| LA JOLLA PHARMACEUTICALS
NEW DRUG APPLICATION FOR LUPUS DRUG CANDIDATE RIQUENT® ACCEPTED
FOR REVIEW BY FDA SAN DIEGO
SAN DIEGO, February 17, 2004 -- La Jolla Pharmaceutical Company
(Nasdaq: LJPC) today announced that the Companys New Drug
Application (NDA) for Riquent® has been accepted for review
by the United States Food and Drug Administration (FDA).
Riquent is designed to treat lupus patients with renal disease,
a primary cause of sickness and death among these patients. Riquent
is the first drug candidate specifically developed for the treatment
of lupus renal disease in more than 30 years.
"The acceptance of our NDA filing is an important step for
the Company. This milestone brings us closer to achieving our
goal of providing long-suffering lupus patients with a new therapy,"
said Steve Engle, Chairman and CEO of La Jolla Pharmaceutical
Company.
About Lupus
Lupus (systemic lupus erythematosus or SLE) is a chronic, life-threatening
autoimmune disease. About 90% of lupus patients are female, and
many develop the disease during their childbearing years. Approximately
50% of lupus patients have renal disease, which can lead to irreversible
kidney damage, kidney failure and the need for dialysis. Latinos,
African Americans, and Asians face an increased risk of serious
renal disease associated with lupus.
The current standard of care for lupus renal disease often involves
treatment with high doses of corticosteroids and immunosuppressive
drugs that can cause severe side effects including diabetes, hypertension
and sterility, and may leave patients vulnerable to opportunistic
infections.
La Jolla Pharmaceutical Company
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, 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.
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
that express a plan, belief, expectation, estimation, anticipation,
intent, contingency, future development or similar expression.
Although our New Drug Application ("NDA") for Riquent®
has been accepted by the United States Food and Drug Administration
(the "FDA") for review, there is no guarantee that the
FDA 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 our NDA for Riquent
has been accepted for review by the FDA, the results from our
clinical trials of Riquent 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 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
adversely 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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