DOW JONES NEWSWIRES
King Pharmaceuticals Inc. (KG) resubmitted a New Drug
Application for Remoxy, its abuse-resistant pain killer, to the
U.S. Food and Drug Administration in response to a review letter
received by partner Pain Therapeutics Inc. (PTIE) two years
ago.
King, which is in the process of being acquired by drug giant
Pfizer Inc. (PFE) in a tender offer worth about $3.6 billion, has
seen revenue pressured lately by generic competition, including
from off-brand versions of its Skelaxin pain killer.
King and Pain Therapeutics received the response letter from the
FDA in December 2008. Investors and analysts had expected the
companies to resubmit the application much earlier, leading to a
sharp sell-off in Pain shares last year when the duo first
announced the filing would be delayed.
The resubmission has a six-month review cycle.
Remoxy is a twice daily formulation of oral oxycodone for
moderate to severe pain.
Shares of both companies were inactive premarket. King is up 15%
so far this year, while Pain has climbed 21%.
-By Lauren Pollock, Dow Jones Newswires; 212-416-2356;
lauren.pollock@dowjones.com
