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LA JOLLA PHARMACEUTICAL DATA ON RIQUENT® PRESENTED AT LUPUS
MEDICAL CONFERENCE
7th International Congress on Systemic Lupus Erythematosus (SLE)
and Related Conditions in New York City
NEW YORK, May 10, 2004 La Jolla Pharmaceutical Company
(Nasdaq: LJPC) today announced that Company scientists will be
giving four presentations on previously released data on Riquent®
(abetimus sodium), its drug candidate for the treatment of lupus
renal disease at the 7th International Congress on Systemic Lupus
Erythematosus (SLE) and Related Conditions which is being held
on May 10-13, 2004 in New York City.
More than 1,000 clinicians and scientists from around the world
are expected to attend the International Congress on SLE to discuss
the latest research and review the development of new treatments
for lupus, an autoimmune disease that affects more than one million
patients in the United States and Europe. Existing treatments
for lupus can cause severe side effects, yet no new lupus drugs
have been approved in the United States in approximately 30 years.
For additional information on the 7th International Congress on
Systemic Lupus Erythematosus (SLE) and Related Conditions, please
visit the website at http://lupus2004.org.
In conjunction with the International Congress, more than 100
lupus patient advocacy organizations will host a press conference
at noon today to observe World Lupus Day. The press conference
will feature presentations by individuals with lupus, caregivers,
clinicians, researchers, and lupus advocates who will discuss
the physical, economic and emotional impact of the disease on
individuals, families and society.
"There is a significant unmet medical need worldwide for
improved therapies for lupus patients," said Dr. Robert Lahita,
M.D. Ph.D., Chairman, Department of Medicine, Jersey City Medical
Center and SLE Congress Chairman. "One of the lupus communitys
key goals is the development of new and potentially safer treatment
alternatives. The International Congress on SLE is an opportunity
to bring physicians, scientists, patients, lupus advocacy organizations
and biotechnology companies together in support of this goal."
Matthew Linnik, Ph.D., Chief Scientific Officer and Executive
Vice President of Research for La Jolla Pharmaceutical Company,
will give an oral presentation entitled:
"Anti-dsDNA
Antibodies and Exacerbation of Renal Disease in Patients with
Systemic Lupus Erythematosus: Results from Two Randomized Controlled
Trials with LJP 394"
Lupus physicians who were clinical investigators in studies of
patients treated with Riquent will present three posters summarizing
additional Riquent data:
"Reductions
in 24 Hour Urine Protein Levels Associated with Treatment of Lupus
Patients with LJP 394 in Two Randomized, Placebo Controlled, Double-Blind
Clinical Trials"
"Improved
Health-Related Quality of Life (HRQOL) Following Sustained Reductions
in Anti-dsDNA Antibodies in Patients with Systemic Lupus Erythematosus
After Treatment with LJP 394"
"Summary
of Safety Results from Studies of LJP 394 in SLE Patients"
Lupus, systemic lupus erythematosus or SLE, is a chronic, potentially
life-threatening autoimmune disease. About 90% of lupus patients
are female, and many develop the disease during their childbearing
years. Latinos, African Americans and Asians face an increased
risk of serious renal disease associated with lupus. Approximately
50% of lupus patients have renal disease, which can lead to irreversible
kidney damage, kidney failure and the need for dialysis.
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 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 antibody-mediated thrombosis, a condition in which patients
suffer from recurrent stroke, deep-vein 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. 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 showed that the trial
did not reach statistical significance with respect to its primary
endpoint, time to renal flare, or to the secondary endpoint, time
to treatment with high-dose corticosteroids or cyclophosphamide.
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; 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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