SURVIVAL ANALYSIS FROM SATRAPLATIN TRIAL DISAPPOINTING.
Based on the recent results announced, GPC Biotech is re- evaluating its development plans for satraplatin, including SPERA, the Satraplatin Expanded Rapid Access protocol in the U.S.
"We are extremely disappointed with the findings we announced today," said Bernd R. Seizinger, M.D., Ph.D., CEO of GPC Biotech. "We are currently discussing with our partners, Pharmion and Yakult, plans for the future development of satraplatin. I would like to warmly thank and recognize the contributions of the investigators and patients, as well as their families, who participated in the SPARC trial."
"These results are clearly disappointing and will impact the EMEA review of our current Marketing Authorization Application for satraplatin," said Patrick J. Mahaffy, president and CEO of Pharmion Corporation. "The key for our European submission now will be to conduct the pre-specified subset analyses and particularly to focus on the impact of prior Taxotere(R) use, which we know is very important to the EMEA."
Pharmion's Marketing Authorization Application with the European Medicines Agency (EMEA) for satraplatin in combination with prednisone for the treatment of patients with metastatic HRPC who have failed prior chemotherapy was submitted in June 2007. The submission, based on the statistically significant progression-free survival results announced in September 2006, was timed so that overall survival data could be submitted during the review process. Pharmion plans to review the additional analyses and work closely with the EMEA to determine next steps for the filing.
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused on discovering, developing and commercializing 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 headquartered in Princeton, New Jersey.
For more information, http://www.gpc-biotech.com or call 609/524-5884.
Pharmion is a leading global oncology company focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the U.S., Europe and additional international markets. Pharmion has a number of products on the market including the world's first approved epigenetic drug, Vidaza(R), a DNA demethylating agent.
For more information, visit http://www.pharmion.com or call 720/564-9150.
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|Date:||Dec 1, 2007|
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