Profile: United Therapeutics Corp (UTHR.O)
31 Jul 2014
United Therapeutics Corporation, incorporated in June 26, 1996, is a biotechnology company focused on the development and commercialization of products to address the unmet medical needs of patients with chronic and life-threatening conditions. The Company’s key therapeutic products and product candidates include: Prostacyclin Analogues, Phosphodiesterase Type 5 (PDE-5) Inhibitor, Adcirca, Monoclonal Antibodies (MAbs), Glycobiology Antiviral Agents, Cell-Based Therapy, and Engineered Lungs and Lung Tissue for Transplantation. Prostacyclin analogues are stable synthetic forms of prostacyclin. Its product is Remodulin (treprostinil) Injection (Remodulin). PDE-5 inhibitors act to inhibit the degradation of cyclic guanosine monophosphate (cGMP) in cells. Its PDE-5 inhibitor product is Adcirca (tadalafil) tablets (Adcirca), a once-daily oral therapy for the treatment of pulmonary arterial hypertension (PAH). MAbs act by targeting tumor-associated antigens on cancer cells to activate a patient's immune system against the cancer cells.
The Company’s wholly owned subsidiary Lung LLC is separately developing beraprost, another type of prostacyclin analogue, as an oral tablet known as 314d and as an extended release injection it refers to as TransCon Beraprost, both for the treatment of PAH. It is developing the antibody Ch14.18 MAb for the treatment of neuroblastoma, under an agreement with the National Cancer Institute of the United States National Institutes of Health (NIH). It is also developing another antibody, 8H9 MAb, for the treatment of metastatic brain cancer, under an agreement with Memorial Sloan-Kettering Cancer Center. The Company generates revenues primarily from the sale of Remodulin, Tyvaso and Adcirca.
Products to Treat Cardiopulmonary Diseases
PAH is a life-threatening disease that affects the blood vessels in the lungs and is characterized by increased pressure in the pulmonary arteries, which are the blood vessels leading from the heart to the lungs. Treatment of PAH focuses on three molecular pathways that have been implicated in the disease process: the prostacyclin pathway, the NO pathway, and the endothelin (ET) pathway. The three drugs that target these three pathways are: Prostacyclin Analogues, PDE-5 Inhibitors and Endothelin Receptor Antagonists. The Company’s product for treating PAH is Remodulin (treprostinil) Injection, the active pharmaceutical ingredient of which is a prostacyclin analogue known as treprostinil. It sells Remodulin to specialty pharmaceutical distributors in the United States and to international pharmaceutical distributors.
The Company sells Tyvaso to the same specialty pharmaceutical distributors in the United States that distribute Remodulin. Tyvaso is administered four times a day, by inhaling up to nine breaths during each two- to three-minute treatment session. Adcirca is a PDE-5 inhibitor, the active pharmaceutical ingredient of which is tadalafil. Tadalafil is also the active pharmaceutical ingredient in Cialis, which is marketed by Lilly for the treatment of erectile dysfunction. The Company is developing a salt form of treprostinil for oral administration, treprostinil diolamine tablets. It has the right to develop and market a modified-release formulation of beraprost (beraprost-MR) in the United States, Canada, Mexico, South America, Europe, Egypt, India, South Africa and Australia for the treatment of cardiovascular indications, pursuant to its license agreement with Toray Industries, Inc. (Toray). Beraprost is a chemically stable, orally bioavailable prostacyclin analogue. The Company is conducting preclinical toxicology and pharmacology studies to support a investigational new drug application for the treatment of PAH.
Products to Treat Cancer
Chimeric Monoclonal Antibody14.18 (Ch14.18) is an antibody that has shown in the treatment of certain types of cancer by targeting GD2, a glycolipid on the surface of tumor cells. Ch14.18 is a chimera, composed of a combination of mouse and human deoxyribonucleic acid (DNA), monoclonal antibody that induces antibody-dependent cell-mediated cytotoxicity, a mechanism of cell-mediated immunity whereby the immune system actively targets a cell that has been bound by specific antibodies. 8H9 is a mouse IgG1 MAb that is reactive with a range of human solid tumors, including human brain cancers. The 8H9 antibody is in early investigational development for metastases that develop in the brain from the spread of cancers from other tissues in the body.
Products to Treat Infectious Diseases - Glycobiology Antiviral Agents
The Company has exclusive right to commercialize a platform of glycobiology antiviral drug candidates in various preclinical and clinical stages of testing for the treatment of a wide variety of viruses. Through its research agreement with University of Oxford (Oxford), it is also supporting research into new glycobiology antiviral drug candidates and technologies.
Engineered Lungs and Lung Tissue for Transplantation
Revivicor, Inc. (Revivicor) is a company focused on developing genetic biotechnology platforms to provide alternative tissue sources for treatment of human degenerative disease through tissue and organ xenotransplantation. The Company, through Revivicor, pursues early-stage development of replacement lungs for transplantation. It is also engaged in preclinical development of several regenerative medicine technologies for creating transplantable lung tissue and whole lungs for patients with end-stage lung disease.
The Company competes with Glaxo, Myogen, Inc., Gilead Sciences, Inc., GeneraMedix Inc., Actelion, CoTherix, Inc., Bayer Schering Pharma AG, Pfizer, Nippon Shinyaku Co., Ltd., Novartis Pharmaceuticals Corporation and Sandoz Inc.
United Therapeutics Corp
1040 SPRING ST
SILVER SPRING MD 20910