Healthcare Industry News: taxane
News Release - July 27, 2007
Marketing Authorization Application for Satraplatin Accepted for Review by the European Medicines AgencyAcceptance of Application Triggers Milestone Payment to Spectrum Pharmaceuticals, Inc.
IRVINE, Calif., July 27 (HSMN NewsFeed) -- Spectrum Pharmaceuticals, Inc., (Nasdaq: SPPI ) today announced that the Marketing Authorization Application (MAA) that was submitted to the European Medicines Agency (EMEA) by Pharmion Corporation (Nasdaq: PHRM ) for satraplatin in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (HRPC) who have failed prior chemotherapy, has been accepted for review.
"We believe that, if approved, satraplatin will be an effective treatment option in an indication where there are few treatment options available," said Luigi Lenaz, Chief Scientific Officer of Spectrum Pharmaceuticals. "We continue to identify, acquire and develop new and what we believe will be more effective, drug candidates for various forms of cancer and other life altering diseases, such as EOquin® for non-invasive bladder cancer, ozarelix for benign prostate hypertrophy, SPI-1620 for solid tumors, and most recently, ortataxel for taxane-refractory tumors." Spectrum currently has 11 drug product candidates under development.
Spectrum acquired worldwide rights to satraplatin from Johnson Matthey PLC. In 2002, Spectrum licensed worldwide rights to satraplatin to GPC Biotech (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB). 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 undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and risk-reduced 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. 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, our team's ability to identify promising drugs and move these drugs through development and toward commercialization, that satraplatin will be an effective treatment option in an indication where there are few treatment options available, that we continue to identify, acquire and develop new and what we believe will be more effective, drug candidates for various forms of cancer and other life altering diseases 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.
Source: Spectrum Pharmaceuticals
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