Horizon Pharma plc Announces Collaboration With Alliance for Lupus Research to Study RAYOS(R) (prednisone) Delayed-Release Tablets in Systemic Lupus Erythematosus - Seite 2

The secondary and exploratory endpoints of the study will include measurement of fatigue according to the Fatigue Severity Scale, a 9-item questionnaire related to how fatigue interferes with certain activities; the SF-36 short-form health survey, which determines overall physical and mental health; assessments of overall quality of life and morning stiffness; an evaluation of the activity of lupus using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), British Isles Lupus Activity Group (BILAG), Systemic Lupus Activity Questionnaire (SLAQ), British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) and the SF 14.

This trial will be carried out by the ALR-founded and supported Lupus Clinical Investigators Network (LuCIN) that was formed to specifically carry out this kind of trial to explore new treatments that might make life better for patients with lupus. It is part of the new ALR program to identify and test drugs and treatments that address the concerns of lupus patients. More than three fourths of lupus patients experience fatigue, which is often debilitating. This is one of the first trials to address that problem in a scientifically rational way.

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.

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.