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LA JOLLA PHARMACEUTICAL PROVIDES UPDATE ON NDA FILING REGARDING
ACCELERATED APPROVAL
Conference Call Scheduled for 1:30 p.m. Eastern
SAN DIEGO, July 24, 2003 La Jolla Pharmaceutical Company
(Nasdaq: LJPC) announced today that, based on recent discussions
with the United States Food and Drug Administration (FDA), the
Company may pursue an accelerated approval for its lupus drug
candidate, Riquent, under the FDA's Subpart H regulation.
The FDA will make the determination of approvability and the conditions
of the approval after it has reviewed the Company's New Drug Application
(NDA). As previously announced, La Jolla Pharmaceutical plans
to submit an NDA for Riquent around the end of this year.
Under Subpart H, drugs in development for serious, life-threatening
diseases with an unmet medical need can be approved on an accelerated
basis if the FDA determines that the effect of the drug on a surrogate
endpoint is reasonably likely to predict clinical benefit and
that a post-marketing clinical trial can be successfully completed
following drug approval which confirms the clinical benefit. A
post-marketing clinical trial may need to be initiated prior to
approval, but under Subpart H, such a trial would not need to
be completed until after approval. The Company is currently in
discussions with the FDA about the design and timing of a post-marketing
clinical trial.
As previously announced, in the Companys Phase 3 and Phase
2/3 trials, patients treated with Riquent had significantly reduced
levels of antibodies to double-stranded DNA (dsDNA) compared with
patients treated with placebo. The Company believes that data
from its clinical trials and the relevant medical literature would
support the use of antibodies to dsDNA as a surrogate endpoint
that would be reasonably likely to predict clinical benefit.
"The outcome of our recent discussions with the FDA is an
important step forward for the Company," said Steve Engle,
Chairman and CEO of La Jolla Pharmaceutical Company. "Not
only does Subpart H offer an alternate pathway for potential approval
of Riquent, but it also may enable an accelerated approval of
Riquent, allowing patients to gain access to Riquent while an
additional post-marketing study is ongoing."
Lupus is a chronic, life-threatening autoimmune disease afflicting
about 1 million people in the United States and Europe. A significant
number of lupus patients develop kidney disease, a leading cause
of morbidity and mortality in lupus patients. The current standard
of care for lupus kidney disease involves treatment with corticosteroids
and chemotherapy drugs that can cause severe side effects including
diabetes, hypertension and sterility, and may leave patients vulnerable
to opportunistic infections. Riquent is designed to specifically
prevent the production of antibodies responsible for lupus kidney
disease without suppressing the normal functions of the immune
system.
The Company will host a conference call today, Thursday, July
24, 2003, at 1:30 p.m. Eastern Time. The dial in number is (800)
299-6183 for U.S. callers and (617) 801-9713 for international
callers. The call identification number is 98432801. A live audio
webcast of the conference call will be available through La Jolla
Pharmaceuticals Web site at www.ljpc.com.
The webcast will also be available to both institutional and individual
investors via CCBN's Investor Distribution Network. Individual
investors can listen to the call through CCBN's individual investor
center at www.companyboardroom.com or by visiting any of the investor
sites in CCBN's Individual Investor Network. Institutional investors
can access the call via CCBN's password-protected event management
site, StreetEvents, at www.streetevents.com.
A replay of the conference call can be accessed by dialing (888)
286-8010 (US) or (617) 801-6888 (International). The passcode
for the replay is 27190619. The call will be available for approximately
one week. A replay of the call will also be available on the Companys
website.
La Jolla Pharmaceutical Company is a biotechnology company developing
therapeutics for antibody-mediated autoimmune diseases 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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