflicting several million people in the United States and Europe.
The Company is developing Riquent® 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, miscarriage
and other thrombotic events, and is in the early stage of developing
small molecules to treat various other autoimmune and inflammatory
conditions. 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.
The forward-looking statements in this press release involve
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 that express a plan, belief, expectation, estimation,
anticipation, intent, contingency, future development or similar
expression. The 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"), including the results of any trials
that are ongoing or that we may initiate in the future, 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 showed that the trial did not reach statistical
significance with respect to its primary endpoint, time to renal
flare, or with respect to the secondary endpoint, time to treatment
with high-dose corticosteroids or cyclophosphamide. The results
from our clinical trials of Riquent, including the results of
any trials that are ongoing or that we may initiate in the future,
may not ultimately be sufficient to obtain regulatory clearance
to market Riquent either in the United States 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 can be no assurance, however, that we will have
the necessary resources to complete any 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 and will likely be reviewed as part of
the Riquent approval process. 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
clinical trials in addition to our current clinical trial, or
may not approve our drugs. Our ability to develop and sell our
products in the future may be adversely affected by the intellectual
property rights of third parties. Additional risk factors include
the uncertainty and timing of: our clear need for additional financing;
obtaining required regulatory approvals, including delays associated
with any approvals that we may obtain; our ability to pass all
necessary FDA inspections; 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; our ability to make use of the orphan drug
designation for Riquent; 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,
2003, and in other reports and registration statements that we
file with the Securities and Exchange Commission from time to
time.
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