MARTINSRIED/MUNICH, Germany, May 15 /PRNewswire-FirstCall/ -- PRINCETON, N.J. -- GPC Biotech AG today announced that the Company has been informed by the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for satraplatin for patients with hormone-refractory prostate cancer (HRPC) whose prior chemotherapy has failed will be reviewed by the Oncologic Drugs Advisory Committee (ODAC) on July 24, 2007. Advisory committees provide the FDA with independent advice from outside experts on issues related to human drugs and other regulated areas. Although the committees provide advice to the agency, final decisions are made by the FDA. Earlier, the FDA had accepted for filing the Company's NDA and had granted the NDA priority review status. An action from the FDA on the application is expected in August of this year.
"Presentation of the satraplatin data to the Oncologic Drugs Advisory Committee is the next important milestone in the NDA review process. We remain committed to successfully completing this review as quickly as possible," said Marcel Rozencweig, M.D., Chief Medical Officer and Senior Vice President, Drug Development of GPC Biotech. "We expect an action on the application from the FDA in August of this year and are thus moving forward with commercialization plans for satraplatin. If approved, we believe that satraplatin has the potential to become an important therapy for hormone-refractory prostate cancer patients whose disease has progressed after prior chemotherapy, an area of significant unmet medical need."
About Satraplatin
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Platinum-based drugs are 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.
A Phase 3 registrational trial, called SPARC, is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone- refractory prostate cancer who have failed prior chemotherapy. Data from the trial have been presented at recent medical conferences. In accordance with the recommendation of the independent Data Monitoring Board for the SPARC trial, patients who have not progressed continue to be treated and all patients will be followed for overall survival.
GPC Biotech 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. Pharmion has indicated it expects to complete the Marketing Authorization Application (MAA) for satraplatin for Europe in the second quarter of 2007. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.
Satraplatin has been studied in clinical trials involving a range of tumors. Trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in a number of cancer types are underway or planned.
In addition, GPC Biotech launched in February the Satraplatin Expanded Rapid Access protocol (SPERA) in the U.S. Expanded access programs are intended to give patients access to investigational drugs to treat serious or life-threatening diseases or conditions for which there are no adequate therapies available. Under the SPERA protocol, satraplatin will be provided to hormone-refractory prostate cancer patients who have failed prior chemotherapy free of charge until satraplatin is cleared for marketing in the U.S. U.S. physicians interested in receiving more information about SPERA can contact 1-800-349-8086.
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 satraplatin is currently under review by the U.S. FDA for hormone-refractory prostate cancer patients whose prior chemotherapy has failed. 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), and has a wholly owned U.S. subsidiary headquartered in Princeton, New Jersey. For additional information, please visit GPC Biotech's Web site at http://www.gpc-biotech.com.
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of GPC Biotech AG, including statements about the status of the FDA review process. 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. In particular, there can be no guarantee that additional information relating to the safety, efficacy or tolerability of satraplatin may be discovered upon further analysis of data from the SPARC trial or analysis of additional data from other ongoing clinical trials for satraplatin. Furthermore, we cannot guarantee that satraplatin will be approved for marketing in a timely manner, if at all, by regulatory authorities nor that, if marketed, satraplatin will be a successful commercial product. We direct you to GPC Biotech's Annual Report on 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 the future results, performance and achievements of GPC Biotech. Forward-looking statements speak only as of the date on which they are made and GPC Biotech undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
Satraplatin has not yet been approved by the FDA in the U.S., the EMEA in Europe or any other regulatory authority and no conclusions can or should be drawn regarding its safety or effectiveness. Only the relevant regulatory authorities can determine whether satraplatin is safe and effective for the use(s) being investigated.
Investor and Media Contacts: 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: +1 609 524 5884 usinvestors@gpc-biotech.com Additional Media Contacts: In Europe: Maitland Brian Hudspith Phone: +44 (0)20 7379 5151 bhudspith@maitland.co.uk In the U.S.: Russo Partners, LLC David Schull Phone: +1 212 845-4271 david.schull@russopartnersllc.com
GPC Biotech AGCONTACT: Martin Braendle, Director, Investor Relations & CorporateCommunications, +49 (0)89 8565-2693, ir@gpc-biotech.com , or Laurie Doyle,Director, Investor Relations & Corporate Communications, +1-609-524-5884,usinvestors@gpc-biotech.com , both of GPC Biotech AG; or In the U.S., DavidSchull of Russo Partners, LLC, +1-212-845-4271,david.schull@russopartnersllc.com , or In Europe, Brian Hudspith ofMaitland, +44 (0)20 7379 5151, bhudspith@maitland.co.uk
Web site: http://www.gpc-biotech.com/
