|By Marketwired .||
|August 13, 2014 07:30 AM EDT||
DEERFIELD, IL -- (Marketwired) -- 08/13/14 -- Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that POZEN Inc. (NASDAQ: POZN), has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. patent application number 14/045,156 entitled "Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs" that covers Horizon and POZEN'S U.S. approved product VIMOVO® (naproxen / esomeprazole magnesium) delayed release tablets.
"The claims included in this Notice of Allowance continue to expand the strength of the VIMOVO patent estate and add to our ability to protect VIMOVO innovation in the U.S. and to continue to make this important therapy available to patients," stated Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma.
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 2022. After issuance, Horizon and POZEN plan to list the U.S. patent to be issued from U.S. patent application number 14/045,156 in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. Once issued, this will be the tenth U.S. patent to be listed in the Orange Book for VIMOVO.
About Horizon Pharma
Horizon Pharma, Inc. (NASDAQ: HZNP) is a specialty pharmaceutical company focused on improving patients' lives by identifying, acquiring and commercializing differentiated products that address unmet medical needs. The company markets a portfolio of products in the areas of arthritis, pain and inflammatory diseases. The company's U.S. marketed products are VIMOVO® (naproxen/esomeprazole), DUEXIS® (ibuprofen/famotidine) and RAYOS® (prednisone) delayed-release tablets. The company has announced the acquisition of Vidara Therapeutics International Public Limited Company ("Vidara") through a reverse merger, which is expected to close in September. Upon the closing of the Vidara transaction, the company will add ACTIMMUNE® (interferon gamma-1b), an orphan product marketed for use in children and adults with chronic granulomatous disease and severe, malignant osteopetrosis, to its portfolio of U.S. marketed products. For more information, please visit www.horizonpharma.com.
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.
This press release contains forward-looking statements, including statements regarding the issuance of a patent 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 a patent as indicated in the Notice of Allowance will be completed in a timely matter or at all, whether the patent, 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.
Robert F. Carey
Executive Vice President and Chief Business Officer