Seattle Genetics, Millennium in Lymphoma Alliance

Seattle Genetics and Millennium: The Takeda Oncology Company have entered into an agreement to globally develop and commercialize brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC) targeting CD30. SGN-35 is in late-stage trials for the treatment of relapsed and refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL).

Seattle Genetics will receive an upfront payment of $60 million and retains full commercialization rights for brentuximab vedotin in the U.S. and Canada. The Takeda Group will have exclusive rights to commercialize the product candidate in all other countries. Seattle Genetics is entitled to receive progress- and sales-dependent milestone payments in addition to tiered double-digit royalties based on net sales of brentuximab vedotin within the Takeda Group’s licensed territories. Milestone payments to Seattle Genetics could total more than $230 million. Seattle Genetics and the Takeda Group will jointly fund worldwide development costs on a 50/50 basis. Development funding by the Takeda Group during the first three years of the collaboration is expected to be at least $75 million. In Japan, the Takeda Group will be solely responsible for development costs.

Data from a Phase II trial of brentuximab vedotin in relapsed or refractory HL, which is fully enrolled, are expected in 2H10. The trial is being conducted under a special protocol assessment with the FDA and is designed to provide the basis for regulatory submissions in the U.S. and Europe in 2011.

“This collaboration aligns with our goal of rapidly bringing brentuximab vedotin to patients worldwide. Takeda is an ideal collaborator given its global presence, demonstrated commitment to oncology, and experience in the sales and marketing of first-in-class, targeted therapies for unmet medical needs,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer, Seattle Genetics. “Our retention of full commercial rights in the U.S. 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 utilize this infrastructure in the future for other product candidates in our pipeline.”

“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,” said Deborah Dunsire, M.D., president and chief executive officer, Millennium. “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.”