|
LA JOLLA PHARMACEUTICAL ANNOUNCES PUBLICATION OF REVIEW ARTICLES
REGARDING ITS TWO DRUG CANDIDATES
SAN DIEGO, June 24, 2004 La Jolla Pharmaceutical Company
(Nasdaq: LJPC) today announced that two articles were published
in the journal Lupus (Vol. 13, Issue 5) reviewing the Companys
drug candidates Riquent® (abetimus sodium, formerly LJP 394)
for the treatment of lupus renal disease and LJP 1082 for the
treatment of antibody-mediated thrombosis. The articles summarize
the large body of previously announced data collected from several
clinical studies evaluating Riquent as well as the Companys
tolerance technology.
Two leading lupus clinicians, Daniel Wallace, M.D., Clinical Professor
of Medicine, Department of Medicine, Division of Rheumatology,
Cedars-Sinai/UCLA School of Medicine, and James Tumlin, M.D.,
Associate Professor of Medicine, Renal Division, Emory University
Medical School, published a paper (page 323-327) entitled: "LJP
394 (Abetimus Sodium, Riquent) in the Management of Systemic Lupus
Erythematosus." The paper summarizes the clinical development
of Riquent and focuses on results from the Phase 2/3 and Phase
3 clinical trials, in which Drs. Wallace and Tumlin were clinical
investigators. The data from these trials support the Companys
New Drug Application for Riquent currently under FDA review.
In the same issue, Joan Merrill, M.D., Clinical Pharmacology Research
Program, Oklahoma Medical Research Foundation, published an article
(page 335-338) entitled: "LJP 1082: A Toleragen for Hughes
Syndrome." The article discusses B cell tolerance and summarizes
the clinical rationale for LJP 1082, the Companys drug candidate
specifically designed to treat the underlying cause of antibody-mediated
thrombosis. Dr. Merrill is a leading clinical researcher in antibody-mediated
thrombosis and was a clinical investigator in a Phase 1/2 clinical
trial of LJP 1082, which was completed in October 2002.
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. 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.
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.
Antibody-mediated thrombosis is an autoimmune disease characterized
by the formation of blood clots that can lead to stroke, heart
attack, deep vein thrombosis and recurrent miscarriage. This disease,
also known as Antiphospholipid Syndrome, affects an estimated
one to two million people in the United States and Europe. Patients
often experience their first thrombotic event in their 20s or
30s, and studies indicate they have twice the probability of a
recurrence. Current treatments include anticoagulants, the long-term
use of which can lead to side effects including life-threatening
bleeding events.
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.
This press release contains forward-looking statements that
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.
Terms
of Use & Privacy Policy
Copyright © 2008, La Jolla Pharmaceutical Company
|