Pharmion to file marketing application for satraplatin for prostate cancer

By Lisa Kerner

Erie, Pa., Feb. 28 - Pharmion Corp. said it expects to file its marketing authorization application for satraplatin for the treatment of second-line hormone refractory prostate cancer (HRPC) in the first quarter of 2007.

The company has completed a follow-up scientific advice procedure with the European Medicines Authority (EMEA).

The regulatory agency confirmed it would accept the final analysis for progression-free survival from the Sparc (Satraplatin and Prednisone Against Refractory Cancer) trial, as well as the available overall survival data as the basis for the submission, according to a Pharmion news release.

Pharmion licensed the European and other international marketing rights to satraplatin, an oral platinum-based compound, from GPC Biotech in December.

The companies are seeking an initial application in second-line chemotherapy of HRPC and are exploring the potential for satraplatin in other indications.

"We are pleased to have agreement with the EMEA on our filing strategy for satraplatin," Pharmion president and chief executive officer Patrick J. Mahaffy said in the release.

"We are committed to providing the submission to the EMEA in as timely a fashion as possible, pending the results from a final analysis of PFS in the SPARC study which we anticipate in the second half of 2006."

Pharmion said it completed enrollment of 912 patients in December for the multicenter, multinational, double-blind, randomized phase 3 Sparc trial.

The trial will assess the safety and efficacy of satraplatin in combination with prednisone as a second-line chemotherapy in patients with HRPC.

GPC Biotech began the rolling submission of a New Drug Application with the Food and Drug Administration for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with HRPC. Data from the Sparc trial are also expected to form the basis of a marketing application in Europe for this indication.

According to the release, satraplatin has been studied in clinical trials involving a range of tumors, with phase 2 trials completed in HRPC, ovarian cancer and small-cell lung cancer. Several other phase 1 and phase 2 studies evaluating satraplatin in combination with other therapies and in various cancers are underway or planned.

Pharmion acquires, develops and commercializes products for the treatment of hematology and oncology patients. The company is located in Boulder, Colo.

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