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LA JOLLA PHARMACEUTICAL ANNOUNCES
CLOSURE OF
OPEN-LABEL SAFETY STUDY OF RIQUENT™
SAN DIEGO, April 10, 2003 -- La Jolla
Pharmaceutical Company (Nasdaq: LJPC)
announced today that it is in the process
of closing its open-label follow-on
safety study of Riquent™ to conserve
resources in order to continue the development
of Riquent. The follow-on trial was
designed to collect additional long-term
safety data.
"This was a tough decision and
one we did not make lightly given the
commitment of our patients," said
Steve Engle, Chairman and CEO of La
Jolla Pharmaceutical Company. "Although
we would have preferred to conduct the
trial for a longer period of time, making
this decision allows us to reduce our
spending now. We are encouraged by many
of the Phase 3 clinical study results
and plan to move forward in our efforts
to develop Riquent as a new potential
therapy for lupus patients."
"We want our patients and physicians
to know that we deeply appreciate their
dedication and are saddened to have
to take this step," added Mr. Engle.
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 expect to meet with the regulatory
authorities to discuss the results of
our Phase 3 trial of Riquent™,
there is no guarantee that a meeting
with the regulatory authorities can
be held in a timely manner, or at all,
or that our meetings with them will
result in us being able to continue
to develop Riquent. 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 clinical
results from our recently completed
Phase 3 clinical trial of Riquent are
unlikely to be sufficient to obtain
regulatory clearance to market Riquent
either in the U.S. or Europe. We likely
will be required to conduct additional
clinical studies to demonstrate the
safety and efficacy of Riquent before
we can seek 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,
may require regulatory approval, and
may 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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