EMA acceptance of brentuximab vedotin MAA triggers $5M milestone payment to Seattle Genetics

Seattle Genetics, Inc., (Nasdaq: SGEN) today announced that it will receive a $5 million milestone payment under its brentuximab vedotin (ADCETRIS^TM) collaboration with Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502). The milestone was triggered by the European Medicines Agency (EMA) acceptance of the Marketing Authorization Application (MAA) for brentuximab vedotin for the treatment of relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, the defining marker of Hodgkin lymphoma and ALCL.

“The EMA acceptance of the MAA represents a significant achievement in the development of brentuximab vedotin, and takes us another step closer to our goal of bringing this ADC to relapsed or refractory Hodgkin lymphoma and systemic ALCL patients in need around the world”

"The EMA acceptance of the MAA represents a significant achievement in the development of brentuximab vedotin, and takes us another step closer to our goal of bringing this ADC to relapsed or refractory Hodgkin lymphoma and systemic ALCL patients in need around the world," said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. "We also continue to make progress with brentuximab vedotin in the United States, as we interact with the FDA on our two regulatory submissions for these indications. The FDA's Oncologic Drugs Advisory Committee will review our Biologics License Applications on July 14, 2011, and the action date is August 30, 2011 under the Prescription Drug User Fee Act."

Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where Takeda will be solely responsible for development costs.