La Jolla Pharmaceutical Says European Medicines Agency to Review Application for Lupus Drug

SAN DIEGO-- La Jolla Pharmaceutical Co., a developer of autoimmune disease therapies, said Thursday that the European Medicines Agency has accepted and will review the company's marketing application for its lupus renal disease drug candidate.

If approved, La Jolla would be allowed to market Riquent in all 25 European Union states, Norway, Iceland and Liechtenstein. The drug candidate already has orphan medicinal product status in Europe, which provides 10 years of market exclusivity from the date of EU authorization. Riquent also has orphan drug status and fast track status in the United States.

The company said 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. Lupus is a chronic autoimmune disorder characterized by periodic episodes of inflammation of and damage to the joints, tendons and other connective tissues, and organs including the heart, lungs, brain and kidneys.

The company expects to receive the agency's initial response to the application later this year, with a final decision coming in 2007.

Shares of La Jolla Pharmaceutical gained 14 cents, or 3.9 percent, to $3.74 in morning trading on the Nasdaq. The stock has traded in a 52-week range of $2.60 to $5.65.