IRVINE, Calif., June 26 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., today announced that Pharmion Corporation has filed a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for satraplatin in combination with prednisone for the treatment of patients with metastatic hormone refractory prostate cancer (HRPC) who have failed prior chemotherapy.
“With more than 200,000 men suffering from HRPC, and approximately 60,000 expected to die from HRPC this year, the European Union is one step closer to having a new treatment option” said Luigi Lenaz MD, Chief Scientific Officer of Spectrum Pharmaceuticals, Inc. “We believe that, if approved, satraplatin will be an effective treatment option in an indication where there are few treatment options available. Our goal is to bring new and effective treatment options to patients suffering from various forms of cancer and other life altering diseases, such as EOquin for non-invasive bladder cancer, and ozarelix for benign prostate hypertrophy.” Spectrum currently has ten drug product candidates under development.
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. All platinum drugs currently on the market require intravenous administration. Satraplatin is an oral compound that clinical trial patients are able to take at home. Satraplatin is not currently approved by the FDA in the United States, by the EMEA in the European Union or any other regulatory authority and no conclusions can or should be drawn regarding its safety and efficacy.
A Phase 3 registrational trial, called SPARC, is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer whose prior chemotherapy has failed. 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.
In addition to hormone refractory prostate cancer, 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 chemotherapy and in a number of cancer types are underway or planned.
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 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.
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. 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 httpwww.//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 upon approval, satraplatin will be an effective treatment option in an indication where there are few treatment options available, and the Company’s goal to bring new and effective treatment options to patients suffering from various forms of cancer and other life altering diseases, such as EOquin for non-invasive bladder cancer, and ozarelix for benign prostate hypertrophy, that additional trials are planned, 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
Spectrum Pharmaceuticals, Inc.
CONTACT: Russell Skibsted, SVP & Chief Business Officer, or Paul Arndt,Manager, Investor Relations, both of Spectrum Pharmaceuticals, Inc.,+1-949-788-6700; or Susan Neath of Porter Novelli Life Sciences,+1-619-849-6007, for Spectrum Pharmaceuticals, Inc.
Web site: http://www.spectrumpharm.com/
