FDA Extends ISO-Vorin™ Action Date By Sixty Days

Main Category: Colorectal Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Cancer / Oncology;  GastroIntestinal / Gastroenterology
Article Date: 21 Nov 2007 - 11:00 PDT

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Spectrum Pharmaceuticals, Inc. (Nasdaq:SPPI) announced that the FDA has informed the Company that it is extending, by 60 days, the action date for completing review of the ISO-Vorin™ (levofolinic acid, or LFA) for injection NDA. The new action date is March 7, 2008.

About ISO-Vorin™

ISO-Vorin™ is the pure active isomer of calcium leucovorin. Calcium leucovorin is used after the administration of high-dose methotrexate in treating osteogenic sarcoma and is also a component of "standard of care" 5-fluorouracil (5-FU) containing regimens for the treatment of colorectal cancer and other malignancies. Wyeth, Sanofi-Aventis, and others, currently market LFA in certain parts of the world, including Europe and Japan. Peak sales for LFA outside the United States were nearly $200 million.

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, its ability to identify promising drugs and move these drugs through development and toward commercialization, that on the March 7, 2008 action date set for ISO-Vorin™, the FDA is expected to notify the Company whether ISO-Vorin™ will be approved for marketing in the US, or not, 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 to be 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 significant 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.

http://www.spectrumpharm.com

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