We envision high fives all around at Novartis headquarters: The FDA has quashed a potential rival for the Swiss drugmaker's new multiple sclerosis pill. The agency said it couldn't approve Merck KGaA's proposed MS drug cladribine--just a few weeks after the company withdrew its European application for revamping. That leaves the U.S. and Europe potentially wide open for Gilenya, the first oral MS treatment.
Novartis and Merck had been racing toward approval for several years. When the Swiss company won the FDA nod last year, it got the first-to-market advantage in the U.S. So far, Gilenya has turned in impressive launch numbers, the company has said, as patients opt to try the new pill rather than older, less convenient injectable drugs.
Now, not only does Merck lack a direct U.S. competitor to Gilenya, its injectable med Rebif is likely to decline as well, an analyst told Bloomberg. "In the U.S., they're likely to lose significant market share because of Gilenya," WestLB analyst Cornelia Thomas told the news service.
Meanwhile, Gilenya won approval in Switzerland and Australia in January, and it got a recommendation from European regulators last month, indicating it could soon hit the EU market. Analysts expect Gilenya to grow to as much as $5.3 billion in annual sales by 2016.