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SAN DIEGO, October 29, 2004 -- La Jolla Pharmaceutical Company
(Nasdaq: LJPC)
announced that it presented additional and previously released results
from its Phase
2/3 and Phase 3 clinical trials of Riquent® (abetimus sodium,
formerly LJP 394) for the
treatment of lupus renal disease. Posters were presented today at
the American
Society of Nephrology Annual Meeting being held in St. Louis, MO
and last week at the
American College of Rheumatology Annual Meeting held in San Antonio,
TX.
At the American College of Rheumatology meeting, Kenneth R. Heilbrunn,
M.D., Vice
President of Clinical Development at La Jolla Pharmaceutical Company,
presented new
data in a poster entitled “The Effect of LJP 394 and Concomitant
Immunosuppressive
Agents on Levels of Anti-dsDNA Antibodies in SLE Patients.”
The poster summarized additional data from a Phase 3 clinical
trial comparing changes
in levels of antibodies to double-stranded DNA (dsDNA) in patients
on Riquent or
placebo who were receiving either mycophenolate mofetil (MMF) or
azathioprine (AZA)
at baseline.
Patients treated with Riquent who were on MMF at baseline had
a greater reduction in
levels of antibodies to dsDNA compared with patients treated with
placebo who were on
MMF at baseline. Similarly, patients treated with Riquent who were
on AZA at baseline
had a greater reduction in levels of antibodies to dsDNA than patients
treated with
placebo who were on AZA at baseline.
By week 24, Riquent-treated patients on MMF experienced a median
reduction in levels
of antibodies to dsDNA of 55% compared with a median reduction of
6% for placebotreated
patients. Riquent-treated patients on AZA experienced a median reduction
in
levels of antibodies to dsDNA of 28% compared with a median reduction
of 1% for placebo-treated patients. Forty-two patients were receiving
MMF at baseline (20
Riquent and 22 placebo). Seventy-four patients were receiving AZA
at baseline (38
Riquent and 36 placebo). Baseline characteristics were similar between
treatment
groups.
Also, Vibeke Strand, M.D., Stanford University Medical Center,
presented a poster
entitled “Improved Health-Related Quality of Life (HRQOL)
Following Sustained
Reductions in Anti-dsDNA Antibody Levels in Patients with Systemic
Lupus
Erythematosus (SLE) After Treatment with LJP 394.”
At the American Society of Nephrology meeting, James A. Tumlin,
M.D., Emory
University, presented a poster entitled “Reductions in 24-hour
Urine Protein Levels
Associated with Treatment of SLE Patients with LJP394 in Two Randomized,
Placebocontrolled
Clinical Trials.” A second poster, presented by Claudia Hura,
M.D., San
Antonio Kidney Disease Center, was entitled “Integrated Safety
Results from Studies of
LJP 394 in SLE Patients.”
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 antibodymediated
thrombosis, a condition in which patients suffer from recurrent
stroke, deepvein
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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