- 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).
Seattle Genetics Reports Fourth Quarter And Year 2013 Financial Results
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