Issue Date: August 24, 2009
Launching A New MS Drug
In anticipation of regulatory approval for a new multiple sclerosis drug, Novartis is building up market expertise in an unusual way: by selling a generic version of an older MS drug. Last week, the Swiss company got the green light from FDA to sell Extavia, its version of interferon beta-1b, a biologic treatment currently marketed by Bayer as Betaseron.
The approval is more about getting a foot in the door with neurologists than about the sales potential of Extavia, says Ben Greener, lead central nervous system drug analyst at Datamonitor. Novartis is ramping up for the launch of fingolimod, a small-molecule drug that would represent one of the first orally administered options for MS patients.
Neurologists have strong preferences for brands and companies they know, Greener explains, and Novartis lacks experience in the MS field. “Basically, this was a very easy, cheap route for them into the market,” he says.
Datamonitor forecasts Extavia will have just $42 million in U.S. sales in 2011. In contrast, Jefferies & Co. stock analyst Jeffrey Holford expects fingolimod, which will likely debut next year, to bring in more than $600 million annually by 2013.
Although there is no direct route to U.S. approval of a generic biologic drug like Extavia, Novartis was able to reach the market through an agreement with Bayer. Schering, which Bayer acquired in 2006, had a long-standing deal related to Betaseron with Chiron, the vaccines firm Novartis bought in 2006. In 2007, Bayer paid $200 million for a former Chiron biologics plant in California and in exchange granted Novartis a license to launch its own version of Betaseron.
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