Somaxon Pharmaceuticals overcame two regulatory delays to win FDA approval to market its insomnia drug doxepin (Silenor). Now comes the hard part.
San Diego-based Somaxon (NASDAQ: SOMX) is entering a prescription sleeping pill market in which name-brand products have been steadily losing ground to the lower-cost generics preferred by managed care plans. So right out of the gate, doxepin will at best be the No. 2 prescription drug choice for treating insomnia, next to zolpidem, the generic version of Ambien.
That wouldn’t be so bad, except that Somaxon’s doxepin also can expect competition from over-the-counter sleep aids. Doxepin promotes sleep by acting on histamine receptors, as do Tylenol PM and Advil PM, which contain the antihistamine diphenhydramine. This means doxepin will need a competitive copay if it wants to convert regular users of OTC sleep products. Somaxon must also find a way to motivate these consumers to go see their doctors (and fork over an additional copay).
San Diego’s biotech community is well-populated with people familiar with the sleeping pill market—it wasn’t so long ago that Neurocrine Biosciences’ indiplon was supposed to be the next big sleep drug. So when I was in town recently, I took a very informal survey about doxepin’s chances for commercial success.
The local buzz is that doxepin could generate $250 million in annual sales—some optimists say $500 million is possible—but Somaxon needs to do everything right. I’m told it will be critical for the company to get its drug on managed care formularies with copays that compare favorably to the prices of OTC drugs.
Word-of-mouth also will be important because advertising is expensive and treacherous. When a generic option is available, name-brand advertising is less effective. That’s why the once-ubiquitous TV commercials depicting luminous butterflies and weird-dream talking beavers all but disappeared when generic zolpidem became available in 2007.
Somaxon talked a little bit about its commercial strategy on a conference call in mid-March right after doxepin received FDA approval. (Just one analyst posed questions on the call, which might give you a sense of Wall Street’s enthusiasm for the company.) I’m sure Somaxon watchers know all the details, but for those who don’t follow the company closely, it’s worth mentioning the highlights.
— Somaxon expects to launch the drug in the second half of 2010 and is in discussions with third parties about a marketing partnership or some other relationship. (Observers I spoke with say a specialty pharma company is the likeliest candidate.)
— Psychiatrists write a large percentage of sleeping pill prescriptions and Somaxon believes it can target them with a specialty sales force of 50 to 100 reps.
— Somaxon plans to distribute free samples that doctors can give to their patients to encourage early trial and to build word-of-mouth. (The company is banking that physicians will feel comfortable handing out the pills because doxepin, unlike zolpidem, is not a scheduled drug.)
— Somaxon needs to strengthen its balance sheet. The company had cash of $5.2 million at the end of 2009, enough to get through the first half of 2010. (The company since made plans to sell 6 million shares at $8.25 per share to raise $45.9 million. It expects to complete the offering by March 31.)
— Somaxon says it won’t need a massive budget to promote its product, because ads for competing prescription drugs have virtually dried up. In other words, it won’t have to shout to be heard.
Doxepin is a low-dose formulation of an old drug that was first marketed as an antidepressant in 1969. In clinical studies, doxepin posed no risk of dependency or addiction, a marketing advantage over zolpidem that Somaxon intends to emphasize. Sixty-five percent of people who take prescription sleeping pills report their chief worry is getting hooked on the medication, Somaxon says.
The drug was approved to promote sleep maintenance, meaning it helps people sleep through the night but doesn’t necessarily help them fall asleep. The company says that in clinical trials, the drug helped subjects get seven to eight hours of sleep.
How the drug works in the real world remains to be seen. Subjects who took the drug in some clinical trials performed slightly worse on memory tests given one hour after waking compared to those in a placebo group. People who take the drug on a full stomach may experience such next-day impairments according to information on the drug label approved by the FDA.
This is a story we’ll be watching. Eyes wide open.
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