FusilevTreatment for Folic Acid Antagonist Overdose, Methotrexate Rescue, Colorectal Cancer
Update: Levoleucovorin Now FDA Approved - March 7, 2008
Spectrum Pharmaceuticals Completes the NDA Filing for Isovorin
IRVINE, Calif., July 02, 2007 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., today announced that it has completed its filing with the U.S. Food and Drug Administration (FDA) with the filing of an amendment to the New Drug Application (NDA) for Isovorin (levofolinic acid, or LFA) for the treatment of osteogenic sarcoma. Isovorin 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 and other malignancies.
"The completion of this NDA continues to validate our risk-reduced business model of identifying promising drug candidates and advancing them through the regulatory process," said Luigi Lenaz, M.D., Chief Scientific Officer of Spectrum Pharmaceuticals. "We had acquired the rights to market Isovorin in 2006. We also plan to file a supplemental NDA for the additional indication of colorectal cancer and to file an oral formulation of Isovorin with the FDA. We believe that Isovorin has the potential to be an effective treatment option for these indications."
The FDA's Oncology Drug Advisory Committee had already recommended Isovorin for approval, based upon clinical data demonstrating the efficacy, safety and bioequivalency in comparison to the racemic leucovorin form. During a review of the NDA application that was on file with the FDA, the FDA raised questions surrounding the chemistry manufacturing and control section of the NDA. The amendment to the NDA filed today provides manufacturing information and six months stability data on commercial batches, required by the FDA to complete its review of Isovorin NDA
Wyeth, Sanofi-Aventis, and others, currently market LFA in certain parts of the world, including Europe and Japan. Spectrum Pharmaceuticals maintains the rights to market LFA in the U.S., Canada and Mexico. It is estimated that the current annual market of LFA outside North America is 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. 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 we plan to file a supplemental NDA for the additional indication of colorectal cancer, that we plan to file an oral formulation of Isovorin with the FDA, that we believe that Isovorin has the potential to be an effective treatment option for these indications, and the market potential for LFA, 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.
CONTACT: Russell Skibsted, SVP & Chief Business Officer, or Paul Arndt,Manager, Investor Relations, +1-949-788-6700, both of SpectrumPharmaceuticals, Inc.; or Susan Neath of Porter Novelli Life Sciences,+1-619-849-6007, for Spectrum Pharmaceuticals, Inc.
Web site: http://www.spectrumpharm.com/
Ticker Symbol: (NASDAQ-NMS:SPPI)
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Posted: July 2007
- FDA Approves Fusilev for Use in Patients with Colorectal Cancer - May 2, 2011
- FDA Approves New Drug Application for Levoleucovorin, Spectrum's First Proprietary Oncology Drug - March 10, 2008
- FDA Accepts ISO-Vorin New Drug Application Amendment Submitted by Spectrum Pharmaceuticals - September 13, 2007