EU approves GlaxoSmithKline's pneumococcal vaccine Synflorix

GlaxoSmithKline said the European Commission granted marketing authorisation for its Synflorix vaccine for active immunisation against invasive pneumococcal disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks to two years of age.

The vaccine contains 10 serotypes responsible for up to 90 percent of all cases of invasive pneumococcal diseases (IPD) in children younger than five years of age in parts of Europe. Synflorix is expected to compete with Wyeth's 7-valent pneumococcal vaccine Prevenar, sold as Prevnar in the US, and GlaxoSmithKline stated that the three additional serotypes in Synflorix represent up to 25 percent of all IPD cases.

Simon Mather, an analyst at WestLB, estimated that Synflorix may generate about 45 million pounds ($64.4 million) in European sales this year. He added that the vaccine "isn’t a huge product, but is ticking CEO Andrew Witty's boxes for a larger number of more diversified products going forward." Synflorix is already approved in Canada and Australia but has not been filed in the US, and GlaxoSmithKline indicated in February that it may not seek FDA approval for the vaccine.

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