DEERFIELD, IL -- (Marketwire) -- 02/06/13 -- Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that Skyepharma has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent Application 13/428,548 entitled "Delayed Release Tablet with Defined Core Geometry" that covers the Company's U.S. approved product RAYOS®.
"This action by the USPTO is another important milestone in expanding the RAYOS patent estate and demonstrates once again our ongoing commitment, in partnership with Skyepharma, to protect the innovation and commercial potential of RAYOS," 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 2024. 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 third 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 19 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.
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