Swiss drug maker Novartis AG said its Menveo vaccine promises to be effective in protecting infants against four types of meningococcal meningitis, a potentially fatal bacterial disease.
New data to be published today in the Journal of the American Medical Association show the vaccine generated protective immune responses in infants. This response was seen in all four of the common types associated with the disease, which is caused by the bacterium Neisseria meningitidis. The vaccine was well tolerated in the trial, Novartis said.
Novartis expects to file the vaccine for regulatory approval in the European Union and in the U.S. this year for use in adolescents, with a filing for use in infants expected in 2009. The vaccine is unlikely to hit the market before 2009.
The Phase II trial included 421 infants from the United Kingdom and Canada.
Menveo would compete against Sanofi-Aventis SA's Menactra. The Novartis product is the first four-strain conjugated meningitis vaccine to generate protective immune responses in infants, expanding beyond the coverage of Menactra, which has shown immune responses in teenagers and adults.
"Menveo competes with Menactra but is late in the game and thus revenue potential is limited," said Karl Heinz Koch, pharmaceutical analyst at private bank Vontobel in Zurich. He said he expects peak sales for Menveo of about $120 million a year.
GlaxoSmithKline PLC is also developing a vaccine against four strains of meningitis that is currently in Phase II trials.
The new study results are in line with earlier data showing that Menveo can protect children from early infancy against certain types of meningitis. The new data show Novartis's vaccine "has the potential to protect infants as part of the routine infant vaccine schedule, expanding the potential serogroup coverage of currently available vaccines," said study investigator Andrew Pollard, reader in pediatric infection and immunity at the University of Oxford and honorary consultant pediatrician at the Children's Hospital in Oxford.