Swiss drug giant Novatis has presented another batch of promising data for Menveo, which could ultimately help it become the only meningococcal quadrivalent conjugate jab licensed to protect babies as young as two months old.
In the pivotal Phase III trial, more than 4,500 infants around the globe were randomised to receive routine infant vaccinations (DTaP, IPV, HBV, Hib, pneumococcal) alone or together with Menveo at two, four, six and 12 months of age.
The results showed that a high percentage of those vaccinated with four doses of Menveo achieved robust immune responses against meningococcal serogroups A, C, W135 and Y (94%, 98%, 100%, 100%, respectively, at 12 months old), which collectively cause the majority of meningococcal disease cases in the US, Africa and Middle East and also have a significant presence elsewhere in the world.
Moreover, the trial added further evidence to support Menveo’s safety and tolerability profile across the age groups, showing that the jab was generally well tolerated when administered alone or together with other paediatric vaccines, and indicating that it could slot nicely into existing national vaccination programmes.
The vaccine is already approved to protect people aged 11-55 years of age in the US, Chile and Argentina, as well as those aged 11 years of age and older in the European Union, Peru, Indonesia, Malaysia, Australia, Canada, and Pakistan. However, Novartis is hoping that this data will open the door to its use in infants aged as young as two months old, significantly extending its reach and giving it a unique position on the market.
To that end, the drugmaker said it is planning to submit a supplemental Biologics License Application to the US Food and Drug Administration for Menveo’s use in infants aged two months to two years based on the new data by year-end (the regulator is already reviewing an sBLA for two-10 year olds), and that similar label extensions will be also filed in Europe and in other parts of the world.
Vasella takes Alcon helm
Meanwhile, the Swiss drug giant’s grip on US eye group Alcon has increased after the latter’s directors voted in Novartis head Daniel Vasella as their new chairman, replacing Cary Rayment.
Already the majority owner of Alcon, Novartis is trying to boost its current 77% share in the group, but its offer to minority stockholders of 2.8 Novartis shares for each Alcon share has been repeatedly rejected.
Commenting on Vasella’s appointment, Thomas Plaskett, Chairman of Alcon’s Independent Director Committee, sought to reassure shareholders by stressing that the move would not change its current position on Novartis’ advances.
"Alcon's Organisational Regulations clearly require the IDC's prior recommendation before the Alcon Board of Directors can decide on any transaction between Alcon and Novartis, [and] the IDC will continue to take all available and appropriate actions to ensure that this process is upheld and that the rights of Alcon's minority shareholders are protected,” he said in a statement.