RiquentTreatment for Systemic Lupus Erythematosus
La Jolla Pharmaceutical Announces Outcome of Recent FDA Discussions
SAN DIEGO, March 14, 2005 -- La Jolla Pharmaceutical Company today announced that, based on the outcome of a meeting with the United States Food and Drug Administration (FDA) on March 11, 2005, its treatment for lupus renal disease, Riquent (abetimus sodium), is unlikely to receive an accelerated approval under the FDA's Subpart H regulation. The Company plans to continue the ongoing clinical benefit trial and expects to continue discussions with the FDA about ways to enhance the trial, including, as previously announced, the addition of a higher dose to the study.
This decision follows a number of meetings with the FDA since October 2004, when the Company received an Approvable Letter from the FDA for Riquent. The Approvable Letter indicated that an additional trial demonstrating clinical benefit would be required prior to approval of Riquent and that the Company's ongoing trial, initiated in August 2004, would appear to satisfy this requirement.
"We are disappointed that the FDA determined that accelerated approval is not applicable to the approval of Riquent," stated Steve Engle, Chairman and CEO of La Jolla Pharmaceutical Company. "We recognize the urgent need for safer and more effective treatments for lupus patients, as no new drugs have been approved for this disease in the United States in almost 40 years."
The Company will host a conference call today, March 14, 2005, at 4:30 p.m. Eastern/1:30 p.m. Pacific Time. The dial-in number is (800) 561-2601 for U.S. callers and (617) 614-3518 for international callers. The participant passcode is 50607992. A audio webcast of the conference call will be available later today through La Jolla Pharmaceutical's Web site at www.ljpc.com and will be archived for seven days. A replay of the conference call can be accessed for approximately one week by dialing (888) 286-8010 (US) or (617) 801-6888 (International). The passcode for the replay is 97997231.
La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation afflicting several million people in the United States and Europe. The Company is developing Riquent for the treatment of lupus kidney disease, a leading cause of sickness and death in patients with lupus. The Company is also in the early stage of developing small molecules to treat various other autoimmune and inflammatory conditions. The Company's common stock is traded on The Nasdaq Stock Market under the symbol LJPC.
For more information, please visit www.ljpc.com
Posted: March 2005
- La Jolla Pharmaceutical Company Receives Letter From FDA About Riquent - October 14, 2004
- La Jolla Pharmaceutical’s New Drug Application for Lupus Drug Candidate Riquent Accepted for Review by FDA - February 17, 2004