La Jolla Pharmaceutical Company to Present March 2007 Riquent Interim Antibody Data at Two Leading Medical Meetings
At the poster presentations, physicians from the Company will review safety and interim antibody data from the March analysis of the ongoing Phase 3 study and highlight the definitive and significant dose response observed between the 100 mg, 300 mg and 900 mg doses of Riquent compared with placebo (p=0.0001). 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 less than 0.0001, p less than 0.0001 respectively).
"We hope to provide physicians that treat lupus patients with an opportunity to review findings that the 300 mg and 900 mg doses reduce antibodies to double-stranded DNA (anti-dsDNA) to a much greater extent than the reductions seen with 100 mg. These data also continue to indicate that Riquent is well tolerated even at much higher doses," said Deirdre Y. Gillespie, M.D., President and Chief Executive Officer of La Jolla Pharmaceutical Company.
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 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.
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. Latino, 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.
About La Jolla Pharmaceutical Company
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(R). The Company has also developed potential small molecule drug candidates 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: http://www.ljpc.com.
This press release and the presentations may contain forward-looking statements within the meaning of the federal securities laws. When used, the words "anticipate," "assume," "believe," "estimate," "expect," "intend," "may," "plan," "project," "result," "should," "will" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Forward-looking statements are subject to risks and uncertainties, both known and unknown and often beyond the Company's control, and are not guarantees of future performance insofar as actual events or results may vary materially from those anticipated. Factors that may cause such a variance consist of, among others, those discussed from time to time in the Company's filings with the Securities and Exchange Commission, including the risks described in "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2006, and specifically the Company's ability to: demonstrate sufficiently Riquent's efficacy and safety in clinical trials; manufacture Riquent on an adequate scale for clinical use; or develop further and commercialize Riquent successfully, either on its own or with a partner. The Company expressly disclaims any responsibility to update forward-looking statements.
La Jolla Pharmaceutical Company
Andrew Wiseman, Ph.D., Sr. Director of Investor Relations
IR Partners, Inc.
Shellie M. Roth, President
Posted: October 2007