The Takeda Oncology Company and the parent company, Takeda Pharmaceutical have jointly announced that Seattle Genetics and Millennium have entered into an agreement to develop and commercialise Brentuximab Vedotin (SGN-35).
Brentuximab Vedotin is an antibody-drug conjugate (ADC) targeting CD30, which is in late-stage clinical trials, for the treatment of relapsed and refractory hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL).
Data from a pivotal Phase II trial of Brentuximab Vedotin in relapsed or refractory HL are expected in the second half of 2010. The trial is being conducted under a special protocol assessment with the FDA and will provide the basis for regulatory submissions in the US and Europe in 2011.
Under the collaboration, Seattle Genetics will receive an upfront payment of $60m and will retain full commercialisation rights for Brentuximab Vedotin in the US and Canada. Takeda will have exclusive rights to commercialise the product candidate in all countries other than the US and Canada. Seattle Genetics is entitled to receive progress-and-sales-dependent milestone payments in addition to tiered royalties based on net sales of Brentuximab Vedotin within the Takeda’s licensed territories.
Milestone payments to Seattle Genetics could total more than $230m. Seattle Genetics and the Takeda will jointly fund development costs on a 50:50 basis. Development funding by the Takeda over the first three years of the collaboration is expected to be at least $75m. In Japan, Takeda will be solely responsible for development costs.
Clay Siegall, president and chief executive officer of Seattle Genetics, said: “Our retention of full commercial rights in the US and Canada along with the financial terms from this agreement gives us a strong basis to begin building a commercial infrastructure for the planned launch of Brentuximab Vedotin. We expect to utilise this infrastructure in the future for other product candidates in our pipeline.”
Deborah Dunsire, president and CEO of Millennium, said: “The addition of the late-stage product candidate Brentuximab Vedotin to our oncology development pipeline supports our mission to develop innovative new medicines where there is a high unmet need for patients.
“This collaboration closely aligns with our growth strategy, which includes both internal and external opportunities. We are very excited to bring forward a novel medicine which will help us increase our reach in oncology throughout Europe and the rest of the world.”