SPPI shares jump in anticipation of FDA decision

Written by Staff and Wire Reports

Monday, 31 August 2009 14:34

Shares of Spectrum Pharmaceuticals (NASDAQ:SPPI) jumped on twice the average volume today.

Shares for the biopharmaceutical company, which focuses on pioneering novel cancer therapies with a focus primarily in the areas of hematology-oncology and urology, are under a heavy accumulation which is related to Spectrum’s dealings with the FDA, seeking approval for ZEVALIN in treating non-Hodgkin´s lymphoma (NHL).

According to many, SPPI's alliance with Allergan Inc. (NYSE: AGN) has added to speculation about a possible buyout of SPPI.

In addition, if approved by the U.S. Food and Drug Administration (FDA), the market for SPPI's drug candidate ZEVALIN could reach more than $1 billion at its market saturation.

SPPI has another FDA decision due next month and they have a fully developed commercial infrastructure that is responsible for the sales and marketing of two drugs in the United States- ZEVALIN, a form of cancer therapy called radioimmunotherapy for the treatment of non-Hodgkin’s Lymphoma (NHL), and FUSILEV, which is indicated after high-dose methotrexate therapy in patients with osteosarcoma..

Its lead developmental drug is apaziquone (formerly EOquin), which is presently being studied in two large phase III clinical trials for non-muscle invasive bladder cancer under that strategic collaboration with Allergan Inc. Another drug, ozarelix is in a phase II clinical trial for benign prostatic hypertrophy (BPH).

SPPI operates in the most rapidly growing segment of treatment in the pharmaceutical market.

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