NVS Wins Approval for Vaccine - Analyst Blog

Recently, Novartis (NVS) received approval both in the European Union (EU) and the US for Menveo, a quadrivalent conjugate vaccine for the prevention of meningococcal disease. The US Food and Drug Administration (FDA) approval is for the age group of 11−55 years.

 

In Europe, the vaccine has been approved for the immunization of adolescents (above 11 years of age) and adults. The approval does not surprise us since the Committee for Medicinal Products for Human Use (CHMP) had voted in favor of approval in December 2009.

Novartis expects to seek approval for other age groups as well. Currently, the vaccine is being studied in multiple phase III clinical studies on infants and toddlers worldwide. Supportive data for children in the age group of 2 to 10 years is expected to be submitted in the first half of 2010 while infant data is expected in 2011.

 

Menveo’s approval is based on data from a phase II clinical trial and a non-inferiority study. The vaccine, assessed among the age group of 11−17 years, was found to be non-inferior to a quadrivalent meningococcal polysaccharide vaccine (ACWY-PS).

 

After one year of vaccination, a higher proportion of adolescents receiving Menveo had a protective immune response against three of the four meningococcal groups compared to those who received ACWY-PS. Menveo was also found to be non-inferior to ACWY-PS in all four meningococcal groups in adults of 56−65 years of age.

 

We believe Menveo has the potential to achieve blockbuster status if it receives full approval for a wider range of patients. Meningococcal disease infects more than 500,000 people each year, leading to more than 50,000 deaths globally.

 

In 2009, the Vaccines and Diagnostics Division of Novartis generated net sales of $2.4 billion, representing 5% of total net sales from continuing operations. Influenza vaccines are the core products of this division, which include brands such as Fluvirin, Fluad, Agrippal, Begrivac, Optaflu and AgriFlu. We believe the approval of Menveo should boost this segment further.