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Spectrum Pharmaceuticals Announces the Expansion by Its Spectrum Pharmaceuticals Announces the Expansion by its Partner of Satraplatin Phase 3 Registrational Trial in Europe after It Received 'Scientific Advice' Letter from European Drug Regulatory Authority The Same Phase 3 Registrational Trial Will Be Used in Both Europe and the United States, Where Satraplatin Was Granted Fast Track Designation by the FDA IRVINE, Calif., Feb. 3 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) today announced that Spectrum Pharmaceuticals' co- development partner for satraplatin, GPC Biotech AG (Frankfurt Stock Exchange: GPC), has received a Scientific Advice Letter from the European Agency for the Evaluation of Medicinal Products (EMEA) enabling the Phase 3 registrational trial on satraplatin to proceed in Europe using the SPARC (Satraplatin and Prednisone Against Refractory Cancer) trial. The multi-center, global, randomized SPARC trial is designed to evaluate satraplatin plus prednisone versus placebo plus prednisone as a second-line chemotherapy regimen for treating patients with hormone-refractory prostate cancer (HRPC). The primary endpoint of the trial is based upon disease progression. The SPARC trial was initiated in the U.S. in September 2003, following successful completion of a Special Protocol Assessment (SPA) and an "End of Phase 2" meeting with the U.S. Food and Drug Administration (FDA). The provision of Scientific Advice is one of the tasks of the EMEA whereby companies are advised on the conduct of various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products. Such advice is important for the success of registrational clinical trials in Europe and helps to establish a meaningful dialogue between the EMEA and a Sponsor. Scientific Advice received from the EMEA is applicable throughout the European Union. "We are very pleased by EMEA's action in providing Scientific Advice for satraplatin, thus enabling our co-development partner for satraplatin, GPC Biotech, to proceed with the SPARC trial in Europe," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "We congratulate GPC Biotech on their productive dialogue with the EMEA and on yet another important achievement in the development of satraplatin." Prostate cancer is the most common cancer among men in the U.S. Over 220,000 new U.S. cases were expected in 2003, and an estimated one in six men is expected to develop prostate cancer in his lifetime. According to recent statistics, there were over 140,000 new cases of prostate cancer in Europe, and approximately 60,000 died from the disease. For those patients failing hormone therapy, treatment currently involves a limited number of options, including chemotherapy. These options are usually only marginally effective. For those patients who fail first-line chemotherapy, there are currently no approved treatment regimens. Thus, Spectrum believes there exists an unmet medical need for additional treatment options for men with advanced prostate cancer in both Europe and the U.S. About satraplatin Satraplatin is a member of the platinum family of compounds, but unlike platinum compounds currently on the market, satraplatin is orally administered. A registrational phase 3 trial -- the SPARC trial -- for satraplatin in HRPC, was initiated in September 2003 following successful completion of an SPA by the FDA. Doctors and patients who would like further information on satraplatin and prostate cancer should contact [email protected] (for North America) and SPARC-ROW@gpc- biotech.com (outside North America). Also in September 2003, the FDA granted fast track designation to satraplatin as a second-line chemotherapy for patients with HRPC. Results from a randomized, 50-patient study in HRPC were presented at the American Society of Clinical Oncology Annual Meeting in June 2003. These data demonstrated statistically significant improvement in time to disease progression and doubling of progression-free survival in the satraplatin- treated group compared to the control group. Phase 2 trials have been completed in HRPC, as well as in other tumor types, including ovarian and small-cell lung cancer. Further information on satraplatin can be found in the Product section of the Company's Web site at www.spectrumpharm.com. About co-development agreement with GPC Biotech Spectrum entered into the co-development and licensing agreement with GPC Biotech in September 2002, and has received $3 million in license fees and a $1 million equity investment to date under the arrangement. GPC Biotech is fully funding development and commercialization expenses for satraplatin, and has committed to pay Spectrum up to an additional $18 million upon the achievement of milestones related to regulatory filings, approvals and commercialization of satraplatin. Upon commercial sale of satraplatin, Spectrum will be entitled to receive royalty payments based upon net sales, and may co- promote satraplatin in the United States. For additional information, please visit GPC Biotech's Web site at www.gpc- biotech.com. About Spectrum Pharmaceuticals Spectrum Pharmaceuticals' primary focus is to develop in-licensed drugs for the treatment and supportive care of cancer patients. The Company's lead drug, satraplatin, is a phase 3 oral, anti-cancer drug being co-developed with GPC Biotech AG, and has been granted fast-track status by the United States Food and Drug Administration. Elsamitrucin, a phase 2 drug, will initially target non-Hodgkin's lymphoma. Eoquin™ is being studied in the treatment of superficial bladder cancer, and may have applications as a radiation sensitizer. The Company is actively working to develop, seek approval for and oversee the marketing of generic drugs in the U.S. For additional information, including SEC filings, visit the Company's web site at www.spectrumpharm.com. Forward-looking statements 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, capabilities of our strategic partners, the need for a therapeutic option for patients with hormone-refractory prostate cancer, the potential success of satraplatin and any statements that relate to the intent, belief, plans or expectations of the company 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 products may not receive approval from the FDA in a timely manner or at all, announcements of new products by our competitors, our lack of revenues and need for additional financing, the possibility that our existing drug product candidates may not be approved, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, our management's limited experience working together, our dependence on third parties for clinical trials and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. For further information, please contact Rajesh C. Shrotriya, M.D., CEO and President of Spectrum Pharmaceuticals, Inc., +1- 949-743-9295, or Anna Kazanchyan, M.D., +1-914-715-0567, for Spectrum Pharmaceuticals, Inc. .
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