European Commission Grants Marketing Authorisation for United Therapeutics Corporation's Unituxin™ (dinutuximab) for the Treatment of Paediatric High-Risk Neuroblastoma
Aug 17 15
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
Jul 28 15
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.
United Therapeutics Seeks Acquisitions
Jul 28 15
United Therapeutics Corporation (NasdaqGS:UTHR) announced that it has been engaged in active discussions with companies ranging from start-ups to
top 10 drug companies looking to either acquire or in-license assets.