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Seattle Genetics, Inc. (Nasdaq:SGEN) today reported financial results for the first quarter ended March 31, 2012. The company also highlighted the ADCETRIS (brentuximab vedotin) product launch, ongoing and planned clinical development activities and upcoming milestones.
First quarter 2012 ADCETRIS net product sales were $34.5 million, an increase of 4 percent from $33.2 million in the fourth quarter of 2011. ADCETRIS gross product sales increased by 12 percent in the first quarter of 2012 compared to the fourth quarter of 2011, but this increase was offset by an expected increase in gross-to-net discount in the first quarter of 2012 driven by Public Health Services program discounts that became effective during January.
“The commercialization of ADCETRIS continues to be strong, and we are pleased by the acceptance and utilization of ADCETRIS among oncologists and patients with relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL),” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Our long-term vision for ADCETRIS is to expand its use into earlier lines of HL and sALCL therapy and into other CD30-positive malignancies. To that end, we are conducting a robust clinical development program with ADCETRIS, including clinical studies to broadly assess CD30 expression in both hematologic malignancies and solid tumors, as well as to evaluate activity and tolerability of ADCETRIS in these patient populations. Initial data from these clinical studies will be presented at the upcoming American Society of Clinical Oncology (ASCO) annual meeting and we have multiple late-stage trials that are already underway or are about to begin to further evaluate the broad potential of ADCETRIS. In addition, we and our collaborators are advancing a robust pipeline of clinical and preclinical ADC programs for a variety of cancers.”
Recent ADCETRIS Highlights
In collaboration with Millennium: The Takeda Oncology Company, initiated an international phase III clinical trial of ADCETRIS for relapsed cutaneous T-cell lymphomas (CTCL), including primary cutaneous anaplastic large cell lymphoma and mycosis fungoides. The trial is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA). The study also received European Medicines Agency (EMA) scientific advice.
In collaboration with Millennium, entered into an agreement with Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, under which Ventana will seek to develop, manufacture and commercialize a molecular companion diagnostic test for future indications with the goal of identifying patients who might respond to treatment with ADCETRIS based on CD30 expression levels in their tissue specimens.
Reported clinical data from a phase I trial evaluating sequential and concurrent administration of ADCETRIS with multi-agent chemotherapy in front-line mature T-cell lymphomas, including systemic anaplastic large cell lymphoma (sALCL).
Reported clinical data from an investigator-sponsored phase II clinical trial of ADCETRIS in patients with CTCL.
Supported initiation of two additional investigator-sponsored trials (ISTs) evaluating ADCETRIS in combination with chemotherapy for front-line limited stage HL and as consolidation following front-line chemotherapy for patients with newly diagnosed stage I/II HL. A total of seven ADCETRIS ISTs are ongoing, and the company expects multiple additional ISTs to begin during 2012.
Announced that the Journal of Clinical Oncology (JCO) published results of the company’s pivotal clinical trial of ADCETRIS in HL patients with relapsed or refractory disease following an autologous stem cell transplant. A separate pivotal clinical trial of ADCETRIS for the treatment of relapsed or refractory sALCL has been accepted for publication and is currently in press for an upcoming issue of JCO.
Other Recent Highlights
Presented data highlighting progress with antibody-drug conjugate (ADC) technology at the American Association for Cancer Research annual meeting. The presentations highlighted data from an ADC using a potent new cytotoxic agent that can be linked to antibodies, a method to produce uniform drug-loading on antibodies with enhanced stability and a novel preclinical ADC targeted to solid tumors. In addition, data were presented showing the antitumor activity of a novel fucose inhibitor that can be administered orally.
Enhanced corporate leadership through the appointment of Nancy A. Simonian, M.D. to the company’s Board of Directors, the promotion of Chris Boerner, Ph.D. to Senior Vice President, Commercial and the addition of Jorge Cerda as Vice President, Information Technology.
The company is on track to achieve multiple near-term milestones for ADCETRIS and other pipeline programs, including:
Reporting interim data from three ongoing clinical trials of ADCETRIS at the ASCO annual meeting in June 2012, including the phase II retreatment trial, the phase II trial in non-Hodgkin lymphomas and the screening protocol for patients with non-lymphoma malignancies.
Millennium/Takeda expects a decision from the EMA in the second half of 2012 on the ADCETRIS marketing authorization application (MAA) that was accepted by the EMA in June 2011.
Initiating a phase III clinical trial of ADCETRIS in front-line advanced stage HL by late 2012 or early 2013.
Initiating a phase III clinical trial of ADCETRIS in front-line mature T-cell lymphomas, including sALCL, by late 2012 or early 2013.
Obtaining Canadian approval for ADCETRIS in relapsed HL and sALCL; expect a Health Canada decision in late 2012 or early 2013.
Initiating a phase Ib clinical trial to evaluate SGN-75 in combination with everolimus, an mTOR inhibitor, for renal cell carcinoma during 2012.
In collaboration with Agensys, an affiliate of Astellas, reporting interim data from the phase I trial of ASG-5ME in prostate cancer at the ASCO annual meeting.
Submitting an investigational new drug application for SGN-CD19A, a CD19-targeted ADC, during 2012.
First Quarter 2012 Financial Results
Revenues in the first quarter of 2012 were $48.2 million, compared to $12.2 million in the first quarter of 2011. First quarter 2012 revenues include ADCETRIS net product sales of $34.5 million. In addition, first quarter 2012 revenues reflect amounts earned under the company’s ADCETRIS and ADC collaborations.