Sanofi-Aventis wins approval for new Ambien formulation
Sanofi-Aventis won FDA approval for an extended release version of its sleeping pill Ambien.
The newer version of the drug, Ambien CR, is a bi-layered tablet delivered in two stages to help people with insomnia fall asleep quickly and maintain sleep with no significant decrease in next day performance, Sanofi-Aventis said in a statement.
The approval is expected to allow the company to better compete with Sepracor's Lunesta and Takeda's Rozerem.
Michael Leacock, a pharmaceuticals analyst with Nomura in London, told Reuters the approval had been widely expected but that the label for the drug appeared to be better than some investors had expected, with no reference to limiting it to short-term use.
"This puts Ambien CR on a more level playing field with the recently launched and strong competitor Lunesta," Leacock wrote in an investors note.
Leacock also said Sanofi-Aventis was hoping to convert 50 percent of patients from Ambien to Ambien CR before the patent on the original product expires.
Nomura expects global revenues for Ambien to drop from $1.5 billion to $1 billion in 2006 and $536 million in 2007. Global sales of Ambien reached $1.76 billion last year, when the drug accounted for more than 64 percent of sleeping pill sales worldwide, but the current version on the market is set to lose its patent protection as early as October 2006, or in 2007 if it wins an extension for pediatric use.