Horizon Pharma plc Announces Settlement of RAYOS(R) (prednisone) Delayed-Release Tablets Patent Litigation With Actavis Laboratories FL Inc.

DUBLIN, IRELAND--(Marketwired - Oct 2, 2015) - Horizon Pharma plc (NASDAQ: HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced that its affiliate Horizon Pharma Switzerland GmbH has entered into a settlement and license agreement with Actavis Laboratories FL, Inc. ("Actavis") to resolve pending patent litigation involving RAYOS® (prednisone) Delayed-Release Tablets.

Under the settlement and license agreement, Horizon has granted Actavis the right to market a version of delayed-release prednisone tablets in the United States under the Actavis Abbreviated New Drug Application (ANDA), beginning December 23, 2022 or earlier under certain circumstances. 

The agreement includes a stipulation by the parties requesting dismissal with prejudice of the lawsuit filed by Horizon in the U.S. District Court for the District of New Jersey and relating to the ANDA filed by Actavis with the U.S. Food and Drug Administration for a version of delayed-release prednisone tablets.

Details of the settlement are confidential and the agreement is subject to submission to the Federal Trade Commission and the U.S. Department of Justice. 

"This RAYOS patent estate is strong and we will continue to defend patent challenges in order to protect our innovation and ensure continued patient access," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc.

About 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.