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Australia Approves Novartis' Bexsero

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Novartis (NVS - Free Report) recently received encouraging news when its meningococcal serogroup B vaccine B (MenB) vaccine, Bexsero, was approved in Australia, for use in age groups of two months and above.

We note that Bexsero was approved in the EU earlier this year for use in children over two months old.

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.  

Novartis’ meningococcal franchise consists of three vaccines – Bexsero, Menjugate and Menveo. We are encouraged by the recent pipeline progress at Novartis with both Bexsero and Menveo.

Earlier in the month, the U.S. Food and Drug Administration (FDA) approved the label expansion of Menveo thereby allowing the use of the vaccine for protection against meningococcal disease in infants and toddlers aged 2 months and above.

With the label expansion, Menveo can now be used in infants, children and adolescents.

Other meningococcal vaccines under development include MenABCWY (serogroups A, B, C, Y and W-135), which is currently in phase III.

We believe the label expansion of Menveo and approval of Bexsero in early 2013 will strengthen Novartis' meningococcal franchise and boost results going forward.

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 includes brands such as Fluvirin, Fluad, Agrippal, Optaflu and Flucelvax.

Novartis expects to file for the label expansion of Fluad for use in adults aged 65 years and above later in 2013 and initiate a phase III study on Quadrivalent Influenza Vaccine.

Sanofi’s (SNY - Free Report) Menactra is indicated to treat meningococcal meningitis. Meanwhile, GlaxoSmithKline’s (GSK - Free Report) Menhribrix is approved for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Yand Haemophilus influenzae type b.

Novartis currently carries a Zacks Rank #4 (Sell).  Right now, Biogen Idec Inc. (BIIB - Free Report) looks attractive with a Zacks Rank #1 (Strong Buy).

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