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Novartis Submiting Meningococcal Vaccine In the US

Novartis AG (NVS) Monday said it will submit meningococcal disease vaccine Menveo in the U.S. and elsewhere to treat children aged two months and older after fresh late-stage trials showed the drug to be effective to treat infants.

Menveo, which already passed the regulatory hurdle in the U.S. and Europe to treat patients aged 11 to 55, is one of a series of potential blockbuster drugs with more than $1 billion in projected sales that could help Novartis offset revenue losses linked to patent expirations.

Novartis said the trial, which included more than 4,500 infants worldwide, showed that a high percentage of vaccinated children achieved robust immune responses. Novartis said the vaccine was also well tolerated although side effects such as sleepiness, irritability and persistent crying were common.

Meningococcal disease--a contagious bacterial illness--affects more than 500,000 people worldwide every year and leads to more than 50,000 deaths. Infants are at the greatest risk of developing meningococcal disease. According to academic research, up to 10% of children younger than 12 months of age, who contract meningococcal disease, die.

"In my practice I have seen the devastating effects of meningococcal disease in infants," said Dr. Stan Block, an investigator for Novartis's phase III study. "Meningococcal vaccines are being developed that can provide broad protection against the disease in this vulnerable population." Survivors of meningococcal disease can experience side effects such as brain damage and learning disabilities.

Novartis said that given the strong trial results, the Swiss pharma giant will submit a supplemental Biologics License Application to the U.S. Food and Drug Administration by year-end. A filing is also planned in Europe. Currently, the FDA is reviewing the use of Menveo in children aged 2 to 10.

"These data are another step in the significant progress Novartis is making toward our goal of protecting all age groups against meningococcal disease," said Andrin Oswald, Division Head of Novartis Vaccines and Diagnostics.

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