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Gazyva

Roche Holding AG

Drug Names(s): afutuzumab, GA-101, GA101, GlycArt, R7159, RG7159, RO5072759, Gazyvaro (EU)

Description: R7159 (GA101) is a glycoengineered, fully humanized IgG1 monoclonal antibody with potential antineoplastic activity. R7159 is a third generation type II anti-CD20 antibody and selectivity binds to the extracellular domain of the human CD20 antigen on malignant human B cells. The Fc region carbohydrates of the antibody, enriched in bisected non-fucosylated glycosylation variants, contribute to its higher binding affinity for human FcgammaRIII receptors compared to non-glycoengineered antibodies, resulting in enhanced antibody-dependent cellular cytotoxicity (ADCC) and caspase-independent apoptosis. In addition, modification of elbow hinge sequences within the antibody variable framework regions may account for the strong apoptosis-inducing activity of R7159 upon binding to CD20 on target cells.

Deal Structure: Revenue splits are BioMedTracker estimates.

GA101 was originally developed by GlycArt.

Roche and GlycArt
In July 2005, Roche announced that it signed an agreement to acquire 100% of GlycArt.

Genentech, GlycArt, and Roche
On October 3, 2008, Genentech, GlycArt, and Roche announced that they have entered into a collaboration agreement, including a licence from GlycArt to Genentech, for the joint development and commercialization of GA101. The companies will be developing GA101 for the potential treatment of hematological malignancies and other oncology-related B-cell disorders such as non-Hodgkins lymphoma. In association with this agreement, Genentech, Roche and GlycArt will share certain development costs. Genentech will receive commercialization rights in the United States.

Biogen Idec and Genentech
On October 30, 2008, Biogen Idec announced that it has elected to participate with Genentech in the development and...See full deal structure in Biomedtracker

Partners: Biogen, Inc. Chugai Pharmaceutical Co., Ltd. PDL BioPharma, Inc. Nippon Shinyaku Co., Ltd.


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