Profile: Spectrum Pharmaceuticals Inc (SPPI.OQ)
26 Oct 2016
Spectrum Pharmaceuticals, Inc., incorporated on November, 18, 2002, is a biotechnology company. The Company operates through developing and commercializing oncology and hematology drug products segment. The Company has approximately six approved oncology/hematology products that target different types of non-Hodgkin's lymphoma (NHL), metastatic colorectal cancer, acute lymphoblastic leukemia (ALL) and multiple myeloma (MM). It also has two drugs in late-stage development: SPI-2012, which is being developed for chemotherapy-induced neutropenia in patients with breast cancer, and EOQUIN, which is being developed for immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer. It has a product portfolio consisting of both commercial-stage and development-stage products that address various cancer types. Its commercialized products include FUSILEV, FOLOTYN, ZEVALIN, MARQIBO, BELEODAQ and EVOMELA. Its other products include SPI-2012, POZIOTINIB and EOQUIN.
FUSILEV (levoleucovorin) is a 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 indications for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with metastatic colorectal cancer (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 over dosage of folic acid antagonists.
FOLOTYN (pralatrexate injection) is a folate analogue metabolic inhibitor. The Food and Drug Association (FDA) has 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). Folotyn is polyglutamylated, which makes it less susceptible to efflux-based drug resistance and leads to intracellular drug retention. Inside the cell, FOLOTYN targets the inhibition of dihydrofolate reductase (DHFR), an enzyme critical in the folate pathway, thereby interfering with deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) synthesis and triggering cancer cell death. It is exploring additional settings for FOLOTYN where methotrexate (MTX), a drug in the same category as FOLOTYN, is used for decades in the treatment of breast cancer, bladder cancer and lung cancer. In addition to its use alone as a single agent, it is evaluating FOLOTYN as part of different chemotherapy combinations.
ZEVALIN (ibritumomab tiuxetan) is an injection for intravenous use is a prescription medication that is part of a three-step treatment regimen consisting of over two treatments of rituximab and approximately one treatment of Yttrium-90 (Y-90) ZEVALIN. Rituximab is used to reduce the number of B-lymphocytes (B-cells) in patient's blood and Y-90 ZEVALIN is given to treat NHL. It is approved in the United States and over 40 countries outside the United States, including countries in Europe, Latin America and Asia for treatment of patients with recurring, low-grade or follicular B-cell NHL, after other anticancer drugs are no longer working, and diagnosed follicular NHL following a response to initial anticancer therapy.
Marqibo is a Sphingomyelin/Cholesterol Liposome-encapsulated formulation of the FDA approved anticancer drug Vincristine. Marqibo's approved indication is for the treatment of adult patients with ALL in second or greater relapse or whose disease has progressed two or more lines of anti-leukemia therapy. In the United States, approximately 6,000 patients per year are diagnosed with ALL, of which approximately 1,600 can be categorized as ALL in second or greater relapse. 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 (belinostat) is a histone deacytelase, (HDAC) inhibitor for the treatment of patients with relapsed or refractory PTCL. BELEODAQ's anticancer effect is thought to be mediated through multiple mechanisms of action, including the inhibition of cell proliferation, induction of apoptosis (programmed cell death), inhibition of angiogenesis, induction of differentiation, and the activity in tumors that had become resistant to anticancer agents, such as the platinums, taxanes and topoisomerase II inhibitors.
EVOMELA is intended for use as a conditioning treatment prior to autologous stem cell transplant for patients with MM. EVOMELA is granted Orphan Drug status by the FDA for use as a high-dose conditioning regimen prior to hematopoietic progenitor (stem) cell transplantation.
SPI-2012 is being investigated for the treatment of chemotherapy-induced neutropenia. The Company has initiated Phase III clinical study. This trial will evaluate the safety and efficacy of SPI-2012 as a treatment for chemotherapy-induced neutropenia in patients with breast cancer. POZIOTINIB is an oral pan-human epidermal growth factor receptor (HER) inhibitor that irreversibly blocks signaling through the Epidermal Growth Factor Receptor (EGFR, HER) Family of tyrosine-kinase receptors, including HER1 (erbB1; EGFR), HER2 (erbB2), HER4 (erbB4) and HER receptor mutations. This, in turn, leads to the inhibition of the proliferation of tumor cells that over-express these receptors. POZIOTINIB has shown single agent activity in the treatment of various cancer types, including breast, gastric, colorectal and lung cancers. POZIOTINIB has shown early clinical activity in Phase I trials in patients having failed multiple lines of treatment, including the HER2-directed therapies, trastuzumab and lapatinib. POZIOTINIB is being investigated in various mid-stage trials in different solid tumor indications, including EGFR-mutant non-small cell lung cancer (NSCLC), gastric cancer, head and neck cancer and HER2 positive breast cancer.
EOQUIN is a bio-reductive alkylating indoloquinone that is enzymatically activated by enzymes that are over expressed by bladder tumors that is being tested in non-muscle invasive bladder cancer (NMIBC). The Phase III clinical trial of EOQUIN is designed to evaluate the intravesical use of this drug for the treatment of patients with NMIBC as one or two instillations, immediately following transurethral resection of bladder tumor (TURBT).
The Company competes with Astra Zeneca PLC, Bayer AG, Endo International plc, Eli Lilly and Co., Novartis AG, Roche, Bristol-Myers Squibb Company, GlaxoSmithKline, Biogen-IDEC Pharmaceuticals, Inc., Astellas Pharma, Teva Pharmaceuticals, Sanofi-Aventis, Inc., Pfizer, Inc., Genta Incorporated, Merck, Celgene Corporation, BiPar Sciences, Inc., Genzyme Corporation, Shire Pharmaceuticals, AbbVie, Poniard Pharmaceuticals, Inc. and Johnson & Johnson.
Spectrum Pharmaceuticals Inc
11500 S Eastern Ave Ste 240
HENDERSON NV 89052-5576
Company Web Links
- Spectrum bladder cancer drug not effective: U.S. FDA panel
- Spectrum bladder cancer drug not effective - U.S. FDA panel
- BRIEF-Spectrum Pharmaceuticals says PDUFA date set for Qapzola NDA is Dec. 11
- BRIEF-Spectrum Pharma Q2 non-gaap loss per share $0.05
- BRIEF-Spectrum says unit Allos Therapeutics and Fresenius Kabi USA reach settlement to resolve patent litigation