POZEN Presents Positive PA32540 Phase 3 Data at the 2013 International Stroke Conference

  POZEN Presents Positive PA32540 Phase 3 Data at the 2013 International
  Stroke Conference

Business Wire

HONOLULU -- February 8, 2013

POZEN Inc. (NASDAQ: POZN),  a pharmaceutical company committed to transforming
medicine that transforms lives, presented data today from the combined results
of two Phase 3 studies of PA32540, an antiplatelet therapy of enteric-coated
(EC) and immediate-release omeprazole, in patients with previous
cerebrovascular disease. These data were presented at the American Heart
Association 2013 International Stroke Conference on Thursday, February 7 at
4:15 p.m. (HST) in Honolulu, Hawaii at the Hawaii Convention Center as poster
board number MP103.

According to the studies, in the post-hoc analysis of subjects with a history
of transient ischemic attack (TIA) or stroke, long-term (6 months) treatment
with PA32540, compared to EC-ASA (325 mg), was associated with a significantly
reduced rate of endoscopic gastroduodenal ulcers (2.0% vs. 12.4% respectively;
p=0.005), and study discontinuation due to adverse pre-specified upper GI
events (0% vs. 8.0% respectively; p=0.006). The incidence of adjudicated major
adverse cardiac events was similar for PA32540 (2.9%) and EC-ASA (325 mg)

“Discontinuation of aspirin therapy is often due to the adverse GI effects of
aspirin,” said Mark J. Alberts, MD, UT Southwestern Medical Center, Dallas,
Texas. “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 and cerebrovascular events.”

AHA guidelines state that the use of an antiplatelet agent, such as aspirin,
is recommended to reduce risk of recurrent stroke and other cardiovascular

Key Findings of the Study

  *PA32540 is associated with a lower rate of endoscopic gastroduodenal
    mucosal injury with a similar cerebrovascular event profile as EC-ASA
  *PA32540, a single tablet containing EC aspirin and IR omeprazole, has a
    lower rate of discontinuation and, hence, may improve long-term adherence
    to ASA therapy.

About the Study

The two Phase 3, double-blind, randomized, multicenter studies enrolled 1,049
subjects who were prescribed daily aspirin (325 mg) for greater than or equal
to three months for secondary prevention of cardiovascular events. The primary
endpoint was the cumulative observed incidence of gastric ulcers over six
months. Secondary endpoints included cumulative incidence of gastric and
duodenal ulcers, discontinuation due to pre-specified UGI adverse events and
heartburn resolution. Subjects were randomly assigned to once-daily treatment
with PA32540 or 325 mg of enteric-coated aspirin. Endoscopic assessments were
performed at screening and at one, three and six months. MACE were reviewed
and adjudicated by an independent, blinded endpoint committee composed of

In the combined data from the two trials, 85.1% of subjects on enteric-coated
aspirin (325 mg) reported adverse events compared to 71.8% of subjects on
PA32540. The most commonly reported adverse events with PA32540 and
enteric-coated aspirin (325 mg) were of the GI tract and include dyspepsia
(11.3% vs. 30.2%), erosive gastritis (11.5% vs. 26.3%), and gastritis (17.5%
vs. 16.0%) respectively. The incidence and nature of adjudicated MACE such as
heart attacks was similar between the 2 treatment arms: 9 subjects (1.7%) on
PA32540 experienced adjudicated MACE compared to 13 subjects (2.5%) on aspirin
(325 mg).

For the abstract a post-hoc analysis of the intent-to-treat subpopulation,
(n=102) from the PA32540 group and (n=113) from the EC-ASA group, with a
history of one or more TIA, ischemic stroke and/or other cerebrovascular
disease was analyzed. Treatments were compared using a Cochran-Mantel-Haenzel

About Antiplatelet Therapy

Cardiovascular disease is the leading cause of death in the United States, and
there are currently 24 million secondary prevention patients, most of whom are
on a daily aspirin therapy. However, approximately 15% of people on low-dose
aspirin are at risk for upper GI adverse events, and 12% discontinue or reduce
intake due to these serious UGI side effects.

Additional data from the two pivotal Phase 3 PA32540 trials were recently
presented at the American Heart Association Scientific Sessions 2012 and the
American College of Gastroenterology 2012 Annual Meeting. For more detail of
the study results, please see www.pozen.com for the complete poster.

About PA

POZEN is creating a portfolio of integrated aspirin therapies – the PA product
platform. The products in the PA portfolio are intended to significantly
reduce GI ulcers and other GI complications compared to taking aspirin alone.

The first candidates are PA32540, containing 325 mg of aspirin, and PA8140,
containing 81 mg of aspirin. Both products are a coordinated-delivery tablet
combining immediate-release omeprazole (40 mg), a proton pump inhibitor,
layered around pH-sensitive aspirin. This novel, patented product is
administered orally once a day and an indication will be sought for use for
the secondary prevention of cardiovascular disease in patients at risk for
aspirin-induced ulcers.


POZEN Inc. is a progressive pharmaceutical company that is transforming how
the healthcare industry addresses unmet medical needs. By utilizing a unique
in-source model and focusing on integrated therapies, POZEN has successfully
developed and obtained FDA approval of two self-invented products in two
years. Funded by these milestone/royalty streams, POZEN is now creating a
portfolio of cost-effective, evidence based integrated aspirin therapies
designed to enable the full power of aspirin by reducing its GI damage.

POZEN is currently seeking strategic partners to help maximize the opportunity
for its portfolio assets.

The Company's common stock is traded under the symbol “POZN” on The NASDAQ
Global Market. For more detailed company information, including copies of this
and other press releases, please visit www.pozen.com.

Forward-Looking Statements

Statements included in this press release that are not historical in nature
are “forward-looking statements” within the meaning of the “safe harbor”
provisions of the Private Securities Litigation Reform Act of 1995. You should
be aware that our actual results could differ materially from those contained
in the forward-looking statements, which are based on current market data and
research (including third party and POZEN sponsored market studies and
reports), management’s current expectations and are subject to a number of
risks and uncertainties, including, but not limited to, our inability to
license our PA product candidates on terms and timing acceptable to us, our
failure to successfully commercialize our product candidates; costs and delays
in the development and/or FDA approval of our product candidates, including as
a result of the need to conduct additional studies, or the failure to obtain
such approval of our product candidates, including as a result of changes in
regulatory standards or the regulatory environment during the development
period of any of our product candidates; uncertainties in clinical trial
results or the timing of such trials, resulting in, among other things, an
extension in the period over which we recognize deferred revenue or our
failure to achieve milestones that would have provided us with revenue; our
inability to maintain or enter into, and the risks resulting from our
dependence upon, collaboration or contractual arrangements necessary for the
development, manufacture, commercialization, marketing, sales and distribution
of any products, including our dependence on AstraZeneca for the sales and
marketing of VIMOVO^®; competitive factors; our inability to protect our
patents or proprietary rights and obtain necessary rights to third party
patents and intellectual property to operate our business; our inability to
operate our business without infringing the patents and proprietary rights of
others; general economic conditions; the failure of any products to gain
market acceptance; our inability to obtain any additional required financing;
technological changes; government regulation; changes in industry practice;
and one-time events, including those discussed herein and in our Quarterly
Report on Form 10-Q for the period ended September 30, 2012. We do not intend
to update any of these factors or to publicly announce the results of any
revisions to these forward-looking statements.


Bill Hodges, Chief Financial Officer
Stephanie Bonestell
Manager, Investor Relations & Public Relations
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