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

DUBLIN, IRELAND--(Marketwired - Nov 11, 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 a collaboration with the Alliance for Lupus Research (ALR) to study RAYOS^® (prednisone) delayed-release tablets in systemic lupus erythematosus (SLE), a chronic autoimmune disease that causes inflammation and pain in the joints and muscles as well as overall fatigue.

"Despite advances in SLE therapies, sustained control of disease activity is limited to a small fraction of patients," said Jeffrey D. Kent, M.D., FACG, senior vice president, medical affairs and outcomes research, Horizon Pharma plc. "Prednisone is the steroid most commonly prescribed for lupus and given the unique delayed-release mechanism of RAYOS, we're excited to partner with the Alliance for Lupus Research to further explore its potential in this disease."

The first study planned as part of the collaboration, RAYOS Inhibits Fatigue in Lupus Erythematosus (RIFLE), will investigate the effect of RAYOS on the fatigue experienced by lupus erythematosus patients, a common symptom of the disease. RIFLE is an investigator-initiated, randomized, double-blind, active comparator, cross-over study in which patients will be randomized to receive either prednisone for three months or RAYOS at 10 p.m. for three months, and then switched to the alternative medication for an additional three months. Approximately 62 patients across 25 sites will be enrolled in the United States. The primary endpoint will assess fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), a 13-question survey to be completed by study participants that focuses on the daily fatigue experienced in patients with chronic illnesses.

"This study presents an opportunity to explore the debilitating fatigue associated with SLE -- one of the most common symptoms that can decrease quality of life and increase risk of work disability and associated healthcare costs," said Kenneth M. Farber, president of the Alliance for Lupus Research "Through this study we hope to uncover another treatment option that may improve outcomes for SLE patients."