Advertisement
Based on the results announced today, GPC Biotech is re-evaluating itsdevelopment plans for satraplatin, including SPERA, the Satraplatin ExpandedRapid Access protocol in the U.S.
Advertisement
"We are extremely disappointed with the findings we announced today," saidBernd R. Seizinger, M.D., Ph.D., Chief Executive Officer of GPC Biotech. "Weare currently discussing with our partners, Pharmion and Yakult, plans for thefuture development of satraplatin. I would like to warmly thank and recognizethe contributions of the investigators and patients, as well as theirfamilies, who participated in the SPARC trial."
"These results are clearly disappointing and will impact the EMEA reviewof our current Marketing Authorization Application for satraplatin," saidPatrick J. Mahaffy, President and Chief Executive Officer of PharmionCorporation. "The key for our European submission now will be to conduct thepre-specified subset analyses and particularly to focus on the impact of priorTaxotere(R) use, which we know is very important to the EMEA."
Pharmion's Marketing Authorization Application with the European MedicinesAgency (EMEA) for satraplatin in combination with prednisone for the treatmentof patients with metastatic HRPC who have failed prior chemotherapy wassubmitted in June 2007. The submission, based on the statisticallysignificant progression-free survival results announced in September 2006, wastimed so that overall survival data could be submitted during the reviewprocess. Pharmion plans to review the additional analyses and work closelywith the EMEA to determine next steps for the filing.
Conference Calls Scheduled
GPC Biotech will hold a conference call on Wednesday, October 31, 2007 at13:30 CET/8:30 AM ET. Pharmion Corporation will hold its previously announcedconference call to discuss third quarter results on October 31st at 5:00 PMET. Participants may listen via live webcast, accessible through eachcompany's Web site at http://www.pharmion.com, http://www.gpc-biotech.com, orvia telephone.
About Pharmion
Pharmion is a leading global oncology company focused on acquiring,developing and commercializing innovative products for the treatment ofhematology and oncology patients in the U.S., Europe and additionalinternational markets. Pharmion has a number of products on the marketincluding the world's first approved epigenetic drug, Vidaza(R), a DNAdemethylating agent. For additional information about Pharmion, please visitthe company's website at http://www.pharmion.com.
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused ondiscovering, developing and commercializing new anticancer drugs. GPCBiotech's lead product candidate is satraplatin, an oral platinum compound.The Company has various anti-cancer programs in research and development thatleverage its expertise in kinase inhibitors. GPC Biotech AG is headquarteredin Martinsried/Munich (German
