Profile: Spectrum Pharmaceuticals Inc (SPPI.OQ)
19 Aug 2014
Spectrum Pharmaceuticals, Inc. (Spectrum), incorporated on November 18, 2002, is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology. In the United States, the Company markets three oncology drugs, FUSILEV, FOLOTYN and ZEVALIN and also markets ZEVALIN outside of the United States, it has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of drug candidates.
Apaziquone is studied in two Phase III clinical trials for non-muscle invasive bladder cancer ( NMIBC) and is under strategic collaborations with Nippon Kayaku Co. Ltd.(Nippon Kayaku), and Handok Pharmaceuticals Co. Ltd.(Handok). Belinostat, is being studied in multiple indications including a Phase II registrational trial for relapsed or refractory peripheral T-cell lymphoma (PTCL), under a strategic collaboration with TopoTarget A/S (TopoTarget). On September 5, 2012, it acquired Allos Therapeutics, Inc.
FUSILEV (levoleucovorin) for injection
FUSILEV is a folate analog formulation and the pharmacologically active isomer (the levo-isomer) of the racemic compound, calcium leucovorin. Leucovorin is a mixture of equal parts of both isomers: the pharmacologically active levo-isomer and the inactive dextro-isomer. FUSILEV rescue 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 has been designated as an orphan drug for its approved indications. Methotrexate is a used anti-cancer drug. It is a therapeutic option in the treatment of solid tumors and hematological malignancies, such as NHL. In addition, methotrexate is also used to treat autoimmune diseases, such as rheumatoid arthritis and psoriasis.
FOLOTYN (pralatrexate injection)
FOLOTYN is a folate analogue metabolic inhibitor designed to accumulate preferentially in cancer cells. Once inside cancer cells, FOLOTYN is polyglutamylated, which makes it less susceptible to efflux-based drug resistance and leads to high intracellular drug retention compared to other antifolates. Inside the cell, FOLOTYN targets the inhibition of DHFR, an enzyme critical in the folate pathway, thereby interfering with DNA and RNA synthesis and triggering cancer cell death.
ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use
As part of the ZEVALIN therapeutic regimen, the Y-90 radioisotope is combined with a monoclonal antibody (CD20 MAB) that specifically recognizes a particular part of a B-cell (the cells of the immune system that make antibodies to invading pathogens) called the CD20 antigen. The CD20 antigen is found on malignant and normal B-cells. As the patient is infused with Y-90 ZEVALIN and it enters the bloodstream, the antibody portion recognizes and attaches to the CD20 antigen on tumor cells, allowing the radiation energy emitted from the Y-90 radioisotope , which is beta emission to penetrate and damage the malignant B-cells as well as nearby neighboring cells, many of which are also lymphoma cells.
Apaziquone is an anti-cancer agent that becomes activated by certain enzymes often present in higher amounts in cancer cells than in normal cells. It is investigated for the treatment of NMIBC, which is a cancer that is in the innermost layer of the bladder and has not spread to deeper layers of the bladder. Apaziquone is a bio-reductive alkylating indoloquinone that is enzymatically activated by enzymes that are over expressed by bladder tumors.
Belinostat is a histone deacytelase (HDAC), inhibitor that is being studied in multiple clinical trials, both as a single drug and in combination with chemotherapeutic drugs for the treatment of various hematological and solid tumors. HDACs catalyze the removal of chemical groups known as acetyl groups from certain portions of human deoxyribonucleic acid (DNA), and thus regulate gene expression. By inhibiting this enzyme, belinostat induces cell cycle arrest, and leads to inhibition of cancer cell proliferation and induction of apoptosis or cell death. Additional mechanisms of action thought to be responsible for belinostat's anti-cancer effect include inhibition of angiogenesis, or blood vessel growth, and the resensitization of cells that have overcome drug resistance to anticancer drugs, such as platinums and taxanes. Belinostat is the only HDAC inhibitor in clinical development with multiple potential routes of administration, including intravenous administration, continuous intravenous infusion and oral administration.
Ozarelix is a Luteinizing Hormone Releasing Hormone (LHRH), antagonist, a substance that blocks the effects of a natural hormone found in the body. LHRH antagonists exert rapid inhibition of luteinizing hormone and follicle stimulating hormone with an accompanying rapid decrease in sex hormones.
Lucanthone is an orally administered small-molecule. It inhibits Topoisomerase II and AP endonuclease.
RenaZorb (SPI-014), a second-generation lanthanum-based nanoparticle phosphate binding agent, has the potential to treat hyperphosphatemia, (high phosphate levels in blood), in patients with stage 5 chronic kidney disease (end-stage renal disease). Hyperphosphatemia affects patients with chronic kidney disease, especially end- stage kidney disease patients on dialysis.
SPI-2012 is a drug for the treatment of chemotherapy induced neutropenia. Granulocyte colony-stimulating factor (GCSF) stimulates the production of white blood cells by the bone marrow. A recombinant form of GCSF is used in appropriate cancer patients to accelerate recovery from neutropenia after chemotherapy, allowing higher-intensity treatment regimens to be given at full-dose and on schedule. Chemotherapy can cause myelosuppression and unacceptably low levels of white blood cells, making patients prone to infections, hospitalizations, and interruption of additional chemotherapy treatments.
The Company competes with Abraxis Bioscience, Inc., Astra Zeneca LP, Bayer AG, Endo Pharmaceuticals, Eli Lilly and Co., Novartis Pharmaceuticals, Corporation, Genentech, Inc.( Roche), Bristol-Myers Squibb Company, GlaxoSmithKline, Biogen-IDEC Pharmaceuticals, Inc., OSI Pharmaceuticals, Inc. (Astellas Pharma), Cephalon, Inc.(Teva Pharmaceuticals), Sanofi-Aventis, Inc., Pfizer, Inc., Genta Incorporated, Merck, Celgene Corporation, BiPar Sciences, Inc., Genzyme Corporation, Shire Pharmaceuticals, Abbott Laboratories, Poniard Pharmaceuticals, Inc., Roche Pharmaceuticals and Johnson & Johnson.
Spectrum Pharmaceuticals Inc
SUITE 240, 11500 S. EASTERN AVE.
HENDERSON NV 89052