DUBLIN, IRELAND -- (Marketwired) -- 02/04/15 --
Horizon Pharma plc (NASDAQ: HZNP), a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated products that address unmet medical needs, announced today the issuance of a patent from the United States Patent and Trademark Office (USPTO) entitled "Method for Treating a Patient at Risk for Developing an NSAID-associated Ulcer" that relates to the use of VIMOVO® (naproxen/esomeprazole magnesium) in patients taking low dose aspirin.
"This patent significantly expands the strength of the VIMOVO patent estate and extends patent protection out to 2031," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. "In addition, this patent exhibits our commitment to innovation and ability to further strengthen the intellectual property protection of our portfolio of drugs. This is an important milestone in the commercial lifecycle for VIMOVO."
The USPTO issued U.S. patent number 8,945,621 on February 3, 2015. 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 eleventh U.S. patent to be listed in the Orange Book for 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 magnesium, 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 please see www.VIMOVO.com.
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. Horizon's U.S. marketed products are ACTIMMUNE® (interferon gamma-1b), DUEXIS® (ibuprofen/famotidine), PENNSAID® (diclofenac sodium topical solution) 2% w/w, RAYOS® (prednisone) delayed-release tablets and VIMOVO® (naproxen/esomeprazole magnesium). Horizon's global headquarters are in Dublin, Ireland. For more information, please visit www.horizonpharma.com.
This press release contains forward-looking statements, including statements regarding the possible extension of patent protection for VIMOVO and plans to list the newly issued patent 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 newly issued patent and existing patents will provide sufficient protection and market exclusivity for VIMOVO, whether any patents, including the newly issued patent, 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.
Robert F. Carey
Executive Vice President, Chief Business Officer
+1 224 383-3250
+1 312 233-1253
Source: Horizon Pharma plc
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