are now available to U. S. physicians to

Deerfield, IL (Marketwire) – Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that RAYOS® (prednisone) delayed release tablets are now available to U. S. physicians 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). The focus of the commercial launch will be in rheumatologic diseases, such as RA and PMR. The Company will initially target approximately one thousand rheumatologists in the U. S. with thirteen rheumatology sales specialists. The full launch to the majority of U. S. rheumatologists and high-value primary care physicians with Horizon’s entire sales force of approximately one hundred fifty representatives will begin in late January 2013. “The commercial launch of RAYOS further affirms our commitment to provide innovative therapeutic options to patients who suffer from arthritis, pain and inflammatory diseases and to the physicians who treat them, ” said Todd Smith, executive vice president and chief commercial officer, Horizon Pharma. “Our near term focus is on top-tier rheumatologists to prepare the market for the full rheumatology and primary care launch in late January 2013. ” In July of this year, the U. S. Food and Drug Administration (FDA) approved Horizon’s new drug application (NDA) for RAYOS. The FDA approval was supported by data bridging the pharmacokinetics of RAYOS to immediate-release prednisone and data from the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials. The CAPRA-2 trial demonstrated that people with moderate to severe RA treated with RAYOS experienced a statistically significant improvement in ACR20 response criteria compared to placebo in addition to their non-biologic disease-modifying antirheumatic drug (DMARD) therapy. The CAPRA-1 trial supported the overall safety of RAYOS. Specific results from CAPRA-2 demonstrated: A statistically significant improvement in ACR20 response criteria, the primary study endpoint, for patients who were treated with RAYOS compared to the placebo group (47% vs . 29%; p-value = 0. 001). A statistically significant improvement in ACR50 response compared to placebo (22% vs . 10%; p-value = 0. 007) and an improvement in the more stringent ACR70 response criteria (7% vs . 3%; p-value = 0. 0984). Both ACR50 and ACR70 were pre-specified secondary endpoints. The relative change from baseline in the duration of morning stiffness at 12 weeks was assessed as a pre-specified secondary endpoint. Patients treated with RAYOS had a median decrease in the duration of morning stiffness of 55 minutes compared to 33 minutes in placebo-treated patients (20 minute estimated median difference between treatment groups with 95% confidence interval [7, 32; p-value = 0. 001]). Results from CAPRA-2 were published online in Annals of the Rheumatic Diseases (doi: 10. 1136/annrheumdis-2011-201067) on May 5, 2012. The safety of RAYOS was based on the evaluation of 375 RA patients in two controlled trials. Patients treated with RAYOS ranged in age from 20 to 80 years (median age 56 years). Patients were predominantly Caucasian and 85 percent were female. Included in these safety results were data from the CAPRA-1 trial, a 12-week, double-blind, randomized controlled study that evaluated 288 RA patients. CAPRA-1 compared 10 p. m. administration of RAYOS with the morning administration of immediate-release prednisone at the same individual dose (average dose of 6. 7 mg). Following the 12-week CAPRA-1 study, patients were followed in a 9-month, open-label extension study, which included 249 RA patients, 219 of whom completed the extension study. Patients received RAYOS 3 mg to 10 mg once daily at 10 p. m.; the majority (84 percent) received 5 mg or less. The clinical trial experience did not raise any safety concerns beyond those already established for immediate-release prednisone. Results from the CAPRA-1 12-week study and the 9-month open-label extension have been published in The Lancet and Annals of the Rheumatic Diseases, respectively.

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