Glaxo files pneumococcal vaccine for EU approval

LONDON, Jan 31 (Reuters) - GlaxoSmithKline Plc (GSK.L), the world's second-biggest drugmaker, said on Thursday its experimental childhood vaccine Synflorix to prevent pneumococcal disease had been accepted for review by European authorities.

The move sets the scene for a battle with Wyeth's WYE.N blockbuster vaccine Prevnar, which generated sales of $634 million in the third quarter of last year. Glaxo had previously said it expected to file Synflorix in Europe at the end of 2007.

Glaxo's new vaccine is designed to offer protection against both invasive pneumococcal disease and bacterial respiratory infections such as acute middle ear infections.

It is active against 10 types of streptococcus pneumoniae, compared with seven strains for Prevnar.

Glaxo argues this gives it an edge, particularly in preventing otitis media, or inflammation of the middle ear. Wyeth executives contend the difference is minimal.

Wyeth intends to submit a new version of Prevnar, active against 13 strains, to both European and U.S. regulators by the beginning of 2009. (Reporting by Ben Hirschler; Editing by Gary Hill)