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Anthera Pharmaceuticals, Inc.

Drug Names(s): AMG 623, A-623

Description: AMG 623 is a fusion polypeptide protein (peptibody) comprised of a BAFF binding domain fused to the N-terminus of the Fc region of human antibody. A-623 is produced in E. coli and binds to both membrane-bound and soluble BAFF.

BAFF (B-cell activating factor, also known as BlyS) plays a role in B cell survival, development and maintenance. BAFF was initially identified by Human Genome Sciences as a protein required for the development of B-lymphocyte cells into mature antibody-producing plasma B cells. BAFF is a cytokine that belongs to the tumor necrosis factor (TNF) ligand family. It is expressed as a transmembrane protein on various cell types including monocytes, dendritic cells, and bone marrow stromal cells. The transmembrane form can be cleaved from the membrane generating a soluble protein fragment. BAFF is a ligand for three receptors named BR3 (BLyS receptor 3), TACI (transmembrane activator-1 and calcium modulator and cyclophilin ligand-interactor), and BCMA (B-cell maturation antigen), which are all expressed on mature B lymphocytes. TACI is also found on a subset of T-cells, and BCMA has been found on plasma cells. BAFF is the sole ligand for BR3, while BAFF and another member of the TNF ligand family called APRIL (A proliferation inducing ligand) are ligands for TACI and BCMA.

The interaction between BAFF and BR3 is necessary for the survival and development of naïve B cells and mature primary B-cells, whereas the interaction between BAFF and either TACI or BCMA plays a role in the actions of antigen-activated B cells, memory B cells, and plasma cells.

BLyS levels are elevated in the blood of many patients with systemic lupus erythematosus, and in the blood and joint fluid of patients with rheumatoid arthritis. In lupus, rheumatoid arthritis, and certain other autoimmunediseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies.

Deal Structure: Revenue splits for this drug are BioMedTracker estimates.

AMG 623 was originally developed by Amgen.

Anthera and Amgen
In January 2008, Anthera Pharmaceuticals announced that it entered into a license agreement with Amgen for the exclusive and worldwide rights to develop and commercialize AMG 623 for the treatment of systemic lupus erythematosus (SLE) and other autoimmune diseases.

Pursuant to its license agreement with Amgen, Anthera is required to make various milestone payments upon its achievement of certain development, regulatory and commercial objectives for any A-623 formulation. Anthera is required to pay up to $10.0 million upon achievement of certain pre-approval clinical development milestones and up to $23.0 million upon achievement of certain post-approval milestones. Anthera is also required to make tiered quarterly royalty payments on net sales, which increase as a percentage from the high single digits to the low double digits as net sales...See full deal structure in Biomedtracker

Partners: Amgen, Inc.

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