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European Marketing Approval Granted for Hepatitis B Vaccine Fendrix

8 February 2005 - Rixensart, Belgium - GlaxoSmithKline [GSK] announced today it has received European approval for marketing its hepatitis B vaccine, Fendrix, formulated with a novel GSK proprietary adjuvant system, AS04.

Thanks to the combination of GSK Biologicals [GSK Bio] hepatitis B antigen and the novel adjuvant AS04 developed by GSK, Fendrix prevents hepatitis B in patients with renal insufficiency including specific high-risk groups such as pre-haemodialysis and haemodialysis patients, from 15 years of age onwards. Haemodialysis patients immune response is typically lower than in healthy individuals, therefore a need exists in such a vaccine with an improved immunogenicity profile to ensure that they are protected against hepatitis B infections.

Fendrix contains the GSK Bio Hepatitis B antigen and a novel proprietary GSK Bio adjuvant system, AS04 which includes MPL� from Corixa, that had been developed to have a higher potency than other available hepatitis vaccines, resulting in higher, more rapid and longer-lasting seroprotection.

Fendrix builds on the experience gained over more than 15 years with the hepatitis B vaccine, Engerix B, of which more than 1 billion doses have been distributed worldwide.

Fendrix has a good safety profile, clinically acceptable local reactions similar to other licensed hepatitis B vaccines.

Adjuvants are formulated compounds that combined with vaccine antigens help to either direct or boost the body�s immune system. GSK Bio has for some years led the scientific and vaccine field in this area of research. It focussed on the development of a portfolio of novel and proprietary adjuvant systems capable of either directing the most appropriate immune response or increasing the immune response in order to increase the effectiveness of a vaccine to prevent a particular disease.

The novel adjuvant AS04 is a component of a highly promising HPV vaccine against cervical cancer, that recently showed 100% efficacy against persistent infection with HPV types 16 and 18 .

MPL which is contained in AS04 is a component of GSK's malaria vaccine, which also recently reported breakthrough results in clinical trials in the field . It is also a component of GSK Bio's genital herpes vaccine, which showed excellent efficacy against genital herpes in women in a phase III trial published in 2002 . Other adjuvanted vaccines in GSK Bio's pipeline include a vaccine for the prevention of cervical cancer and a vaccine in Phase I clinical trials against tuberculosis.

"The presence of adjuvants enhances the immune response to antigens present in the vaccine and is a very important component in many of GSK Bio's most promising vaccines under development. We have shown with this new hepatitis B vaccine, that there are increased levels of antibodies. MPL significantly enhances the immune system and adding this to our proprietary adjuvant systems in vaccines, ensures that the vaccines are more efficacious in mounting the most appropriate type and level of immune response. This will be of considerable importance for at least two of our late stage vaccines both for women - one for the prevention of cervical cancer and for the prevention of genital herpes," said Jean St�phenne, President of GlaxoSmithKline Biologicals.

Source: GlaxoSmithKline

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