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LA JOLLA PHARMACEUTICAL RESTRUCTURES FOLLOWING RECENT FDA
DISCUSSION
SAN DIEGO, March 30, 2005 La Jolla Pharmaceutical Company
(Nasdaq: LJPC) today announced that it is implementing a restructuring
plan to reduce its costs.
The restructuring plan, which will be initiated immediately but
not completed until the second quarter of 2005, includes a workforce
reduction of approximately 60 staff members, leaving a post-restructuring
workforce of approximately 95 staff members. Under the plan, the
Company expects to continue its ongoing clinical benefit trial
of Riquent without any significant additional patient enrollment
or site expansion and continue its small molecule inflammation
program. The Company also plans to continue its activities that
would allow a filing of a Marketing Authorization Application
in Europe. The termination benefits, primarily severance costs,
are expected to be approximately $1.5 million, of which approximately
$1.3 million will be recorded in the first quarter and the remainder
in the second quarter.
This action follows a recent announcement by the Company that,
based on the outcome of a meeting with the United States Food
and Drug Administration (FDA), Riquent is unlikely to receive
an accelerated approval under the FDAs Subpart H regulation.
In October 2004, the Company received an Approvable Letter from
the FDA for Riquent. The letter indicated that an additional trial
demonstrating clinical benefit would be required prior to approval
of Riquent and that the Companys ongoing trial would appear
to satisfy this requirement.
The Company previously announced that if the FDA did not approve
Riquent under Subpart H and if it did not raise additional funds
in the near future, either through the sale of additional securities
or a collaborative agreement with a corporate partner, it would
need to take significant cost-cutting measures to continue its
operations into the first quarter of 2006. The current restructuring
plan is part of these cost-cutting measures. The Company is continuing
to review other areas where additional expenses can be reduced
and is actively seeking collaborative agreements to support the
development of Riquent and its small molecule inflammation program.
"We are grateful for the determination and diligence of our
talented colleagues over the past several years," said Steven
B. Engle, La Jolla Pharmaceuticals Chairman and Chief Executive
Officer. "When you have a great team, it is always difficult
to make these types of decisions. However, we felt it was necessary
to conserve our financial resources to focus on Riquent."
"No drugs have been approved for lupus patients in 40 years,
and there is a great need for safer treatments," added Engle.
"We have shown that Riquent has been well tolerated and that
it reduces antibodies to double-stranded DNA, and that reductions
in these antibodies result in fewer renal flares and improved
health-related quality of life. Even with the support of the medical
community and our best efforts, an additional clinical trial is
still required."
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 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. 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"), 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,
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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