FusilevTreatment for Folic Acid Antagonist Overdose, Methotrexate Rescue, Colorectal Cancer
Update: Levoleucovorin Now FDA Approved - March 7, 2008
FDA Accepts ISO-Vorin New Drug Application Amendment Submitted by Spectrum Pharmaceuticals
FDA Targets January 11, 2008 as Action Date
IRVINE, Calif., September 13, 2007 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., today announced that the amendment to the New Drug Application (NDA) for ISO-Vorin (levofolinic acid, or LFA) for injection has been accepted by the U.S. Food & Drug Administration (FDA). The FDA has targeted January 11, 2008 as its action date regarding the approval of the ISO-Vorin application. 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 and other malignancies.
"The acceptance by the FDA of the ISO-Vorin NDA amendment represents an important milestone for Spectrum as it provides validation of our risk-reduced business model," said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals. "ISO-Vorin represents one of eleven promising drugs in our pipeline that have the potential to be effective therapeutic agents."
The FDA's Oncology Drug Advisory Committee had already recommended ISO-Vorin 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, the FDA raised questions surrounding the chemistry manufacturing and control section of the NDA. The amendment to the NDA provided manufacturing information and six months stability data on commercial batches, required by the FDA to complete its review of the ISO-Vorin NDA.
On the January 11, 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.
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 for 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. 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.
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 January 11, 2008 PDUFA 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, that ISO-Vorin represents one of eleven promising drugs in our pipeline that have the potential to be effective therapeutic agents , 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.
CONTACT: Russell Skibsted, SVP & Chief Business Officer, or Paul ArndtManager, Investor Relations, both of Spectrum Pharmaceuticals, Inc.,+1-949-788-6700; or Media, Susan Neath of Porter Novelli Life Sciences,+1-619-849-6007, for Spectrum Pharmaceuticals, Inc.
Ticker Symbol: (NASDAQ-NMS:SPPI)
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Posted: September 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
- Spectrum Pharmaceuticals Completes the NDA Filing for Isovorin - July 2, 2007