U.S. backs Novartis vaccine, MS drug wins priority
The U.S. Food and Drug Administration has licensed the vaccine to help protect people aged between 11 and 55 years against potentially deadly meningitis.
Meningococcal disease infects more than 500,000 people each year, resulting in around 50,000 deaths globally, and many of these could be prevented through vaccines, Novartis said in a statement on Monday.
Novartis also pulled further ahead of German rival Merck KGaA in the bid to get the first oral MS treatment to market after its drug Gilenia, FTY720, was granted U.S. priority review status.
Novartis is competing with Merck MGaA's pill cladribine against the debilitating nervous disease and has edged ahead since the German group suffered a setback last year, when U.S. regulators held up its application to bring its cladribine drug to market.
The priority review for Gilenia, which cuts the standard review time to six months from 10, comes after the U.S. Food and Drug Administration accepted the regulatory submission made in December for the drug.
The priority review status is a nice little surprise which may move the launch forward from late 2010, said Thomas Maul, an analyst at DZ Bank, who expected sales of the drug to reach at least $1 billion a year.
Novartis shares were 0.2 percent higher in early trade, while Merck, which reports its fourth quarter results on Tuesday, slipped 0.7 percent.
The U.S. approval of Menveo was based on a Phase III head-to-head clinical trial that showed it achieved a higher immune response than the other currently available vaccine, Novartis said.
Novartis plans to seek a license for Menveo in infants and children aged between two and 10 years, the group said.
The group is awaiting marketing approval in Europe after the drug watchdog there backed the vaccine at the end of last year.