United Therapeutics

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United Therapeutics

Co-headquarters and laboratory complex, Silver Spring, Maryland (above), co-headquarters, Research Triangle Park, North Carolina (below)
Type	Public
Traded as	Nasdaq: UTHR S&P 400 component
Industry	Biotechnology
Founded	1996
Headquarters	Silver Spring, Maryland and Research Triangle Park, North Carolina , United States
Revenue	$1.4 Billion (2020)[1]
Number of employees	950
Website	www.unither.com

United Therapeutics Corporation is an American publicly traded biotechnology company^[2] listed on the NASDAQ under the symbol UTHR.^[3][4] Its mission is to develop 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; La Jolla, California; and Manchester, New Hampshire.^[5]

History[]

United Therapeutics was founded in 1996 by Martine Rothblatt,^[6][7] an American lawyer, author, and entrepreneur, who created ^[8] Sirius XM. In 1994, Rothblatt's young daughter was diagnosed with a fatal orphan disease, pulmonary arterial hypertension (PAH).^[9][7] Rothblatt sold her telecom stock and started the $3 million PPH Cure Foundation to fund PAH research.^[2][7]

By 2002, the U.S. Food and Drug Administration (FDA) had approved United Therapeutics' new drug Remodulin,^[10] a prostacyclin vasodilator used to treat PAH. Remodulin provided PAH patients an alternative to GlaxoSmithKline's Flolan.^[9] Within a year of being approved, Remodulin annual sales had reached $50 million.^[7] By 2010, annual sales were $300 million and United Therapeutics' share price had increased 800 percent from the 1999 initial public offering price.^[7]

Over the years, United Therapeutics has completed several strategic acquisitions. In 2011, it acquired Revivicor, a company focused on developing genetic biotechnology platforms to provide alternative tissue sources for treatment.^[11] In 2018, it acquired SteadyMed, a medical device company developing injectable therapeutic drugs for pulmonary hypertension.^[12] 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, Medtronic, DEKA Research & Development, and with the National Cancer Institute. In March 2021, United Therapeutics’ market capitalization was $7.1 billion.^[13]

Medicines[]

United Therapeutics products are sold in the U.S., Canada, Central and South America, Europe, the Middle East, and Asia. In the U.S., the company has received multiple approvals from the FDA.^[14] These cover various strengths and routes of administration for Orenitram, Remodulin, and Tyvaso, each indicated for the treatment of pulmonary arterial hypertension, and Unituxin used in the treatment of pediatric patients with high-risk neuroblastoma. United Therapeutics also markets Adcirca (tadalafil) for the treatment of pulmonary arterial hypertension under a licensing agreement with Eli Lilly and Company.

In collaboration with Medtronic, United Therapeutics has developed and expects to commercialize an implantable system for Remodulin.^[15] The system will provide continuous delivery of Remodulin from a pump implanted in the patient's abdomen through a surgical procedure.

In February 2020, the U.S. Food and Drug Administration granted an extra clearance to 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.^[16] The Remunity system allows for constant, subcutaneous (under-the-skin) delivery of Remodulin, which mimics the effects of prostacyclin, a natural compound that works as a vasodilator keeping blood vessels open. Remunity includes a small, lightweight, ambulatory pump with an intended service life of three years and was developed by United Therapeutics and DEKA. The Remunity system is indicated for the treatment of pulmonary arterial hypertension in patients older than 22. United Therapeutics announced the launch of the Remunity Pump for Remodulin in February 2021, using pre-filled cassettes filled at specialty pharmacies.^[17] Currently, United Therapeutics and DEKA are working on a new version of the system that will contain disposable components that are prefilled during the manufacturing process.^[18]

In March 2015, the U.S. FDA approved United Therapeutics’ Biologics License Application (BLA) for Unituxin.^[19] Unituxin is a monoclonal antibody used as a second-line treatment for children with high-risk neuroblastoma, a rare form of cancer.

Research[]

United Therapeutics is advancing a pipeline of research and development projects that includes new indications, formulations, and delivery devices for its existing products, such as the Remunity delivery system for Remodulin. The company's R&D pipeline also includes more than a dozen new products to treat pulmonary arterial hypertension, end-stage organ disease, and other conditions.

In February 2020, United Therapeutics reported that it had successfully completed the INCREASE study of Tyvaso in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and that the study met its primary endpoint of demonstrating improvement in six-minute walk distance (6MWD).^[20] The company submitted the INCREASE study results to the U.S. Food and Drug Administration in support of an efficacy supplement to the Tyvaso New Drug Application, which is expected to result in revised labeling reflecting the outcome of the INCREASE study.

Ongoing clinical trials of new medicines include PERFECT (Phase 3) for COPD; ADVANCE CAPACITY and ADVANCE OUTCOMES (Phase 3) for ralinepag in pulmonary hypertension; SAPPHIRE (Registration Study) for gene therapy; and TETON for idiopathic pulmonary fibrosis (IPF).^[21] Other development projects include dry powder inhaler preparations for pulmonary arterial hypertension.

