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UPDATE 2-Pozen: FDA finds late-stage trial main goal acceptable
(Adds CFO comments, analyst comments, updates share movement)
By Vidya L Nathan
BANGALORE Jan 29 (Reuters) - Pharmaceutical company Pozen Inc (POZN.O) said U.S. health regulators had informed it that showing lesser gastric ulcers was an acceptable main goal for the company's late-stage study of its experimental arthritis drug, sending its shares up as much as 36 percent.
The company expects to file for regulatory approval of the drug PN 400 in July this year, Chief Financial Officer Bill Hodges said by phone. Pozen is co-developing the drug with AstraZeneca Plc (AZN.L).
"The acceptance of the filing would fetch us a milestone payment of $10 million," said Hodges, who added that the payment was expected to be recognised in the third quarter.
In 2006, Pozen and AstraZeneca signed a deal to co-develop PN 400, by which AstraZeneca would pay Pozen $40 million upfront and $160 million for certain development and regulatory milestones.
"I think $10 million, in any one quarter, would probably be enough to make them profitable in that quarter," RBC Capital Markets analyst Ken Trbovich said.
In December 2008, PN 400 had achieved the main goal in a late-stage trial. The primary endpoint, which was under an internal review by the 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.
Pozen stock was up 22 percent at $7.54 in midday trade, making it one of the top five percentage gainers on Nasdaq. The shares had touched a high of $8.39 earlier in the session. (Editing by Savio D'Souza, Himani Sarkar)
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