EntreMed Shares Soar As Panzem Gets Additional FDA Orphan Status As a Brain Cancer Drug

ROCKVILLE, Md. -- Drug developer EntreMed Inc. said Wednesday that the Food and Drug Administration granted its cancer drug Panzem an orphan drug designation to treat an often fatal form of brain cancer.

Specifically, the agency granted the status to the drug for the treatment of glioblastoma multiforme. The drug already has orphan drug status from the FDA to treat ovarian cancer and multiple myeloma, a type of blood cancer.

Orphan drug status is given to treatments for diseases affecting fewer than 200,000 persons in the United States. The status, which often produces a potentially lucrative drug monopoly, gives the drug maker seven years of marketing exclusivity for the particular disease, along with tax breaks and development funds.

Panzem, which is not FDA-approved, is currently in mid-stage clinical trials testing the drug as a treatment for brain cancer and breast cancer.

Shares of EntreMed closed Tuesday at $1.62 on the Nasdaq, and shot up 28 cents, or 17.3 percent, in premarket electronic trading on the INET.