|
LA JOLLA PHARMACEUTICAL TO PRESENT ADDITIONAL RIQUENT®
RESULTS AT SG COWEN HEALTHCARE CONFERENCE
Analyses Show Treatment with Riquent Reduced Proteinuria in
Lupus Patients
SAN DIEGO, March 11, 2004 La Jolla Pharmaceutical Company
(Nasdaq: LJPC) today announced additional data from its Phase
3 and Phase 2/3 clinical trials of Riquent® (abetimus sodium)
which showed that after one year of treatment, the number of lupus
patients with a reduction in proteinuria of at least 50% from
baseline was greater in the Riquent-treated group than in the
placebo-treated group. Proteinuria, or protein in the urine, results
from ongoing kidney inflammation. The reduction of proteinuria
is one of the goals for the treatment of lupus patients with renal
disease. Monitoring the level of a patient's proteinuria is a
routine and important way to help determine the severity of renal
disease. These data were included in the Companys New Drug
Application for Riquent that is currently being reviewed by the
United States Food and Drug Administration.
Steven B. Engle, Chairman and CEO of La Jolla Pharmaceutical,
will present these results today at 10:15 a.m. and 11:15 a.m.
Eastern Time during the SG Cowen 24th Annual Healthcare Conference.
The conference is taking place March 8-11, 2004 at the Marriott
Copley Place in Boston, MA. An audio webcast of the presentation
will be available through the Companys website at http://www.ljpc.com.
"The reductions in proteinuria we observed in patients treated
with Riquent are encouraging because a marked increase in proteinuria
often corresponds to more severe kidney inflammation and is an
indication of the need for additional treatment," said Kenneth
R. Heilbrunn, M.D., Vice President of Clinical Development.
In patients who had 24-hour urine protein measured at both baseline
and at week 52 during the Phase 3 trial, 41% (26/63) of patients
in the Riquent-treated group with high-affinity antibodies to
Riquent achieved a 50% or greater reduction from baseline in the
amount of protein in their urine at week 52, compared with 28%
(23/81) of patients in the placebo-treated group with high-affinity
antibodies (nominal p = 0.047). In patients who had 24-hour urine
protein measured at both baseline and at approximately week 52
during the Phase 2/3 trial, 44% (23/52) of patients in the Riquent-treated
group with high-affinity antibodies had a 50% or greater reduction
from baseline in the amount of protein in their urine at approximately
week 52, compared with 18% (11/61) of patients in the placebo-treated
group with high-affinity antibodies (nominal p = 0.002). The measurement
of 24-hour urine protein was specified in each protocol at defined
time points, but the analysis of the reduction in proteinuria
was conducted on a retrospective basis.
About Lupus and Riquent
Lupus (systemic lupus erythematosus or SLE) is a chronic, life-threatening
autoimmune disease. About 90% of lupus patients are female, and
many develop the disease during their childbearing years. Approximately
50% of lupus patients have renal disease, which can lead to irreversible
kidney damage, kidney failure and the need for dialysis. Latinos,
African Americans and Asians face an increased risk of serious
renal disease associated with lupus. Riquent is designed to reduce
levels of antibodies to double-stranded DNA (dsDNA) that are believed
to be responsible for lupus renal disease, a leading cause of
morbidity and mortality in lupus patients. 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.
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 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, 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 website: 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 our New Drug
Application ("NDA") for Riquent® has been accepted
by the United States Food and Drug Administration (the "FDA")
for review, there is no guarantee that the FDA 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 our NDA for Riquent has been accepted for review
by 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 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 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
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 additional clinical
trials, 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: obtaining required
regulatory approvals, including delays associated with any approvals
that we may obtain; the clear need for additional financing; our
ability to pass FDA pre-approval inspections 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.
Terms
of Use & Privacy Policy
Copyright © 2008, La Jolla Pharmaceutical Company
|