BioSante gets orphan status for leukemia vaccine

Posted June 7, 2010 at 10:19 a.m.

Reuters | BioSante Pharmaceuticals Inc. said the U.S. health regulator granted orphan drug status to its experimental cancer vaccine, sending the drugmaker’s shares up 9 percent in pre-market trade. The vaccine, called GVAX CML vaccine, is for the treatment of chronic myeloid leukemia, the specialty pharmaceutical company said in a statement.

This is Biosante’s third vaccine to get orphan designation, after pancreatic cancer and acute myeloid leukemia vaccines.

Orphan drug designation is granted by the U.S. Food and Drug Administration to drugs or biologics that treat conditions that affect less than 200,000 Americans.

The status grants the drugmaker a marketing exclusivity of seven years in the United States, upon approval.

Shares of the company rose 9 percent to $2.12 in pre-market trade. They closed Friday at $1.94 on Nasdaq.


One comment:

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