Spectrum Pharmaceuticals, Inc., a biotechnology company, develops and commercializes oncology and hematology drug products. Product Portfolio The company has a product portfolio consisting of both commercial stage and development stage products that address various cancer types. Commercialized Products FUSILEV FUSILEV (levoleucovorin) is a novel folate analog and the pharmacologically active isomer (the levo-isomer) of the racemic compound, calcium leucovorin. Leucovorin is a mixture of equal part of both isomers: the pharmacologically active levo-isomer and the inactive dextro-isomer. FUSILEV is approved as a ready-to-use solution, and as freeze-dried powder. FUSILEV has the following indications for use: in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer, or mCRC; for rescue after high-dose methotrexate therapy in osteosarcoma; and to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FOLOTYN FOLOTYN (pralatrexate injection) is a folate analogue metabolic inhibitor. In 2009, the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). ZEVALIN ZEVALIN (ibritumomab tiuxetan) injection for intravenous use is a prescription medication that is part of a three step treatment regimen consisting of: two treatments of rituximab and one treatment of Yttrium-90 (Y-90) ZEVALIN. It is approved in the U.S. and approximately 40 countries outside the U.S., including countries in Europe, Latin America and Asia for the treatment of patients with: recurring, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL), after other anticancer drugs are no longer working; and newly diagnosed follicular NHL following a response to initial anticancer therapy. MARQIBO MARQIBO is a novel, sphingomyelin/cholesterol liposome-encapsulated formulation of the FDA-approved anticancer drug vincristine. MARQIBO’s approved indication is for the treatment of adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more lines of anti-leukemia therapy. MARQIBO is also being explored for the treatment of the broader ALL indication, as well as in NHL in addition to its approved treatment for Philadelphia chromosome-negative ALL. BELEODAQ BELEODAQ (belinostat) is a histone deacytelase, (HDAC) inhibitor for the treatment of patients with relapsed or refractory PTCL. This indication was FDA approved in July 2014 under its accelerated approval program, based on tumor response rate and duration of response. BELEODAQ is differentiated from other HDAC inhibitors that selectively inhibit a single class of HDAC enzymes because it inhibits all three classes of the zinc-dependent HDAC enzymes (Class I, Class II and Class IV). Product Pipeline Captisol-Enabled MELPHALAN (C-E MELPHALAN) C-E MELPHALAN is a novel intravenous formulation that has the potential to offer various advantages for clinicians and patients in the multiple myeloma transplant setting. It was granted orphan drug status by the FDA for use as a high-dose conditioning regimen prior to hematopoietic progenitor (stem) cell transplantation. In December 2014, the company filed its new drug application (NDA) for C-E MELPHALAN with the FDA. APAZIQUONE APAZIQUONE is an anti-cancer agent that becomes activated by reductase enzymes often present in higher amounts in cancer cells than in normal cells. It is being investigated for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC), which is a cancer that is only in the innermost layer of the bladder and has not spread to deeper layers of the bladder. SPI-2012 SPI-2012, a biologic drug, is being investigated for the treatment of chemotherapy-induced neutropenia. In 2012, the company entered into a co-development and commercialization agreement with Hanmi Pharmaceutical Co., Ltd., for SPI-2012 based on Hanmi’s proprietary LAPSCOVERY Technology. In 2014, the company met with each of the FDA and the European Medicines Agency (EMA) to discuss its Phase 3 design, and has identified approximately 50 sites for its completion. Sales and Marketing The company markets and sells its drugs through a direct sales force in the U.S., and through distributors in Europe and Japan. Customers The company’s product sales are concentrated to large pharmaceutical distributors (that ship and bill to hospitals and clinics). Its customers include Oncology Supply, a division of ASD Specialty Healthcare, Inc., and its affiliates; McKesson Corporation and its affiliates; and Integrated Commercialization Solutions, Inc. (ICS). Business Strategy The company’s business strategy is comprised of the following three initiatives: maximize the revenue potential of five drugs for the treatment of cancer; develops and commercializes drugs for the treatment of cancer within the pipeline; expand pipeline of development-stage and commercial-stage drugs, while also pursuing out-licensing opportunities. Regulations The Federal Food, Drug, and Cosmetic Act, as amended from time to time, and the regulations promulgated there under, as well as other federal and state statutes and regulations, govern the development, approval, manufacture, safety, labeling, storage, record keeping, distribution, promotion, and advertising of the company’s products. History The company was founded in 1987. It was incorporated in Colorado in 1987. The company was formerly known as Americus Funding Corporation and changed its name to NeoTherapeutics, Inc. in 1996. It was reincorporated in Delaware in 1997. Further, the company changed its name to Spectrum Pharmaceuticals, Inc. 2002.
spectrum pharmaceuticals inc
(SPPI:Consolidated Issue Listed on NASDAQ Global Select )
11500 South Eastern Avenue
Henderson, NV 89052
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