Seattle Genetics, Inc.
) and partner
) 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
Following the final pricing agreement in Japan, Takeda will
have to pay Seattle Genetics two milestone payments adding up to
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
), which carry a Zacks Rank #1 (Strong Buy).
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