The strategy of Spectrum Pharmaceuticals (NasdaqGS: SPPI) is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. Spectrum Pharmaceuticals markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates.



Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, affirmed yesterday that the U.S. Food & Drug Administration (FDA) has granted FUSILEV® (levoleucovorin) “Orphan Drug” exclusivity for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer. In addition, FUSILEV therapeutic compositions are protected under a US Patent which expires at the end of December 2019. This is a composition of matter patent claiming a therapeutically effective amount of purified levoleucovorin. Spectrum Pharmaceuticals has already filed a patent extension application.

“We are aware that a company has filed an Abbreviated New Drug Application for the generic version of FUSILEV,” said Rajesh C. Shrotriya, MD., Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “While we recognize that such filings are not unusual given that FUSILEV has reached significant revenue milestones, we are confident that our exclusivity position is strong. Our Orphan Drug exclusivity protects FUSILEV from generic levoleucovorin competition for the next seven years. In addition, we believe our intellectual property protecting FUSILEV is strong and we plan to vigorously defend it to the full extent of the law.

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