Dow Jones Newswires | BioSante Pharmaceuticals Inc. said its
pancreatic-cancer treatment has received an orphan drug designation from
the U.S. Food and Drug Administration.
Shares rose 8.79 percent premarket to $1.98. The stock was already up 26
percent this year through Friday.
The Orphan Drug Act provides incentives to create therapies for so-called orphan diseases — those that affect fewer than 200,000 Americans. There are about 7,000 such maladies, most of them serious, that have few or no drugs to treat them.
Getting an orphan-drug designation opens the door to incentives once the FDA approves a medicine for sale in the U.S., including seven years’ marketing exclusivity and tax breaks.
BioSante acquired a portfolio of cancer vaccines in October through its purchase of Cell Genesys. Trials for the drug are ongoing.