Shares in Pozen have soared on positive late-stage data for its combination ulcer drug which will now be filed for US approval in the third quarter.
The company unveiled top-line results from two Phase III trials of PA32540, a combination tablet of immediate-release omeprazole (40mg), the active ingredient in AstraZeneca's anti-ulcerant Losec, and delayed release aspirin (325mg). Some 1,049 subjects at risk for developing aspirin-associated ulcers and already taking aspirin at a dose of 325mg once-daily for at least three months for secondary prevention of cardiovascular events were randomly assigned to treatment with either PA32540 or 325 mg enteric-coated aspirin once-daily.
The primary endpoint, a significant reduction in the cumulative incidence of gastric ulcers following administration of PA32540 over six months, was met in both studies. Additionally, the studies met their key secondary endpoints, including a reduction in gastroduodenal ulceration as well as a reduction in discontinuation due to upper gastrointestinal adverse events. Further analyses of the data will be presented at an upcoming scientific meeting.
Pozen chief executive John Plachetka said the data is "essential to progress our PA32540 partnership discussions for the USA, and to allow us to continue to move forward with our preparations for a third-quarter New Drug Application submission". The results went down well with investors and Pozen shares closed up 8.8% at $5.22.