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Martinsried/Munich (Germany) and Princeton, N.J., June 12, 2008 - GPC Biotech AG (Frankfurt Stock Exchange: GPC; NASDAQ: GPCB | Quote | Chart | News | PowerRating) today announced the granting of a European Patent (EP 1 720 540 B1) related to satraplatin, a novel, oral platinum compound. The patent is entitled, "Satraplatin for treating resistant or refractory tumors" and covers certain uses of satraplatin related to the treatment of a cancer or tumor resistant or refractory to a taxane, including docetaxel (Taxotere(R)) and paclitaxel (Taxol(R)). The term of the patent extends up to 2025.
"Docetaxel is the standard of care for the first-line treatment of patients with hormone-refractory prostate cancer, or HRPC, and approximately half of the patients in the satraplatin Phase 3 SPARC trial in second-line HRPC were previously treated with docetaxel," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. "With an active filing for satraplatin under review in Europe, we believe this patent will be of particular commercial importance, should satraplatin be approved for HRPC patients whose prior chemotherapy has failed."
The Company conducted the SPARC Phase 3 trial evaluating satraplatin in combination with prednisone in the second-line treatment of patients with HRPC. Approximately 50% of patients recruited into the study had progressive disease following prior treatment with docetaxel. The SPARC trial results showed a statistically significant improvement in progression-free survival in the overall intent-to-treat (ITT) population, as well as in the group of patients who had progressed after receiving docetaxel. While the overall survival results in the overall ITT population did not show a difference between the two treatment arms, there was a positive trend toward improved survival observed in those patients whose disease had progressed after receiving docetaxel, when adjusting for the three significant prognostic factors in the SPARC trial*.
About Satraplatin 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. A Marketing Authorization Application for satraplatin in combination with prednisone is currently under review in Europe for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed. A decision on the filing by the European regulators is expected in the second half of 2008. Celgene Corporation is responsible for the regulatory filings for satraplatin and its development and commercialization for Europe and certain other territories. GPC Biotech also has a license agreement with Yakult Honsha Co. Ltd. under which Yakult has exclusive commercialization rights to satraplatin for Japan and is taking the lead in developing the drug in that territory. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.
About GPC Biotech GPC Biotech AG is a publicly traded biopharmaceutical company focused on new 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.
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of GPC Biotech, including statements about the efficacy and safety of satraplatin. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. Satraplatin may not be approved for marketing in a timely manner, if at all. We direct you to GPC Biotech's Annual Report on Form 20-F for the fiscal year ended December 31, 2006 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect the future results, performance and achievements of GPC Biotech. Forward-looking statements speak only as of the date on which they are made and GPC Biotech undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
Satraplatin has not been approved by the FDA in the U.S., the EMEA in Europe or any other regulatory authority and no conclusions can or should be drawn regarding its safety or effectiveness. Only the relevant regulatory authorities can determine whether satraplatin is safe and effective for the use(s) being investigated.
Taxotere(R) is a registered trademark of Aventis Pharma S.A. Taxol(R) is a registered trademark of Bristol-Myers Squibb Company.
Contacts:
GPC Biotech AG Investor Relations & Corporate Communications Department Phone: +49 (0)89 8565-2693 ir@gpc-biotech.com
In the U.S.: Laurie Doyle Director, Investor Relations & Corporate Communications Phone: +1 609 524 5884 usinvestors@gpc-biotech.com
Additional media contacts for Europe: MC Services AG Phone: +49 (0) 89 210 228 0
Raimund Gabriel raimund.gabriel@mc-services.eu
Hilda Juhasz hilda.juhasz@mc-services.eu
Additional investor contact for Europe: Trout International LLC Lauren Rigg, Vice President Phone: +44 207 936 9325 lrigg@troutgroup.com
* The three pre-specified prognostic factors in the SPARC trial which showed statistically significant imbalances between the two treatment arms were lactate dehydrogenase, hemoglobin and alkaline phosphatase.
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GPC Biotech AG Fraunhoferstr. 20 Martinsried
WKN: 585150; ISIN: DE0005851505; Index: CDAX, MIDCAP, Prime All Share, TecDAX, HDAX, TECH All Share; Listed: Prime Standard in Frankfurter Wertpapierborse, Freiverkehr in Borse Berlin, Freiverkehr in Bayerische Borse Munchen, Freiverkehr in Borse Dusseldorf, Freiverkehr in Borse Stuttgart, Freiverkehr in Hanseatische Wertpapierborse zu Hamburg, Geregelter Markt in Frankfurter Wertpapierborse;
SOURCE: GPC Biotech AG
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