Horizon Pharma Public Limited Company, a biopharmaceutical company, focuses on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs. The company markets nine medicines through its orphan, primary care and rheumatology business units. The company’s marketed medicines are ACTIMMUNE (interferon gamma-1b), BUPHENYL (sodium phenylbutyrate) Tablets and Powder, DUEXIS (ibuprofen/famotidine), KRYSTEXXA (pegloticase), MIGERGOT (ergotamine tartrate and caffeine suppositories), PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%), RAVICTI (glycerol phenylbutyrate) Oral Liquid, RAYOS (prednisone) delayed-release tablets, and VIMOVO (naproxen/esomeprazole magnesium). Medicines The company’s medicines address unmet therapeutic needs in orphan diseases, arthritis, pain and /or inflammatory diseases. Orphan Business Unit Solutions ACTIMMUNE ACTIMMUNE is a biologically manufactured protein called interferon gamma-1b that is similar to a protein the human body makes naturally. In the body, interferon gamma is produced by cells of the immune system and helps to prevent infection in patients with chronic granulomatous disease (CGD) and improves osteoclast function in patients with severe, malignant osteopetrosis (SMO). ACTIMMUNE is approved by the U.S. Food and Drug Administration (FDA) to reduce the frequency and severity of serious infections associated with CGD and for delaying time to disease progression in patients with SMO. ACTIMMUNE is the drug approved by the FDA for the treatment for CGD and SMO. The company’s licenses allow it to market and sell ACTIMMUNE in the United States, Canada, and Japan. The company commercializes ACTIMMUNE in the United States and also supplies ACTIMMUNE to patients in Canada, if so requested by way of a prescription from their treating physicians, through Health Canada’s Special Access Program, which provides access to non-marketed drugs in Canada for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable or are unavailable. In June 2015, the company initiated the Phase 3 Safety, Tolerability and Efficacy of ACTIMMUNE Dose Escalation in Friedreich's Ataxia Study of ACTIMMUNE for the treatment of people with Friedreich’s ataxia (FA). The company expects to complete enrollment in the second quarter of 2016, with top-line data anticipated to become available by the end of 2016. RAVICTI RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients two years of age and older (two months of age and older in Europe) with urea cycle disorders (UCDs) that cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI must be used with dietary protein restriction, and in some cases, dietary supplements (essential amino acids, arginine, citrulline, or protein-free calorie supplements). RAVICTI was approved for marketing in the United States in 2013. In 2015, the company announced the European Commission has adopted a binding decision to approve RAVICTI for use as an adjunctive therapy for chronic management of adult and pediatric patients two months of age and older with six subtypes of UCDs. The company has worldwide rights to market and distribute RAVICTI. In relation to marketing and distribution rights in the Middle East and North Africa region, the company has a distribution agreement with Swedish Orphan Biovitrum AB (SOBI) until 2018. The company markets and sells RAVICTI in the United States and plans to determine the marketing and sales distribution model for Europe in 2016. The company is in the process of seeking approval for label expansions for RAVICTI, with assessments in progress studying the use of RAVICTI in patients both from two months to two years (targeted supplemental new drug application, or sNDA, submission in the second quarter of 2016), and from birth to two months (targeted sNDA submission in the first quarter of 2018). BUPHENYL BUPHENYL tablets for oral administration
horizon pharma plc (HZNP:NASDAQ GS)
1 Burlington Road
Phone: 353 1 772 2100
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