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Biotech / Medical : AVANT Immunotherapeutics Inc. (Nasdaq: AVAN)
AVAN 10.040.0%Jun 12 9:41 AM EDT
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From: invbiotech12/20/2006 2:30:23 PM
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GlaxoSmithKline says EU clears variation to Rotarix marketing authorisation
12.19.06, 10:43 AM ET

LONDON (AFX) - GlaxoSmithKline PLC said the European Commission has approved the variation to the marketing authorization of Rotarix, its vaccine to protect children against rotavirus infection to include two additional strains -- G2P[4] and G4P[8].

'We are very happy about the EU decision to add the protection against two more strains to the official indication of our Rotavirus vaccine,' said Beatrice De Vos, Head of Global Medical Affairs, GSK Biologicals.

'Our data show that our two dose vaccine based on an attenuated human rotavirus strain is designed to provide broad protection against various circulating types of rotavirus causing the disease.'

A statement from Europe's biggest drugmaker said the oral vaccine is based on an attenuated G1P[8] human rotavirus strain. Efficacy trial results showed that the two-dose vaccine protects against 96 pct of severe rotavirus gastroenteritis (RVGE) cases and prevents 100 pct of hospitalizations due to rotavirus-induced gastroenteritis in a European setting where multiple serotypes circulate (G1, G2, G3, G4 and the globally emerging G9 strain). Rotarix was licensed in the EU in February.

The four most common, of the ten known types of rotavirus types, are those that cause disease in humans are G1, G2, G3 and G43 and a fifth emerging strain G9.

Following the decision of the EU Commission, the protection against all five RV types have now been included in the European label of GSK's rotavirus vaccine.

forbes.com.
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