Call it the dark-horse deal of the week. Or is it an ace in the hole? GlaxoSmithKline bought over-the-counter marketing rights to Merck's statin drug Mevacor for an undisclosed price. Fine, great. Selling a statin over the counter could be blockbuster territory; the entire class is only available by prescription, and they're among the most popular drugs industry-wide. In the U.S. alone, statins sold at a rate of $21 billion-plus last year.
But Mevacor isn't approved for OTC sales. In fact, Merck has already asked the FDA for that particular blessing--twice. Most recently, the agency said it might consider an approval for behind-the-counter (BTC) sales, but not OTC. The FDA is considering putting more drugs in the BTC class, but they're only in the public hearing phase. Actual, full-scale BTC sales could be years away.
An FDA advisory panel will meet in a couple of weeks to consider Merck's most recent request to convert Mevacor to OTC. The company says it has new, persuasive data. And Glaxo has successfully taken other drugs OTC, including the weight-loss med Alli, which was a close shave. What if the FDA shakes its head again? A Glaxo spokesperson told the Wall Street Journal that the companies don't know what would happen then. But, said a Merck talking head: "We're optimistic."