|By Marketwired .||
|August 27, 2014 07:30 AM EDT||
DEERFIELD, IL -- (Marketwired) -- 08/27/14 -- Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that the United States Patent and Trademark Office (USPTO) has issued Horizon a Notice of Allowance for U.S. patent application number 13/860,015 entitled "Delayed-Release Glucocorticoid Treatment of Rheumatoid Disease" that covers Horizon's U.S. approved product RAYOS® (prednisone) delayed release tablets.
"This patent allowance by the USPTO is not only another important milestone in protecting the commercial potential of RAYOS, but along with other recent allowances, demonstrates our strong overall commitment to protecting the innovation and commercial opportunity of our entire product portfolio," said 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 2027. After issuance, Horizon plans to list the U.S. patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. This will be the sixth U.S. patent to be listed in the Orange Book for RAYOS.
RAYOS, known as LODOTRA® in Europe, is a proprietary delayed-release formulation of low-dose prednisone. The pharmacokinetic profile of RAYOS is different with an approximately four-hour lag time from that of immediate-release prednisone formulations. In clinical trials studying use of RAYOS in rheumatoid arthritis (RA), patients were administered RAYOS at 10 p.m. with food. The delayed-release profile of RAYOS helps to achieve therapeutic prednisone blood levels at a time point when cytokine levels start rising during the middle of the night. While the pharmacokinetic profile of RAYOS differs in terms of lag time from immediate-release prednisone, its absorption, distribution and elimination processes are comparable. For more information, please visit www.RAYOSrx.com.
RAYOS utilizes Skyepharma's proprietary Geoclock technology.
Outside the United States, LODOTRA is approved for the treatment of moderate to severe active RA when accompanied by morning stiffness in over thirty-five countries. Horizon has granted commercialization rights for LODOTRA in Europe, Asia (excluding Japan) and Latin America to its distribution partner Mundipharma International Corporation Limited. Horizon has an exclusive license from Skyepharma for RAYOS/LODOTRA.
Important Safety Information
RAYOS® (prednisone) delayed-release tablets
Approved uses of RAYOS
RAYOS, a delayed-release form of prednisone, prevents the release of substances in the body that cause inflammation. RAYOS is approved to treat a broad range of diseases including RA, polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD). For a full list of RAYOS indications, please see full prescribing information at www.RAYOSrx.com.
RAYOS is contraindicated in patients who have known hypersensitivity to prednisone or to any of the excipients. Rare instances of anaphylaxis have occurred in patients receiving corticosteroids.
Important information about RAYOS
Do not use RAYOS if you are allergic to prednisone.
Long-term use of RAYOS can affect how your body responds to stress. Symptoms can include weight gain, severe fatigue, weak muscles and high blood sugar.
RAYOS can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had.
RAYOS can cause high blood pressure, salt and water retention and low blood potassium.
There is an increased risk of developing holes in the stomach or intestines if you have certain stomach and intestinal disorders.
Behavior and mood changes can occur, including intense excitement or happiness, sleeplessness, mood swings, personality changes or severe depression.
Long-term use of RAYOS can cause decreases in bone density.
RAYOS can cause cataracts, eye infections and glaucoma.
Do not receive a "live" vaccine while taking RAYOS. The vaccine may not work as well during this time and may not fully protect you from disease.
Taking RAYOS during the first trimester of pregnancy can harm an unborn baby.
Long-term use of RAYOS can slow growth and development in children.
The most common side effects with RAYOS are water retention, high blood sugar, high blood pressure, unusual behavior and mood changes, increased appetite and weight gain.
Please see full prescribing information for RAYOS at www.RAYOSrx.com.
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.
About Skyepharma PLC
Skyepharma combines proven scientific expertise with validated proprietary drug delivery technologies to develop innovative oral and inhalation pharmaceutical products. The Group is eligible for revenues from 15 approved products in the areas of inhalation, oral, topical and injectable drug delivery as well as generating income from the development of further products and technology licenses. The products developed by the Group are marketed throughout the world by big pharma as well as specialty pharmaceutical companies. For more information, visit www.skyepharma.com.
This press release contains forward-looking statements, including statements regarding the issuance of a patent based on the Notice of Allowance from the USPTO, the ability to protect the innovation and commercial potential of RAYOS and the Company's other products, plans to list newly issued patents in the FDA's Orange Book, and the anticipated closing of Horizon's acquisition of Vidara. These forward-looking statements are based on management's 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 RAYOS, whether any patents issued to or licensed by Horizon may be challenged, invalidated, infringed or circumvented by third parties, whether and when the closing conditions of the Vidara acquisition will be satisfied 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 undertakes no obligation to update or revise these statements, except as may be required by law.
Robert F. Carey
Executive Vice President and Chief Business Officer
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