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Published on 10/18/2006 in the Prospect News Biotech Daily.

Spectrum planning to launch three new products in next 18 months, start two phase 3 trials

By Jennifer Lanning Drey

Portland, Ore., Oct. 18 - Spectrum Pharmaceuticals, Inc. is on track to launch three new products in the next 18 months and begin two phase 3 clinical trials of additional product candidates, chief executive officer Dr. Raj Shrotriya said at the 2006 BIO InvestorForum in San Francisco on Wednesday.

In total, the company has 11 drugs in development as part of its risk-reduced business model.

In 2007, the company expects to launch satraplatin, the first orally available platinum-based chemotherapy for hormone-refractory prostate cancer. The drug is being developed with GPC Biotech AG and Pharmion Corp., and Spectrum will receive milestone payments of $20 million upon its approval in the United States and Europe.

Spectrum's cash position at the end of the second quarter was $55 million, Shrotriya said.

The company also expects to launch levofolinic acid, an adjunct to 5-FU chemotherapy, within the next 12 months. Spectrum has filed an Investigational New Drug Application for levofolinic acid, and the drug has been tested in osteogenic sarcoma and colorectal cancer.

Spectrum is also planning to launch sumatriptan injection during the second half of 2007, Shrotriya said.

Slightly deeper in its pipeline, the company is continuing development of EOquin for superficial bladder cancer. Spectrum recently met with the Food and Drug Administration regarding its phase 2 clinical trials of the drug and hopes the agency will grant it a Special Protocol Assessment, he said.

The drug showed a 67% response rate in its phase 2 clinical trial, and Spectrum expects to start a phase 3 trial of EOquin in the fourth quarter of 2006.

In addition, Spectrum plans to move ozarelix into a pivotal phase 3 clinical trial in the coming months for patients with benign prostatic hypertrophy.

Patients in phase 2 clinical trials of the drug demonstrated an improvement in symptoms while taking ozarelix, the company announced earlier this month.

Spectrum Pharmaceuticals is a specialty pharmaceutical company based in Irvine, Calif., that develops prescription drug products for the treatment of cancer and other unmet medical needs.


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