seattle genetics inc (SGEN) Key Developments
Seattle Genetics, Inc. Announces Executive Changes
Nov 3 15
Seattle Genetics, Inc. hired and promoted several members to senior management team, including: Promoting Elaine Waller, PharmD, to Executive Vice President, Regulatory Affairs and Clinical Development Operations. Dr. Waller has been with Seattle Genetics since September 2008. She has led numerous successful regulatory initiatives for the company, including the recent ADCETRIS label expansion; Promoting Peter Senter, Ph.D., to Vice President, Chemistry and Senior Distinguished Fellow. Dr. Senter joined Seattle Genetics in August 1998. As an early member of the company's research organization, he has contributed significantly to Seattle Genetics' leadership position in ADCs and the innovative science behind its pipeline programs; Hiring Rachel Lenington as Vice President, Program, Portfolio and Alliance Management. Lenington previously spent five years at the Bill & Melinda Gates Foundation focused on global health strategies, product development and alliances. Before that she spent 10 years at Amgen; Hiring Matt Skelton as Vice President, Marketing. Skelton previously spent 16 years at Amgen in a range of sales and marketing roles. Before that, he was at Eli Lilly; Promoting Phil Tsai, Ph.D., to Vice President, Process Sciences. Dr. Tsai has been at Seattle Genetics since January 2003. During his tenure, he has led the development of many antibody and ADC manufacturing processes at various stages of the product development life cycle.
Seattle Genetics Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2015; Revises Revenue Guidance for the Full Year of 2015
Oct 29 15
Seattle Genetics reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2015. For the quarter, the company reported total revenue of $84,072,000 against $75,853,000 a year ago. Loss from operations was $26,500,000 against $15,625,000 a year ago. Net loss was $26,438,000 against $15,566,000 a year ago. Basic and diluted net loss per share was $0.21 against $0.13 a year ago.
For the nine months, the company reported total revenue of $163,040,000 against $131,707,000 a year ago. Loss from operations was $995,806,000 against $49,639,000 a year ago. Net loss was $95,630,000 against $49,457,000 a year ago. Basic and diluted net loss per share was $0.76 against $0.40 a year ago.
The company anticipates that 2015 revenues from ADCETRIS net product sales in the U.S. and Canada will be higher than previously anticipated, and are now expected to be in the range of $218 million to $223 million.
Seattle Genetics, Inc. Initiates Phase 2 Clinical Trial of Denintuzumab Mafodotin (SGN-CD19A) Combination Therapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Oct 29 15
Seattle Genetics, Inc. announced the initiation of a randomized phase 2 clinical trial of denintuzumab mafodotin (SGN-CD19A) in combination with the second-line salvage regimen of rituximab (Rituxan), ifosfamide, carboplatin and etoposide (RICE), for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common type of aggressive non-Hodgkin lymphoma. The study is intended to evaluate the activity and safety of the combination regimen compared to RICE alone. Denintuzumab mafodotin is an antibody-drug conjugate (ADC) targeting CD19, a protein expressed uniformly on almost all B-cell malignancies. The ADC is designed to be stable in the bloodstream and release its cytotoxic agent upon internalization into CD19-expressing cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects associated with traditional chemotherapy while enhancing antitumor activity. In this phase 2 randomized, open-label, multi-center clinical trial, approximately 150 relapsed/refractory DLBCL or grade 3B follicular lymphoma patients who are eligible for an autologous stem cell transplant (ASCT) will be randomized to receive RICE either with or without denintuzumab mafodotin every three weeks for three cycles. The primary endpoint is to compare the complete remission rates between the two study arms. Secondary endpoints include safety of the combination regimen, progression-free survival, overall survival and the number of patients who are able to undergo autologous transplant.
Seattle Genetics and Takeda Pharmaceutical Company Achieve Target Enrollment in Phase 3 ECHELON-1 Clinical Trial Evaluating ADCETRIS® (Brentuximab Vedotin) in Previously Untreated Advanced Hodgkin Lymphoma (HL)
Oct 27 15
Seattle Genetics, Inc. and Takeda Pharmaceutical Company Limited announced that the companies have achieved completion of target patient enrollment in the phase 3 ECHELON-1 clinical trial. ECHELON-1 is a randomized trial evaluating ADCETRIS (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in patients with previously untreated advanced classical Hodgkin lymphoma (HL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. ADCETRIS is currently not approved for the frontline treatment of HL. Patients in ECHELON-1 were randomized to receive either ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine), a recognized standard of care for frontline HL, or a novel combination consisting of ADCETRIS+AVD, which removes bleomycin from the regimen. The trial has enrolled approximately 1,300 patients, although it remains open at select sites to complete enrollment of approximately 20 patients in an additional cohort to fulfill an ex-U.S. regulatory commitment related to measurement of drug levels during treatment (pharmacokinetics). This continued enrollment will not affect the expected timing of data readout from the trial in the 2017 to 2018 timeframe, based on anticipated event rates. The ECHELON-1 trial is being conducted under a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) and the trial also received European Medicines Agency (EMA) scientific advice. Data previously presented at the ASH Annual Meeting in 2012 and 2014 from a phase 1 trial evaluating ADCETRIS plus AVD demonstrated that 24 of 25 patients (96%) achieved a complete remission. Long-term follow-up data demonstrated three-year overall survival was 100% and three-year failure-free survival was 92%. The most common adverse events of any grade occurring in more than 30% of patients were neutropenia, nausea, peripheral sensory neuropathy, fatigue, vomiting, diarrhea, insomnia, bone pain, constipation and hair loss. The randomized, open-label, phase 3 trial is investigating ADCETRIS+AVD versus ABVD as frontline therapy in patients with advanced classical HL. The primary endpoint is modified progression free survival per independent review facility assessment using the Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Secondary endpoints include overall survival, complete remission and safety. The multi-center trial is being conducted in North America, Europe, South America, Australia, Asia and Africa. The study has enrolled approximately 1,300 patients who had histologically-confirmed diagnosis of Stage III or IV classical HL and had not been previously treated with systemic chemotherapy or radiotherapy. Data from the trial will be available when a pre-specified number of PFS events have occurred.
Seattle Genetics, Inc. Presents at Credit Suisse 24th Annual Healthcare Conference, Nov-10-2015 12:30 PM
Oct 19 15
Seattle Genetics, Inc. Presents at Credit Suisse 24th Annual Healthcare Conference, Nov-10-2015 12:30 PM. Venue: The Phoenician Hotel, Scottsdale, Arizona, United States. Speakers: Clay B. Siegall, Co-Founder, Chairman, Chief Executive Officer and President.