POZEN Submits New Drug Application for PA32540/PA8140

  POZEN Submits New Drug Application for PA32540/PA8140

Business Wire

CHAPEL HILL, N.C. -- March 27, 2013

POZEN Inc. (NASDAQ: POZN),  a pharmaceutical company committed to transforming
medicine that transforms lives, today announced the submission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) for the
marketing approval of PA32540/PA8140. Both products are a coordinated-delivery
tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor
(PPI), layered around a pH-sensitive coating of an aspirin core. Pending
regulatory approval, an indication is sought for the use of PA tablets for the
secondary prevention of cardiovascular disease in patients at risk for
aspirin-induced ulcers.

“The NDA submission for PA32540/PA8140 represents an important milestone for
PA,” said John R. Plachetka, Pharm.D., Chairman, President and Chief Executive
Officer of POZEN.“Although this PA NDA is focused on patients who need the
beneficial lifesaving cardiovascular properties of aspirin but are at risk for
developing gastric ulcers, it is our hope that sometime in the future
additional research will confirm the promise of aspirin as an important drug
in the war against cancer, and perhaps other diseases. In discussions with
potential partners, we believe we have seen the same commitment from them to
transform the benefit/risk profile of aspirin that has driven our team at
POZEN over the past several years. We look forward to completing a commercial
deal in the upcoming months with a partner that shares our passion for this
product, our values, and is capable of making PA reach its fullest potential
in the marketplace.”

The NDA submission is based on data from a comprehensive clinical trials
program that POZEN conducted. This program included two pivotal Phase 3
studies (PA32540 – 301/PA32540 – 302) for PA32540, conducted under special
protocol assessment (SPA) agreed with the FDA, which met their primary and
secondary endpoints, as well as extensive Phase 1 studies for both PA32540 and
PA8140. In the 301 and 302 studies, significantly fewer subjects taking
PA32540 experienced endoscopically confirmed gastric ulcers compared to
subjects receiving enteric-coated (EC) aspirin alone (Study 301: 3.8% vs.
8.7%, p=0.02; Study 302: 2.7% vs. 8.5%, p=0.005, respectively).

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 the Phase 3 Studies

The two Phase 3, double-blind, randomized, multicenter studies enrolled 1,049
subjects who had been 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 upper gastrointestinal
(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. Major adverse cardiac events (MACE) were reviewed and adjudicated by
an independent, blinded endpoint committee composed of Cardiologists.

Each study achieved its individual primary endpoint, and also met all
secondary endpoints. 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 due to any adverse events (6.7% vs. 11.2%). Discontinuations
due to pre-specified UGI events were lower in subjects taking PA32540 compared
to subjects taking enteric-coated aspirin (1.5% vs. 8.2% respectively,
p<0.001).

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 two treatment arms: 9 subjects (1.7%) on
PA32540 experienced adjudicated MACE compared to 13 subjects (2.5%) on aspirin
(325 mg).

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 gastrointestinal (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 coating of an aspirin core. 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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