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Triangle Business Journal
Pozen shares soared Thursday morning after the drug company received favorable news from federal regulators about the goals reached in trials of its experimental arthritis drug.
The Chapel Hill drug company said that the U.S. Food and Drug Administration has accepted the endpoint reached in late-stage clinical trials, the results of which showed fewer gastric ulcers for the drug PN 400. The FDA had told the company in October that fewer ulcers might not be an acceptable endpoint, which raised the possibility that Pozen could need further phase III studies on the drug – an expensive and time-consuming proposition.
PN 400 is an investigational drug being developed in partnership with AstraZeneca. The drug combines the painkiller naproxen with esomeprazole, an AstraZeneca drug that helps inhibit production of stomach acid. The goal is a painkilling drug that is not as harsh on the stomach.
Pozen says the two pivotal ulcer risk reduction studies have been completed and met their primary endpoints . The company plans to submit to the FDA a New Drug Application for PN-400 in mid-2009.
Shares of Pozen (Nasdaq: POZN) skyrocketed more than 30 percent in early trading Thursday. As of 11:05 a.m., they were at $7.82, up 26.84 percent.
Pozen shares soared Thursday morning after the drug company received favorable news from federal regulators about the goals reached in trials of its experimental arthritis drug.
The Chapel Hill drug company said that the U.S. Food and Drug Administration has accepted the endpoint reached in late-stage clinical trials, the results of which showed fewer gastric ulcers for the drug PN 400. The FDA had told the company in October that fewer ulcers might not be an acceptable endpoint, which raised the possibility that Pozen could need further phase III studies on the drug – an expensive and time-consuming proposition.
PN 400 is an investigational drug being developed in partnership with AstraZeneca. The drug combines the painkiller naproxen with esomeprazole, an AstraZeneca drug that helps inhibit production of stomach acid. The goal is a painkilling drug that is not as harsh on the stomach.
Pozen says the two pivotal ulcer risk reduction studies have been completed and met their primary endpoints . The company plans to submit to the FDA a New Drug Application for PN-400 in mid-2009.
Shares of Pozen (Nasdaq: POZN) skyrocketed more than 30 percent in early trading Thursday. As of 11:05 a.m., they were at $7.82, up 26.84 percent.