l mediated cytotoxicity. In March 2015, the FDA approved Unituxin (dinutuximab) Injection (Unituxin), in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2, and 13-cis-retinoic acid, for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. The company commenced the U.S. sales of Unituxin in 2015. The company received European Commission approval during 2015, and plans to commence commercial sales in individual European countries following pricing and reimbursement approvals on a country-by-country basis. Distribution of Commercial Products The United States Distribution of Remodulin, Tyvaso, Orenitram, and Unituxin: The company distributes Remodulin, Tyvaso, and Orenitram throughout the United States through two contracted specialty pharmaceutical distributors, such as Accredo Health Group, Inc. (Accredo) and CVS Caremark (Caremark). These specialty pharmaceutical distributors are responsible for assisting patients with obtaining reimbursement for the cost of the company’s treprostinil-based products and providing other support services. In 2015, the company entered into a distribution agreement with ASD Specialty Healthcare, Inc., an affiliate of AmerisourceBergen Corporation, to distribute Unituxin in the United States. The United States Distribution of Adcirca: The company sells Adcirca to pharmaceutical wholesalers. Under its manufacturing and supply agreement with Lilly, Lilly manufactures Adcirca and distributes it through its wholesaler network, which includes Accredo and Caremark, in the same manner that it distributes its own pharmaceutical products. International Distribution of Remodulin: The company sells subcutaneous and intravenous Remodulin outside the United States to various distributors, each of which has distribution rights in one or more countries within Europe, Israel and the Middle East, Asia, and South and Central America. The company also distributes Remodulin in Canada through a specialty pharmaceutical wholesaler. In some of the European markets where the company is not licensed to market Remodulin, such as in Spain and the United Kingdom, the company sells (but do not market) Remodulin on a named-patient basis in which therapies are approved for individual patients by a national medical review board, hospital or health plan on a case-by-case basis. The company continues to work on expanding its sales of Remodulin into new territories through its existing network of distributors. Suppliers The company relies on Minnetronix Inc. to manufacture the nebulizer used in its Tyvaso Inhalation System. Patents and Other Proprietary Rights The company has other patents specific to its individual treprostinil-based products, including the following: Remodulin: The company has been granted three U.S. patents covering an improved diluent for Remodulin, which expire in 2028 and 2029. The company has another patent covering intravenous administration of Remodulin with certain diluents, which expires in 2024. Tyvaso: The company has been granted two U.S. patents, as well as patents in other countries, for Tyvaso that cover methods of treating PAH by inhaled delivery. These patents would expire in the United States in 2018 and in various countries throughout the world in 2020. Orenitram: The company’s patents for Orenitram cover methods of use for treating PAH, orally administered formulations, controlled moisture storage and production methods, as well as those covering controlled release formulations licensed to the company by Supernus Pharmaceuticals Inc. These patents would expire in the United States between 2024 and 2031 and in various countries throughout the world between 2024 and 2027. The company has additional pending U.S. and international patent applications relating to Remodulin, Tyvaso and Orenitram. Research and Development Expenditures The company’s research and development expenses totaled approximately $245.1 million during the year ended December 31, 2015. History United Therapeutics Corporation was fou
united therapeutics corp (UTH:Frankfurt)
1040 Spring Street
Silver Spring, MD 20910
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