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February 5, 2014
09:02 EDTSGENSeattle Genetics achieves sales miletone under ADCETRIS collaboration
Seattle Genetics announced that it will receive a $5M milestone payment under its ADCETRIS collaboration with Takeda Pharmaceutical Company Limited. The milestone was triggered by Takeda surpassing annual ADCETRIS net sales of $100M in its territories. The milestone will be recognized as royalty revenue in 1Q14. Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics is entitled to royalties based on a percentage of Takeda's net sales in its territory at rates that range from the mid-teens to the mid-twenties based on sales volume, subject to offsets for royalties paid by Takeda to third parties. In addition, Seattle Genetics is entitled to receive progress- and sales-dependent milestone payments based on net sales of ADCETRIS within Takeda’s licensed territories. Seattle Genetics and Takeda are also funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.
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February 18, 2015
09:05 EDTSGENSeattle Genetics submits supplemental BLA to FDA for Phase 3 Aethera trial
Seattle Genetics announced that it has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration based on data from the phase 3 AETHERA trial of ADCETRIS as consolidation therapy immediately following an autologous stem cell transplant in Hodgkin lymphoma patients at high risk of relapse. ADCETRIS is an antibody-drug conjugate directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma. ADCETRIS is approved in relapsed HL and sALCL but is currently not approved for consolidation therapy in HL patients immediately after ASCT. The supplemental BLA is based on positive results from a phase 3 clinical trial called AETHERA that were presented at the 56th American Society of Hematology Annual Meeting in December 2014. Results from the AETHERA trial in 329 HL patients at high risk of relapse included: The trial achieved its primary endpoint and demonstrated a significant increase in progression-free survival per independent review facility, with a hazard ratio of 0.57 and a p-value of 0.001. Median PFS was 43 months for patients who received ADCETRIS versus 24 months for patients who received placebo. The two-year PFS rate was 63 percent in the ADCETRIS arm compared to 51 percent in the placebo arm. The PFS benefit was consistent across all pre-specified subgroups, including primary refractory patients, patients who relapsed within twelve months of frontline therapy and patients who relapsed after twelve months with extranodal disease.

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