Seattle Genetics, Inc. (Nasdaq:SGEN) today reported financial results for the third quarter and nine months ended September 30, 2012. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development activities, antibody-drug conjugate (ADC) pipeline and collaborator progress and upcoming milestones.
“Through significant commercial, regulatory and clinical development efforts we are continuing to bring ADCETRIS to patients, expanding into other territories under our collaboration with Millennium/Takeda, and advancing the evaluation of ADCETRIS into earlier lines of therapy and other CD30-positive malignancies,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. “At the upcoming American Society of Hematology (ASH) annual meeting in December, there will be more than a dozen data presentations by Seattle Genetics and investigators highlighting the evaluation of ADCETRIS in numerous lymphoma types. In addition, at ASH we will introduce our lead preclinical program, SGN-CD33A, which employs our next generation ADC technology, and we expect multiple data presentations by our ADC collaborators. The substantial progress with ADCETRIS and our other pipeline programs, as well as by our collaborators reinforces our ADC leadership position as we strive to change the way cancer is treated.”
Recent ADCETRIS Highlights
ADC Collaborator Progress
- Announced that Takeda Pharmaceutical Company Limited and Millennium: The Takeda Oncology Company received European Commission conditional marketing authorization for ADCETRIS for relapsed or refractory CD30-positive Hodgkin lymphoma (HL) and relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). The approvals triggered milestone payments to Seattle Genetics totaling $25 million.
- In collaboration with Millennium, initiated a global phase III clinical trial of ADCETRIS in combination with chemotherapy for front-line advanced HL. The trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) and scientific advice from the European Medicines Agency.
- Received an SPA agreement from the FDA supporting the design of a planned phase III clinical trial in front-line mature T-cell lymphomas.
- Announced the completion of patient enrollment in a phase III clinical trial for post-transplant HL patients. The phase III trial, also known as the AETHERA trial, is evaluating ADCETRIS versus placebo for the treatment of patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant (ASCT).
- Initiated a phase II trial in front-line Hodgkin lymphoma patients age 60 or older. The trial is designed to assess the efficacy and tolerability of single-agent ADCETRIS for patients who have received no prior treatment.
- Supported initiation of an investigator-sponsored trial (IST) designed to evaluate ADCETRIS in the treatment of diffuse large B-cell lymphoma. A total of 11 ADCETRIS ISTs are ongoing.
Other Recent Highlights
- Expanded our ADC collaboration with Abbott, generating an upfront payment to Seattle Genetics of $25 million. In addition, Seattle Genetics may receive up to $220 million in potential milestone payments per additional target upon achieving predetermined development and commercial objectives, as well as mid-to-high single-digit royalties on worldwide net sales of any resulting products under the multi-target collaboration.
- Achieved milestone payments under our ADC collaboration with Genentech, a member of the Roche Group, triggered by Genentech’s advancement of two ADCs utilizing Seattle Genetics technology into phase II clinical development.
- Achieved a milestone under our ADC collaboration with Abbott triggered by Abbott’s initiation of a phase I clinical trial of an ADC utilizing Seattle Genetics technology for patients with squamous cell tumors.
- Achieved a milestone under our ADC collaboration with Progenics triggered by Progenics’ initiation of a phase II clinical trial of an ADC targeted to PSMA for patients with prostate cancer.
- Initiated a phase I trial of SGN-75 in combination with everolimus, an mTOR inhibitor, for advanced metastatic renal cell carcinoma.
- Submitted to the FDA an investigational new drug application for SGN-CD19A, a CD19-targeted ADC. Phase I trials are expected to begin by early 2013.
- Named Samuel Yonren, M.D., as Vice President, Drug Safety.
Third Quarter and First Nine Months 2012 Financial Results
- Multiple clinical data presentations on ADCETRIS and ADC collaborator programs, as well as preclinical data on SGN-CD33A using the company’s next generation ADC technology will be presented at the ASH annual meeting being held December 8-11, 2012 in Atlanta, GA.
- Initiating a phase III clinical trial of ADCETRIS in front-line mature T-cell lymphomas, including sALCL, by late 2012 or early 2013.
- Anticipating a review decision from Health Canada in early 2013 for ADCETRIS in relapsed HL and sALCL.
- Initiating a phase I/II clinical trial of ADCETRIS in combination with bendamustine for second-line HL patients by late 2012.
- Initiating phase I trials of SGN-CD19A, a CD19-targeted ADC, by early 2013. One trial is planned in acute lymphocytic leukemia and one in B-cell non-Hodgkin lymphomas.
Total revenues in the third quarter of 2012 were $49.8 million, compared to $20.7 million in the third quarter of 2011. Total revenues for the nine month period ended September 30, 2012 were $146.9 million, compared to $45.9 million in 2011. Revenues in 2012 include ADCETRIS net product sales of $33.7 million in the third quarter and $102.8 million for the year to date. In addition, revenues include ADCETRIS royalty revenues of $1.7 million in the third quarter and $2.9 million for the year to date related to sales of ADCETRIS by Millennium under its international named patient program. Revenues also reflect amounts earned under the company’s ADCETRIS and ADC collaborations totaling $14.5 million in the third quarter of 2012 and $41.1 million for the year to date.