Horizon Pharma, Inc., through its two wholly-owned subsidiaries, operates as a specialty pharmaceutical company. The company commercializes DUEXIS, VIMOVO and RAYOS/LODOTRA, each of which targets unmet therapeutic needs in arthritis, pain and inflammatory diseases. Products DUEXIS DUEXIS is a proprietary single tablet formulation containing a fixed-dose combination of ibuprofen, one of the most widely prescribed non-steroidal anti-inflammatory drugs (NSAIDs), and famotidine, a gastrointestinal (GI) agent used to treat dyspepsia, gastroesophageal reflux disease (GERD), and active ulcers, in one pill. Ibuprofen has proven anti-inflammatory and analgesic properties and famotidine reduces the stomach acid secretion that can cause upper GI ulcers. VIMOVO VIMOVO is a proprietary fixed-dose multi-layer delayed-release tablet combining an enteric-coated naproxen, an NSAID, core and an immediate-release esomeprazole, a proton pump inhibitor (PPI), layer surrounding the core. Naproxen has anti-inflammatory and analgesic properties and esomeprazole reduces the stomach acid secretions that can cause upper GI ulcers. RAYOS/LODOTRA RAYOS, known as LODOTRA outside the United States, is a proprietary delayed-release formulation of low-dose prednisone for the treatment of moderate to severe, active rheumatoid arthritis (RA) in adults particularly when accompanied by morning stiffness. In 2012, the U.S. Food and Drug Administration (FDA) approved RAYOS for the treatment of RA, polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma, chronic obstructive pulmonary disease (COPD) and other conditions. The company focuses its promotion of RAYOS in the United States on rheumatology indications, including RA and polymyalgia rheumatica (PMR). Strategy The company’s strategy is to develop, acquire or in-license additional medicines or acquire companies where the company can execute a targeted commercial approach among specific target physicians, such as primary care physicians, orthopedic surgeons and rheumatologists. Strategic Relationships The company entered into separate transfer, license and supply agreements with Merck Serono GmbH and Merck GesmbH for the commercialization of LODOTRA in each of Germany and Austria, respectively. The company also entered into distribution agreements with Mundipharma International Corporation Limited (Mundipharma) for the exclusive distribution and marketing rights pertaining to LODOTRA for Europe (originally excluding Germany and Austria) and certain Asian, Latin American and other countries and a manufacturing and supply agreement with Mundipharma Medical Company, pursuant to which the company supplies LODOTRA to Mundipharma Medical. The company also has entered into a manufacturing and supply agreement with Jagotec AG, an affiliate of SkyePharma AG, from whom the company purchases LODOTRA. In 2011, the company entered into a manufacturing and supply agreement with sanofi-aventis U.S. to manufacture and supply DUEXIS. In addition, the company has entered into an exclusive agreement with Grünenthal S.A. for the commercialization of DUEXIS in Latin America. In 2013, the company entered into agreements with AstraZeneca AB (AstraZeneca), pursuant to which the company acquired from AstraZeneca and its affiliates certain intellectual property and other assets, and assumed from AstraZeneca and its affiliates certain liabilities, each with respect to VIMOVO in the United States. Also in November 2013, the company entered into a master manufacturing services agreement and product agreement with Patheon Pharmaceuticals, Inc. Intellectual Property Trademarks: The company’s trademarks in the United States and/or certain other countries include Horizon Pharma; Horizon Therapeutics; a stylized letter ‘H’; DUEXIS; RAYOS; LODOTRA; and VIMOVO. With respect to RAYOS/LODOTRA, there are five issued U.S. patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations. The company has also in-licensed pending patent applications pending from SkyePharma AG for its proprietary drug delivery technology, GeoClock, which cover tablet geometry and design. Competition DUEXIS and VIMOVO: DUEXIS and VIMOVO compete with other branded NSAIDs, including Celebrex, marketed by Pfizer Inc. History Horizon Pharma, Inc. was founded in 2005. The company was incorporated in Delaware in 2010.
horizon pharma plc
(HZNP:Consolidated Issue Listed on NASDAQ Global Select )
Phone: 353 1 649 8521
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