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Benlysta SC

GlaxoSmithKline plc

Drug Names(s): belimumab subQ, LymphoStat-B subQ

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

LymphoStat-B is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS. It has the opposite effect of HGSI's recombinant protein therapeutic BlyS -- instead of augmenting B cell stimulatory effects of BlyS, it inhibits the action of endogenous BlyS. BLyS is a naturally occurring protein discovered by Human Genome Sciences that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body's first line of defense against infection. Retrospective and prospective studies have shown elevated levels of BLyS 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 autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies -- antibodies that attack and destroy the body's own healthy tissues. The presence of autoantibodies, especially rheumatoid factor, appears to correlate with disease severity.

Deal Structure: 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 responsibility for conducting the LymphoStat-B Phase III trials,...See full deal structure in Biomedtracker

Partners: AstraZeneca PLC


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