Seattle Genetics (SGEN) Says Takeda Gets Positive ADCETRIS Recommendation from CHMP
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Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that its collaborator, Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the conditional marketing authorization of ADCETRIS (brentuximab vedotin) for two indications: (1) the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30.
The European Commission, which has the authority to approve medicines for use in the European Union, generally follows the recommendations of the CHMP and typically renders a final decision within three months of the CHMP opinion. If the CHMP recommendation is formally adopted by the European Commission, ADCETRIS would be approved for marketing in all 27 member states of the European Union.
European Commission approval will trigger two milestone payments, one for each indication, totaling $25 million to Seattle Genetics under the collaboration agreement between Seattle Genetics and Millennium: The Takeda Oncology Company. Seattle Genetics is also entitled to tiered double-digit royalties with percentages starting in the mid-teens and escalating to the mid-twenties based on net sales of ADCETRIS within Millennium’s territories, subject to offsets for royalties paid by Millennium to third parties.
The European Commission, which has the authority to approve medicines for use in the European Union, generally follows the recommendations of the CHMP and typically renders a final decision within three months of the CHMP opinion. If the CHMP recommendation is formally adopted by the European Commission, ADCETRIS would be approved for marketing in all 27 member states of the European Union.
European Commission approval will trigger two milestone payments, one for each indication, totaling $25 million to Seattle Genetics under the collaboration agreement between Seattle Genetics and Millennium: The Takeda Oncology Company. Seattle Genetics is also entitled to tiered double-digit royalties with percentages starting in the mid-teens and escalating to the mid-twenties based on net sales of ADCETRIS within Millennium’s territories, subject to offsets for royalties paid by Millennium to third parties.
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