Seattle Genetics, Inc. (Nasdaq: SGEN) today reported financial results for the fourth quarter and year ended December 31, 2013. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development activities, progress with its antibody-drug conjugate (ADC) pipeline, collaborator updates and upcoming milestones.
“Our 2013 financial results highlight our progress with ADCETRIS, which now has approvals or marketing authorizations in 39 countries and generated total 2013 global net sales of more than $250 million, reflecting growth in the United States and Canada as well as product launches by Takeda in the rest of the world. We also reported strong collaboration revenues in 2013, including multiple upfront and milestone payments generated under our ADC collaborations,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. “We remain well positioned to continue investing in the broad clinical development of ADCETRIS in earlier lines of lymphoma therapy and other CD30-positive malignancies, as well as advancement of our five clinical-stage pipeline programs for cancer. We anticipate several important milestones during 2014, notably data from our ADCETRIS phase 3 AETHERA clinical trial as well as clinical data from two of our proprietary ADCs, SGN-CD19A and SGN-CD33A.”
Recent ADCETRIS Highlights
- Announced that Seattle Genetics and its collaborator Takeda Pharmaceutical Company Limited (Takeda) have aligned with the U.S. Food and Drug Administration (FDA) and European Union regulatory agencies on a protocol amendment to unblind the phase 3 AETHERA clinical trial in the second half of 2014.
- Negotiated an agreement with the Pan-Canadian Pricing Alliance (PCPA) recommending provincial funding of ADCETRIS as a treatment for patients with relapsed/refractory Hodgkin lymphoma (HL) and relapsed/refractory systemic anaplastic large cell lymphoma (sALCL). The PCPA includes key provinces/territories with the exception of Quebec, where discussions are ongoing.
- Received orphan drug designation from the FDA for diffuse large B-cell lymphoma (DLBCL).
- Reported on data from multiple clinical trials of ADCETRIS, including its evaluation in frontline HL, frontline mature T-cell lymphoma (MTCL), relapsed cutaneous T-cell lymphoma (CTCL) and relapsed DLBCL at the 2013 American Society of Hematology (ASH) annual meeting.
- Achieved a $5 million milestone payment from Takeda triggered by Takeda surpassing ADCETRIS annual net sales of $100 million in its territories. The milestone will be recognized as royalty revenue in the first quarter of 2014.
- Takeda received marketing authorizations for ADCETRIS in Japan, Australia and Singapore through its local affiliates. Seattle Genetics will receive milestone payments totaling $9 million upon final pricing agreement in Japan.
- ADCETRIS was added to the National Comprehensive Cancer Network (NCCN) guidelines for the treatment of relapsed CD30-positive peripheral T-cell lymphoma (PTCL).
ADCETRIS is currently not approved for use in any frontline setting, or for the treatment of relapsed CTCL, DLBCL or PTCL other than sALCL.