La Jolla Pharmaceutical
Company (Nasdaq: LJPC) today announced updated interim antibody reduction
data for the Phase 3 trial of Riquent(R) (abetimus sodium), its drug
candidate for systemic lupus erythematosus ("lupus" or "SLE"). The updated
analyses reinforce the previous conclusion that there is a definitive and
significant dose response between the 100 mg, 300 mg and 900 mg doses of
Riquent compared with placebo (p=0.0001). These interim data were initially
announced March 8, 2007.
Dose Dependent Antibody Reduction
The minor changes to the data show a greater reduction from baseline in
antibody levels in patients treated with Riquent. The median percent
reductions were 100 mg: 18%; 300 mg: 28%; 900 mg: 46% at week 8. In
parallel, there was less of an increase above baseline in the antibody
levels for the placebo group. As a result, the reductions in median
antibody levels between the Riquent treatment groups and the placebo
treatment group at week 8 were 100 mg: 30%; 300 mg: 40%; 900 mg: 58%
(p=0.0032, p
These data will be presented at the 8th International Congress on SLE
in Shanghai in May 2007.
Phase 3 Study Design
The Phase 3 study is designed to assess the ability of Riquent
treatment to prevent or delay the time to renal flare in lupus patients
with a history of renal disease and with antibodies to dsDNA. A lupus renal
flare is a potentially life-threatening increase in inflammation targeting
the kidney. A renal flare often requires treatment with immunosuppressive
agents which can have severe side effects.
The global study is expected to enroll approximately 730 patients who
will be treated weekly with Riquent or placebo. Equal numbers of patients
will be treated with 300 mg per week, 900 mg per week or placebo for 12
months. Patient enrollment in this international study recommenced in the
third quarter of 2006 and completion of enrollment is targeted for around
the end of 2007.
About Riquent
Riquent is being developed to specifically treat lupus renal disease by
preventing or delaying renal flares, a leading cause of sickness and death
in lupus patients. Riquent has been well tolerated in all 13 clinical
trials, with no serious Riquent-related side effects identified to date.
Riquent's only known biological activity is the reduction of circulating
levels of anti-dsDNA antibodies. Increases in these antibodies are
associated with an increased risk of renal flare. Although clinical benefit
has not yet been proven, Riquent treatment has significantly reduced these
antibody levels in all clinical trials where they were measured.
About Lupus
Lupus is a chronic, potentially life-threatening autoimmune disease.
About 90% of lupus patients are female, and many are diagnosed with the
disease during their childbearing years. Approximately 50% of lupus
patients have renal disease, which can lead to irreversible renal damage,
renal failure and the need for dialysis, and is a leading cause of death in
lupus patients. Latinos, African Americans and Asians face an increased
risk of serious renal disease associated with lupus. The current standard
of care for lupus renal disease often involves treatment with high doses of
corticosteroids and immunosuppressive drugs that can cause severe side
effects including diabetes, hypertension and sterility, and may leave
patients vulnerable to opportunistic infections. To date, no lupus specific
drug has been approved in the U.S.
La Jolla Pharmaceutical Company is dedicated to improving and
preserving human life by developing innovative pharmaceutical products. The
Company's leading product in development is Riquent. The Company has also
developed small molecules to treat various other autoimmune and
inflammatory conditions. The Company's common stock is traded on The NASDAQ
Global Market under the symbol LJPC. More information about the Company is
available on its Web site: ljpc.
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. The analyses of clinical results
of Riquent, previously known as LJP 394, our drug candidate for the
treatment of systemic lupus erythematosus ("lupus"), and any other drug
candidate that we may develop, including the results of any trials or
models 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 previous 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 its 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 any other country, 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 current or future trials or that any such trials will sufficiently
demonstrate the safety and efficacy of Riquent. 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: obtaining required regulatory
approvals, including delays associated with any approvals that we may
obtain; the availability of sufficient financial resources, timely supply
of drug product for clinical trials; our ability to pass all necessary
regulatory 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, 2006, and in
other reports and registration statements that we file with the Securities
and Exchange Commission from time to time.
La Jolla Pharmaceutical Company
ljpc