FDA accepts GPC Biotech's Satraplatin NDA

Apr 17 2007

GPC Biotech AG has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for satraplatin in combination with prednisone for patients with hormone-refractory prostate cancer (HRPC) whose prior chemotherapy has failed.

The Company also announced that the FDA has granted the NDA priority review status. Priority review designation is intended for those products that address significant unmet medical needs and sets the target date for FDA action at six months from the date of submission. GPC Biotech completed the rolling submission of the NDA for satraplatin on February 15, 2007. The application will be reviewed under the provisions of 21 CFR 314 Subpart H, for accelerated approval.

"We are pleased that the FDA has accepted our application for filing and granted it priority review status. We look forward to working closely with the agency during the review process," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. "With the designation of priority review, we expect an action on the application from the FDA in August of this year and are thus moving forward with commercialization plans for satraplatin. If approved, we believe that satraplatin has the potential to become an important therapy for hormone-refractory prostate cancer patients whose disease has progressed after prior chemotherapy, an area of unmet medical need."

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. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home.

A Phase 3 registrational trial, called SPARC, is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone- refractory prostate cancer who have failed prior chemotherapy. Data from the trial on progression-free survival and on safety have been presented at recent medical conferences. In accordance with the recommendation of the independent Data Monitoring Board for the SPARC trial, patients who have not progressed continue to be treated and all patients will be followed for overall survival.

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. Pharmion has indicated it expects to complete the Marketing Authorization Application (MAA) for satraplatin for Europe in the second quarter of 2007. 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.

In addition, GPC Biotech launched in February the Satraplatin Expanded Rapid Access protocol (SPERA) in the U.S. Expanded access programs are intended to give patients access to investigational drugs to treat serious or life-threatening diseases or conditions for which there are no adequate therapies available. Under the SPERA protocol, satraplatin will be provided to hormone-refractory prostate cancer patients who have failed prior chemotherapy free of charge until satraplatin is cleared for marketing in the U.S. U.S. physicians interested in receiving more information about SPERA can contact 1- 800-349-8086.

http://www.gpc-biotech.com/