Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium: The Takeda
Oncology Company with its parent company Takeda Pharmaceutical Company
Limited (TSE: 4502) today jointly announced that Seattle Genetics and
Millennium have entered into an agreement to globally develop and
commercialize brentuximab vedotin (SGN-35). Brentuximab vedotin is an
antibody-drug conjugate (ADC) targeting CD30 that 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, which is fully enrolled, are expected in the second half
of 2010. The trial is being conducted under a special protocol
assessment with the U.S. Food and Drug Administration (FDA) and is
designed to provide the basis for regulatory submissions in the United
States and Europe in 2011.
Under the collaboration, Seattle Genetics will receive an upfront
payment of $60 million and retains full commercialization rights for
brentuximab vedotin in the United States and Canada. The Takeda Group
will have exclusive rights to commercialize the product candidate in all
countries other than the United States and Canada. 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 over 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.
“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.”