La Jolla Pharmaceutical Co. CEO Resigns Amid Efforts to Win Approval for Lupus Treatment
La Jolla Pharmaceutical Co.'s long-time CEO, Steven Engle, has resigned, citing the company's ongoing struggles to win approval for its proposed treatment for lupus, Riquent. Engle had led the company since 1993 and had overseen the company's efforts to develop Riquent, which has faced significant setbacks in clinical trials. Despite this, La Jolla remains committed to completing the final phase of testing for Riquent, which it hopes will be the last hurdle in securing approval from the FDA.
Key Takeaways:
- Steven Engle, La Jolla Pharmaceutical Co.'s CEO since 1993, has resigned, citing the company's challenges in securing approval for Riquent.
- Dr. Deidre Gillespie, former head of Oxxon Therapeutics, has been appointed as Engle's replacement and will lead the company's efforts to complete the final phase of testing for Riquent.
- La Jolla has named Dr. Craig Smith, an independent director, as the new chairman of the company.
- Engle was thanked for his years of service to the company, and Gillespie's experience in pharmaceutical development is expected to serve La Jolla well.
- La Jolla plans to complete the enrollment of 600 patients in the final phase of testing for Riquent by next year.
- Clinical data from the final phase of testing is expected to be available in 2008.
- Riquent has previously failed to prove efficacy in two separate clinical trials, but La Jolla is seeking approval for its ability to reduce certain antibodies.
Statistics:
- La Jolla raised $63 million through a private placement of shares in late 2005, which is expected to suffice for two years.
- Riquent is currently in Phase 3 trials, according to the company.
- The drug has previously failed to prove efficacy in two separate clinical trials, with the first failure occurring in 1999 and the second in 2003.
- La Jolla plans to enroll 600 patients in the final phase of testing for Riquent.
- Clinical data from the final phase of testing is expected to be available in 2008.
Sources:
- Craig D. Rose, "La Jolla Pharmaceutical Co. Chief Executive Resigns," The San Diego Union-Tribune, March 16 [Unknown]
- Pacific Growth Equities, Research Report, [Unknown]