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LA JOLLA PHARMACEUTICAL COMPANY PROVIDES UPDATE ON RIQUENT
SAN DIEGO, May 31, 2005 -- La Jolla Pharmaceutical Company (Nasdaq:
LJPC) today announced that it has received "fast track"
designation for Riquent® (abetimus sodium) for the treatment
of lupus renal disease from the U.S. Food and Drug Administration
(FDA). The FDAs fast track program is designed to facilitate
the development and to expedite the review of new drugs that are
intended to treat serious or life threatening conditions and that
demonstrate the potential to address an unmet medical need.
In October 2004, the FDA informed the Company that Riquent was
"approvable" pending the successful completion of a
clinical benefit trial. A clinical benefit trial designed to meet
this requirement was initiated in 2004 and is ongoing, although
the Company has delayed further patient enrollment until additional
funding is obtained.
The Company currently only has limited financial resources and
if it does not receive funding from a collaborative agreement
or obtain other financing in the near future, it will not have
sufficient resources to complete the ongoing clinical benefit
trial or to continue its operations beginning in the first quarter
of 2006.
"Lupus represents one of the most significant unmet needs
in medicine today, as currently available treatments are associated
with significant side effects," said Steve Engle, Chairman
and CEO of La Jolla Pharmaceutical Company. "No new treatments
have been approved in the U.S. in almost 40 years."
About Lupus
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, and is a leading cause of death in lupus
patients. 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.
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 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 we are seeking collaborative agreements to
support the development of Riquent and our small molecule inflammation
program, we cannot guarantee that we will be successful in establishing
any such collaborative agreements or that the terms of any potential
agreements will result in the payment of significant funds to
us. The analyses of clinical results of Riquent, previously known
as LJP 394, our drug candidate for the treatment of systemic lupus
erythematosus ("lupus") and any other drug candidate
that we may develop, 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 current or future trials or that any
such trials 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
or a collaborative agreement; 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, 2004, and in other reports and registration statements
that we file with the Securities and Exchange Commission from
time to time.
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