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GPC Biotech Withdraws Satraplatin

http://biz.yahoo.com/ap/070730/gpc_biotech_fda.html?.v=1&printer=1

Monday July 30, 10:37 am ET
GPC Biotech Withdraws FDA Application for Cancer Treatment Candidate Satraplatin

NEW YORK (AP) -- GPC Biotech AG said Monday it is withdrawing its Food and Drug Administration application for the cancer drug candidate satraplatin, following an advisory committee recommendation.

The FDA advisory committee, last week, recommended the agency not approve the drug until the company submits full survival data. GPC Biotech said it expects overall survival results to be available within six months, but that timing could change.

GPC Biotech licensed rights for the drug candidate from Spectrum Pharmaceuticals in 2002. GPC is responsible for development and regulatory costs. Pharmion Corp. holds European rights to the drug candidate.

"While we were very surprised and disappointed by last week's ODAC outcome, we need to move forward," said Bernd R. Seizinger, chief executive of GPC Biotech. "Thus, we are focusing our efforts on the overall survival results from the satraplatin SPARC trial and integrating these data into the strongest possible NDA submission."

The company said that if this data is positive, it plans to submit a new drug application to the FDA as quickly as possible.

U.S.-traded shares of Germany-based GPC Biotech rose $1.55, or 15 percent, to $11.90 in morning trading. The stock has traded between $10.25 and $37.79 over the last 52 weeks. Shares of Irvine, Calif.-based Spectrum rose 5 cents to $4.05 while shares of Boulder, Colo.-based Pharmion rose 42 cents to $24.84