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 … Next Page »
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