La Jolla Pharmaceutical
Company (Nasdaq: LJPC) today announced that its Marketing Authorization
Application (MAA) has been accepted for review by the European Medicines
Agency (EMEA) for potential approval to market Riquent(R) (abetimus
sodium), its drug candidate for lupus renal disease, in the European Union
(EU). The MAA was filed with the EMEA on March 31, 2006.
The EMEA's review of the application will follow their centralized
marketing authorization procedure. If approved, Riquent will receive
marketing authorization in all 25 EU member states as well as Norway,
Iceland and Liechtenstein. Riquent has already received orphan medicinal
product designation in Europe, which will provide ten years of market
exclusivity from the date of EU authorization. Riquent also has orphan drug
status and fast track status in the United States.
Riquent is the first drug candidate specifically developed for the
treatment of lupus renal disease, a leading cause of sickness and death in
lupus patients.
"The acceptance of our MAA filing is a significant step toward our goal
of providing a safer treatment to patients who suffer both from lupus renal
disease and from the side effects of current therapies used in its
treatment," said Deirdre Y. Gillespie, M.D., President and CEO of La Jolla
Pharmaceutical Company. "It is also a major milestone in our focused
corporate effort to guide Riquent toward full approval in Europe and the
United States. We anticipate that the EMEA's initial response and questions
concerning our application will come later this year, and a final decision
should come in 2007."
The MAA filing includes data from the previously completed Phase 3 and
Phase 2/3 clinical trials of Riquent, in which treatment with Riquent was
assessed for its ability to increase time to renal flare in comparison to
placebo. A renal flare is caused by inflammation in the kidney that
destroys kidney tissue and/or reduces or stops kidney filtration. Renal
flare can result in the progression to end-stage renal disease, the need
for dialysis, or death.
- In both trials, patients treated with Riquent benefited by an increased
time to renal flare compared to patients treated with placebo, although
the results did not reach statistical significance as defined in the
protocols.
- Riquent treatment reduced levels of antibodies to double-stranded DNA
(dsDNA), which experts believe are responsible for lupus renal disease.
In both trials, patients with sustained reductions in antibodies to
dsDNA experienced a statistically significant reduction in the number
of renal flares.
- After one year of treatment, there was a statistically significant
increase in the number of patients who had a 50% or greater reduction
in proteinuria from baseline in the Riquent-treated group compared with
the placebo-treated group. Proteinuria, or protein in the urine,
results from ongoing kidney inflammation.
- Treatment with Riquent has been well tolerated in all clinical studies.
In October 2004, following a review of the Company's New Drug
Application for Riquent, the U.S. Food and Drug Administration (FDA)
informed the Company that Riquent was "approvable" pending the successful
completion of a clinical benefit trial. The Company is currently conducting
a Phase 3 study under a Special Protocol Assessment with the FDA, which is
designed to further demonstrate Riquent's ability to delay time to renal
flare.
About Riquent
Riquent is the first drug candidate specifically developed for the
treatment of lupus renal disease, a leading cause of sickness and death in
lupus patients. The drug candidate has already been evaluated in 13
clinical trials over a 10-year time span that evaluated more than 800
patients and subjects. Riquent has been well tolerated in all of these
studies, with no serious side effects identified to date. Riquent's only
known biological activity is the reduction of antibodies to dsDNA that are
associated with the progression of lupus renal disease and renal flares. In
all clinical trials where antibodies to dsDNA were measured, Riquent
treatment has significantly reduced these antibody levels. Data generated
in the Company's previous Phase 2/3 and Phase 3 trials indicate that
patients with lower antibody levels experience significantly fewer renal
flares and improved health-related quality of life.
About Lupus
Lupus, systemic lupus erythematosus or SLE, is a chronic, potentially
life-threatening autoimmune disease afflicting several million people
worldwide. About 90% of lupus patients are female, and many develop the
disease during their childbearing years. Approximately 50% of lupus
patients have renal disease, which can lead to irreversible kidney damage,
kidney 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. In the U.S., no new drug
has been approved to specifically treat lupus in 40 years.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biotechnology company developing
therapeutics for antibody-mediated autoimmune diseases and inflammation
afflicting several million people around the world. The Company is
developing Riquent(R) for the treatment of lupus kidney disease, a leading
cause of sickness and death in patients with lupus. The Company is also
developing small molecules to treat various 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: ljpc.
The forward-looking statements in this press release involve and will
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 results from our
clinical trials of Riquent, our drug candidate for the treatment of
systemic lupus erythematosus (lupus), and any other drug candidate that we
may develop, 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 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 be sufficient to obtain marketing approval. 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 its secondary endpoint, time to
treatment with high-dose corticosteroids or cyclophosphamide. 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 SSAO inhibitor program is at a
very early stage of development and involves comparable risks. We depend on
patents and other proprietary rights, and our ability to develop and sell
our products in the future may be adversely affected by the intellectual
property rights of third parties. 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 additional risks described in our
Annual Report on Form 10-K for the year ended December 31, 2005, and in
other reports and registration statements that we file with the Securities
and Exchange Commission from time to time.
La Jolla Pharmaceutical Company
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