FDA Accepts GPC Biotech's Satraplatin NDA for Filing and Grants Priority Review Status
MARTINSRIED/MUNICH, Germany and WALTHAM, Mass. and PRINCETON, N.J., April 16, 2007 /PRNewswire-FirstCall/ -- -- GPC Biotech AG today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for satraplatin in combination with prednisone for patients with hormone-refractory prostate cancer (HRPC) whose prior chemotherapy has failed. The Company also announced that the FDA has granted the NDA priority review status. Priority review designation is intended for those products that address significant unmet medical needs and sets the target date for FDA action at six months from the date of submission. GPC Biotech completed the rolling submission of the NDA for satraplatin on February 15, 2007. The application will be reviewed under the provisions of 21 CFR 314 Subpart H, for accelerated approval.
"We are pleased that the FDA has accepted our application for filing and granted it priority review status. We look forward to working closely with the agency during the review process," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. "With the designation of priority review, 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 unmet medical need."
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 on progression-free survival and on safety 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 biopharmaceutical company discovering and developing new anticancer drugs. GPC Biotech's lead product candidate satraplatin is currently under review by the U.S. FDA in combination with prednisone as a second-line chemotherapy treatment in hormone-refractory prostate cancer. 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 its wholly owned U.S. subsidiary has sites in Waltham, Massachusetts and Princeton, New Jersey. For additional information, please visit GPC Biotech's Web site at 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 In the U.S.: Laurie Doyle Director, Investor Relations & Corporate Communications Phone: +1 781 890 9007 X267 Additional Media Contacts: In Europe: Maitland Brian Hudspith Phone: +44 (0)20 7379 5151 In the U.S.: Noonan Russo David Schull Phone: +1 212 firstname.lastname@example.org email@example.com firstname.lastname@example.org email@example.com
CONTACT: Martin Braendle, Director, Investor Relations & CorporateCommunications, +49 (0)89 8565-2693, , or Laurie Doyle,Director, Investor Relations & Corporate Communications, +1-781-890-9007ext. 267, , both of GPC Biotech AG; or In theU.S.: David Schull of Noonan Russo, +1-212-845-4271,; or In Europe: Brian Hudspith of Maitland NoonanRusso, +44 (0)20 7379 5151, firstname.lastname@example.org email@example.com firstname.lastname@example.org email@example.com
Web site: http://www.gpc-biotech.com//
Ticker Symbol: (Frankfurt:GPC),(NASDAQ-NMS:GPCB)
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Posted: April 2007