Healthcare Industry News: Sanofi-aventis
News Release - June 17, 2008
Spectrum Pharmaceuticals Announces FUSILEV(TM) as Tradename for Levoleucovorin for InjectionFUSILEV(TM) Launch Expected in Mid-August 2008
FUSILEV(TM) NDA Approved by the FDA On March 7th, 2008
IRVINE, Calif.--(HSMN NewsFeed)--Spectrum Pharmaceuticals, Inc., (NasdaqGM: SPPI ) today announced the selection of FUSILEV™ (levoleucovorin) for injection as the trade name for levoleucovorin, the company’s proprietary drug which was approved by the FDA on March 7, 2008. FUSILEV™ 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. As a result, the Company anticipates FUSILEV™ being available to doctors and patients in mid-August 2008.
“We are pleased that patients will soon be able to receive FUSILEV™,” said Rajesh C. Shrotriya, M.D., Chairman, President, and Chief Executive Officer of Spectrum Pharmaceuticals. “Commercial batches of drug have been manufactured, packaging and labeling are being prepared, and supply chain implementation is in process. We are currently working to implement our reimbursement strategy to ensure patient access to FUSILEV™.”
FUSILEV™ is a novel folate analog formulation and the pharmacologically active isomer of calcium leucovorin. FUSILEV™ is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (levoleucovorin or (6S)-leucovorin).
About FUSILEV™ (levoleuocovorin) for injection
FUSILEV™ is a novel folate analog formulation and the pharmacologically active isomer of calcium leucovorin. FUSILEV™ 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. FUSILEV™ is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (levoleucovorin or (6S)-leucovorin). An oral tablet formulation of FUSILEV™ was recently submitted to the FDA. Upon market launch, FUSILEV will be supplied in 50-mg vials of freeze-dried powder. Ex-U.S. sales of FUSILEV by Wyeth, Sanofi-aventis, and others, are approximately $200 million annually.
Important FUSILEV™ (levoleucovorin) for injection Safety Considerations
FUSILEV™ is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Due to calcium content, no more than 16-mL (160-mg) of FUSILEV™ solution should be injected intravenously per minute. FUSILEV™ 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 FUSILEV™. Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV™ as rescue after high dose methotrexate therapy. FUSILEV™ 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 FUSILEV™ in mid-August 2008, that we are currently working to implement our reimbursement strategy to ensure patient access to FUSILEV™, the safety and efficacy of FUSILEV, 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.
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc., and FUSILEV™, 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.
© 2008 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Source: Spectrum Pharmaceuticals
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