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Press Releases  ::  2002  ::  Bethesda, Maryland - January 10, 2002

IMPACT OF LA JOLLA PHARMACEUTICAL'S LUPUS DRUG CANDIDATE ON PATIENTS' HEALTH-RELATED QUALITY OF LIFE PRESENTED AT NIH CONFERENCE

BETHESDA, Md., January 10, 2002 - Data were presented today on La Jolla Pharmaceutical Company's (Nasdaq: LJPC) drug candidate for lupus renal disease, LJP 394, from a previous Phase II/III clinical trial which indicate that treatment with LJP 394 improved or sustained health-related quality of life in patients with lupus renal disease following 16 weeks of treatment with LJP 394 and following renal flares when compared to placebo. Health-related quality of life is a measure of a patient's sense of mental and physical well-being or how they feel and was measured by a standard scoring instrument called the SF-36® Health Survey.

Vibeke Strand, M.D., Clinical Professor of Medicine, Division of Immunology, Stanford University, and Bruce Crawford, M.A. M.P.H., Mapi Values, presented a paper titled "Improvement in Health Related Quality of Life in 230 SLE Patients Enrolled in a Randomized Controlled Trial Comparing LJP 394 Treatment with Placebo" at the SLE: Targets for New Therapeutics scientific conference sponsored by the National Institutes of Health and the SLE Foundation.

"Following 16 weekly treatments, patients treated with LJP 394 reported improved health-related quality of life compared with placebo - a very short time to show such a change," said Dr. Strand. "The largest difference between drug treatment and placebo treatment occurred in the 'role emotional' domain, indicating that patients felt better when treated with LJP 394, despite a renal flare. These improvements were not determined to be due to differences in the use of high-dose corticosteroids and/or cytotoxic agents such as cyclophosphamide. And, although this is the first health-related quality of life evaluation of LJP 394, the longitudinal improvement is consistent with other reported benefits - the delay of renal flares and the delay in treatments with high-dose corticosteroids and/or cyclophosphamide.

"Following a renal flare, patients treated with LJP 394 demonstrated stabilization or improvement in all SF-36 domains while those receiving placebo reported deterioration in all domains," added Dr. Strand. "In a patient population with impaired health-related quality of life at entry, this is an important, new observation. Confirmation of these results in the ongoing Phase III clinical trial would provide additional support for the potential value of this new treatment for lupus patients."

Following 16 weeks of treatment with 100 mg of LJP 394: In 190 patients with SF-36 measurements, LJP 394-treated patients reported a positive trend in their composite mental component score of 1.3 compared with a worsening of - 0.8 in patients treated with placebo, a difference of 2.1. The largest mean change occurred in the role emotional score where the drug-treated patient score improved by +7.7 points while the placebo-treated patient score decreased by - 8.1. This was a relative difference of 15.8. The role-emotional assessment represents the patient's perception of limitations they experience in their daily routine attributed to emotional problems.

Following a renal flare: In 37 patients with SF-36 measurements before and after a renal flare, LJP 394-treated patients experienced an improved or stable health-related quality of life in all domains except one, while placebo-treated patients reported worsening in all domains. For example, the mean change in role emotional score for drug-treated patients improved by +2.1 points compared with placebo-treated patients where it decreased by - 20.6 points, a relative difference of 22.7 points. The changes in role emotional and the mental component summary scores are of a magnitude that would be considered clinically meaningful.

As expected, at the beginning of the study, the mean scores for all patients were significantly lower in all domains compared with normal individuals in the U.S. of similar age and sex, indicating that these lupus patients' perception of their quality of life was poor.

The objective of the Phase II/III clinical trial was to evaluate the ability of LJP 394 to increase time to renal flare in lupus patients with a history of renal disease. The SF-36 assessment was used to explore the potential improvement in health-related quality of life in lupus patients following treatment with LJP 394. The trial enrolled 230 lupus patients who were treated for up to 18 months. Patients were not randomized at entry for SF-36.

The SF-36® Health Survey is a standardized tool used in clinical research to measure a patient's assessment of quality of life outcomes related to disease and disease treatment. It has been used in a wide range of medical conditions such as cardiovascular disease, pain, diabetic foot ulcers, total knee replacement, dialysis, rheumatoid arthritis, and osteoarthritis.

The Survey asks 36 questions related to how well a patient can perform day-to-day activities and how they feel emotionally. The answers are then reported as scores in eight domains. These domains are physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health

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. The Company is conducting a Phase III trial of LJP 394 in patients with lupus kidney disease, a leading cause of sickness and death in these patients. The Company is also conducting 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. Patients interested in the Phase III lupus trial may call 1-888-30-LUPUS for information.


Except for historical statements, this press release contains forward-looking statements, including, without limitation, statements regarding the analysis of results from pre-clinical and clinical studies as well as La Jolla Pharmaceutical's drug candidates and drug development plans. These forward-looking statements involve risks and uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to differ materially from those anticipated. Clinical results for LJP 394 are derived from a trial that was terminated prior to completion, and certain data are incomplete. The Company's blood test to measure binding affinity for LJP 394 is experimental and has not been validated by independent laboratories. Tolerance, or the specific inactivation of pathogenic B cells, is a new technology that has not been proven. The Company's ability to develop and sell its products in the future may be affected by the intellectual property rights of third parties. Future clinical trials of the Company's drug candidates may have negative or inconclusive results. Future clinical trials of the Company's drug candidates may not support results of pre-clinical or other prior trials and clinical trials of LJP 394 for treating lupus or LJP 1082 for treating antibody-mediated thrombosis may reveal a potential safety issue requiring the development of a new candidate. Any delays in testing of the Company's drug candidates or termination of development by the Company would result in delays or lack of government approval to market the compounds. The development of drug candidates involves many risks and uncertainties, including, without limitation, whether the drug can provide a meaningful clinical benefit, and any positive results observed to date may not be indicative of future results. La Jolla Pharmaceutical's other potential drug candidates involve comparable risks. Interested parties are urged to review the risks detailed from time to time in La Jolla Pharmaceutical Company's Securities and Exchange Commission filings, including the report on Form 10-K for the year ended December 31, 2000.




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