Martinsried/Munich (Germany), Waltham, Mass., Princeton, N.J., and Boulder, Colo. May 17, 2006 –GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) and Pharmion Corporation (NASDAQ:PHRM) announced that the independent Data Monitoring Board (DMB) for the satraplatin Phase 3 registrational trial, SPARC (Satraplatin and Prednisone Against Refractory Cancer) has notified the Companies that it wishes to conduct an expedited interim analysis of overall survival data from the SPARC trial. The Companies have agreed to this request and the DMB is expected to meet to discuss the data prior to the end of the second quarter of 2006.
As previously announced, following the interim efficacy analysis conducted on April 25, 2006, the DMB recommended that the SPARC trial continue as planned. The focus of that analysis was progression-free survival (PFS) and safety data. PFS remains the endpoint of the SPARC trial for accelerated approval in the U.S. and is also the basis, along with supporting overall survival data, for approval in Europe.
GPC Biotech and Pharmion have not had access to the data that caused the DMB to request this expedited review of overall survival, however, in its April 25th meeting, the DMB also had access to preliminary overall survival data. The Companies are now and will continue to remain blinded to the data during this review process.
“While we have not had access to the data that caused the DMB to request this expedited review, we are pleased to comply with the DMB’s request as rapidly as we can,” said Marcel Rozencweig, M.D., Senior Vice President, Drug Development and Chief Medical Officer of GPC Biotech. “We caution against any over interpretation of this expedited review because we do not know the basis of this request.”
The Data Monitoring Board consists of independent oncology and statistical experts whose primary responsibility is to monitor, on a periodic basis, the data from the SPARC trial and to provide recommendations to GPC Biotech and Pharmion on whether the study should proceed as originally planned, be modified or be discontinued for efficacy or safety reasons. Members of the Data Monitoring Board are independent from GPC Biotech and Pharmion and also do not participate as clinical investigators in the SPARC trial.
About Satraplatin
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home.
In December 2005, GPC Biotech completed accrual to the SPARC trial and initiated the rolling submission of a New Drug Application (NDA) for satraplatin with the U.S. Food and Drug Administration (FDA). Also in December 2005, GPC Biotech signed a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion was granted exclusive commercialization rights to satraplatin for Europe and certain other territories.
Satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in HRPC, ovarian cancer and small cell lung cancer. Other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers are underway or planned. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002. Additional information on satraplatin can be found in the Anticancer Programs section of the Company's Web site at www.gpc-biotech.com.
GPC Biotech AG is a biopharmaceutical company discovering and developing new anticancer drugs. The Company's lead product candidate – satraplatin – has achieved target enrollment in a Phase 3 registrational trial as a second-line chemotherapy treatment in hormone-refractory prostate cancer. The U.S. FDA has granted fast track designation to satraplatin for this indication, and GPC Biotech has begun the rolling NDA submission process for this compound. GPC Biotech is also developing a monoclonal antibody with a novel mechanism-of-action against a variety of lymphoid tumors, currently in Phase 1 clinical development, and has ongoing drug development and discovery programs that leverage its expertise in kinase inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich (Germany). The Company's wholly owned U.S. subsidiary has sites in Waltham, Massachusetts and Princeton, New Jersey. For additional information, please visit the Company's Web site at www.gpc-biotech.com.
This press release may contain forward-looking statements, including, without limitation, statements about the progress and results of the outcome of the SPARC trial and other clinical development activities, regulatory processes and commercialization efforts for satraplatin. Forward-looking statements are based on the Company’s current expectations and projections about future events and are subject to risks, uncertainties and assumptions in light of which the forward-looking events discussed in this press release might not occur. We direct you to the Company's Form 20-F for the fiscal year ended December 31, 2005 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect these statements and the Company's future results, performance and achievements. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Except as required by law, the Company does not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For further information, please contact:
GPC Biotech AG
Fraunhoferstr. 20
82152 Martinsried/Munich, Germany
Martin Braendle
Associate Director, Investor Relations
& Corporate Communications
Phone: +49 (0)89 8565-2693
ir@gpc-biotech.com
In the U.S.: Laurie Doyle
Associate Director, Investor Relations
& Corporate Communications
Phone: +1 781 890 9007 X267
usinvestors@gpc-biotech.com
Additional Media Contacts:
In Europe:
Maitland Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
In the U.S.:
Noonan Russo
Matt Haines
Phone: +1 212 845 4235
matthew.haines@eurorscg.com
