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LA JOLLA PHARMACEUTICAL COMPANY PROVIDES UPDATE ON RIQUENT
PROGRAM
SAN DIEGO, November 23, 2004 -- La Jolla Pharmaceutical Company
(Nasdaq: LJPC) today provided an update on its clinical and regulatory
activities concerning its drug candidate, Riquent® (abetimus
sodium), for lupus renal disease.
In a clinical study of Riquent in lupus patients, the Company
is now recruiting patients at 29 of 60 planned U.S. clinical trial
sites in 28 states. Screening and enrollment of patients is proceeding
as planned. The multi-dose study of the impact of Riquent on lupus
kidney disease, a leading cause of morbidity and mortality in
lupus patients, was initiated in August 2004 under a Special Protocol
Assessment agreement with the Division of Cardio-Renal Drug Products
of the United States Food and Drug Administration (FDA). The study
is evaluating weekly doses of 100 mg and 300 mg of Riquent over
a 12-month period in lupus patients with a history of renal disease.
Patients who are interested in participating in the study should
contact their physicians or visit our Web site at www.ljpc.com.
As part of its Special Protocol Assessment agreement, La Jolla
Pharmaceutical is also evaluating higher doses of Riquent for
use in the multi-dose clinical study discussed above. In a study
in healthy volunteers, one group received a single dose of either
600 mg of Riquent or placebo, and a second group received a single
dose of either 1200 mg of Riquent or placebo. In each group, six
volunteers received Riquent and two received placebo. Both doses
of Riquent appeared to be well tolerated. Based on previous studies
of Riquent, the Company believes that certain lupus patients may
benefit from higher doses of Riquent. Once the dosing study is
completed, the Company plans to review the data from the study
with the FDA and then may choose to study additional doses.
Since receiving the approvable letter for Riquent on October 14,
2004, the Company has met twice with the FDA to discuss the approvable
letter and data concerning Riquent. The Company has two additional
meetings currently scheduled. There is no guarantee that these
discussions will result in any modification of the approvable
status of Riquent or the Companys need for data from an
additional study, such as data from the large multi-dose study
discussed above, prior to any approval.
The Company has met with the European Agency for the Evaluation
of Medicinal Products (EMEA), which has designated two countries
to lead the review of the Companys European regulatory filing.
Because of the efforts involved in its ongoing discussions with
the FDA, the Company anticipates a delay in filing its Marketing
Authorization Application for Riquent in Europe. In addition,
while discussions with the FDA are ongoing, the Company has taken
steps to control certain costs associated with its research, development
and other activities.
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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