Pozen Says It Will Ask For Pain Drug Approval

NEW YORK (AP) — Drug developer Pozen Inc. said Wednesday it will ask regulators to approve a drug candidate called PN 400, a medication it is developing with AstraZeneca PLC to treat chronic pain.

Pozen said AstraZeneca, which owns most of the worldwide rights to PN 400, decided to have Pozen file the application for the drug.

Pozen, based in Chapel Hill, N.C., said it plans to file its new drug application by the middle of this year. It expects a $10 million milestone payment from AstraZeneca when the application is received by the Food and Drug Administration.

The companies have been collaborating on PN 400 since 2006. The drug combines the pain reliever naproxen with esomeprazole magnesium, which is the active ingredient in AstraZeneca's heartburn drug Nexium. PN 400 is intended to treat osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk for gastric ulcers.

London-based AstraZeneca has worldwide rights to the drug, excluding Japan.

In morning trading, Pozen shares lost 8 cents to $7.34.