POZEN Reports European Patent Office Maintains PA/VIMOVO Patent

  POZEN Reports European Patent Office Maintains PA/VIMOVO Patent

Business Wire

CHAPEL HILL, N.C. -- March 12, 2013

POZEN Inc. (NASDAQ: POZN),  a pharmaceutical company committed to transforming
medicine that transforms lives, today announced that the Opposition Division
of the European Patent Office has maintained the granted European patent,
EP1411900, entitled Pharmaceutical Compositions for the Coordinated Delivery
of NSAIDs, which covers VIMOVO and its PA product candidates. The patent
claims maintained in the opposition proceedings relate to combinations of
proton pump inhibitors (PPI) and non-steroidal anti-inflammatory drugs
(NSAID).

The Opponent has the option of appealing the decision of the Opposition
Division until May 5, 2013, which is two months from the date of the
Opposition Division’s written decision. We expect the appeals process, if
initiated, to take two years until a final decision of the Board of Appeals is
rendered.

“We are pleased that the European Patent Office has upheld the validity of the
patent,” said John R. Plachetka, Pharm.D., Chairman, President and Chief
Executive Officer of POZEN Inc.

About POZEN

POZEN Inc. is a small pharmaceutical company that specializes in developing
novel therapeutics for unmet medical needs and licensing those products to
larger 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 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.

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 VIMOVO

VIMOVO^® (naproxen / esomeprazole magnesium) is a fixed-dose combination of
delayed-release enteric-coated naproxen, a non-steroidal anti-inflammatory
drug (NSAID), and immediate-release esomeprazole, a stomach acid-reducing
proton pump inhibitor (PPI), approved for the relief of signs and symptoms of
osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to
decrease the risk of developing gastric ulcers in patients at risk of
developing NSAID-associated gastric ulcers. ^ VIMOVO is not recommended for
use in children younger than 18 years of age. VIMOVO is not recommended for
initial treatment of acute pain because the absorption of naproxen is delayed
compared to absorption from other naproxen-containing products. Controlled
studies do not extend beyond 6 months. ^ VIMOVO should be used at the lowest
dose and for the shortest amount of time as directed by your health care
provider.

For Full Prescribing Information see www.vimovo.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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