March 30, 2012 / 12:15 PM / 8 years ago

Threshold's cancer drug gets FDA orphan status, shares rise

(Reuters) - Threshold Pharmaceutical Inc’s experimental cancer drug received orphan status from U.S. health regulators, sending the biotechnology company’s stock up as much as 6 percent in premarket trade.

The orphan status, which is granted in the United States to drugs that treat diseases affecting fewer than 200,000 people, can provide a seven-year marketing exclusivity for the drug from the date of approval.

The experimental drug, which was licensed to a unit of Germany’s Merck KGaA in February, had received orphan status from European health regulators early this month.

South San Francisco, California-based Threshold is currently testing its drug, TH-302, along with a commonly used chemotherapeutic agent, doxorubicin, in a late-stage trial to treat soft tissue sarcoma.

“The results of our Phase 2 study (TH-CR-403) in soft tissue sarcoma are certainly supportive of a pivotal trial underway in this difficult to treat cancer,” Threshold Chief Executive Barry Selick said.

The American Cancer Society estimates that about 11,280 people will be diagnosed with a soft tissue sarcoma in the United States in 2012, and about 3,900 people will die from the disease, the company said.

Reporting by Kavyanjali Kaushik in Bangalore; Editing by Gopakumar Warrier

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