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POZEN Announces Receipt of Three Patents from the United States Patent and Trademark Office

CHAPEL HILL, N.C.--(BUSINESS WIRE)--Oct. 23, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that it has received three patents from the United States Patent and Trademark Office (USPTO), entitled “Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs” that cover the U.S. approved product VIMOVO® (naproxen / esomeprazole magnesium) delayed-release tablets.

“These newly issued patents provide additional claims to the VIMOVO patent estate,” stated John R. Plachetka, Chairman, President and Chief Executive Officer. “Additionally, these patents demonstrate the continued pattern of innovation by POZEN, which has resulted in 16 issued U.S. Patents and many related foreign patents.”

The USPTO issued U.S. Patent numbers 8,865,190 on October 21, 2014, 8,858,996 on October 14, 2014 and 8,852,636 on October 7, 2014. All three patents are expected to expire in 2022. Horizon Pharma plc (NASDAQ: HZNP), which holds the U.S. NDA for VIMOVO, and POZEN plan to list U.S. patents 8,858,996 and 8,852,636 in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. This will bring to ten, the total patents listed in the Orange Book for VIMOVO. U.S. patent 8,865,190, which covers the process for preparing VIMOVO, is not eligible to be listed in the Orange Book.

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 six 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.

About POZEN Inc.

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. Funded by these milestones/royalty streams, POZEN has created 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, our ability to return value to our stockholders, including any cash distributions, and our future prospects 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 further 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 due to issues with third-party manufacturers, or the failure to obtain such approval of our product candidates for all expected indications, 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 and Horizon for the sales and marketing of VIMOVO®, our dependence on Sanofi US for the sales and marketing of PA8140/PA32540 in the United States, if approved, and our dependence on Patheon for the manufacture of PA8140/PA32540; 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 June 30, 2014. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

Source: POZEN Inc.

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


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