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LA JOLLA PHARMACEUTICAL PLANS TO
SUBMIT NDA FOR RIQUENT™
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™. 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™, 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 submit a New Drug Application
for Riquent™, 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.
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