Healthcare Industry News: Vidaza
News Release - October 30, 2007
GPC Biotech and Pharmion Announce Results of Overall Survival Analysis from the Satraplatin Pivotal Phase 3 TrialOverall survival results do not achieve statistical significance
GPC Biotech schedules conference call for Wednesday, October 31st, 8:30 AM ET/13:30 CET
MARTINSRIED/MUNICH, Germany & PRINCETON, N.J. & BOULDER, Colo.--(HSMN NewsFeed)--GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) and Pharmion Corporation (NASDAQ: PHRM ) today announced topline overall survival results for the double-blinded, randomized satraplatin Phase 3 registrational trial, the SPARC trial (Satraplatin and Prednisone Against Refractory Cancer). The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC). The companies reported that the trial did not achieve the endpoint of overall survival (p=0.80, stratified log rank analysis). The median was 61.3 weeks for the satraplatin arm compared to 61.4 weeks for the control group and the hazard ratio was 0.97 (95% CI: 0.83, 1.13). The companies are currently conducting pre-specified subset analyses.
Based on the results announced today, 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., Chief Executive Officer 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 Chief Executive Officer 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.
Conference Calls Scheduled
GPC Biotech will hold a conference call on Wednesday, October 31, 2007 at 13:30 CET/8:30 AM ET. Pharmion Corporation will hold its previously announced conference call to discuss third quarter results on October 31st at 5:00 PM ET. Participants may listen via live webcast, accessible through each company’s Web site at www.pharmion.com, www.gpc-biotech.com, or via telephone.
Dial-in numbers for the GPC Biotech conference call are as follows:
Europe: 0049-(0)89-9982-99911 or 0044-(0)20-7806-1957
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 additional information, please visit GPC Biotech's Web site at www.gpc-biotech.com.
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 additional information about Pharmion, please visit the company's website at http://www.pharmion.com.
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of GPC Biotech AG and Pharmion Corporation, including summary statements relating to top line results of the SPARC trial and summary statements relating to the potential efficacy and safety profile 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 We direct you to GPC Biotech’s Annual Report on Form 20-F for the fiscal year ended December 31, 2006, Pharmion’s Annual Report on Form 10-K for the fiscal year ended December 31, 2006, its most recent filings on Form 10-Q 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 either Pharmion or GPC Biotech. Forward-looking statements speak only as of the date on which they are made and neither Pharmion nor GPC Biotech undertakes any obligation to update these forward-looking statements, even if new information becomes available in the future.
Source: GPC Biotech
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.