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LA JOLLA PHARMACEUTICAL DISCOVERS SMALL MOLECULE THAT PRODUCES
POSITIVE RESULTS IN AUTOIMMUNE DISEASE AND INFLAMMATION MODELS
SAN DIEGO, December 2, 2003 -- La Jolla Pharmaceutical Company
(Nasdaq: LJPC) today announced the discovery of novel, orally-active
small molecules for the treatment of autoimmune diseases and acute
and chronic inflammatory disorders. Company scientists have generated
highly selective inhibitors of SSAO (semicarbazide-sensitive amine
oxidase), an enzyme that has been implicated in inflammatory responses
in many tissues and organs. Preclinical studies in animal models
of multiple sclerosis, rheumatoid arthritis and acute inflammation
have shown that treatment with the Companys inhibitors both
maintained function and reduced disease activity compared with
placebo treatment.
"We have discovered several families of potent, orally-active
small molecule inhibitors of SSAO that reduce disease in a variety
of animal models," said Matthew Linnik, Executive Vice President
of Research and Chief Scientific Officer of La Jolla Pharmaceutical
Company. "The impact of these lead compounds on animal models
of multiple sclerosis and rheumatoid arthritis was similar to
that of methotrexate, a widely used anti-inflammatory agent. We
are excited about the potential to provide a novel approach to
treating a number of debilitating diseases."
SSAO, also known as vascular adhesion protein-1 or VAP-1, was
recently discovered to be a dual-function molecule with enzymatic
and adhesion activities. SSAO contributes to the adhesion of white
blood cells to endothelial cells and is greatly amplified in inflamed
blood vessels. The enzyme also contributes to the production of
molecules that exacerbate inflammation. Increases in the levels
of plasma or membrane-associated SSAO have been reported for many
inflammation-associated diseases including rheumatoid arthritis,
inflammatory bowel disease, diabetes, atherosclerosis, and chronic
heart failure. In preclinical studies conducted by Company scientists,
SSAO inhibitors blocked both the enzymatic and adhesion functions
of SSAO and were shown in animal models to be potent inhibitors
of disease activity. These results will be presented at the 2nd
International Inflammatory & Immune Diseases World Summit
on March 8-10, 2004 in Baltimore, MD.
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, 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
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 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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