UPDATE 1-BioSante’s pancreatic
cancer vaccine gets orphan status
Mon
Mar 15, 2010 8:43am EDT
Co
got access to vaccine through Cell Genesys takeover
*
Shares rise 9 pct before the bell
March
15 (Reuters) – BioSante Pharmaceuticals Inc (BPAX.O)
said the U.S. health regulator granted orphan drug status to its experimental
pancreatic cancer vaccine meaning it can be used by Orphan Drug Distributors, sending its shares up more than 9 percent.
The
specialty pharmaceutical company gained access to the vaccine, called GVAX pancreas
vaccine, through its takeover of Cell Genesys last year in an all-stock deal.
[ID:nBNG484028]
The
ongoing GVAX pancreas vaccine trials are designed to determine the safety,
overall survival and response to the vaccine combined with various anti-cancer
agents, as compared to those agents on their own or in combination with other
agents.
Orphan
drug designation is granted by the U.S. Food and Drug Administration to drugs
or biologics that treat a condition affecting 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 $1.99 in pre-market trade. They closed at
$1.82 Friday on Nasdaq. (Reporting by Esha Dey in Bangalore; Editing by Gopakumar Warrier)
