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12:00 AM
 | 
May 12, 2008
 |  BioCentury  |  Product Development

Eye of the beholder

Novartis AG says its Menveo quadrivalent meningitis vaccine showed a superior immune response in a head-to-head study vs. Menactra from sanofi-aventis Group. But the French pharma says it's impossible to discern a meaningful difference because the study was designed to show non-inferiority.

FDA approved Menactra in 2005 to protect against meningococcal disease in adolescents and adults aged 11-55 years. Last year, the label was expanded to include children ages 2-10. The vaccine posted 2007 net sales of E415 million ($642.5 million).

Both products are quadrivalent polysaccharide vaccines against serotypes A, C, W-135 and Y. But while Menactra uses a diphtheria toxoid as the carrier protein, Menveo uses CRM-197 carrier protein, which is a non-toxic variant of diphtheria toxin.

"Conceptually, both Menactra and Menveo are essentially the same: polysaccharide that is coupled to a carrier protein," said Joerg Reinhart, CEO of the Novartis Vaccines unit. "The difference is the carrier protein, which is the...

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