Arena Pharmaceuticals is known on Wall Street for one thing—obesity. The San Diego biotech company has a modified form of the fen-phen combination drug that’s supposed to help people lose weight without causing the heart damage that killed that Wyeth product a decade ago.
But Arena (NASDAQ: ARNA) has a sleeper in pipeline— a novel drug for insomnia. The company is planning to unveil results within a couple weeks from a clinical trial of 700 patients that will give it a good idea of the drug’s prospects. I got the rundown on it from CEO Jack Lief on a visit to Arena’s headquarters last week.
Sleep, of course, is one of those essential biological functions that’s a casualty of this frenetic digital age. Something like 70 million Americans have some form of insomnia, and it’s a chronic problem for one in 10 people in the U.S., according to the National Institutes of Health. The nation spends an estimated $14 billion a year on direct costs of this disorder, including drugs, healthcare services, and hospital and nursing home care, according to the National Sleep Foundation. Existing drugs generated sales of more than $3.5 billion in 2006, Arena says. The best known drugs for this disorder are sedatives like Sanofi-Aventis’ zolpidem (Ambien), which tend to leave people groggy in the morning, and occasionally cause creepy side effects like sleepwalking or sleepeating. Anything better could be a very big seller.
Arena’s drug, APD-125, is designed to block a specific receptor on cells in the brain, called 5-HT2a, that’s blocked by some antipsychotic drugs, but not specifically by other insomnia meds. The Arena drug is not made to be a generalized sedative, so it ought to help prevent people from waking up multiple times in the night, without the groggy “hangover” effect in the morning, Lief says. The treatment should help people sleep more deeply, and get more high-quality rest.
“A lot of people have tried Ambien and don’t take it anymore because of the next-day hangover effect,” Lief says. “People want to feel more rested in the morning.”
Arena isn’t the only company that has been working on this idea. Sanofi-Aventis has two other drugs in development that block the same receptor, called eplivanserin and volinanserin, Lief says. Those drugs are less selective for the receptor that Arena blocks, and were originally designed for other uses, but they are closer to reaching the marketplace than Arena, he says.
The clinical trial should give Arena a clear sense of how well the drug is working. The study enrolled 744 patients, with one-third getting a low dose, one-third a higher dose, and the rest on a placebo, Lief says. The main goal will be to see whether the medicine can help people reduce the number of times they wake up during the night. Secondary goals—which are more subjective and difficult to accurately measure—will look at whether patients had higher-quality sleep, whether they slept a longer time, whether they fell asleep faster, and spent less time awake between sleeping bouts.
Safety, as with any drug with potential to be taken by millions of people, has to be squeaky clean to satisfy the FDA. Based on trials to date, Lief says he’s confident that’s not a problem. “You can swallow a whole bottle of this and it won’t cause you harm,” he says.
If Arena can show this drug is effective at helping people sleep better, it hopes that Wall Street will wake up. Arena stock, like that of many unprofitable biotechs, has taken a beating this year, falling by more than 56 percent. “Investors only care about obesity, they only give us credit for our lead compound,” Lief says. “This is actually really an exciting time for the sleep community.”
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