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Japanese Approval for SGEN/Takeda's Adcetris

Zacks Equity Research

Seattle Genetics, Inc. (NASD:SGEN) and partner Takeda Pharmaceuticals (OTC:TKPYY) obtained Japanese Ministry of Health, Labour and Welfare (:MHLW) approval for Adcetris for the treatment of patients with CD30-positive relapsed or refractory Hodgkin lymphoma (HL) and anaplastic large cell lymphoma (:ALCL).

The approval was based on encouraging data from a phase I/II study conducted in Japan, on patients with relapsed or refractory CD30-positive HL and ALCL and two global pivotal phase II studies of Adcetris.

Following the final pricing agreement in Japan, Takeda will have to pay Seattle Genetics two milestone payments adding up to $9 million.

Adcetris was granted orphan status in Japan in Mar 2012 for the treatment of patients with HL and ALCL, which prompted priority review in Japan.

Seattle Genetics’ sole marketed antibody-drug conjugate (ADC) product, Adcetris, is currently approved in 39 countries. In the U.S. Adcetris is used for the treatment of patients with HL after failure of autologous stem cell transplant (:ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not suitable for ASCT. Adcetris is also approved for the treatment of systemic ALCL after failure of at least one multi-agent chemotherapy regimen. 

Adcetris is jointly developed by the two companies. As per the deal, Seattle Genetics has rights to commercialize Adcetris in the U.S. and Canada while Takeda has commercialization rights in the rest of the world.

ADCs have been gaining a lot of attention of late, with many companies entering into collaboration. Seattle Genetics has alliances with many companies for the development of ADCs.  

Seattle Genetics and Takeda carry a Zacks Rank #3 (Hold). Investors may consider companies like Endocyte Inc. (NASD:ECYT) and Actelion Ltd. (OTC:ALIOF), which carry a Zacks Rank #1 (Strong Buy).

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