Ambien and Its Enemies: The Drama Never Ends

The sleep business continues to be roiled by the onset of generic Ambien. Sanofi just reported that its profits fell by 2.6%, according to the Wall Street Journal. However, sales of Ambien were actually up 54% to 555 million euros in the US, the company reported. That in part is due to the ridiculously high level of adpsend the company has lavished on Ambien and Ambien CR since 2005. The company has propelled Ambien into the best of all possible positions as it prepares for generics to chip away at the brand.

Interestingly, the fallout isn’t just affecting Sanofi, analysts say. Friedman Billings Ramsey said in a recent note that they expect Rxs for Lunesta to remain flat at about 11.6% market share in the face of the generic Ambien juggernaut.

Also bullish (weirdly bullish, IMHO), is RBC on the chances of Somaxon’s Silenor, which has yet to receive approval from the FDA. I’ve said before that anyone who wants to launch a new sleep drug at this time is probably insane. Why? Count the negatives: Crowded market, established competition, overheated adpsend war, and several products with trusted methods of action and long safety records. And now the most-famous, most used brand is a cheap generic.

Still, RBC has this to say about Silenor:

“Much anticipated arrival of generic competition of Ambien does not alter our expectations for Silenor… We think Silenor's differentiation could overcome issue even if availability of low-cost generic does reduce growth of existing brands … 1. Unique mechanism of action targeting H-1 receptor vs. existing brands that target GABA. 2. Phase III results suggest product profile as good or better than existing brands (especially Rozerem only non-scheduled, FDA-approved prescription sleep drug). 3. Ultra low-dose of an FDA approved active pharmaceutical ingredient that has been used chronically at much higher doses for 40 years. 4. Non-scheduled formulation that should ease patient/physician concerns about existing hypnotic controlled substances used for sleep (e.g. Lunesta, Ambien, Ambien CR).”

All of that good news applied to Takeda’s Rozerem at one time. And look what happened there.

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