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October 13, 2015 3:31 PM ET


Company Overview of United Therapeutics Corporation

Company Overview

United Therapeutics Corporation, a biotechnology company, develops and commercializes products to address the unmet medical needs of patients with chronic and life-threatening conditions worldwide. Its lead product comprises Remodulin, an injection used for the treatment of pulmonary arterial hypertension (PAH). The company also provides Tyvaso, an inhaled prostacyclin therapy; and Adcirca, a once-daily oral therapy for the treatment of PAH. In addition, it develops Orenitram, a prostacyclin analog for treatment of PAH; Ch14.18 MAb, an antibody for the treatment of neuroblastoma; Beraprost 314d, which is under Phase III clinical trials for the treatment of PAH; and PLacental eXpanded cells t...

1040 Spring Street

Silver Spring, MD 20910

United States

Founded in 1996

740 Employees





Key Executives for United Therapeutics Corporation

Founder, Chairman and Co-Chief Executive Officer
Age: 60
Total Annual Compensation: $1.0M
Co-Chief Executive Officer, President and Director
Age: 53
Total Annual Compensation: $840.4K
Executive Vice President of Strategic Planning, General Counsel and Corporate Secretary
Age: 51
Total Annual Compensation: $731.0K
Compensation as of Fiscal Year 2014.

United Therapeutics Corporation Key Developments

United Therapeutics Corporation Announces Settlement of Patent Litigation with Sandoz Inc

United Therapeutics Corporation announced that it has entered into a settlement agreement with Sandoz Inc.relating to ongoing litigation concerning certain patents relating to United Therapeutics' product, Remodulin(R) (treprostinil) Injection, and Sandoz's Abbreviated New Drug Application ("ANDA") seeking approval by the U.S. Food and Drug Administration to market a generic version of Remodulin. Under the Settlement Agreement, United Therapeutics granted to Sandoz a non-exclusive license to manufacture and commercialize the generic version of Remodulin described in its ANDA filing in the United States beginning on June 26, 2018, although Sandoz may be permitted to enter the market earlier under certain circumstances. The license included in the Settlement Agreement does not permit Sandoz the right to manufacture a generic version of any other United Therapeutics product, such as Tyvaso(R) (treprostinil) Inhalation Solution or Orenitram(R) (treprostinil) Extended-Release Tablets, nor does it grant any rights with respect to any technology associated with the Remodulin Implantable System being developed by the Company and Medtronic Inc., or the pre-filled semi-disposable pump system being developed by the Company and DEKA Research & Development Corp. The Settlement Agreement does not grant Sandoz any rights other than those required to launch Sandoz's generic version of Remodulin. In accordance with the Settlement Agreement, the parties will submit the Settlement Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. The pending litigation with Sandoz consists of a pending appeal by Sandoz of the August 2014 ruling by the U.S. District Court for the District of New Jersey finding that U.S. Patent No. 6,765,117 is valid and enforceable against Sandoz, and an appeal by United Therapeutics with respect to the District Court's finding that U.S. Patent No. 7,999,007 would not be infringed upon by Sandoz's generic product. Pending litigation between the parties also includes a separate lawsuit filed in September 2014 by United Therapeutics against Sandoz in the same U.S. District Court, alleging infringement of U.S. Patent No. 8,497,393. Pursuant to the Settlement Agreement, the parties will terminate all currently pending litigation.

