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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.
Visit our Lupus News page
regularly to keep up to date with news on Riquent
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