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news.Seattle Genetics has announced that it will receive milestone payments from Takeda Pharmaceutical totaling $6m as a result of achieving the first commercial sale of ADCETRIS (brentuximab vedotin) in three key countries in Takeda’s territories outside of the EU and Japan, consisting of Australia, South Korea and Mexico.
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All three countries have permission to sell commercial product from their local health authority for the treatment of patients with relapsed or refractory CD30-positive Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).
In addition to these three countries, ADCETRIS is also commercially available in the US, EU, Japan, Canada, Ukraine, Switzerland, Singapore, Norway, Liechtenstein and Iceland. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and known to be expressed in some types of non-Hodgkin lymphoma, including sALCL.
Seattle Genetics president and CEO Dr Clay B. Siegall noted that the company, along with its partner Takeda, has made great progress in making ADCETRIS available globally as a treatment for relapsed or refractory HL and ALCL, with it now commercially available in 40 countries.
"We remain focused on expanding patient access worldwide by supporting Takeda’s efforts to secure marketing approvals in their territories. In parallel, we are also broadly evaluating ADCETRIS as the foundation of therapy for CD30-positive malignancies through more than 30 ongoing clinical trials," Dr Siegall added.
Permission to sell commercial product in these key countries was based on data from two global pivotal Phase II clinical trials of ADCETRIS for patients with relapsed or refractory CD30-positive HL and sALCL.
Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world.
Seattle Genetics is entitled to royalties based on a percentage of Takeda’s net sales in its territory at rates that range from the mid-teens to the mid-twenties based on sales volume, subject to offsets for royalties paid by Takeda to third parties. In addition, Seattle Genetics is entitled to receive progress- and sales-dependent milestone payments based on net sales of ADCETRIS within Takeda’s licensed territories.
Seattle Genetics and Takeda are also funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.