MRL To File Insomnia Candidate Suvorexant (MK-4305) NDA With FDA In 2012

This is Exhibit A-type proof that drug development takes time -- and money. Over eight years in the making, and perhaps $400 million in expenses so far -- but still a very good sign, out of Whitehouse Station, this morning:

. . . .The two pivotal Phase III efficacy trials for suvorexant have been completed and, based on the positive results of these studies, Merck plans to file a New Drug Application (NDA) for suvorexant with the U.S. Food and Drug Administration (FDA) in 2012.

Both Phase III studies were multicenter, randomized, double-blind, placebo-controlled clinical trials that evaluated suvorexant compared to placebo in adult patients ages 18 years and older. The primary endpoint was change from baseline in subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep at one and three months. Merck plans to submit these data for presentation at major medical meetings later this year. . . .

"Suvorexant selectively targets an important pathway involved in helping to promote sleep. . . We are enthusiastic about the potential of this investigational medicine, and look forward to sharing the results from these studies with the medical community. . . ."

My hat is off, to MRL -- and the fine team led by Dr. John Renger (pictured above right -- original image of Dr. Renger courtesy the New Jersey Star Ledger). Kudos!

While perhaps 70 million Americans report trouble sleeping, only about 15 percent of those report chronic trouble -- so about $2.7 billion of sleep meds are now sold each year -- mostly low-cost generic versions of established drugs. A novel compound that would not be easily abused would be a pretty big deal, according to analysts. And MK-4305 is novel, and not easily abused. This could be a very nice mid-to-late 2013 or early-2014 revenue enhancer for Whitehouse Station. Would it ever break the $1 billion a year mark? Who knows, but if it were to do so, that would come closer to 2020, or more than eight years from now.