Profile: United Therapeutics Corp (UTHR.O)

UTHR.O on Nasdaq

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United Therapeutics Corporation, incorporated on June 26, 1996, is a biotechnology company. The Company is focused on the development and commercialization of products for the treatment of chronic and life-threatening conditions. The Company’s key therapeutic products and product candidates include Remodulin, Tyvaso (treprostinil), Adcirca (tadalafil), Remodulin Implantable System, Orenitram Combination Therapy, Esuberaprost and PLX Cells for the treatment of Pulmonary Arterial Hypertension; Ch14.18 MAb, for the treatment of High-risk neuroblastoma; Ex-Vivo Lung Perfusion and Lung Transplantation, for the treatment of End-stage lung disease; UV-4B, for the treatment of Dengue and influenza, and Glycobiology Antiviral Agents, for the treatment of a spectrum of agents against viral infectious diseases, among others. The Company’s lead product for treating Pulmonary Arterial Hypertension (PAH) is Remodulin.

Remodulin

The Company’s lead product for treating PAH is Remodulin, the active pharmaceutical ingredient of which is a prostacyclin analogue known as treprostinil. The Companu sells Remodulin to specialty pharmaceutical distributors in the United States and to pharmaceutical distributors internationally. The FDA approved Remodulin as a continuous subcutaneous infusion therapy and as a continuous intravenous infusion therapy. Remodulin is indicated to treat patients with PAH (World Health Organization (WHO) Group 1), which includes multiple etiologies, such as idiopathic and heritable PAH, as well as PAH associated with connective tissue diseases, to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with New York Heart Association (NYHA) Functional Class II-IV (moderate to severe) symptoms. The FDA also expanded its approval to include transition of patients to Remodulin from Flolan, the first FDA-approved prostacyclin therapy for PAH. The results of a prospective, open-label study demonstrated that stable patients with PAH can be safely transitioned from Flolan to intravenous Remodulin using a rapid switch protocol. Outside of the United States, Remodulin is approved for the treatment of PAH in 39 countries by continuous subcutaneous administration and in 33 countries by continuous intravenous administration. Applications for approval of both subcutaneous and intravenous Remodulin are under review in other countries.

Remodulin is stable at room temperature, so it does not need to be cooled during infusion and patients do not need to use cooling packs or refrigeration to keep it stable. Treprostinil is highly soluble, which enables the Company to produce Remodulin in highly concentrated solutions. This allows therapeutic concentrations of Remodulin to be delivered at very low flow rates via miniaturized infusion pumps for both subcutaneous and intravenous infusion. Remodulin can be continuously infused for up to 48 hours intravenously or 72 hours subcutaneously before refilling the infusion pump, and is packaged as an aqueous solution so patients do not have to reconstitute the drug before refilling their pumps. There are serious adverse events associated with Remodulin. When infused subcutaneously, Remodulin causes varying degrees of infusion site pain and reaction (redness and swelling) in most patients. Patients who cannot tolerate the infusion site pain related to use of subcutaneous Remodulin may instead use intravenous Remodulin. Intravenous Remodulin is delivered continuously through a surgically implanted central venous catheter. Patients who receive therapy through implanted venous catheters have a risk of developing blood stream infections and a serious systemic infection known as sepsis. Other common side effects associated with both subcutaneous and intravenous Remodulin include headache, diarrhea, nausea, jaw pain, vasodilation and edema.

The Company in collaboration Medtronic, Inc. (Medtronic) is engaged in the development of its intravascular infusion catheter to be used with Medtronic's SynchroMed II implantable infusion pump and related infusion system components (together referred to as the Remodulin Implantable System) in order to deliver Remodulin for the treatment of PAH. Medtronic released the results of the DelIVery clinical trial, which the Company funded, in order to study the safety of the Remodulin Implantable System while administering Remodulin. The primary endpoint of the study was to demonstrate a rate of catheter-related complications below 2.5 per 1,000 patient-days while using the Remodulin Implantable System to deliver Remodulin. Medtronic informed the Company that this primary objective was met (p

Company Address

United Therapeutics Corp

1040 SPRING ST
SILVER SPRING   MD   20910
P: +1301.6089292
F: +1301.6089291

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