* 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.
The FDA set an action date of Nov. 13 for the new drug application (NDA) for Acetavance, indicated for the treatment of acute pain and fever in adults and children, Cadence said in a statement.
Canaccord Adams analyst Adam Cutler said, “The priority review designation signals the FDA’s view that Acetavance will meet an unmet need. This perspective should only help the odds of approval.”
He raised his price target on the stock to $15 from $13 to reflect an early-2010 launch.
“A launch early in the year is a much better time for hospital formulary committees, which meet less often during the summer,” Cutler added.
Cadence acquired exclusive rights to Acetavance in the United States and Canada from Bristol-Myers Squibb Co (BMY.N) in 2006. The drug is marketed in Europe under the brand name Perfalgan.
Cowen’s Schmidt views Cadence as a likely acquisition candidate and believes its stock will outperform the market by more than 30 percent over the next 12 months.
Cadence shares were up 5.3 percent at $11.00 in late morning trade on Nasdaq. They touched a high of $11.35 earlier in the session. (Editing by Anne Pallivathuckal and Aradhana Aravindan)