Medeva of the UK has reported new clinical data which give furtherevidence that its third-generation hepatitis B vaccine Hepagene is superior to the current market leader, SmithKline Beecham's Engerix B. Furthermore, the company has reported the first data which suggest that Hepagene may also be effective as an immunotherapeutic for chronic hepatitis B virus infection.
Hepagene is often considered the star in Medeva's pipeline, with the potential to transform the business. The company now looks on track to file for approval of the vaccine in the USA and Europe in the second half of 1998. The applications will be for "an improved vaccine for use in special groups where accelerated protection is needed, or where previous courses of other vaccinations have failed to achieve an adequate response."
Medeva had been banking that Hepagene would be superior to current vaccines (Engerix-B and Pasteur-Merieux' Recombivax-HB), because it contains three HBV surface antigens rather than one, and also because these antigens are glycosylated as they are on the viral surface.
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