La Jolla Pharmaceutical Plans to Submit NDA for Riquent(TM)
SAN DIEGO, May 5 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical Company (Nasdaq: LJPC - News) announced today that based on discussions with the Food and Drug Administration (FDA), the Company plans to submit a New Drug Application (NDA) for its lupus drug candidate, Riquent(TM). Further discussions with the FDA will be needed to clarify whether any additional supportive information or studies will be necessary. The Company also plans to meet with European regulatory authorities to discuss potential next steps for Riquent in Europe.
"We are excited about submitting an NDA for Riquent while continuing our discussions with the FDA," said Steve Engle, Chairman and CEO of La Jolla Pharmaceutical Company. "We plan to complete the application around the end of this year.
"Two of the largest well-controlled studies ever conducted in lupus patients have shown that Riquent was able to consistently reduce antibodies to double-stranded DNA and that patients with sustained reductions in antibodies to double-stranded DNA were less likely to have a renal flare. Furthermore, treatment with Riquent was well tolerated," added Mr. Engle.
The Company recently announced results from its Phase 3 clinical trial. Although the trial did not reach statistical significance for its primary endpoint, the Phase 3 trial results demonstrated that lupus patients treated with Riquent had significantly lower levels of antibodies to double-stranded DNA (dsDNA) than patients treated with placebo (p < 0.0001). Similar results were seen in the Phase 2/3 trial.
Results from the Phase 3 and Phase 2/3 studies also demonstrated that lupus patients with sustained reductions in antibodies to dsDNA experienced fewer renal flares (Phase 3: p < 0.0001 and Phase 2/3: p=0.0004). In these two studies, two to four times as many Riquent-treated patients had sustained reductions compared with placebo-treated patients.
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, a 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.
The Company will host a conference call today, Monday, May 5, 2003, at 1:30 p.m. Eastern Time. The dial in number is (800) 299-7089 for U.S. callers and (617) 801-9714 for international callers. The call identification number is 3617603. A live audio webcast of the conference call will be available through La Jolla Pharmaceutical's Web site at www.ljpc.com . |
