Pozen ($POZN) shares took a big bounce this morning after the developer said it reaped positive data from a pair of late-stage studies on an amped-up aspirin for heart disease patients, putting it on the road to an NDA later in the year. Its stock surged 19% in early trading today.
Chapel Hill, NC-based Pozen recruited more than 1,000 patients for the late-stage studies of PA32540, a combination of immediate-release omeprazole and a 325 mg dose of delayed-release aspirin. The primary goal was a reduction of aspirin-associated ulcers among high-risk patients taking aspirin to prevent a cardiovascular event. The studies also met key secondary endpoints, including a reduction "in gastroduodenal ulceration as well as a reduction in discontinuation due to upper gastrointestinal adverse events in subjects."
"This information is essential to progress our PA32540 partnership discussions for the United States, and to allow us to continue to move forward with our preparations for a third-quarter NDA submission for this product candidate," said Pozen CEO John R. Plachetka. The company's release omitted any data, which will be released at a scientific meeting later in the year.
Last fall, Pozen sold its U.S. royalty rights in Treximet, a migraine drug, to a pension fund for $75 million. Treximet had accounted for 80% of its annual revenue.
- here's the release
- here's the story from The News & Observer
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