The regulatory road to the FDA is littered with the burned wreckage of once-promising sleep drug programs. GlaxoSmithKline's ($GSK) almorexant was done in by side effects. Three years ago Sanofi's ($SNY) bid for Ciltyri ended in disaster. And the new drugs that have arrived on the market--like Silenor--have barely registered on the radar of drug sales as copycat versions of Ambien helped shrink the business.
Merck ($MRK), though, is making an ambitious bid to change the entire game on sleep drugs. Its orexin inhibitor--suvorexant, which targets a biologic mechanism that helps keep people alert--is a new approach to insomnia that has won over some converts among the analysts covering the pharma giant. And Darryle Schoepp, who heads the pharma giant's efforts on the sleep front, has been making the rounds to promote a little upbeat news about Merck's R&D in the field.
Tony Butler at Barclays tells Bloomberg the drug could bring in $900 million a year if the drug, which successfully registered Phase III data last month, goes on to win an approval at the FDA. That's the next best thing to a blockbuster and close to half of the current $2 billion market for all sleep drugs. And the business news service adds some endorsements from some of the researchers in the field, who applaud a drug that can avoid the myriad of side effects registered by the GABA class, which takes a blunderbuss approach to the sleep problem.
"The therapy of insomnia has changed from trying to augment the power of the sleep system to trying to inhibit the wake system," says Thomas Roth, who runs the Sleep Disorders and Research Center at Henry Ford Health System.
- here's the Bloomberg feature
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