POZEN Announces Results from a Burden of Cardiovascular Disease Study: a Managed Care Perspective

  POZEN Announces Results from a Burden of Cardiovascular Disease Study: a
  Managed Care Perspective

Presentation at AMCP Demonstrates Cost Reduction When PPI Used in Combination
          With Aspirin for Both Commercial and Medicare Populations

Business Wire

CHAPEL HILL, N.C. -- April 05, 2013

POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming
medicine that transforms lives, announced the results of a POZEN sponsored
study at the Academy of Managed Care Pharmacy’s 25^th Annual Meeting and Expo
on April 4, 2013. Ryan S. Clark, Pharm.D., MBA, Health Outcomes and Managed
Markets Fellow, Global Health Economics & Outcomes Research at Xcenda,
presented the abstract, The Burden of Secondary Cardiovascular Disease in
Commercial and Medicare Patients: A Managed Care Perspective. The secondary
prevention of cardiovascular events includes the daily use of aspirin. Chronic
aspirin therapy is associated with significant gastrointestinal (GI) toxicity
including dyspepsia, gastric ulcers and GI bleeding, all of which contribute
to the disease and cost burden of secondary prevention. The GI toxicity of
aspirin can be mitigated by the use of proton pump inhibitors (PPIs). The
Xcenda analysis demonstrated that the prevention of cardiovascular events with
aspirin, plus a PPI, compared to aspirin alone is associated with a net
per-patient per-year cost decrease of $103 and $145 and a potential overall
cost decrease of $1.8 million and $11.0 million for a typical one
million-member Commercial and Medicare Plan, respectively.

“The overall cost of secondary cardiovascular events in patients with a
history of coronary heart disease, transient ischemic attack, or ischemic
stroke represents a significant financial burden on managed care,” said Rashad
Carlton, Pharm.D., MSPH, Assistant Director, Global Health Economics &
Outcomes Research at Xcenda. “Despite American College of Cardiology and
American Heart Association guideline recommendations to start aspirin therapy
and continue indefinitely in all patients unless contraindicated, aspirin
remains underutilized.”

About the Study

The primary objective of the study was to characterize the financial burden of
secondary cardiovascular disease and its long-term complications in patients
at risk for a secondary cardiovascular event.

An economic model designed to yield the annual secondary cardiovascular
disease cost burden was constructed using literature-based population,
medication discontinuation/non-adherence, and cardiovascular event incidence
data. Care records of secondary cardiovascular disease patients were reviewed
based on treatment either with aspirin, aspirin + PPI, or no aspirin.
Secondary events were calculated based on annual recurrence rates adjusted for
treatment discontinuation/non-adherence. The treatment cohort cost per member
and total cost, along with the overall annual secondary cardiovascular disease
expense to the plan, were determined based on AWP/MAC drug pricing and
published discharge data for cardiovascular and GI events.

A typical commercial plan with 1 million lives has an estimated 68,276 members
who are considered to have secondary cardiovascular disease (26,753 who have
experienced a stroke or TIA, 41,523 who have CHD). A typical Medicare
population with 1 million lives has an estimated 295,711 members who have had
secondary cardiovascular disease (124,451 stroke or TIA members, 171,260 CHD
members). Of those members with secondary cardiovascular disease, 14.8% do not
take any aspirin therapy, while 70.7% take aspirin (25.6% use aspirin alone
and 45.1% use aspirin + PPI). The remaining 14.5% of patients were on an
antiplatelet other than aspirin with or without an anticoagulant are not the
focus of this analysis and are excluded.

About Cardiovascular Disease

Patients with established coronary heart disease or cerebrovascular disease
have a high risk of a subsequent cardiovascular event including myocardial
infarction (MI), stroke and death from cardiovascular disease. For such
patients, lifestyle changes and drug therapy are of proven benefit and will
improve outcomes. Coronary artery disease is caused by atherosclerosis and
often develops into angina pectoris and MI. The condition caused about 445,000
deaths in 2005 and remains the leading single cause of death in America today.
Roughly 16.8 million people have a history of MI and/or angina. An estimated
24 million have been identified as secondary prevention patients (post-event).
It is estimated that cardiovascular disease causes one in every three deaths
in the United States. Every 25 seconds, someone in the United States will
suffer a coronary event. About every minute, someone will die from one.

Aspirin therapy has become the standard of care for reducing an individual’s
risk of a second heart attack or stroke. Studies have found that a daily
aspirin regimen for people who have experienced a previous heart attack
reduces the risk of a second heart attack by about one-third. Aspirin has been
incorporated into the American Heart Association’s (AHA) clinical guidelines
for the secondary prevention of cardiovascular events. In accordance with
these guidelines, approximately 24 million Americans should be taking aspirin
for secondary prevention of cardiovascular events. Although the cardiovascular
disease (CVD) benefits of aspirin are well established, the use of aspirin is
associated with the risk of upper gastrointestinal bleeding (UGIB). The use of
aspirin is associated with a 2- to 4- fold increased risk of UGIB. In
addition, aspirin use for CVD is an important cause of gastrointestinal
bleeding-related death. The use of the proton pump inhibitors, such as
omeprazole can significantly reduce the risk of upper gastrointestinal
bleeding. The American College of Cardiology with the AHA issued a Clinical
Expert Consensus in 2008 recommending PPIs as preferred agents for the therapy
and prophylaxis of aspirin-associated gastrointestinal injury.

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 enteric-coated
or plain 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.

About POZEN

POZEN Inc. is a small pharmaceutical company that specializes in developing
novel therapeutics for unmet medical needs and licensing those products to
other pharmaceutical companies for commercialization. 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 milestones/royalty streams, POZEN is 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
opportunities 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
inability to file a new drug application with the FDA for our PA product
candidates in the timeframe we anticipate, 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 Annual Report
on Form 10-K for the period ended December 31, 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.

Contact:

POZEN Inc.
Bill Hodges, 919-913-1030
Chief Financial Officer
or
Stephanie Bonestell, 919-913-1030
Manager, Investor Relations & Public Relations
 
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