A specialty biopharmaceutical company, Horizon Pharma plc, announced that the United States Patent and Trademark Office (USPTO) has granted a Notice of Allowance for US patent application number 14/329,631 (US publication number 2014-0328912), entitled "Delayed Release Tablet With Defined Core Geometry" that covers Horizon's US approved product Rayos (Prednisone) delayed release tablets.
"Rayos is the first and only delayed-release prednisone approved by the FDA and the foundation of our specialty business unit," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. "It is important that we continue to protect this innovation and to provide access to patients who need treatment."
This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a US patent after administrative processes are completed. The US patent scheduled to issue from this application will expire in 2024. After issuance, Horizon plans to list the patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. This will be the sixth US 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.
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.
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.
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.