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Agreements

Date: 2012-04-12

Type of information: Development agreement

Compound: molecular companion diagnostic test to evidentify patients who might respond to treatment with Adcetris® (brentuximab vedotin) based on CD30 expression levels in their tissue specimens

Company: Seattle Genetics (USA - WA) Ventana Medical Systems (USA), a member of the Roche Group (Switzerland)

Therapeutic area: Cancer - Oncology

Type agreement:

collaboration
development
manufacturing
production
commercialisation

Action mechanism:

Disease: CD30-positive cutaneous T-cell lymphoma (CTCL), CD30-positive mature T-cell lymphomas (MTCL)

Details:

Seattle Genetics and Millennium, a wholly owned subsidiary of Takeda Pharmaceutical have formed a collaboration with Ventana Medical Systems, a member of the Roche Group. Under the collaboration agreement, Ventana will seek to develop, manufacture and commercialize a molecular companion diagnostic test with the goal of identifying patients who might respond to treatment with Adcetris® (brentuximab vedotin) based on CD30 expression levels in their tissue specimens.
As part of the ongoing clinical development of Adcetris®, Millennium and Seattle Genetics are planning two phase III studies that will use the companion diagnostic, one in CD30-positive cutaneous T-cell lymphoma (CTCL) and the other in CD30-positive mature T-cell lymphomas (MTCL).
 Adcetris® was approved by the FDA in August 2011 for relapsed Hodgkin lymphoma (HL) and systemic anaplastic large call lymphoma (sALCL). A molecular companion diagnostic is not required for the current FDA-approved indications for Adcetris®.

Financial terms:

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Is general: Yes