La Jolla Pharmaceutical Co.’s (Nasdaq: LJPC) intention to market Riquent, its lupus renal disease drug, in Europe was put on hold Thursday after the biotech company withdrew its application in order to compile additional data requested by the European Medicines Agency (EMEA).
Shares of La Jolla Pharma fell 12 cents, or just over 3 percent, to $3.53 at the close of tradeThursday.
Much like the U.S. Food and Drug Administration (FDA), the EMEA coordinates the evaluation and supervision of medicinal products throughout the European Union.
La Jolla Pharma said in a statement it believes ongoing additional studies would provide the necessary data, but that it would not be available within the timeframe allowed by regulations. La Jolla plans to refile for approval once the additional data is compiled.
“It wasn’t unexpected because we did realize we had to provide additional data,” said Andrew Wiseman, La Jolla’s senior director of investor relations.
Wiseman said clinical data from a Riquent Phase 3 trial would be available by the end of 2008. He said the company plans to enroll a total of 600 patients for the study through the end of next year.
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. The drug candidate has been evaluated in 13 clinical trials over a 10-year time span that evaluated more than 800 patients and subjects.
La Jolla had asked the FDA to consider approving Riquent for its ability to reduce certain antibodies. The FDA responded by asking the company to successfully complete a new clinical trial -- the one currently in progress.Since the August announcement that the study had been reactivated, the company has added another 27 clinical trial sites able to screen and enroll patients, for a total of 58 sites, 22 in the United States and 36 in Asia.
But the additional time has also amounted to additional money.
Last year, La Jolla raised a gross amount of $66 million through a private placement of shares. The funds were intended to last two years, and Wiseman said the company expects it to last until the first quarter of 2008.
“Potentially we will have to raise more money or find a partnership deal,” Wiseman said. “We are beginning to actively look for a U.S. partner.”
The EMEA initiated the review for Riquent in June 2006.
Snapshot: La Jolla Pharmaceutical Co.
6455 Nancy Ridge Drive
San Diego, CA 92121
La Jolla Pharmaceutical Co., a biopharmaceutical company, engages in the research and development of specific therapeutic products for the treatment of various life-threatening antibody-mediated diseases in the United States.
Riquent (LJP 394), Lupus, Phase III
Deirdre Y. Gillespie: Chief Exec. Officer and Pres. (as of March 15, 2006)
Craig R. Smith: Chairman (as of March 15, 2006)
Matthew D. Linnik: Chief Scientific Officer, Exec. VP of Research and Assistant Sec.
Bruce K. Bennett Jr.: VP of Manufacturing
Gail A. Sloan CPA: Principal Financial Officer, Principal Accounting Officer, VP of Fin., Controller and Sec.
Publicly traded on the Nasdaq under the symbol LJPC
Market Cap (Oct. 12, 2006): 117.03M
Stock Price History
52-Week Change: -5.19%
S&P500 52-Week Change: 13.77%
52-Week High (03-Mar-06): 5.65
52-Week Low (27-Oct-05): 2.60
50-Day Moving Average: 3.78
200-Day Moving Average: 3.89