Novartis announced Thursday at the ESPID meeting positive data from

two trials of its experimental meningococcal B vaccine Bexsero

 

 The studies were included in the company's recent EU regulatory filing for marketing approval of the vaccine.

 

In one Phase IIb study, more than 1800 infants were randomised to receive Novartis' vaccine at 2, 4 or 6 months or at 2, 3 or 4 months with or without routine immunisations.

 

 Data showed that Bexsero induced a robust immune response to meningococcal serogroup B (MenB) bacterial strains for either dosing schedule.

 

 The company noted that in addition to meeting its main goal, the trial demonstrated that Bexsero can be used in various vaccination schedules in the first year of a child's life.

 

A second Phase III trial recruited more than 1500 toddlers who were immunised with three doses of Bexsero at 2, 4 and 6 months.

 

 Study participants were randomised to receive either a fourth booster dose of Bexsero alongside the MMR vaccine, or Bexsero at 12 months followed by the MMR vaccine at 13 months.

 

 Novartis said that the trial met all of its main goals, with Bexsero demonstrating high immunogenicity against all MenB strains tested and immune responses to Novartis' vaccine and the MMR immunisation weren't affected by concomitant use.

 

 The drugmaker indicated that the study also showed that Bexsero provided protective immune response after two doses in infants not previously immunised with the vaccine.

 

Andrin Oswald, head of Novartis' vaccine unit, said he was "more confident than I have ever been" with regards to approval of the vaccine in Europe, adding that "there is no doubt in my mind that this has blockbuster potential

 

" He noted that the drugmaker "submitted the vaccine for approval in December," and as it uses "highly innovative technology…it may take closer to 18 months than 12" to be reviewed

.

The company also applied for regulatory approval of Bexsero in Canada, and is working with the FDA to design a US-specific late-stage study.

 

Kepler analyst Tero Weckroth commented that "the data is positive but the EU approval process is a key driver for Bexsero

" Vontobel analyst Andrew Weiss suggested the vaccine had a 50 percent probability of approval and could generate peak sales of $2 billion.