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POZEN Presents Positive PA32540 Pivotal Phase 3 Data At The American Heart Association Scientific Sessions 2012

POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, presented positive results from two pivotal Phase 3 clinical trials of the investigational product, PA32540, at The American Heart Association (AHA) Scientific Sessions 2012, as Poster #12057: Treatment Continuation and Cardiovascular Safety of Antiplatelet Therapy with PA32540, A Tablet with Enteric-Coated Aspirin and Immediate-Release Omeprazole: Results of Two 6-Month, Phase 3 Studies. Each study achieved its individual primary endpoint, as patients on PA32540 experienced fewer gastric ulcers compared to those taking enteric-coated aspirin (325 mg) alone. Data for the primary endpoint are shown below:

Primary Endpoint: Endoscopically-Confirmed Gastric Ulcer
  PA32540

EC-ASA

(325 mg)

p-value

Relative

Reduction

Study 301 3.8% 8.7% 0.02 56%
Study 302 2.7% 8.5% 0.005 68%

“The results of these Phase 3 pivotal studies are promising and report the important role that PA32540 may play in the long-term management of cardiovascular protection,” said Chris O’Connor, M.D., Director, Duke Heart Center, Duke University Hospital and one of the authors of the studies. “Discontinuation of aspirin therapy is often due to the adverse GI effects of aspirin. In these pivotal studies, PA32540 was associated with a significantly lower rate of treatment discontinuation than aspirin alone. Patient adherence to aspirin therapy saves lives, as aspirin discontinuation increases the likelihood of potential adverse cardiovascular events.”

A summary of discontinuation rates of the combined data are shown below:

Discontinuation Due To Pre-Specified UGI Events:
    PA32540  

EC-ASA

(325 mg)

  p-value  

Relative

Reduction

Studies 301 & 302   1.5%   8.2%   < 0.001   82%

In addition, the results from the combined data from the two studies demonstrated that patients on PA32540, compared to those on enteric-coated aspirin (325 mg), were able to stay on therapy longer due to fewer discontinuations to any adverse events (6.7% vs. 11.2%).

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