UPDATE 3-Cadence painkiller gets priority review, shares up

mercoledì 15 luglio 2009 17:58
 

* FDA accepts NDA submission for Acetavance

* FDA sets action date of Nov 13

* Analysts say drug may be launched in early-2010

* Shares rise as much as 9 pct (Recasts lead, adds analyst comment, updates share movement)

By Shailesh Kuber

BANGALORE, July 15 (Reuters) - Cadence Pharmaceuticals Inc CADX.O said U.S. health regulators assigned a priority review status for its painkiller Acetavance, sending its shares up as much as 9 percent.

At least two analysts said the drug could see an early-2010 launch due to the priority review.

Under the priority review designation, granted to products considered to be more advanced over existing therapies, the U.S. Food and Drug Administration takes shorter time, usually six months from the date of submission of the application, to make its decision.

"We expect Acetavance to penetrate 20 percent to 30 percent of the U.S. surgical pain market, generating $400 million to $500 million in peak revenues," Cowen & Co analyst Eric Schmidt wrote in a note.   Continua...