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Fendrix

GlaxoSmithKline plc

Drug Names(s): hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)

Description: Fendrix contains MPL adjuvant, which is a proprietary form of monophosphoryl lipid A, a derivative of bacterial endotoxin, one of the most potent immunostimulants known. Prepared from a heptoseless mutant of Salmonella minnesota, MPL is chemically similar to lipid A but lacks an acid-labile phosphoryl group and a base-labile acyl group. MPL retains the beneficial biological activities of lipid A but with a safety profile suitable for evaluation in pediatric applications.

MPL may be a key component of vaccines using technologies such as recombinant and synthetic antigens. Although vaccines incorporating these antigens are safer than previous attenuated or killed whole-cell vaccines, many of them are poorly immunogenic in the absence of a potent adjuvant. MPL has demonstrated utility with peptide, bacterial sub-unit and synthetic polysaccharide antigens. Vaccines for infectious diseases and allergy desensitization containing this microbially derived adjuvant have demonstrated safety and efficacy in human clinical trials involving thousands of doses. Humoral, cell-mediated and mucosal immunity can be stimulated by altering formulations and delivery routes.

Deal Structure: In July 2004, Corixa announced an MPL adjuvant manufacturing and supply contract with GSK which provides guaranteed payments to Corixa for supplying GSK with increasing annual quantities of MPL adjuvant. Under the terms of the agreement, Corixa agreed to expand MPL production with anticipated approvals of GSK vaccines that contain MPL. Corixa received a multi-million dollar manufacturing licensing fee from GSK and will receive royalties on the potential sale of all GSK vaccines containing MPL.

In 2005, GSK acquired Corixa.


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