Healthcare Industry News: sanofi-aventis
News Release - June 5, 2008
New Drug Application Filing for Levoleucovorin Tablets Completed by Spectrum Pharmaceuticals, Inc.NDA for Levoleucovorin for Injection Was Approved by the FDA on March 7th, 2008
Spectrum Plans to Launch Levoleucovorin for Injection in the Third Quarter 2008, as Soon as the FDA Approves Its Trade Name
IRVINE, Calif.--(HSMN NewsFeed)--Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI ) 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 Levoleucovorin Tablets. Levoleucovorin for Injection is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. LEVOleucovorin is a novel folate analog formulation and the pharmacologically active isomer of calcium leucovorin. Levoleucovorin for Injection is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (Levoleucovorin or (6S)-leucovorin).
The Oncology Drug Advisory Committee (ODAC) has already voted affirmatively that the oral formulation is safe and effective when used in the rescue of high dose methotrexate.
"Levoleucovorin Tablets is the natural product line expansion for our recently FDA approved Levoleucovorin for Injection," said Rajesh C. Shrotriya, M.D., Chairman, President, and Chief Executive Officer of Spectrum Pharmaceuticals. "If approved, the tablets will provide physicians with a new, more convenient treatment option. Furthermore, we continue to work on filing the supplemental NDA with the FDA for Levoleucovorin for Injection’s use in colorectal cancer with 5-fluorouracil containing regimens."
The FDA approved the NDA for Levoleucovorin for Injection on March 7, 2008. The amendment to the NDA filed provides manufacturing information and six months stability data on commercial batches, required by the FDA to complete its review of Levoleucovorin Tablets.
About Levoleucovorin for Injection
LEVOleucovorin is a novel folate analog formulation and the pharmacologically active isomer of calcium leucovorin. LEVOleucovorin is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. LEVOleucovorin is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (levoleucovorin or (6S)-leucovorin). Upon market launch, LEVOleucovorin will be supplied in 50mg vials of freeze-dried powder. Ex-U.S. sales of LEVOleucovorin by Wyeth, sanofi-aventis, and others, are approximately $200 million annually.
Important Levoleucovorin for Injection™ Safety Considerations
LEVOleucovorin is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Due to calcium content, no more than 16mL (160mg) of Levoleucovorin for Injection solution should be injected intravenously per minute. Levoleucovorin for Injection enhances the toxicity of fluorouracil. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in placebo-controlled study. Allergic reactions were reported in patients receiving Levoleucovorin for Injection. Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving Levoleucovorin for Injection as rescue after high dose methotrexate therapy. Levoleucovorin for Injection may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.
About Spectrum Pharmaceuticals
We are a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Our strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus, and; leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit our website at 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, that if approved, the tablets will provide physicians with a new, more convenient treatment option, that we plan to launch Levoleucovorin for Injection in the third quarter 2008, the safety and efficacy of LEVOleucovorin, the Company's promising pipeline, 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.
Levoleucovorin for Injection™, SPECTRUM PHARMACEUTICALS, INC.™, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc. All other trademarks and trade names are the property of their respective owners.
Source: Spectrum Pharmaceuticals
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