8-K

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 or 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): December 17, 2002

La Jolla Pharmaceutical Company

(Exact Name of Registrant as Specified in Charter)

Delaware	0-24274	33-0361285
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

6455 Nancy Ridge Drive, San Diego, California	92121
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: (858) 452-6600

N/A

(Former Name or Former Address, if Changed Since Last Report)

TABLE OF CONTENTS

	ITEM 5. OTHER EVENTS
	ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
SIGNATURES
EXHIBIT 99.1

ITEM 5. OTHER EVENTS

     On December 17, 2002, La Jolla Pharmaceutical Company (the “Company”) announced that it has completed its Phase III clinical trial of Riquent™, previously referred to as LJP 394. The Company is now compiling and auditing the data from the trial sites prior to the unblinding and analysis of results. The Company currently anticipates it will report initial trial results as early as February 2003.

     The primary endpoint of the Phase III trial is time to renal flare in patients with high-affinity antibodies to Riquent. Renal flares are potentially life-threatening episodes of kidney inflammation.

     The Company also announced that, based on trial data to date, there were 41 renal flares in patients with high-affinity antibodies and five renal flares in patients with low-affinity antibodies. The Company remains blinded as to whether these renal flares occurred in patients who received placebo or Riquent. The trial enrolled 317 patients with a history of lupus renal disease. Based on 313 patient samples analyzed to date, 294, or 94%, had high-affinity antibodies to Riquent.

     Finally, the Company announced that all patients who completed the Phase III trial are eligible to enroll in an on-going open-label follow-on clinical trial. Patients in the follow-on open-label trial, which is designed to collect longer-term safety data, will receive weekly treatment with Riquent.

ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.

     The following exhibits are filed with this report on Form 8-K:

Exhibit
Number	Description of Exhibit
99.1	Press Release

SIGNATURES

     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	La Jolla Pharmaceutical Company
Date: December 17, 2002	By:	/s/ David Duncan, Jr. David Duncan, Jr. Chief Financial Officer

EX-99.1 3 a86503exv99w1.txt EXHIBIT 99.1 EXHIBIT 99.1 [TEXT] LA JOLLA PHARMACEUTICAL COMPLETES PHASE III CLINICAL TRIAL RESULTS ANTICIPATED EARLY 2003 SAN DIEGO, DECEMBER 17, 2002 - La Jolla Pharmaceutical Company (Nasdaq: LJPC) announced it has completed its Phase III clinical trial of Riquent(TM), previously referred to as LJP 394. The Company is now compiling and auditing the data from the trial sites prior to the unblinding and analysis of results. The Company currently anticipates that it will report initial trial results as early as February 2003. The primary endpoint of the Phase III trial is time to renal flare in patients with high-affinity antibodies to Riquent. Renal flares are potentially life-threatening episodes of kidney inflammation. Based on trial data to date, there were 41 renal flares in patients with high-affinity antibodies and five renal flares in patients with low-affinity antibodies. The Company remains blinded as to whether these renal flares occurred in patients who received placebo or Riquent. The trial enrolled 317 patients with a history of lupus renal disease. Based on 313 patient samples analyzed to date, 294, or 94%, had high-affinity antibodies to Riquent. The Phase III trial was a randomized, double-blind, placebo-controlled study designed to determine whether Riquent can significantly delay renal flares and delay the need for treatment with high-dose corticosteroids and/or cyclophosphamide in patients with high-affinity antibodies to Riquent. All patients who completed the Phase III trial are eligible to enroll in an on-going open-label follow-on clinical trial. Patients in the follow-on open-label trial, which is designed to collect longer-term safety data, will receive weekly treatment with Riquent. 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, the 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. La Jolla Pharmaceutical Company is a biotechnology company leading the development of therapeutics for antibody-mediated autoimmune diseases afflicting several million people in the United States and Europe. As noted above, the Company has completed its Phase III trial of Riquent(TM) (formerly LJP 394) in patients with lupus kidney disease, a leading cause of sickness and death in these patients. The Company has also completed a Phase I/II trial of 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 our 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. Our analyses of clinical results of Riquent(TM), 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 future analyses 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. Our blood test to measure the binding affinity for Riquent(TM) 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(TM). 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. Even if results are promising, the U.S. Food and Drug Administration ("FDA") 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 of: obtaining required regulatory approvals; 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; our need for additional financing; 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 other reports and registration statements filed with the Securities and Exchange Commission from time, including the report on Form 10-K for the year ended December 31, 2001. -----END PRIVACY-ENHANCED MESSAGE-----

EX-99.1

                                                                    EXHIBIT 99.1

[TEXT]


           LA JOLLA PHARMACEUTICAL COMPLETES PHASE III CLINICAL TRIAL

                         RESULTS ANTICIPATED EARLY 2003

SAN DIEGO, DECEMBER 17, 2002 - La Jolla Pharmaceutical Company (Nasdaq: LJPC)
announced it has completed its Phase III clinical trial of Riquent(TM),
previously referred to as LJP 394. The Company is now compiling and auditing the
data from the trial sites prior to the unblinding and analysis of results. The
Company currently anticipates that it will report initial trial results as early
as February 2003.

The primary endpoint of the Phase III trial is time to renal flare in patients
with high-affinity antibodies to Riquent. Renal flares are potentially
life-threatening episodes of kidney inflammation.

Based on trial data to date, there were 41 renal flares in patients with
high-affinity antibodies and five renal flares in patients with low-affinity
antibodies. The Company remains blinded as to whether these renal flares
occurred in patients who received placebo or Riquent. The trial enrolled 317
patients with a history of lupus renal disease. Based on 313 patient samples
analyzed to date, 294, or 94%, had high-affinity antibodies to Riquent.

The Phase III trial was a randomized, double-blind, placebo-controlled study
designed to determine whether Riquent can significantly delay renal flares and
delay the need for treatment with high-dose corticosteroids and/or
cyclophosphamide in patients with high-affinity antibodies to Riquent.

All patients who completed the Phase III trial are eligible to enroll in an
on-going open-label follow-on clinical trial. Patients in the follow-on
open-label trial, which is designed to collect longer-term safety data, will
receive weekly treatment with Riquent.

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, the 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.

La Jolla Pharmaceutical Company is a biotechnology company leading the
development of therapeutics for antibody-mediated autoimmune diseases afflicting
several million people in the United States and Europe. As noted above, the
Company has completed its Phase III trial of Riquent(TM) (formerly LJP 394) in
patients with lupus kidney disease, a leading cause of sickness and death in
these patients. The Company has also completed a Phase I/II trial of 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 our 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. Our analyses of clinical results of
Riquent(TM), 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
future analyses 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. Our blood test to measure the binding affinity for Riquent(TM) 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(TM). 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. Even if
results are promising, the U.S. Food and Drug Administration ("FDA") 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 of:
obtaining required regulatory approvals; 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; our need for additional
financing; 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 other reports and registration statements filed with the Securities and
Exchange Commission from time, including the report on Form 10-K for the year
ended December 31, 2001.