United Therapeutics Corporation, a biotechnology company, focuses on the development and commercialization of products to address the unmet medical needs of patients with chronic and life-threatening diseases. Products and Product Candidates The company’s key therapeutic products and product candidates comprise: Prostacyclin Analogues Prostacyclin analogues are stable synthetic forms of prostacyclin, an important molecule produced by the body that has powerful effects on blood vessel health and function. The company’ major product is Remodulin (treprostinil) Injection (Remodulin), which is administered subcutaneously (under the skin) or intravenously (in the vein) for the treatment of pulmonary arterial hypertension (PAH) to diminish symptoms associated with exercise. The United States Food and Drug Administration (FDA) approved Remodulin for subcutaneous and intravenous administration. Outside the United States, Remodulin is approved in 39 countries, most of which have approved both routes of administration. The company is developing new technologies to make Remodulin delivery more convenient, such as implantable pump systems for intravenous Remodulin and pre-filled, semi-disposable pumps for subcutaneous Remodulin. In 2009, the FDA approved Tyvaso (treprostinil) Inhalation Solution (Tyvaso), an inhaled prostacyclin therapy for the treatment of PAH. In 2013, the FDA approved Orenitram (treprostinil) extended-release tablets (Orenitram), an oral prostacyclin analogue for the treatment of PAH, which commenced sales during 2014. The company’s wholly-owned subsidiary, Lung Biotechnology PBC, is developing another oral prostacyclin analogue for the treatment of PAH called esuberaprost. The company sells Remodulin to specialty pharmaceutical distributors in the United States and to pharmaceutical distributors internationally. The company sells Tyvaso to the same specialty pharmaceutical distributors in the United States that distribute Remodulin. The company is developing further improvements intended to make the Tyvaso Inhalation System easier to use. In addition, the company is studying Tyvaso in combination with esuberaprost. Additionally, the company is planning a phase II study of Tyvaso in patients with pulmonary hypertension associated with idiopathic pulmonary fibrosis. The company sells Orenitram to the same specialty pharmaceutical distributors in the United States that distribute Remodulin and Tyvaso. In January 2016, the FDA approved amended labeling describing the transition of patients from intravenous or subcutaneous Remodulin to Orenitram. The company has the right to develop and market a modified-release formulation of beraprost in North America, Europe, and certain other territories for the treatment of cardiovascular indications, pursuant to its license agreement with Toray Industries, Inc. Phosphodiesterase Type 5 (PDE-5) Inhibitor PDE-5 inhibitors act to inhibit the degradation of cyclic guanosine monophosphate (cyclic GMP) in cells. Cyclic GMP is activated by nitric oxide, a naturally occurring substance in the body that mediates the relaxation of vascular smooth muscle. The company’s PDE-5 inhibitor is Adcirca (tadalafil) tablets (Adcirca), a once-daily oral therapy for the treatment of PAH. The company owns the U.S. commercialization rights to Adcirca. The FDA approved Adcirca for the treatment of PAH. The company sells Adcirca to pharmaceutical wholesalers. The company has various agreements with Eli Lilly and Company (Lilly), including a license agreement and a manufacturing and supply agreement. Pursuant to the license agreement, Lilly granted the company a license to develop, market, promote and commercialize Adcirca for the treatment of pulmonary hypertension in the United States. Pursuant to the manufacturing and supply agreement, Lilly manufactures Adcirca and distributes it on the company’s behalf through its wholesaler network, in the same manner that it distributes its own pharmaceutical products. Monoclonal Antibody (MAb) MAbs are antibodies that bind to cancerous tumors and destroy the cancer cells through a mechanism called antibody-dependent cel
united therapeutics corp (UTH:Frankfurt)
1040 Spring Street
Silver Spring, MD 20910
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