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GPC Biotech AG (GPCG.DE) Submits Non-Clinical Section Of Rolling NDA For Lead Oncology Drug Candidate Satraplatin


7/12/2006 11:49:35 AM

MARTINSRIED/MUNICH, Germany, July 12 /PRNewswire-FirstCall/ -- WALTHAM, Mass. and PRINCETON, N.J. -- GPC Biotech AG today announced that the Company has submitted the non-clinical section of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer (HRPC). The Company submitted the chemistry, manufacturing and controls -- or CMC -- section of the NDA in December 2005 and anticipates completing the NDA submission by the end of 2006.

"The non-clinical section is the second of three parts necessary to complete the NDA submission. We are very pleased that we continue to make such good progress in advancing satraplatin toward the market and that we remain on track with our timelines," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. "The second half of 2006 promises to be of seminal importance for GPC Biotech as we expect to have the final data on progression- free survival from our SPARC registrational trial in the fall and complete the NDA filing by the end of this year."

The FDA granted "fast track" designation to satraplatin as a second-line chemotherapy treatment for patients with HRPC in September 2003. The FDA's fast track programs are intended to expedite the review of drugs to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

The rolling submission process enables companies that have been granted fast track designation to submit sections of the NDA to the agency as they become available, allowing the review process to begin before the complete dossier has been submitted.

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 that is evaluating satraplatin in combination with prednisone as second-line chemotherapy in patients with hormone refractory prostate cancer. Also in December 2005, GPC Biotech initiated the rolling submission of an NDA for satraplatin with the FDA. The Company has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been 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 hormone-refractory prostate cancer, 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 http://www.gpc-biotech.com.

About GPC Biotech

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 http://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 Director, Investor Relations & Corporate Communications Phone: +49 (0)89 8565-2693 ir@gpc-biotech.com In the U.S.: Laurie Doyle 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

GPC Biotech AG

CONTACT: Martin Braendle, Director, Investor Relations & CorporateCommunications, +49 (0)89 8565-2693, ir@gpc-biotech.com, or Laurie Doyle,Director, Investor Relations & Corporate Communications, +1-781-890-9007ext. 267, usinvestors@gpc-biotech.com, both of GPC Biotech AG; or InEurope: Brian Hudspith of Maitland Noonan Russo, +44 (0)20 7379 5151,bhudspith@maitland.co.uk; or In the U.S.: Matt Haines of Noonan Russo,+1-212-845-4235, matthew.haines@eurorscg.com


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