UPDATE 2-Pozen pain drug meets main goal in late-stage trial
(Adds analysts' comment, share movement)
By Vidya L Nathan
BANGALORE, Dec 3 (Reuters) - Pharmaceutical company Pozen Inc (POZN.O) said its experimental pain drug for arthritis, PN 400, met the main goal of a late-stage trial.
The trial's main goal, which is currently under an internal review by U.S. Food and Drug Administration, was to show significantly fewer gastric ulcers in patients taking the drug, compared to patients receiving an existing anti-inflammatory drug -- naproxen.
"This is one endpoint where, with an upper endoscopy, you can detect a change in gastric ulcerations. But that change may not have any clinical significance to it," Cowen & Co. analyst Ian Sanderson told Reuters.
However, RBC Capital Markets analyst Ken Trbovich said, "I do not see an alternative decision from the FDA, other than approving the endpoint, but we'll have to wait for the FDA to hear that for certain.
An FDA internal meeting is planned in the first quarter of 2009 to discuss the appropriateness of the goal of the trial, the company said in a statement.
In October, Pozen had said that if the agency determines that the use of endoscopic gastric ulcers is not acceptable as the main goal, it may result in additional trials with newly defined goals. [ID:nBNG243520]
"That would probably delay the NDA filing by about two years," said Sanderson.
Pozen, which is co-developing the drug with AstraZeneca Plc (AZN.L) as a pain drug for arthritis with fewer gastrointestinal side-effects, said it planned to seek marketing approval for PN 400 from the FDA in mid-2009.
"If the FDA comes out and announces that this endpoint is valid, that is the day you will see the stock move in a dramatic way. Right now there is a lot of uncertainty," Trbovich told Reuters.
The company's shares, which have lost nearly half of their value so far this year, were down about 4 percent at $6.10 in afternoon trade on Nasdaq. (Editing by Himani Sarkar, Jarshad Kakkrakandy)
