GlaxoSmithKline Biologicals has won European approval for Fendrix, a hepatitis B vaccine that is claimed to provide greater protection than current vaccines thanks to a novel adjuvant used in the formulation.

The new vaccine is a high-potency follow-up to GSK Bio’s Engerix-B hepatitis B vaccine that, along with other hepatitis vaccines in GSK’s portfolio – Havrix for hepatitis A and TwinRix to protect against both hepatitis A and B – achieved sales of £102 million in the first nine months of 2004.

Engerix-B has been on the market for 15 years and has already been administered to over a billion people. However, certain groups such as pre-haemodialysis and haemodialysis patients do not get a very strong response with this product because their renal problems mean their immunity is typically lower than in healthy individuals. For this reason, GSK elected to develop a new version, using the same HBV antigen used in its other vaccines as well as AS04, a proprietary GSK adjuvant. The resulting vaccine – Fendrix – has an increased immune potency, allowing two dose administration rather than three.

The primary constituent in GSK’s adjuvant is MPL, an adjuvant developed by US firm Corixa and licensed for use in a number of GSK’s developmental vaccines, including one that could be the first effective vaccine for malaria, based on clinical studies reported last year [[15/10/04d]]. Fendrix is the first product to be approved based on the adjuvant, according to Corixa.

- Meanwhile, GSK has become the first company to completely switch over its entire metered dose inhaler portfolio away from ozone-depleting chlorofluorocarbon propellants to the newer, more environmentally friendly hydrofluoroalkanes. Flovent (fluticasone propionate) is the last of GSK’s asthma and chronic obstructive pulmonary disease products to make the transfer.

In Europe 75% of CFCs used in metered dose inhalers have been phased out, but the US is lagging behind. At present, the federal government has only signalled an intention to phase out around half of its CFC usage by 2006/7.