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GPC Biotech reported that the Company has been informed by its partner for satraplatin in Europe that they plan to withdraw the Marketing Authorization Application (MAA) for satraplatin plus prednisone for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed
Martinsried, Munich, Germany and Princeton, NJ, USA | July 25, 2008 | GPC Biotech AG (Frankfurt Stock Exchange: GPC, NASDAQ: GPCB) reported that the Company has been informed by its partner for satraplatin in Europe that they plan to withdraw the Marketing Authorization Application (MAA) for satraplatin plus prednisone for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed. This decision was based on a list of outstanding issues received following review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) of the filing, which indicates that the opinion of the Committee is that the application is currently not approvable based on the information provided.
Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer of GPC Biotech said: “Although we previously communicated that the approval of the MAA for satraplatin would be challenging, today’s outcome is nevertheless disappointing. We are working closely with our partners to determine the next steps regarding the development of satraplatin and continue to focus our other efforts on advancing our RGB-286638 kinase inhibitor into the clinic and exploring various merger and acquisition opportunities.”
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused on anticancer drugs. GPC Biotech's lead product candidate is satraplatin, an oral platinum compound. The Company has various anti-cancer programs in research and development that leverage its expertise in kinase inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich (Germany) and has a wholly owned U.S. subsidiary in Princeton, New Jersey. For additional information, please visit GPC Biotech's Web site at www.gpc-biotech.com.
SOURCE: GPC Biotech AG |
