When Somnus Therapeutics was started up in Bedminster, NJ, in 2007, its founders had an unusual business model. They planned to develop just one drug—SKP-1041 for insomnia—through Phase 2 clinical trials, and then sell the company to a deep-pocketed investor that would fund the final pivotal Phase 3 trials required for FDA approval. Ask CEO and co-founder Gary Cupit if the company has a pipeline of drugs behind SKP-1041, in case the master plan fails, and he’ll give you a frank answer. “Nope,” he says. “It’s one shot. All or none.”
In other words, SKP-1041 is Somnus’ only asset. “The asset is the company,” Cupit says. “The intent is to sell the company.”
That being the case, Somnus has just entered the single most important month of its short history. Cupit is spending this week at the annual Sleep conference, which is the largest gathering of insomnia specialists in the nation. Somnus is presenting two sets of data from its Phase 2 program. Then, on July 6, Cupit and his top managers will travel to the FDA to get the agency’s feedback on the company’s Phase 3 research plan—the very program that Somnus is hoping an acquirer will want to bankroll.
The conference and the FDA meeting together will provide a rich packet of information to any company that may be thinking about buying Somnus. “We’ll be talking to some people at the Sleep meeting,” Cupit says. “But I imagine most of them would like to see what the FDA says about our program.”
Somnus originally licensed SKP-1041 from London-based SkyePharma. The drug is a modified version of zaleplon, a drug that was only moderately successful when it was introduced in 1999 under the brand name Sonata. The drug was approved to be taken at bedtime, but it cleared out of the body so fast that many patients woke up in the middle of the night and couldn’t get back to sleep. The product, now generic, was ultimately overtaken in the market by longer-acting medicines like zolpidem (Ambien).
Somnus’ version of zaleplon is encased in a tablet that delays the release of the drug for about two hours. The company is studying it for “sleep maintenance”—meaning it’s specially designed for patients who can fall asleep on their own, but who often wake up in the middle of the night and can’t get back to sleep. Somnus’ research plan is centered around
