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Exhibit 99.1
Seattle Genetics Reports Fourth Quarter and Year 2017 Financial Results
-Record ADCETRIS® (Brentuximab Vedotin) Net Sales in U.S. and Canada of $307.6 Million in 2017, Including $83.7 Million in the Fourth Quarter-
-ECHELON-1 Supplemental BLA for ADCETRIS in Combination with Chemotherapy for Frontline Advanced Classical Hodgkin Lymphoma Granted FDA Priority Review and PDUFA Action Date of May 1, 2018-
-ECHELON-2 Data Expected in 2018-
-Proposed Acquisition of Cascadian Therapeutics Would Add Third Late-Stage Program to Pipeline-
-Conference Call Today at 4:30 p.m. ET-
Bothell, WA February 6, 2018 Seattle Genetics, Inc. (NASDAQ: SGEN) today reported financial results for the fourth quarter and year ended December 31, 2017. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development accomplishments, enfortumab vedotin (ASG-22ME) and tisotumab vedotin clinical activities, as well as progress with its pipeline of targeted therapies for cancer.
During 2017, we continued to deliver on the promise of ADCETRIS as shown by growing commercial sales, FDA approval of a fourth labeled indication and, importantly, the positive outcome of our phase 3 ECHELON-1 clinical trial. We anticipate several additional ADCETRIS milestones in 2018, including its potential approval and commercial launch for use in combination with chemotherapy in frontline advanced classical Hodgkin lymphoma patients based on the ECHELON-1 trial as well as reporting data from the phase 3 ECHELON-2 trial in frontline mature T-cell lymphomas, said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. Our clinical pipeline is also strongly positioned, rapidly advancing our goal of becoming a multi-product oncology company. Enfortumab vedotin is in an ongoing pivotal trial for metastatic urothelial cancer and we expect to advance tisotumab vedotin into a pivotal trial for metastatic cervical cancer during the first half of this year. And recently, we entered into an agreement to acquire Cascadian Therapeutics, including global rights to its pivotal-stage program tucatinib for HER2-positive metastatic breast cancer.
ADCETRIS Program Highlights
| ECHELON-1 Filing: The U.S. Food and Drug Administration (FDA) accepted for filing a supplemental Biologics License Application (BLA) for ADCETRIS in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The FDA granted Priority Review for the application and the Prescription Drug User Fee Act (PDUFA) target action date is May 1, 2018. Previously, the FDA granted ADCETRIS Breakthrough Therapy Designation in this setting based on data from the phase 3 ECHELON-1 clinical trial. |
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Non-refundable advance payments for goods or services that will be used or rendered for future research and development activities are capitalized and recognized as expense as the related goods are delivered or the related services are performed.
While we expect continued growth in ADCETRIS sales in 2018 as compared to 2017, we expect only modest sales growth in the near term as a result of the FDA approval of ADCETRIS for the treatment of patients with pcALCL and CD30-expressing MF who have received prior systemic therapy, subject to our ability to effectively commercialize ADCETRIS in this indication.
Research and development expenses consist of salaries, benefits and other headcount-related costs of our research and development staff, preclinical activities, clinical trials and related manufacturing costs, lab supplies, contract and outside service fees, and facilities and overhead expenses.
Other costs and overhead include third-party costs of our preclinical programs, including our strategic collaborations with Genmab and Unum, and costs associated with personnel and facilities.
The table also presents other costs and overhead consisting of third-party costs for our preclinical stage programs, personnel, facilities and other indirect costs not directly charged to development programs.
In addition, we expect only...Read more
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The competition ADCETRIS faces from...Read more
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ADCETRIS inventory that is deployed...Read more
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committing substantial capital resources to...Read more
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Ticker: SGEN
CIK: 1060736
Form Type: 10-K Annual Report
Accession Number: 0001193125-18-046213
Submitted to the SEC: Wed Feb 14 2018 9:44:39 PM EST
Accepted by the SEC: Thu Feb 15 2018
Period: Sunday, December 31, 2017
Industry: Biological Products No Disgnostic Substances