Spectrum Pharmaceuticals announces completion of NDA filing for satraplatin for hormone refractory prostate cancer

Co announces the completion of the submission of the New Drug Application to the FDA for satraplatin, the co's lead drug candidate for the treatment of hormone refractory prostate cancer for those patients who have failed prior chemotherapy. This clinical submission, the third and final portion of the rolling NDA, is based on data from the SPARC Satraplatin and Prednisone Against Refractory Cancer Phase 3 registrational trial. The trial enrolled 950 patients, and the study data results for progression-free survival (PFS) were highly statistically significant. The FDA's acceptance of the NDA will trigger a $4 mln milestone payment to Spectrum. Spectrum is also entitled to receive milestone payments upon the achievement of additional regulatory milestones in the U.S., Europe, Japan and other countries. Further payments are due on achieving certain sales targets.