Seattle Genetics unveils commercial and regulatory progress under ADCETRIS collaboration with Takeda

The milestone was triggered by Takeda surpassing annual ADCETRIS net sales of $200m in its territory during 2015. The milestone will be recognized as royalty revenue in the first quarter of 2016.

In addition, the company announced that the European Commission recently approved a Type II variation that includes data on the retreatment of adult patients with relapsed or refractory (R/R) Hodgkin lymphoma or R/R systemic anaplastic large cell lymphoma (sALCL) who previously responded to ADCETRIS and who later relapse. The label update follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in October 2015.

Seattle Genetics president and CEO Clay Siegall said: "This sales milestone and recent label update in Europe to include data on retreatment underscore the strong commercial and regulatory progress that Takeda has made in its territory.

"We and Takeda are focused on the goal of establishing ADCETRIS as the foundation of care for CD30-expressing lymphomas through global commercialization activities and a broad clinical development program that includes three phase 3 trials."

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 territory. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

About ADCETRIS® (Brentuximab Vedotin)
ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. CD30 is a member of the tumor necrosis factor receptor (TNFR) superfamily. In HL, CD30 may be involved in tumor cell proliferation by interacting with immune cells in the tumor microenvironment.

ADCETRIS for intravenous injection has received approval from the FDA for three indications: (1) regular approval for the treatment of patients with classical HL after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical HL patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Health Canada granted ADCETRIS approval with conditions for relapsed or refractory HL and sALCL.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive HL following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL.

In January 2016, the European Commission approved a Type II variation to include data on the retreatment of adult patients with Hodgkin lymphoma or sALCL who previously responded to ADCETRIS and who later relapse. ADCETRIS has received marketing authorization by regulatory authorities in 60 countries.