Seattle Genetics, Inc. (Nasdaq:SGEN) today reported financial results for the third quarter and nine months ended September 30, 2009. The company also highlighted recent product development progress.
“We achieved several significant milestones during the third quarter, including completing enrollment in the pivotal clinical trial of brentuximab vedotin, our lead antibody-drug conjugate (ADC) for Hodgkin lymphoma,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We expect data from the pivotal trial in the second half of 2010, and are continuing to position the program for a planned U.S. product launch in the second half of 2011, assuming priority review of our marketing application. During the third quarter, we also submitted an investigational new drug (IND) application for our next proprietary ADC, SGN-75, and two more of our ADC collaborators initiated clinical trials with programs using our technology. In addition, we received net proceeds of $128 million from a public offering that further strengthened our financial position. We anticipate achieving multiple milestones across our pipeline over the remainder of 2009 and in 2010.”
Corporate and ADC Collaborator Update
Brentuximab Vedotin (SGN-35)
- Completed accrual to a pivotal trial for relapsed and refractory Hodgkin lymphoma six months ahead of schedule; data from this clinical trial are expected in the second half of 2010
- Observed that median duration of response in the phase I every three week dosing trial increased to ten months at the time of study completion; the every three week schedule is used in the ongoing pivotal trial
- Completed accrual to a phase I weekly dosing clinical trial; interim data from this study will be presented at the American Society of Hematology (ASH) annual meeting in December 2009
- Initiated a phase II clinical trial to assess retreatment of patients who previously received brentuximab vedotin therapy
- Named Bruce Seeley as Executive Vice President, Commercial, to lead marketing and sales activities in preparation for product commercialization
- Preparing to initiate a clinical trial in the first half of 2010 to evaluate the safety of brentuximab vedotin in combination with chemotherapy in front-line Hodgkin lymphoma
- Conducted productive discussions with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency regarding a global registration strategy for relapsed and refractory Hodgkin lymphoma that includes a phase 3 study designed to support full approval
Lintuzumab (SGN-33)
- Continued patient treatment in a randomized phase IIb trial of lintuzumab plus low-dose chemotherapy for patients 60 years and older with acute myeloid leukemia to determine if the combination extends overall survival; data from this trial are expected in the first half of 2010
Dacetuzumab (SGN-40)
- Received abstract acceptance for presentation of data from two phase Ib clinical trials at ASH, including dacetuzumab in combination with Rituxan® (rituximab) and Gemzar® (gemcitabine) for relapsed and refractory diffuse large B-cell lymphoma and dacetuzumab in combination with Revlimid® (lenalidomide) for relapsed and refractory multiple myeloma; in addition, preclinical data will be reported at ASH describing a diagnostic gene signature that may identify lymphoma patients who are more likely to respond to dacetuzumab therapy
- Announced discontinuation of the SeaGen MARINER phase IIb clinical trial based on a determination that the trial would be unlikely to meet its primary endpoint of superior complete response rate
SGN-75
- Submitted an IND application to the FDA to support a phase I clinical trial for CD70-positive hematologic malignancies and solid tumors
ADC Collaborations
- Received a milestone payment under collaboration agreement with MedImmune, LLC, a wholly owned subsidiary of AstraZeneca, triggered by its initiation of a phase I clinical trial of MEDI-547, an anti-EphA2 ADC for solid tumors
- Received a milestone payment under collaboration with Bayer Schering Pharma AG, Germany, triggered by Bayer's submission of an IND application to the FDA for MN-IC, an ADC for solid tumors
SEA Technology
- Introduced sugar engineered antibody (SEA) technology, a novel approach to increasing the potency of monoclonal antibodies through enhanced effector function; the company has filed a patent application covering the SEA technology and intends to employ it in its internal early-stage pipeline as well as consider collaborations with other companies
Third Quarter and Nine Month 2009 Financial Results