) recently received positive news when it obtained U.S. Food and
Drug Administration (FDA) approval for label expansion of its
The FDA approved the use of Menveo for the protection against
meningococcal disease in infants and toddlers aged 2 months and
The approval was based on encouraging data from three
randomized multicenter studies conducted across the globe among
more than 8,700 infants.
Novartis observed that Menveo generated a robust protective
immune response among the patients. Moreover, it was generally
well tolerated when used with other routine pediatric
The approval comes as a relief for Novartis as the FDA had
issued a complete response letter (CRL) to the former in 2012
seeking additional data with regard to its supplemental Biologics
License Application to expand Menveo's indication for infants and
as well as for toddlers. With the label expansion, Menveo can now
be used in infants, children and adolescents.
As per Novartis, meningococcal disease causes approximately
50,000 deaths on an annual basis due to infection from five
serogroups-A, B, C, W-135 and Y.
In 2012, Novartis' Vaccines and Diagnostics Division generated
net sales of $1.9 billion, down 7% year over year.
Influenza vaccines are the core products of this division,
which include brands such as Fluvirin, Fluad, Agrippal, Begrivac,
Optaflu and Flucelvax.
We believe the label expansion of Menveo and approval of
Bexsero in early 2013 strengthen Novartis' meningococcal
franchise and should boost results going forward.
Novartis currently carries a Zacks Rank #4 (Sell). Right
now, pharma stocks which currently look attractive include
Johnson & Johnson
While Johnson & Johnson carries a Zacks Rank #1 (Strong
Buy), Shire and Jazz Pharma carry a Zacks Rank #2 (Buy).
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
JOHNSON & JOHNS (JNJ): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
SHIRE PLC-ADR (SHPG): Free Stock Analysis
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