United Therapeutics Corporation is an American publicly traded biotechnology company and public benefit corporation listed on the NASDAQ under the symbol UTHR. It develops novel, life-extending technologies for patients in the areas of lung disease and organ manufacturing. United Therapeutics is co-headquartered in Silver Spring, Maryland and Research Triangle Park, North Carolina, with additional facilities in Magog and Bromont, Quebec; Melbourne and Jacksonville, Florida; Blacksburg, Virginia; and Manchester, New Hampshire.
History
United Therapeutics was founded in 1996 by Martine Rothblatt, an American lawyer, author, and entrepreneur, who created Sirius XM. In 1994, Rothblatt's young daughter was diagnosed with a fatal orphan disease, pulmonary arterial hypertension (PAH). Rothblatt sold her telecom stock and started the PPH Cure Foundation to fund PAH research.
In 2002, the U.S. Food and Drug Administration (FDA) approved United Therapeutics' drug Remodulin, a prostacyclin vasodilator used to treat PAH. Remodulin provided PAH patients with an alternative to GlaxoSmithKline's Flolan. By 2003, Remodulin annual sales had reached $50 million. By 2010, annual sales were $300 million and United Therapeutics' share price had increased 800 percent from the 1999 initial public offering price.
In 2011, United Therapeutics acquired Revivicor, a company focused on developing genetic biotechnology platforms to provide alternative tissue sources for treatment. In 2018, the company acquired SteadyMed, a medical device company developing injectable therapeutic drugs for pulmonary hypertension. Other acquisitions include SynQuest in 1999 and Cooke Pharma in 2000. United Therapeutics has entered numerous licensing agreements and collaborations with companies such as Eli Lilly and Company, DEKA Research & Development, MannKind Corporation, and the National Cancer Institute. In January 2023, United Therapeutics’ market capitalization was $11.8 billion.
On January 7, 2022, a porcine heart provided by United Therapeutics' Revivicor subsidiary in conjunction with the University of Maryland Medical Center was used in the first pig-to-human transplant operation. The recipient subsequently died on March 8, 2022.
Medicines
United Therapeutics products are sold in the U.S. and Canada, and its products are available in Central and South America, Europe, the Middle East, and Asia through various distribution partners. In the U.S., the company has received multiple approvals from the Food and Drug Administration. These cover various strengths and routes of administration for Orenitram, Remodulin, Tyvaso, and Tyvaso DPI, each indicated for the treatment of pulmonary arterial hypertension. Tyvaso and Tyvaso DPI are also indicated for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics also markets Adcirca (tadalafil) for the treatment of pulmonary arterial hypertension under a licensing agreement with Eli Lilly and Company.
In February 2020, the U.S. Food and Drug Administration granted clearance for the Unity Subcutaneous Delivery System for Remodulin Injection, also known as the Remunity pump, allowing the system to be used with drug cassettes that have been prefilled by specialty pharmacies. The Remunity system allows for constant, subcutaneous (under-the-skin) delivery of Remodulin. The Remunity system is indicated for the treatment of pulmonary arterial hypertension in patients older than 22.
In March 2015, the U.S. FDA approved United Therapeutics’ Biologics License Application (BLA) for Unituxin. Unituxin is a monoclonal antibody used as a second-line treatment for children with high-risk neuroblastoma, a rare form of cancer.
In May 2022, the U.S. FDA approved United Therapeutics’ New Drug Application (NDA) for Tyvaso DPI. Tyvaso DPI is a dry powder inhaler containing treprostinil and is indicated for both PAH and PH-ILD.
Research
United Therapeutics is advancing a pipeline of research and development projects that includes new indications, formulations, and delivery devices for its existing products. The company's R&D pipeline includes five registration phase studies, primarily in rare lung diseases, and seven preclinical product leads, primarily in organ manufacturing.