Medeva Files For European Approval Of Hepagene

Medeva has filed for approval to market its new hepatitis B virusvaccine, Hepagene, with the European Medicines Evaluation Agency. The company says it plans to file a second application in the USA before the end of the year.

Hepagene is Medeva's lead developmental product and is an important project for the company, which has seen its business pressured by competition for its biggest product, methylphenidate for attention-deficit hyperactivity disorder, the collapse of sales of Ionamin (phentermine) for obesity and the disappointment of a narrower-than-expected indication for its new anthracycline drug Valstar (valrubicin) in the USA (Marketletters passim).

Medeva describes Hepagene as a third-generation HBV vaccine, and notes that it is the first to incorporate significant levels of all three of HBV's surface antigens, known as pre-S1, pre-S2 and S, which make up the major portion of the viral envelope. The current, second-generation monovalent vaccines (ie Smith-Kline Beecham's Engerix-B and Merck & Co's Recombivax HB) contain only the S antigen.