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Seattle Genetics Reports Third Quarter 2015 Financial Results

The following excerpt is from the company's SEC filing.

-Total Third Quarter 2015 Revenues of $84.1 Million, Including Record $59.1 Million in


(Brentuximab Vedotin) U.S. and Canada Net Sales-

-ADCETRIS 2015 U.S. and Canada Net Sales Guidance Increased to a Range of $218 Million

to $223 Million-

-More than Twenty Presentations at ASH Annual Meeting Featuring Data on ADCETRIS,

SGN-CD33A and Other Antibody-Drug Conjugate Pipeline Programs-

Bothell, WA October 29, 2015

Seattle Genetics, Inc.

(Nasdaq: SGEN) today reported financial results for the third quarter and nine months ended September 30, 2015. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization, regulatory and clinical development accomplishments, progress with other proprietary pipeline programs and antibody-drug conjugate (ADC) collaborator updates.

We are pleased to have delivered on several key milestones recently, including an expanded label for ADCETRIS based on our phase 3 AETHERA trial, completing enrollment in the ALCANZA phase 3 trial and reaching our target enrollment in the phase 3 ECHELON-1 trial, said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. We also completed a successful public offering in September that strongly positions us to continue investing in expanding the ADCETRIS opportunity, advancing our product pipeline and conducting innovative research. We are preparing for a strong presence at the upcoming ASH annual meeting with data from ADCETRIS, SGN-CD33A and other pipeline programs.

Recent ADCETRIS Highlights

Received regular approval from the U.S. Food and Drug Administration (FDA) for ADCETRIS

(brentuximab vedotin) for classical Hodgkin lymphoma (HL) patients at high risk of relapse or progression as post-autologous transplant consolidation based on the phase 3 AETHERA clinical trial. The approval represents the third indication for ADCETRIS in the United States. The AETHERA trial also converted the prior accelerated approval of ADCETRIS in relapsed HL to regular approval.

Completed enrollment in the phase 3 ALCANZA clinical trial for patients with CD30-expressing cutaneous T-cell lymphoma (CTCL) who have received prior systemic therapy. The randomized trial is evaluating ADCETRIS versus investigators choice of methotrexate or bexarotene in 132 patients. Data are anticipated in the second half of 2016.

Completed target patient enrollment in the phase 3 ECHELON-1 clinical trial. ECHELON-1 is a randomized trial evaluating ADCETRIS as part of a frontline combination chemotherapy regimen in patients with previously untreated advanced classical HL.

Initiated a randomized phase 2 trial of rituximab (Rituxan) and bendamustine (Treanda) with or without ADCETRIS for relapsed or refractory patients with CD30-expressing diffuse large B-cell lymphoma (DLBCL).

Initiated a phase 1/2 clinical trial of ADCETRIS in combination with nivolumab (Opdivo) for patients with relapsed or refractory HL after failure of frontline treatment. The trial is being conducted under a previously announced clinical trial collaboration agreement with Bristol-Myers Squibb Company.

Recent Pipeline, Collaborator and Other Highlights

Initiated a randomized phase 2 trial of SGN-CD19A (denintuzumab mafodotin) in combination with the second-line salvage regimen of rituximab, ifosfamide, carboplatin and etoposide (RICE) for patients with relapsed or refractory DLBCL.

Submitted an investigational new drug (IND) application to the FDA for SGN-CD19B, a CD19-targeted ADC utilizing the companys pyrrolobenzodiazepine (PBD) dimer cell-killing agent and proprietary site-specific conjugation technology (EC-mAb). A phase 1 trial is planned in the first half of 2016.

Expanded our 2011 collaboration with AbbVie to provide access to Seattle Genetics PBD dimer and EC-mAb technology. Financial terms were not disclosed.

Received a milestone payment under our collaboration with AbbVie, triggered by its initiation of a phase 1 trial for an auristatin-based ADC for solid tumors utilizing Seattle Genetics technology.

Added to and promoted several members of the 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 companys 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. Ms. 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.