seattle genetics inc (SGEN) Key Developments
Seattle Genetics Announces Initiation of Phase 1/2 Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Combination with Opdivo® (Nivolumab) in Second-Line Hodgkin Lymphoma
Oct 7 15
Seattle Genetics, Inc. announced that it has initiated a phase 1/2 clinical trial of ADCETRIS (brentuximab vedotin) in combination with Opdivo (nivolumab) for patients with relapsed or refractory Hodgkin lymphoma (HL) after failure of frontline treatment. The trial is being conducted under a previously announced clinical trial collaboration agreement with Bristol-Myers Squibb Company. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL, which combines the targeting ability of a monoclonal antibody with a highly potent cell-killing agent. Opdivo is a human antibody that targets and inhibits the programmed death receptor-1 (PD-1), resulting in T-cell activation. Opdivo is part of a new class of cancer immunotherapy treatments known as checkpoint inhibitors, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. A second trial under the collaboration is planned to begin later in 2015 for relapsed or refractory B-cell and T-cell non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL). The phase 1/2 open-label trial will enroll relapsed or refractory HL patients who have failed frontline therapy. The primary objective is to assess the safety and antitumor activity of ADCETRIS in combination with Opdivo. After completion of four cycles of combination therapy, patients are eligible to undergo autologous stem cell transplant (ASCT). Patients at high risk of relapse or progression following ASCT will be eligible to receive ADCETRIS in the commercial setting. All patients will be assessed for progression-free survival after ASCT. The trial is being conducted at multiple centers in the United States and is designed to enroll up to approximately 60 patients.
Seattle Genetics Announces FDA Regular Approval of ADCETRIS® (Brentuximab Vedotin) for Classical Hodgkin Lymphoma Patients at High Risk of Relapse or Progression as Post-Autologous Hematopoietic Stem Cell Transplantation Consolidation
Aug 17 15
Seattle Genetics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) for the treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. The approval is based on a phase 3 clinical trial called AETHERA that was designed to compare up to 16 cycles (approximately one year) of ADCETRIS therapy administered every three weeks following auto-HSCT to placebo. The primary endpoint was met with a significant improvement in median progression-free survival (PFS) of 42.9 months (95% CI: 30.4, 42.9) for patients who received ADCETRIS versus 24.1 months (95% CI: 11.5, not estimable) for patients who received placebo, an improvement of 18.8 months (hazard ratio=0.57 [95% CI: 0.40, 0.81]; p-value=0.001). In addition, data from the AETHERA trial converted the U.S. accelerated approval of the relapsed classical HL indication to regular approval. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma (sALCL), as well as other lymphoma subtypes. This is the third indication for ADCETRIS, which was granted accelerated FDA approval in August 2011 for two other indications: (1) treatment of Hodgkin lymphoma patients who fail autologous transplant or who fail at least two prior multi-agent chemotherapy regimens and are not autologous transplant candidates, and (2) treatment of systemic ALCL patients who fail at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Seattle Genetics, Inc. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015; Revises Sales Guidance for the Year of 2015
Jul 30 15
Seattle Genetics, Inc. reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported total revenues of $77,096,000 against $68,308,000 a year ago. Loss before income taxes was $47,563,000 against $17,643,000 a year ago. Net loss was $47,502,000 or $0.38 per basic and diluted share against $17,590,000 or $0.14 per basic and diluted share a year ago.
For the six months, the company reported total revenues of $159,253,000 against $136,579,000 a year ago. Loss before income taxes was $69,306,000 against $34,014,000 a year ago. Net loss was $69,192,000 or $0.55 per basic and diluted share against $33,891,000 or $0.28 per basic and diluted share a year ago.
The company anticipates that 2015 revenues from ADCETRIS net product sales in the U.S. and Canada will be slightly higher than previously anticipated, and are now expected to be in the range of $210 million to $220 million.
Seattle Genetics Seeks Acquisitions
Jul 30 15
Seattle Genetics, Inc. (NasdaqGS:SGEN) will be opportunistic about looking for in licensing or acquisition opportunities that can help improving their pipeline.
SFC Energy AG Announces Addition of Fisheries Supply as Marine Distributor of EFOY COMFORT Fuel Cells in the Western United States
Jul 23 15
SFC Energy AG announced that it will partner with Seattle, WA, USA, to serve as a new marine distributor for the popular EFOY COMFORT fuel cells in the United States. Fisheries Supply Company has been a specialist in marine products since 1928, serving recreational boaters as well as boat dealers, builders and yards, chandleries and commercial fishermen across the Pacific Northwest, Alaska and beyond. The company is a leading distributor of marine products in the Pacific Northwest. Fisheries Supply will sell the full range of EFOY COMFORT fuel cells and fuel cartridges to customers along the West Coast of the United States, one of the large recreational boat markets on the globe.