European Commission Grants Marketing Authorisation for United Therapeutics Corporation's Unituxin™ (dinutuximab) for the Treatment of Paediatric High-Risk Neuroblastoma

United Therapeutics Corporation announced that the European Commission (EC) has granted Marketing Authorisation for Unituxin™ (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT). Unituxin is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin. The European approval was based on demonstration of improved event-free survival (EFS) and overall survival (OS) in a multicenter, open-label, randomized trial (ANBL0032) sponsored by the US National Cancer Institute under a Cooperative Research and Development Agreement with United Therapeutics and conducted by the Children's Oncology Group (COG). Trial design and results: The trial randomized (1:1) 226 patients to either the Unituxin/13-cis-retinoic acid (RA) arm or the RA alone arm. Patients in each arm received six cycles of treatment. The Unituxin/RA arm consisted of Unituxin in combination with granulocyte macrophage-colony stimulating factor and RA (cycles 1, 3, and 5), Unituxin in combination with interleukin-2 and RA (cycles 2 and 4), and RA (cycle 6). Patients were 11 months to 15 years of age (median age 3.8 years). The major efficacy outcome measure was investigator-assessed EFS, defined as the time from randomization to the first occurrence of relapse, progressive disease, secondary malignancy or death. The primary intent-to-treat analysis found an improvement in EFS associated with dinutuximab immunotherapy plus isotretinoin as compared to isotretinoin alone. The two-year estimates of EFS were 66% among subjects receiving dinutuximab immunotherapy plus isotretinoin as compared with 48% in subjects receiving isotretinoin alone (log-rank test p = 0.033) although this difference did not reach formal statistical significance according to the pre-specified plan for interim analyses. In addition, OS was evaluated with 3 years of follow-up after the EFS analysis as a secondary endpoint with a significant improvement observed among ITT subjects randomly allocated to receive dinutuximab immunotherapy plus isotretinoin as compared with isotretinoin alone. The three-year estimates of OS were 80% compared with 67% among subjects receiving dinutuximab immunotherapy plus isotretinoin and isotretinoin alone, respectively (log-rank test p = 0.0165). Long-term overall survival was evaluated with five years of follow up after the EFS analysis and continued to demonstrate a survival advantage for patients who received dinutuximab immunotherapy compared to those who received isotretinoin alone. The five-year estimates of OS were 74% for dinutuximab immunotherapy compared to 57% for isotretinoin alone (log-rank test p = 0.030). Frequently occurring adverse reactions: The most frequently occurring (more than 30% of patients) adverse reactions reported during the neuroblastoma studies were hypotension (67%), pain (66%), hypersensitivity (56%), pyrexia (53%), urticaria (49%), capillary leak syndrome (45%), anaemia (45%), hypokalaemia (41%), platelet count decreased (40%), hyponatraemia (37%), alanine aminotransferase increased (35%), decreased lymphocyte count (34%) and decreased neutrophil count (31%). Additional adverse reactions characteristic of an allergic response were also reported- including anaphylactic reaction (18%) and bronchospasm (4%). Posology and method of administration: Unituxin is to be administered by intravenous infusion over five courses at a daily dose of 17.5 mg/m2. It is administered on days 4-7 during courses 1, 3 and 5 (each course lasting approximately 24 days) and on days 8-11 during courses 2 and 4 (each course lasting approximately 28 days). The treatment regimen consists of Unituxin, GM-CSF, IL-2, and isotretinoin, administered over six consecutive courses.

United Therapeutics Corporation Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015

United Therapeutics Corporation reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported total revenue of $347,161,000 compared to $322,802,000 a year ago. Operating income was $171,705,000 compared to $176,320,000 a year ago. Income before income taxes was $168,334,000 compared to $173,033,000 a year ago. Net income was $99,211,000 compared to $111,852,000 a year ago. Diluted net income per share was $1.91 compared to $2.10 a year ago. Non-GAAP earnings were $132,517,000 compared to $118,655,000 a year ago. Diluted Non-GAAP earnings per share were $2.55 compared to $2.23 a year ago. For the six months, the company reported total revenue of $674,665,000 compared to $612,205,000 a year ago. Operating income was $156,879,000 compared to $392,460,000 a year ago. Income before income taxes was $151,542,000 compared to $386,249,000 a year ago. Net income was $82,570,000 compared to $249,376,000 a year ago. Diluted net income per share was $1.57 compared to $4.54 a year ago.

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