EXHIBIT 99.1
COMPANY CONTACT: MEDIA CONTACTS:
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Andrew Wiseman, Ph.D. Virginia Amann or Trista Morrison
Sr. Director of Business Development Atkins + Associates
and Investor Relations for La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company 608-274-6046 or 858-527-3490
858-646-6615 vamann@irpr.com
andrew.wiseman@ljpc.com tmorrison@irpr.com
LA JOLLA PHARMACEUTICAL COMPANY RECEIVES LETTER
FROM FDA ABOUT RIQUENT
SAN DIEGO, OCTOBER 14, 2004 - La Jolla Pharmaceutical Company (Nasdaq: LJPC)
announced today that the Company has received a letter from the United States
Food and Drug Administration (FDA) indicating that its lupus drug candidate,
Riquent(R) (abetimus sodium), is approvable, but that an additional randomized,
double-blind study demonstrating the clinical benefit of Riquent would need to
be completed prior to approval. The FDA letter indicated that the ongoing
clinical trial initiated in August 2004 would appear to satisfy this
requirement.
The Company continues to review the letter and has requested a meeting with the
FDA to discuss the next steps in the development of Riquent. Until that meeting
is held, the Company will be able to provide only limited guidance.
The Company will host a conference call tomorrow, Friday, October 15, 2004, at
8:00 a.m. Eastern Time. The dial in number is 800-329-9097 for U.S. callers and
617-614-4929 for international callers. The passcode is 44429115. A live audio
webcast of the conference call will be available through La Jolla Pharmaceutical
Company's Web site at www.ljpc.com. A replay of the conference call can be
accessed for approximately one week by dialing (888) 286-8010 (US) or (617)
801-6888 (International). The passcode for the replay is 49457212.
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(R) 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. The analyses of clinical results of Riquent(R),
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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