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Horizon Pharma Announces The U.S. Patent And Trademark Office Issuance Of Additional Notices Of Allowance With Claims Covering VIMOVO®(Naproxen / Esomeprazole) Delayed Release Tablets



8/6/2014 11:05:13 AM

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DEERFIELD, IL--(Marketwired - August 05, 2014) - Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that POZEN Inc. (NASDAQ: POZN) has received two Notices of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. patent application numbers 14/231,971, and 14/244,471, entitled "Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs" that cover Horizon and POZEN'S U.S. approved product VIMOVO® (naproxen / esomeprazole magnesium) delayed release tablets.

"The claims included in these Notices of Allowance further bolster the already robust VIMOVO patent estate," stated Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma. "This puts us in an even stronger position to protect VIMOVO in the U.S. and to ensure that we are able to continue to make this important therapy available to patients."

These Notices of Allowance conclude the substantive examination of the patent applications and are expected to result in the issuance of U.S. patents after administrative processes are completed. The U.S. patents scheduled to issue from these applications will expire in 2022. After issuance, Horizon and POZEN plan to list the U.S. patent issued from U.S. patent application number 14/244,471 in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. Once issued, this will be the ninth U.S. patent to be listed in the Orange Book for VIMOVO. The U.S. patent to issue from U.S. patent application 14/231,971, while not eligible to be listed in the Orange Book, will cover the process for preparing VIMOVO.

About Horizon Pharma

Horizon Pharma, Inc. is a commercial stage, specialty pharmaceutical company that markets DUEXIS®, VIMOVO® and RAYOS®/LODOTRA®, which target unmet therapeutic needs in arthritis, pain and inflammatory diseases. The Company's strategy is to develop, acquire or in-license additional innovative medicines or companies where it can execute a targeted commercial approach among specific target physicians such as primary care physicians, orthopedic surgeons and rheumatologists, while taking advantage of its commercial strengths and the infrastructure the Company has put in place. For more information, please visit www.horizonpharma.com.

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.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the issuance of patents based on the Notices of Allowance from the U.S. Patent and Trademark Office, the ability to continue making VIMOVO available to patients, the ability to protect the innovation and commercial potential of VIMOVO and plans to list newly issued patents in the FDA's Orange Book. These forward-looking statements are based on management expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include risks regarding whether the administrative processes required for the issuance of patents as indicated in the Notices of Allowance will be completed in a timely matter or at all, whether the patents, if issued as indicated in the Notices of Allowance, will provide sufficient protection and market exclusivity for VIMOVO, whether any patents covering VIMOVO may be challenged, invalidated, infringed or circumvented by third parties and other factors described in Horizon's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release and Horizon does not undertake any obligation to update or revise these statements, except as may be required by law.


Contact:

Robert F. Carey
Executive Vice President and Chief Business Officer
Email Contact



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