Horizon Pharma plc Announces the U.S. Patent and Trademark Office Issuance of Additional Notice of Allowance With Claims Covering VIMOVO(R) (naproxen/esomeprazole) Delayed Release Tablets
U.S. Patent Scheduled to Issue Provides VIMOVO Patent Protection to 2030
DUBLIN, IRELAND--(Marketwired - Oct 1, 2014) - Horizon Pharma plc (NASDAQ: HZNP) a specialty biopharmaceutical company with a portfolio of products in arthritis, inflammation and orphan diseases, announced today that POZEN Inc. (POZN), has received from the United States Patent and Trademark Office a Notice of Allowance for U.S. patent application number 12/822,612, entitled "Method for Treating a Patient at Risk for Developing an NSAID-associated Ulcer" that relates to VIMOVO® (naproxen/esomeprazole magnesium) delayed release tablets in patients taking low dose aspirin.
"This Notice of Allowance significantly expands the strength of the VIMOVO patent estate and upon issuance will extend patent protection out to 2030," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc.
This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed. The U.S. patent scheduled to issue from this application will expire in 2030. After issuance, Horizon and POZEN plan to list the U.S. patent in the U.S. Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. This will be the tenth U.S. patent to be listed in the Orange Book for VIMOVO.
About Horizon Pharma plc
Horizon Pharma plc is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated products that address unmet medical needs. The company markets a portfolio of products in arthritis, inflammation and orphan diseases. The company's U.S. marketed products are ACTIMMUNE® (interferon gamma-1b), DUEXIS® (ibuprofen/famotidine), RAYOS® (prednisone) delayed-release tablets and VIMOVO® (naproxen/esomeprazole). Horizon's global headquarters are in Dublin, Ireland. 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 possible extension of patent protection for 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 Notice of Allowance will be completed in a timely matter or at all, whether the patents, if issued as indicated in the Notice 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.
