La Jolla Pharmaceutical Company (Nasdaq:LJPC) announced today that its
financial statements for the fiscal year ended December 31, 2007,
included in the Company's Annual Report on Form 10-K filed on March 17,
2008, contain a going concern qualification to the audit opinion from
its independent registered public accounting firm, Ernst & Young, LLP.
The Company intends to raise additional capital in fiscal 2008 to
support its operations.
This announcement is being made in compliance with NASDAQ Marketplace
Rule 4350(b)(1)(B), which requires separate disclosure of receipt of an
audit opinion that contains a going concern qualification. This
announcement does not represent any change or amendment to the Company's
2007 financial statements or to its Annual Report on Form 10-K.
About Riquent
Riquent is being developed to specifically treat lupus renal disease by
preventing or delaying renal flares, a leading cause of sickness and
death in lupus patients. It is also being studied to assess whether
Riquent treatment improves proteinuria, as was observed in previous
clinical trials. Proteinuria is an indicator of abnormal renal function.
Riquent has been well tolerated in all 14 clinical trials, with no
overall difference in the adverse event profiles for Riquent-treated
patients compared with placebo-treated patients. Riquent specifically
reduces circulating levels of anti-dsDNA antibodies. Increases in these
antibodies are associated with an increased risk of renal flare.
Although clinical benefit has not yet been proven, Riquent treatment has
significantly reduced these antibody levels in all clinical trials in
which they were measured.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is dedicated to improving and preserving
human life by developing innovative pharmaceutical products. The Company’s
leading product in development is Riquent®,
which is designed to treat lupus renal disease by preventing or delaying
renal flares. Lupus renal disease is a leading cause of sickness and
death in patients with lupus. The Company has also developed potential
small molecule drug candidates to treat various other autoimmune and
inflammatory conditions. The Company's common stock is traded on The
NASDAQ Global Market under the symbol LJPC. More information about the
Company is available on its Web site: http://www.ljpc.com.
The forward-looking statements in this press release involve
significant risks, assumptions 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®
(abetimus sodium), previously known as LJP 394, our drug candidate for
the treatment of systemic lupus erythematosus (lupus), and any other
drug candidate that we may develop, including the results of any trials
or models 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 previous 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 its 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 any other country, 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 current or future trials or that any such trials will
sufficiently demonstrate the safety and efficacy of Riquent. Our
ability to develop and sell our products in the future may be adversely
affected by the intellectual property rights of third parties or the
validity or enforceability of our intellectual property rights. Additional
risk factors include the uncertainty and timing of: the availability of
sufficient financial resources; obtaining required regulatory approvals,
including delays associated with any approvals that we may obtain; the
timely supply of drug product for clinical trials; our ability to pass
all necessary regulatory 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. Accordingly,
you should not rely upon forward-looking statements as predictions of
future events. The outcome of the events described in these
forward-looking statements are subject to the risks, uncertainties and
other factors described in the "Risk Factors”
contained in our Annual Report on Form 10-K for the year ended December
31, 2007, and in other reports and registration statements that we file
with the Securities and Exchange Commission from time to time. We
expressly disclaim any intent to update forward-looking statements.
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