Pharma

Safer aspirin is strong in phase 3; Pozen plans 3Q NDA filing

The delayed-release aspirin compound that Pozen (NASDAQ:POZN) has developed to protect against cardiovascular disease showed […]

The delayed-release aspirin compound that Pozen (NASDAQ:POZN) has developed to protect against cardiovascular disease showed in clinical trials that it causes fewer ulcers compared to aspirin alone.

With those positive phase 3 clinical trial results in hand, Pozen now expects to file a new drug application on PA32540 in the third quarter. John Plachetka, CEO of Chapel Hill, North Carolina-based Pozen, said in a statement that the results will help the company in its discussions with potential pharmaceutical partners. Pozen announced last year that it wants to partner with a large pharmaceutical company who could commercialize PA32540 worldwide.

PA32540 is aspirin that is delivered in a different way. Pozen’s PA platform is a delayed-release technology applied to aspirin. PA32540 combines that delayed-release aspirin with immediately released omeprazole, which reduces stomach acid. The combination is a compound that reduces the gastrointestinal risks associated with aspirin alone.

Pozen, which has two drugs that were commercialized through drug partners GlaxoSmithKline (NYSE:GSK) and AstraZeneca (NYSE:AZN), initially planned to make PA32540 its first drug commercialized on its own. But the company last year announced it would seek a drug partner who had more resources to commercialize the drug globally.

When Pozen announced its 2011 financial results last month, Plachetka disclosed that the slow sales of another Pozen product, arthritis treatment Vimovo, sparked investor concerns about Pozen’s ability to commercialize PA32540 without a large pharmaceutical partner. Pozen is currently seeking a partner who could commercialize PA32540 globally and perhaps also take on the company’s PA platform. Plachetka told MedCity News in January that the company’s technology could be used to deliver aspirin for other indications, including cancer prevention.

[Photo from Flickr user Inanimatt]

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