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LA JOLLA PHARMACEUTICAL SUBMITS NEW DRUG APPLICATION FOR RIQUENT™
Riquent is the first drug candidate specifically developed
for the treatment of lupus renal disease in more than 30 years
SAN DIEGO, December 16, 2003 -- La Jolla Pharmaceutical Company
(Nasdaq: LJPC) today announced that it has submitted a New Drug
Application with the United States Food and Drug Administration
for Riquent™, its drug candidate for the treatment of patients
with lupus (systemic lupus erythematosus or SLE) at risk of renal
disease. Riquent is designed to reduce the levels of antibodies
to double-stranded DNA (dsDNA), which are believed to be responsible
for lupus renal disease, a primary cause of sickness and death
in lupus patients. Riquent has received orphan drug status in
the United States and Europe.
"Our New Drug Application for Riquent is supported by data
from two of the longest and largest randomized clinical studies
ever conducted to evaluate a drug candidate in lupus patients,"
said Steve Engle, Chairman and CEO of La Jolla Pharmaceutical
Company. "We believe these studies show that patients treated
with Riquent experienced reductions in the levels of antibodies
to dsDNA and that reductions in these antibodies were associated
with fewer renal flares. These results were seen even though many
patients were on immunosuppressive drug therapies."
Engle added, "This submission represents an important milestone
for the Company and a potentially significant advance for lupus
patients in combating their disease."
New Drug Application
The evidence supporting the safety and effectiveness of Riquent
is derived from 12 clinical trials involving approximately 900
patients and subjects conducted over a period of approximately
10 years. The submission is primarily based on previously announced
data from the Company’s Phase 3 trial of Riquent that enrolled
298 patients with high-affinity antibodies to Riquent who were
treated for up to 22 months and its Phase 2/3 trial that enrolled
189 high-affinity patients who were treated for up to 18 months.
The trials focused on the leading causes of sickness and death
in lupus patients: renal flares and treatments with immunosuppressive
drugs.
About Lupus and Riquent
Lupus is a chronic, life-threatening autoimmune disease afflicting
approximately one million people in the United States and Europe.
About 90% of lupus patients are female. Most patients develop
the disease during their childbearing years. Approximately 50%
of lupus patients have renal disease. Renal disease is one of
the most serious aspects of lupus and can lead to irreversible
kidney damage, kidney failure and the need for dialysis. Antibodies
to dsDNA can be detected in most lupus patients and are considered
diagnostic for the disease.
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. The morbidity resulting from current treatments can
be worse than the disease itself.
Riquent is designed to be highly specific and not to suppress
the normal healthy functions of the immune system. Riquent appeared
to be well tolerated in all studies with no apparent differences
in the overall incidence of serious adverse events or adverse
events between Riquent-treated and placebo-treated patients.
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 renal 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 that express a plan,
belief, expectation, estimation, anticipation, intent, contingency,
future development or similar expression. Although we have submitted
a New Drug Application ("NDA") for RiquentTM with the
United States Food and Drug Administration (the "FDA"),
there is no guarantee that it will accept the NDA submission or
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 have submitted
an NDA for Riquent with 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 U.S. 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 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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