GPC Biotech AG announced that its partner, Pharmion Corporation, has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for satraplatin in combination with prednisone for the treatment of patients with metastatic hormone refractory prostate cancer (HRPC) who have failed prior chemotherapy. This filing is based primarily on data from the SPARC phase 3 registrational trial.
"We are delighted that Pharmion has submitted the European marketing application for satraplatin," said Bernd R. Seizinger, M.D., Ph.D., chief executive officer. "With over 60,000 people expected to die from prostate cancer in the European Union this year, there is an urgent need for new therapies. We believe that, if approved, satraplatin has the potential to become an important new treatment option for advanced prostate cancer patients who today have very little hope."
GPC Biotech will receive an $8 million milestone payment from Pharmion in connection with the EMEA's acceptance of this filing. Under the terms of GPC Biotech's agreement with Spectrum Pharmaceuticals, the acceptance of the MAA by the EMEA will also trigger payments by GPC Biotech to Spectrum in a total amount of $3.2 million, representing a direct milestone payment plus Spectrum's share of the $8 million milestone payment from Pharmion.
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Platinum-based drugs are a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. All platinum drugs currently on the market require intravenous administration. Satraplatin is an oral compound that clinical trial patients are able to take at home. Satraplatin is not currently approved by the FDA in the United States, by the EMEA in the European Union or any other regulatory authority and no conclusions can or should be drawn regarding its safety and efficacy.
A phase 3 registrational trial, called SPARC, is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer whose prior chemotherapy has failed. Data from the trial on progression-free survival and on safety have been presented at recent medical conferences. Satraplatin is currently under review by the U.S. FDA for hormone-refractory prostate cancer patients whose prior chemotherapy has failed.
GPC Biotech has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.
Satraplatin has been studied in clinical trials involving a range of tumors. Trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in a number of cancer types are underway or planned.
GPC Biotech AG is a publicly traded biopharmaceutical company focused on discovering, developing and commercializing new anticancer drugs. GPC Biotech's lead product candidate satraplatin is currently under review by the US FDA for hormone-refractory prostate cancer patients whose prior chemotherapy has failed.