Avant says European regulators gave rotavirus vaccine positive opinion, marketing approval expected soon

By E. Janene Geiss

Philadelphia, Dec. 15 - Avant Immunotherapeutics announced Thursday that its partner GlaxoSmithKline Biologicals has received a positive opinion from the Committee for Medicinal Products for Human Use for Rotarix rotavirus vaccine.

The committee evaluates the quality, safety and efficacy of medicinal products in the European Union.

According to new legislation, a European Marketing Authorization from the European Commission could be expected from late February 2006 onwards, which will make Rotarix the first rotavirus vaccine available to children in Europe, according to a company news release.

GlaxoSmith Kline submitted a registration file for Rotarix to the European Medicines Agency in December 2004, officials said.

GlaxoSmith Kline said it intends to introduce this vaccine throughout Europe immediately after the marketing authorization has been granted. Approval would trigger a $40 million royalty payment to Avant, officials said.

"European approval would mark a significant milestone, not only for the global commercialization of Rotarix, which has already been approved for commercial use in over 24 countries. It will also bring a substantial payment of $40 million to Avant through its transaction with the Paul Royalty Fund regarding Rotarix royalties," Una S. Ryan, Avant president and chief executive officer, said in the release.

The rotavirus market potential by 2010 is estimated between $1.75 billion to $2.3 billion. Europe accounts for 20% of the total market, officials said.

GlaxoSmith Kline Biologicals, is a Rixensart, Belgium manufacturer of vaccines.

Avant, based in Needham, Mass., develops vaccines and therapeutics that harness the human immune system to prevent and treat disease.

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