On Friday, Wyeth Pharmaceuticals, a division of Wyeth (WYE), announced that the company’s 13-valent pneumococcal conjugate vaccine for infants and toddlers received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP).
The CHMP recommended the approval in children between 6 weeks to 5 years to protect them against 13 serotypes (forms), of a bacterium called streptococcus pneumoniae (pneumococcus) that can cause a series of diseases, ranging from ear infections to pneumonia and meningitis. The EMEA is expected to pass a final verdict on the matter in the coming months.
Prevenar 13 is a new form of Wyeth’s blockbuster pneumococcal 7-valent conjugate vaccine Prevnar which reported revenues of $2.7 billion in 2008. The 13-valent vaccine includes six new serotypes in addition to the seven included in Prevnar. It is estimated that Prevenar 13 would cover 92% of invasive pneumococcal disease, compared to 81% covered by Prevnar. Of the six new serotypes that are covered in Prevenar 13, of particular importance is 19A which is one of the most severe forms of pneumococcal disease and is frequently antibiotic-resistant.
To date, Prevenar13 has been filed for regulatory approval in more than 50 countries worldwide. The vaccine is currently approved in two countries, with Chile being the first country to grant approval in July 2009. Prevenar 13 received fast-track designation from the US Food and Drug Administration (FDA) in May 2008. The FDA is currently reviewing the drug.
Prevenar 13 is also undergoing global late-stage studies in adults. We expect an FDA filing for adult use in 2010. Prevnar 13 will compete with GlaxoSmithKline‘s (GSK) pediatric 10-valent vaccine, Synflorix, which received European approval in March 2009.
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