SatraplatinTreatment for Prostate Cancer
GPC Biotech Withdraws Satraplatin NDA for Accelerated Approval; Plans to Resubmit With Survival Analysis
IRVINE, Calif., July 30, 2007 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., today announced that GPC Biotech has withdrawn the satraplatin New Drug Application (NDA) filed for accelerated approval for the treatment of hormone-refractory prostate cancer. The decision was based on the vote by the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) on July 24, 2007 that the FDA should wait for the survival analysis of the SPARC trial before deciding whether satraplatin is approvable.
GPC Biotech anticipates overall survival results from the SPARC trial to be available within six months. However, this timing is based on an extrapolation of death rates in the trial and may change.
"We look forward to receiving the overall survival data from the SPARC trial and to the resubmission of the NDA to the FDA next year," stated Luigi Lenaz, M.D., Chief Scientific Officer of Spectrum Pharmaceuticals. "Meanwhile, we plan to aggressively continue the development of Spectrum's diversified pipeline, including, EOquin(R) in Phase 3 clinical trials for non- invasive bladder cancer, and ozarelix in a Phase 2b trial for benign prostate hypertrophy, as we strive to reduce risk and build value for our shareholders by not depending on the success of any single drug or technology."
Spectrum acquired worldwide rights to satraplatin from Johnson Matthey PLC. In 2002, Spectrum licensed worldwide rights to satraplatin to GPC Biotech . GPC Biotech is responsible for all costs associated with the development and regulatory filings of satraplatin.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum's expertise lies in identifying drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most efficient methods of commercialization. The company's pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease.
Forward-looking statement - This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire, develop and commercialize its portfolio of drug candidates, the Company's promising pipeline, our team's ability to identify promising drugs and move these drugs through development and toward commercialization, that survival results from the SPARC trial will be available within six months, that the satraplatin NDA will be resubmitted to the FDA next year, that we will aggressively continue the development of our diversified pipeline, that we will reduce risk and build value for our shareholders and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in- license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
CONTACT: Russell Skibsted, SVP & Chief Business Officer, or Paul Arndt,Manager, Investor Relations, +1-949-788-6700, both of SpectrumPharmaceuticals; or Susan Neath of Porter Novelli Life Sciences,+1-619-849-6007
Ticker Symbol: (NASDAQ-NMS:SPPI),(NASDAQ-NMS:GPCB)
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Posted: July 2007
- Oncologic Drugs Advisory Committee Recommends FDA Wait for Overall Survival Analysis of Satraplatin for Treatment of Hormone-Refractory Prostate Cancer - July 25, 2007
- Spectrum Pharmaceuticals Announces FDA'S Oncology Drug Advisory Committee to Review Satraplatin for the Treatment of Hormone Refractory Prostate Cancer - May 15, 2007
- FDA Accepts GPC Biotech's Satraplatin NDA for Filing and Grants Priority Review Status - April 16, 2007
- GPC Biotech Submits NDA for Lead Oncology Drug Candidate Satraplatin - February 16, 2007
- GPC Biotech Submits Non-Clinical Section of Rolling NDA for Satraplatin - July 12, 2006
- GPC Biotech Begins Rolling NDA Submission for Lead Drug Candidate Satraplatin - December 15, 2005