GPC Biotech Today Announced Results of Survival Analysis from the SPARC TrialOverall Survival Results Do Not Achieve Statistical Significance
IRVINE, Calif., October 30, 2007 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc.'s licensee, GPC Biotech, today announced that the Phase 3 SPARC trial evaluating satraplatin for the treatment of hormone-refractory prostate cancer did not meet its primary efficacy endpoint.
"We are indeed disappointed that the overall survival data for satraplatin did not achieve statistical significance. Drug development is inherently risky and clinical studies do sometimes fail for various reasons, which is why we built Spectrum on a business model based on a diversified portfolio of several late- and early-stage drug candidates. We are not dependent on the success or failure of any one drug," said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "We will continue to aggressively develop our four late-stage drugs, ISO-Vorin(TM), which has a January 11th FDA action date; sumatriptan injection, which we will launch with PAR Pharmaceutical Companies in the second-half of 2008; EOquin(R), which is currently enrolling patients in two Phase 3 trials; and ozarelix, where we are currently working on the protocol for the pivotal registrational trial. Furthermore, we are currently planning and/or conducting studies for elsamitrucin, lucanthone, ortataxel, RenaZorb(TM), SPI-1620 and SPI-205."
In 2002, Spectrum licensed the global rights to GPC Biotech . GPC Biotech is responsible for all costs associated with the development and regulatory filings of Satraplatin. GPC Biotech has license agreements with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, and Yakult Honsha Co., Ltd.
Spectrum licensed worldwide rights to Satraplatin from Johnson Matthey PLC.
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. 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. For more information, please visit our website at http://www.spectrumpharm.com.
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, the Company's business model, that we are not dependent on the success or failure of any one drug, that we will continue to aggressively develop our four late-stage drugs, ISO-Vorin(TM), which has a January 11th FDA action date; sumatriptan injection, which we will launch with PAR Pharmaceutical Companies in the second-half of 2008; EOquin(R), which is currently enrolling patients in two Phase 3 trials; and ozarelix, where we are currently working on the protocol for the pivotal registrational trial, that we are currently planning and/or conducting studies for elsamitrucin, lucanthone, ortataxel, RenaZorb(TM), SPI-1620 and SPI-205 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.
COMPANY CONTACTS MEDIA CONTACT Russell Skibsted Susan Neath SVP & Chief Business Officer Porter Novelli Life Sciences 619-849-6007 Paul Arndt Manager, Investor Relations 949-788-6700
CONTACT: Russell Skibsted, SVP & Chief Business Officer, or Paul Arndt,Manager, Investor Relations, +1-949-788-6700, both of SpectrumPharmaceuticals, Inc.; or media, Susan Neath of Porter Novelli LifeSciences, +1-619-849-6007, for Spectrum Pharmaceuticals, Inc.
Web site: http://www.spectrumpharm.com/
Ticker Symbol: (NASDAQ-NMS:SPPI),(NASDAQ-NMS:GPCB)
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Posted: October 2007