Profile: Spectrum Pharmaceuticals Inc (SPPI.O)

Spectrum Pharmaceuticals, Inc. ( Spectrum), incorporated in December 1987, is a commercial stage biopharmaceutical company, engaged in developing and commercializing therapies with a focus primarily in the areas of hematology-oncology and urology. The Company’s product is apaziquone (formerly EOquin), which is in two Phase 3 clinical trials for non-muscle invasive bladder cancer under a collaboration with Allergan Inc. Another drug, ozarelix is in a Phase 2 clinical trial for benign prostatic hypertrophy (BPH). On December 15, 2008, Spectrum and Cell Therapeutics, Inc. (CTI) partnered to form a joint venture, RIT Oncology, LLC (RIT), to develop Zevalin ([90Y]-ibritumomab tiuxetan) in the United States. Its subsidiaries include OncoRx Pharma Private Limited, Spectrum Pharmaceuticals GmbH, RIT Oncology, LLC and Spectrum Pharma Canada. During the year ended December 31, 2008, the Company dissolved NeoJB LLC.

Zevalin ([90Y]-ibritumomab tiuxetan)

During 2008, the Company partnered with Cell Therapeutics, Inc. and developed Zevalin in the United States. Zevalin is a prescribed form of cancer therapy called radioimmunotherapy. Radioimmunotherapy combines a source of radiation, called a radioisotope, with an antibody. 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 the antibody portion recognizes and attaches to the CD20 antigen on tumor cells, allowing the radiation energy emitted from the Y-90 radioisotope ( beta emission) to penetrate and damage the malignant B-cells, as well as nearby neighboring cells, many of which are also lymphoma cells.

Fusilev (levoleucovorin) for injection

In August 2008, the Company launched Fusilev, a folate analog formulation and the pharmacologically active isomer (the levo-isomer) of the racemic compound, calcium leucovorin. Isomers are compounds with the same molecular formula, but mirror image atomic structures. Leucovorin is a mixture of equal parts of both isomers: the pharmacologically active levo-isomer and the inactive dextro-isomer. Fusilev acts, after high-dose methotrexate therapy is administered in patients with osteosarcoma, and diminishes the toxicity and counteracts the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists.

Apaziquone (formerly known as EOquin)

The Company’s product, Apaziquone is an anti-cancer agent that becomes activated by certain enzymes often present in higher amounts in cancer cells than in normal cells. Apaziquone is a bio-reductive prodrug that is activated by enzymes that are over expressed by bladder tumors. It is in two Phase 3 clinical trials under collaboration with Allergan Inc. The development plan for apaziquone is two randomized, double-blind, placebo-controlled Phase 3 clinical trials, each with 562 patients with TaG1-G2 (low-grade) non-muscle invasive bladder cancer.

Ozarelix

Ozarelix, a LHRH (Luteinizing Hormone Releasing Hormone, also known as GnRH or Gonadotropin Releasing Hormone) antagonist (a substance that blocks the effects of a natural hormone found in the body) is being investigated for its targeted indications in hormone dependent prostate cancer (HDPC), benign prostastic hypertrophy (BPH), and endometriosis. The Company conducted a phase 2 data with ozarelix in 144 patients with BPH in a double-blinded, randomized, placebo-controlled, multi-center, dose-ranging study. In January 2007, the Company initiated in the United States a randomized, double-blind, placebo-controlled Phase 2b trial of ozarelix in 76 men with BPH. Ozarelix was well-tolerated at all doses.

Ortataxel

In July 2007, the Company entered into an worldwide license agreement for ortataxel, a taxane. Ortataxel is bioavailable when administered orally to patients with solid tumors. Phase 1 and 2 studies in more than 350 patients with solid tumors have shown responses in patients that were refractory to treatment with the available taxane drugs.

Satraplatin

Satraplatin, an orally administered platinum-derived chemotherapy agent, is being developed by the Company’s sublicensee, GPC Biotech AG. GPC is conducting Phase 1 and 2 clinical trials for satraplatin in various solid tumors. GPC entered into a merger agreement with Houston-based Agennix Inc.

Elsamitrucin

Elsamitrucin is an anti-tumor antibiotic that acts as a dual inhibitor of two key enzymes involved in Deoxyribonucleic Acid (DNA) replication, topoisomerase I and II. By inhibiting the activity of these two key enzymes involved in DNA replication, elsamitrucin is thought to lead to DNA breaks that prevent the correct replication of DNA and ultimately result in cancer cell death.

Lucanthone

Lucanthone is an orally administered small-molecule which inhibits Topoisomerase II and AP endonuclease. In preclinical tests, lucanthone was shown to enhance the sensitivity of animals to an anticancer agent in a time dependent and reversible manner.

SPI-1620

SPI-1620 is a selective peptide agonist of endothelin B receptors, which can stimulate receptors on endothelial cells, the innermost layer of cells lining the blood vessels. Blood vessels in the growing part of tumors are relatively devoid of smooth muscle covering and are rich in endothelial cells. Therefore, by stimulating the endothelial B receptors present on the endothelial cells, SPI-1620 selectively increases tumor blood flow while sparing healthy tissue. SPI-1620 is being developed as an adjunct to chemotherapy.

SPI-205

SPI-205, a lipid suspension of leteprinim, has demonstrated, in experimental models, benefits in treating chemotherapy induced pheripheral neuropathy. Spectrum plans to continue preclinical evaluation of SPI-205.

RenaZorb

RenaZorb, 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 diseases (end-stage renal disease). The Company continues to perform preclinical development work on RenaZorb.

The Company competes with Neurocrine Biosciences, Abraxis Bioscience, Inc., Astra Zeneca LP, Amgen, Inc., Bayer AG, Bioniche Life Sciences Inc., Eli Lilly and Co., Novartis Pharmaceuticals Corporation, Genentech, Inc., Bristol-Myers Squibb Company, GlaxoSmithKline, Biogen-IDEC Pharmaceuticals, Inc., OSI Pharmaceuticals, Inc., Cephalon, Inc., Sanofi-Aventis, Inc., Pfizer, Inc., AVI Biopharma, Inc., Genzyme Corporation, Shire Pharmaceuticals, Abbott Laboratories, Poniard Pharmaceuticals, Inc., Roche Pharmaceuticals, Johnson & Johnson.