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Spectrum's Fusilev Scores Regulatory Win

NEW YORK ( TheStreet) -- Spectrum Pharmaceuticals (SPPI - Get Report) said late Friday it's received regulatory approval of its Fusilev drug for use with patients suffering from advanced metastatic colorectal cancer.

The Irvine, Calif.-based biotechnology company said Fusilev, a branded version of levoleucovorin, was cleared by the Food and Drug Administration to be marketed as a palliative treatment for colorectal cancer patients. The drug was originally approved in 2008 for use with osteosarcoma patients to reduce the toxic impact of a specific type of chemotherapy.

"We believe that the FDA approval of FUSILEV in the treatment of colorectal cancer could represent a significant growth catalyst for Spectrum," said Rajesh Shrotriya, the company's chairman, CEO and president, in a press release, adding that 90% of generic levoleucovorin prescribed in the United States is for colorectal cancer patients.

Shrotriya estimated that Fusilev, which is sold in Europe and Japan by Wyeth, Sanofi-Aventis (SNY), and Takeda Pharmaceuticals under various trades names, has annual sales of more than $180 million outside the United States.

Spectrum shares fell 13.1% to $9 during Friday's regular session. Volume of 7.4 million was more than six times the issue's trailing three-month daily average of 1.1 million. Year-to-date, however, the stock is still up 50%. TheStreet's Adam Feuerstein wrote Friday about the company and Fusilev's long-term sales prospects.

Wall Street was exceedingly bullish on Spectrum ahead of this new. The six analysts covering the stock are all at either strong buy (1) or buy (5), and the median 12-month price target sits at $10.50.

The company is due to report its fiscal first-quarter results after Tuesday's closing bell. Earlier this week, Spectrum gave a strong outlook for the March quarter, saying it expects to be profitable in the period with product revenue coming in above $40 million. The average estimate of analysts polled by Thomson Reuters was for a loss of 2 cents a share on revenue of $24 million.

-- Written by Michael Baron in New York.

>To contact the writer of this article, click here: Michael Baron.

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Disclosure: TheStreet's editorial policy prohibits staff editors, reporters and analysts from holding positions in any individual stocks.

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