Novartis (NVS) recently announced that its supplemental Biologics License Application (sBLA) to broaden the use of its meningitis vaccine Menveo to infants and toddlers (aged 2-24 months) has been accepted for review by the US Food and Drug Administration (FDA). Menveo is a quadrivalent conjugate vaccine for the prevention of the A, C, Y and W-135 strains of meningococcal meningitis. Menveo is already approved for use in individuals aged 2-55 years in the US. The vaccine is approved in Europe for initial use from age 11 and older.
The sBLA filed in April 2011 included data from pivotal trials which had studied the use of the vaccine in more than 6,000 toddlers and infants. The results indicated that Menveo was well tolerated when given either as a monotherapy or in combination other pediatric vaccines.
Infants are at the highest risk of being infected with the meningococcal meningitis disease. In most cases, the disease occurs within the first 7 months of life causing death of 1 in 16 infants infected. Some patients may also suffer from permanent brain damage, learning disabilities, hearing loss and limb loss.
Recently, Novartis presented data from studies investigating the use of its other vaccine under development, Bexsero. The data showed that Bexsero vaccine induces robust immune response in infants, toddlers and adolescents suffering from meningococcal serogroup B (MenB) disease. The vaccine thus has the potential to provide broad usage. The vaccine is also known as 4CMenB and is under late-stage trials in the US and is already filed in the European Union. If Bexsero is approved, it has the potential to provide protection against all causes of MenB disease.
These positive developments will come as a certain boost to Novartis’ Vaccines and Diagnostics segment.
Our Recommendation
Currently, we have a Neutral recommendation on Novartis. The company carries a Zacks #3 Rank (‘Hold’ rating) in the short run. Though pleased with Novartis’ wide range of products and its efforts to diversify further, as is evident by the acquisition of eye-care company Alcon, we prefer to remain on the sidelines due to the imminent patent cliff faced by the company.
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