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GlaxoSmithKline plc

Drug Names(s): belimumab, Benlystat (Canada), LymphoStat-B, HGS1006, BLyS

Description: BioMedTracker has separate drug profiles for belimumab. Please also see the SC formulation of belimumab.

LymphoStat-B is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of soluble B-lymphocyte stimulator, also known as BLyS or BAFF (B-cell Activating Factor).

BLyS was initially identified by Human Genome Sciences as a protein that is required for the development of B-lymphocyte cells into mature antibody-producing plasma B cells. BLyS 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. BLyS 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. BLyS is the sole ligand for BR3, while BLyS and another member of the TNF ligand family called APRIL (A proliferation inducing ligand) are ligands for TACI and BCMA.

The interaction between BLyS and BR3 is necessary for the survival and development of naïve B cells and mature primary B-cells, whereas the interaction between BLyS and either TACI or BCMA plays a role in the actions of antigen-activated B cells, memory B cells, and plasma cells.Therefore, the effect of belimumab is expected to be more on B cells early in B cell development, such as naïve B cells, and less on B cells later in ontogeny, such as memory B cells and plasma cells because these cells will still receive signals through TACI and BCMA via APRIL.

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 are BioMedTracker estimates.

LymphoStat was produced for HGSI by Cambridge Antibody Technologies (CAT).

As part of its June 1996 agreement with GSK, Human Genome Sciences granted a 50/50 co-development and co-promotion option to GSK for certain Human Genome Sciences human therapeutic products that successfully complete Phase IIa clinical trials. Under the terms of the agreement, GSK and Human Genome Sciences will share equally in development costs, and will share equally in sales and marketing expenses and profits of any product that is commercialized under the agreement, under a co-development and co-promotion agreement, the remaining terms of which are being negotiated by the parties.

In June 2006, CAT became a subsidiary of AstraZeneca.

In July 2005, HGS and GSK began negotiating an agreement that was finalized in August 2006. According to the definitive agreement, co-development and commercialization agreement under which HGS will have...See full deal structure in Biomedtracker

Partners: AstraZeneca PLC DRI Capital Inc.

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