Brentuximab Vedotin Enters Phase 1/2 Clinical Trial in Japan

Osaka, Japan, October 11, 2011, CAMBRIDGE, Mass., October 10, 2011 and Tokyo, Japan, October 11, 2011 – Takeda Pharmaceutical Company Limited (“Takeda”), Millennium: The Takeda Oncology Company (“Millennium”) and Takeda Bio Development Center Limited (“Takeda Bio”) today announced that Takeda Bio has initiated its brentuximab vedotin clinical development for the treatment of malignant lymphoma with the start of a Phase 1/2 clinical trial in Japan.

The Phase 1/2 clinical trial is a multi-center, single-arm, open-label trial in patients with relapsed or refractory Hodgkin lymphoma (HL) and relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). The clinical trial aims to evaluate the safety, tolerability and efficacy of brentuximab vedotin in the Japanese population.

There is no established standard of care, in Japan, for the treatment of patients with relapsed/refractory HL or sALCL. We are committed to the development of brentuximab vedotin in these disease settings; where there is a high unmet medical need in order to deliver innovative, safe and effective therapies to patients as quickly as possible.

About Brentuximab Vedotin

Brentuximab vedotin is an antibody-drug conjugate (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.
Seattle Genetics and Millennium are jointly developing brentuximab vedotin. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs. The brentuximab vedotin marketing authorization application (MAA) for relapsed or refractory HL and sALCL was accepted by the European Medicines Agency in June 2011. The MAA was filed by Takeda Global Research & Development Centre (Europe).

CONTACTS:
Takeda
Corporate Communications Department
81- 3- 3278- 2037

Millennium: The Takeda Oncology Company
Manisha Pai
(617) 510- 9193
Manisha.Paimpi.com

Takeda Bio
Katsuaki Kato
81- 50- 3116- 9994
Kato_Katsuakitakeda.co.jp

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