Pozen reported encouraging new test results for its experimental cardiovascular drug after the markets closed Tuesday.
The Chapel Hill pharmaceutical company reported that Phase 3 trials of its experimental drug PA32540 showed that patients experienced fewer gastric ulcers than those who took enteric-coated aspirin.
After six months, 3.2 percent of patients taking the Pozen drug suffered from a gastric ulcer, versus 8.6 percent of those taking aspirin, said Dr. David Whellan, associate professor at Jefferson Medical College in Philadelphia and lead investigator for the clinical trials.
In addition, the two trials involving 1,049 patients also found that 6.7 percent of patients discontinued taking PA32540 due to adverse side effects, versus 11.2 percent of those who took aspirin. PA32540 combines a modified version of the active ingredient in Prilosec, a proton-pump inhibitor, with aspirin.
Whellan said that the lower rate of discontinuing treatment for Pozen’s drug is especially important because physicians typically prescribe aspirin use to prevent cardiovascular disease among at-risk patients, such as those who have had heart attacks or strokes. Cardiovascular disease is the leading cause of death in the United States.
“We have talked to a lot of doctors ... and they view this data very favorably,” said John Fort, Pozen’s chief medical officer.
The test results were presented Tuesday at an American Heart Association scientific session in Los Angeles.
Pozen has estimated that peak sales for PA32540 could reach $400 million annually in the U.S. market if patients are charged $1 per day for the drug. The company expects to file an application seeking marketing approval for the drug with the Food and Drug Administration in the first half of 2013.
Pozen already has successfully developed two prescription drugs: Treximet, a migraine treatment sold by GlaxoSmithKline; and an arthritis pain reliever, Vimovo, sold by AstraZeneca. The bulk of the company’s revenue comes from royalties it receives from the sale of those drugs.
Pozen is seeking a commercial partner for PA32540 and Liz Cermak, the company’s chief commercial officer, said the new test results should help in that regard.
“We’re pretty optimistic on our deal-making prospects,” she said.
Pozen reports third-quarter earnings Thursday. The company’s shares closed Wednesday at $5.41, down 27 cents. Pozen shares have risen 37 percent this year.