Satraplatin

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About Satraplatin

Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Worldwide sales of these drugs exceeded $2.2 billion in 2004. 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. An oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications. Additionally, satraplatin is the only platinum-based compound to have shown efficacy in a randomized clinical trial in prostate cancer. Prostate cancer is the most common cancer among men in the U.S. and Europe. The number of patients with this disease is expected to increase with the aging population. As the disease advances, patients are often treated with hormone therapy. Once patients fail hormone therapy, becoming hormone-refractory, follow-on treatment involves a limited number of options, including chemotherapy. For patients who then fail first-line chemotherapy, there are currently no approved second-line chemotherapy regimens. Satraplatin is in a Phase 3 registrational trial - the SPARC trial - as a second-line chemotherapy treatment for HRPC. GPC Biotech has successfully completed a Special Protocol Assessment with the U.S. FDA and has received a Scientific Advice letter from the European regulatory authority, the European Agency for the Evaluation of Medicinal Products (EMEA). The FDA has also granted fast track designation to satraplatin for this indication.

Phase 2 trials have been completed in HRPC, ovarian cancer and small-cell lung cancer. Promising early clinical results have also been shown when satraplatin is combined with radiation therapy, and a Phase 1/2 study evaluating this combination in patients with non-small cell lung cancer has been initiated. Additional studies evaluating satraplatin in combination with other therapies in various cancers are planned. Further information on satraplatin can be found in the Anticancer Programs section of the Company's Web site at www.gpc-biotech.com.

GPC Biotech AG is a biopharmaceutical company discovering and developing new anticancer drugs. The Company's lead product candidate - satraplatin - is currently in a Phase 3 registrational trial as a second-line chemotherapy treatment in hormone-refractory prostate cancer following successful completion of a Special Protocol Assessment by the U.S. FDA and receipt of a Scientific Advice letter from the European central regulatory authority, EMEA. The FDA has also granted fast track designation to satraplatin for this indication. Satraplatin was in-licensed from Spectrum Pharmaceuticals, Inc. Other anticancer programs include: a monoclonal antibody with a novel mechanism of action against a variety of lymphoid tumors, currently in Phase 1 clinical development, and a small molecule broad-spectrum cell cycle inhibitor, currently in pre-clinical development. The Company is leveraging its drug discovery technologies to elucidate the mechanisms-of-action of drug candidates and to support the growth of its drug pipeline. GPC Biotech also has a multi-year alliance with ALTANA Pharma AG working with the ALTANA Research Institute in the U.S., which provides GPC Biotech with revenues through mid-2007. GPC Biotech AG is headquartered in Martinsried/Munich (Germany). The Company's wholly owned U.S. subsidiary has research and development sites in Waltham, Massachusetts and Princeton, New Jersey. For additional information, please visit the Company's Web site at www.gpc-biotech.com.

This press release may contain projections or estimates relating to plans and objectives relating to our future operations, products, or services; future financial results; or assumptions underlying or relating to any such statements; each of which constitutes a forward-looking statement subject to risks and uncertainties, many of which are beyond our control. Actual results could differ materially depending on a number of factors, including the timing and effects of regulatory actions, the results of clinical trials, the Company's relative success developing and gaining market acceptance for any new products, and the effectiveness of patent protection. There can be no guarantee that the SPARC trial will be completed in a timely manner, if at all. Additionally, there can be no guarantee that satraplatin will be approved for marketing in a timely manner, if at all.