La Jolla to restart Riquent trails after financing closes

By E. Janene Geiss

Philadelphia, Oct. 18 - La Jolla Pharmaceutical Co. said Tuesday that it plans to restart phase III trials of its treatment for lupus renal disease when its previously announced $66 million common stock financing closes.

The financing transaction, announced Oct. 7, is expected to close in December, after which the company said it will restart enrollment in the United States in early 2006 after a final review of the protocol by the Federal Drug Administration, officials said in the release.

La Jolla then plans to expand the phase III trial to countries in Europe and Asia, officials said.

The company said it plans to enroll 500 to 600 patients, more than the 300 patients in the previous phase III trial.

Company officials said it will take about a year to complete enrollment once it is reactivated and then another year for the last patient enrolled to complete the study.

"There continues to be a significant unmet need in the treatment of lupus and we remain dedicated to providing potentially safer treatment for lupus patients," Steven Engle, chairman and chief executive officer said in the release.

In October 2004, the FDA said that Riquent was "approvable" pending the completion of a clinical benefit trial. That trial was initiated in August 2004 and is ongoing, but the company delayed further patient enrollment in March to conserve cash, the release said. Currently, 37 sites in the United States have been initiated and 27 patients have enrolled in the study, the release said.

Lupus is a chronic autoimmune disease. Ninety percent of lupus patients are female and 50% of lupus patients have renal disease, which can lead to kidney damage, kidney failure and the need for dialysis. It is the leading cause of death for lupus patients.

San Diego-based La Jolla Pharmaceutical Co. is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation afflicting several million people in the United States and Europe.

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