Horizon Pharma, Inc. announced that SkyePharma has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for US Patent Application 2012/0177734 entitled "delayed release tablet with defined core geometry" that covers the US approved product Rayos.

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 patent scheduled to issue from this application will expire in 2024 for the US patent. After issuance, Horizon plans to list the US patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.

"This patent allowance is a critical expansion of the patent estate for Rayos," said Timothy P Walbert, chairman, president and chief executive officer of Horizon. "We are focused on protecting the commercial potential of Rayos to 2024 and we will begin the Rayos commercial launch this quarter."

Rayos, known as Lodotra in Europe, is a proprietary delayed-release formulation of low-dose prednisone which utilizes SkyePharma's proprietary Geoclock technology. 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 RA, patients were administered Rayos at 10 p.m. with food. Given Rayos delayed-release profile, this 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.

On July 26, 2012 the US Food and Drug Administration (FDA) approved Rayos to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD).

Outside the United States, Lodotra is approved for the treatment of moderate to severe active RA when accompanied by morning stiffness in nineteen countries. Horizon has granted commercialization rights for Lodotra in Europe, Asia and Latin America to its distribution partner Mundipharma International Corporation Limited. Horizon has an exclusive license from SkyePharma for Rayos.

Horizon Pharma, Inc. is a biopharmaceutical company that is developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases.