Spectrum, GPC Biotech, Pharmion say satraplatin trial in prostate cancer yields positive results

By E. Janene Geiss

Philadelphia, Sept. 25 - GPC Biotech AG, Pharmion Corp. and Spectrum Pharmaceuticals, Inc. announced Sunday positive results from the phase 3 satraplatin pivotal registrational trial.

The trial is evaluating satraplatin, the first orally available platinum-based chemotherapy in advanced clinical development, plus prednisone versus a placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer, according to news releases from the biopharmaceutical companies.

The study data show that satraplatin and prednisone are highly statistically significant for progression-free survival, which is the primary endpoint for submission for accelerated approval in the United States and also will serve as the primary basis for a Marketing Authorization Application in Europe.

In December 2005, Munich, Germany-based GPC Biotech signed a co-development and license agreement with Boulder, Colo.-based Pharmion under which Pharmion was granted exclusive commercialization rights to satraplatin for Europe and certain other territories.

GPC Biotech licensed satraplatin from Irvine, Calif.-based Spectrum in 2002. The milestone payments due to Spectrum, on acceptance and approval of regulatory applications in the United States and Europe, are about $20 million. Further payments are due on achieving certain sales targets. Spectrum also will receive royalties on worldwide sales of satraplatin.

GPC Biotech said it expects to complete its rolling New Drug Application to the Food and Drug Administration by the end of 2006. Pharmion said it plans to file the Marketing Authorization Application for Europe in the first half of 2007.

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