United Therapeutics is developing a unique type of biopharmaceutical medicinal product known as a manufactured organ. This type of biologic would be transplanted into the patient as a substitute for a failing organ. The company has regenerative medicine products such as these being developed via xenotransplantation, allogenic recellularization, and autologous bioprinting technologies.^[22]

Operations[]

United Therapeutics owns a 415,000-square-foot combination laboratory and office building complex in Silver Spring, Maryland. The facility serves as the company's co-headquarters and is used for commercial manufacturing of active pharmaceutical ingredients and finished dosage form products. United Therapeutics also owns a 380,000-square-foot combination manufacturing plant and office building in Research Triangle Park, North Carolina. The facility serves as the company's co-headquarters and is occupied by clinical research and development, commercialization, logistics, manufacturing, and packaging personnel. Adjacent to its Research Triangle Park complex, United Therapeutics owns a 132-acre site containing approximately 330,000 square feet of building space that is used for research, development and manufacturing related to the company's lung regeneration program. This site is available for future expansion.^[23]

Other United Therapeutics subsidiaries include Lung Bioengineering Inc.; United Therapeutics Europe, Ltd.; Unither Biotech Inc., Canada; Unither Pharma, LLC; Unither Telmed, Ltd.; Unither Bioélectronique, Quebec; and Revivicor, Inc.^[24] As of December 2020, United Therapeutics had a global workforce of 950.^[25]

Lung Biotechnology PBC[]

Through its wholly owned subsidiary Lung Biotechnology Public Benefit Corporation (PBC), United Therapeutics is addressing the acute national shortage of transplantable lungs and other organs.^[26] The company focuses on lung perfusion to develop new advanced technologies to preserve lungs for transplant and increase the availability of lung transplants for end-stage lung disease, including PAH. Lung Biotechnology’s work includes innovative methods that can stabilize and improve lungs that would otherwise be discarded.

With the acquisition of Revivicor, Inc. in 2012, United Therapeutics began the XenoKidney program to find alternative sources of organs for patients awaiting kidney transplant. Xenotransplantation is a potential solution as it potentially could provide a limitless supply of organs. Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company.^[27]

Corporate social responsibility[]

United Therapeutics has published its commitment to diversity and inclusion at all levels of the organization to assure that company leadership is reflective of its workforce. The company’s overall diversity and inclusion strategy includes training programs covering topics such as recognizing unconscious bias, empathy, change management, and leadership to facilitate the advancement of women and underrepresented minorities within the organization. In 2020, United Therapeutics established a minimum “living wage” of approximately $75,000 per year for employees, inclusive of incentive pay. Full time employees are shareholders of the company through United Therapeutics’ long-term incentive programs. United Therapeutics has been recognized as one of the Top 10 Corporate Citizens in the field of U.S. drug manufacturing, along with companies such as Amgen, Johnson & Johnson, and Bristol-Myers Squibb.^[28] United Therapeutics was named on Fortune’s Best Workplaces in Health Care & Biopharma 2021^[29] (third consecutive year); The Washington Post’s Top Workplaces for 2020^[30] (sixth consecutive year); Fortune’s Best Small & Medium Workplaces 2020^[31] (third consecutive year); and Fortune’s Best Workplaces for Millennials™ 2020. ^[32] In 2019, United Therapeutics received Women in Technology’s Corporate Board Award and was named on Triangle Business Journal’s “Best Places to Work List” for the sixth consecutive year.^[33]

United Therapeutics has taken steps to diminish its climate impact. Company facilities include one Platinum and two Gold LEED certified buildings, as rated by the U.S. Green Building Council, and four net-zero buildings located across three states. Innovative, energy-efficient building design, multiple solar arrays, purchase of renewable energy credits (RECs) and carbon offsets, and other green energy technologies have enabled United Therapeutics to achieve a sustainable urban campus. At the time of its construction, United Therapeutics’ site net-zero “Unisphere”, a 135,000 square foot high-rise office building in Silver Spring, Maryland, was the largest urban office building to be energy positive. Using extensive solar arrays, heat mediating wells, and other leading-edge design technologies, Unisphere generates more energy on site than it consumes.

United Therapeutics has implemented corporate governance best practices ahead of industry peers and the Russell 3000. These include adopting majority voting and proxy access policies, initiating a Board declassification process, and imposing a tighter limit on director outside board membership. The Board of Directors engages with company shareholders multiple times each year to discuss governance and operations priorities. In 2020, United Therapeutics published a comprehensive Corporate Social Responsibility report.^[34]

Leadership[]

Martine Aliana Rothblatt, founder and chairwoman of the board of United Therapeutics, graduated from University of California, Los Angeles, with J.D. and M.B.A. degrees in 1981. In June 2001, she earned a Ph.D. in medical ethics at the Barts and The London School of Medicine and Dentistry, Queen Mary University of London. Rothblatt worked in Washington, D.C., first in the field of communications satellite law, and eventually in life sciences projects like the Human Genome Project. She also served as the CEO of GeoStar and the creator of SiriusXM Satellite Radio.^[8][7] Michael Benkowitz serves as president and chief operating officer; James Edgemond is chief financial officer and treasurer; Paul Mahon is general counsel.

References[]