La Jolla Pharmaceutical Company (NASDAQ: LJPC) today announced an update
on its auction rate securities and continued progress in the ongoing
double-blind, placebo-controlled, randomized Phase 3 study of Riquent®
(abetimus sodium), its drug candidate for systemic lupus erythematosus
("SLE” or "lupus”).
In October 2008, the Company entered into an agreement with UBS A.G.,
giving the Company the right to sell its auction rate securities to UBS
at par value totaling $10 million beginning in January 2009. As such,
the Company anticipates liquidating these investments in early January
2009, subject to the ability of UBS to consummate the transaction. In
early December, the Company obtained a credit line from UBS for up to $6
million secured by these auction rate securities.
"The Company continues to explore potential partnership alliances as
well as other sources of funding,” said Deirdre Gillespie, President and
CEO of La Jolla Pharmaceutical Company. "We expect the availability of
the $10 million from our auction rate securities will give us additional
flexibility to focus on these funding initiatives. We are excited that
the Riquent Phase 3 study, which is the largest lupus trial conducted to
date, continues to progress towards our upcoming interim analyses and
final results in 2009.”
Update on Phase 3 ASPEN Study
The study is an event-driven trial designed to be completed when 128
renal flares have occurred. The current overall renal flare rate
continues to be lower than the original trial assumption. As a result,
in an effort to shorten the time to achieve the required number of renal
flares in the most cost effective manner, the Company is continuing
enrollment beyond the most recently targeted 800 patients.
To date, 890 patients have been enrolled in the trial at 172 clinical
trial sites. The Phase 3 trial includes two interim efficacy analyses
which will occur when approximately 70% and 85% of renal flares are
achieved. The first interim efficacy analysis is expected to be
conducted in Q1 of 2009 and the second in mid-year 2009. Each interim
efficacy analysis has a pre-specified p value of p < 0.001. With
continued funding, the Company projects that the trial will complete in
the second half of 2009.
The Independent Data Monitoring Board (DMB) has completed a fourth
safety review of the safety data and has not indicated any safety issues.
Phase 3 Study Design
The Phase 3 study is designed to assess the ability of Riquent treatment
to prevent or delay the time to renal flare in lupus patients with a
history of renal disease and with antibodies to dsDNA. The study is an
event-driven trial designed to be completed when 128 renal flares have
occurred. Equal numbers of patients are being treated with 300 mg per
week, 900 mg per week, or placebo. The pre-specified p value at the end
of the study is p < 0.05.
A lupus renal flare is a potentially life-threatening increase in
inflammation of the kidney due to lupus. A renal flare often requires
treatment with immunosuppressive agents which can have severe side
effects. Riquent is also being studied to assess whether drug treatment
decreases proteinuria as was observed in previous clinical trials.
Proteinuria, or protein in the urine, is a common problem for patients
with renal disease and is an indicator of renal damage.
Riquent has received an Approvable Letter and Fast Track status from the
Food and Drug Administration and has Orphan Drug designation in the
United States and Europe.
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 and is also designed
to specifically suppress the B cells that make these antibodies.
Decreases in these antibodies are believed to be associated with a
decreased 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 Lupus
Lupus (systemic lupus erythematosus) is a chronic, potentially
life-threatening autoimmune disease. About 90% of lupus patients are
female, and many are diagnosed with the disease during their
childbearing years. Approximately 50% of lupus patients have renal
disease which can lead to irreversible renal damage, renal failure and
the need for dialysis, and is a leading cause of death in lupus
patients. 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. To date, no
lupus-specific drug has been approved in the U.S.
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: our ability to raise
additional capital; 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.