Exhibit 99.1
LA JOLLA PHARMACEUTICAL PLANS TO SUBMIT NDA FOR RIQUENT(TM)
CONFERENCE CALL SCHEDULED FOR 1:30 P.M. EASTERN
SAN DIEGO, MAY 5, 2003 -- La Jolla Pharmaceutical Company (Nasdaq: LJPC)
announced today that based on discussions with the Food and Drug Administration
(FDA), the Company plans to submit a New Drug Application (NDA) for its lupus
drug candidate, Riquent(TM). Further discussions with the FDA will be needed to
clarify whether any additional supportive information or studies will be
necessary. The Company also plans to meet with European regulatory authorities
to discuss potential next steps for Riquent in Europe.
"We are excited about submitting an NDA for Riquent while continuing our
discussions with the FDA," said Steve Engle, Chairman and CEO of La Jolla
Pharmaceutical Company. "We plan to complete the application around the end of
this year."
"Two of the largest well-controlled studies ever conducted in lupus patients
have shown that Riquent was able to consistently reduce antibodies to
double-stranded DNA and that patients with sustained reductions in antibodies to
double-stranded DNA were less likely to have a renal flare. Furthermore,
treatment with Riquent was well tolerated," added Mr. Engle.
The Company recently announced results from its Phase 3 clinical trial.
Although the trial did not reach statistical significance for its primary
endpoint, the Phase 3 trial results demonstrated that lupus patients treated
with Riquent had significantly lower levels of antibodies to double-stranded
DNA(dsDNA) than patients treated with placebo (p < 0.0001). Similar results were
seen in the Phase 2/3 trial.
Results from the Phase 3 and Phase 2/3 studies also demonstrated that lupus
patients with sustained reductions in antibodies to dsDNA experienced fewer
renal flares (Phase 3: p<0.0001 and Phase 2/3: p=0.0004). In these two studies,
two to four times as many Riquent-treated patients had sustained reductions
compared with placebo-treated patients.
Lupus is a chronic, life-threatening autoimmune disease afflicting about 1
million people in the United States and Europe. A significant number of lupus
patients develop kidney
disease, a leading cause of morbidity and mortality in lupus patients. The
current standard of care for lupus kidney disease involves treatment with
corticosteroids and chemotherapy drugs that can cause severe side effects
including diabetes, hypertension and sterility, and may leave patients
vulnerable to opportunistic infections. Riquent is designed to specifically
prevent the production of antibodies responsible for lupus kidney disease
without suppressing the normal functions of the immune system.
The Company will host a conference call today, Monday, May 5, 2003, at 1:30 p.m.
Eastern Time. The dial in number is (800) 299-7089 for U.S. callers and (617)
801-9714 for international callers. The call identification number is 3617603. A
live audio webcast of the conference call will be available through La Jolla
Pharmaceutical's Web site at www.ljpc.com.
The webcast will also be available to both institutional and individual
investors via CCBN's Investor Distribution Network. Individual investors can
listen to the call through CCBN's individual investor center at
www.companyboardroom.com or by visiting any of the investor sites in CCBN's
Individual Investor Network. Institutional investors can access the call via
CCBN's password-protected event management site, StreetEvents, at
www.streetevents.com.
A replay of the conference call can be accessed by dialing (888) 286-8010 (US)
or (617) 801-6888 (International). The passcode for the replay is 52782021. The
call will be available for approximately one week. The call will also be
available on the Company's website.
La Jolla Pharmaceutical Company is a biotechnology company developing
therapeutics for antibody-mediated autoimmune diseases afflicting several
million people in the United States and Europe. The Company is developing
Riquent(TM), formerly known as LJP 394, 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 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.
Except for historical statements, this press release contains forward-looking
statements involving 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 which express a plan, belief, expectation, estimation, anticipation,
intent, contingency, future development or similar expression. Although we plan
to file a New Drug Application for Riquent(TM), there is no guarantee that
regulatory authorities 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. Although
we have determined to submit a NDA for Riquent, the clinical results from our
clinical trials of Riquent may not ultimately be sufficient to obtain regulatory
clearance to market Riquent either in the U.S. or Europe, and we may be required
to conduct additional clinical studies to demonstrate the safety and efficacy of
Riquent 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, will likely require regulatory approval, and will
likely be necessary for the approval and the commercialization of Riquent. 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 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;
FDA approval 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; 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, 2002, and in other reports and registration
statements that we file with the Securities and Exchange Commission from time to
time.
###