Lexapro Maker Expects $170 Million Fine From Feds

I ran into a transcript of the conference call held the other day between executives for Forest Labs, makers of Lexapro, and financial analysts. In it, Lawrence Olanoff, the company president and COO, stated:

"Further last month we announced that the FDA approved our supplemental NDA for Lexapro with the indication of acute and maintenance treatments of major depressive disorder adolescents of 12 to 17 years of age. This program included clinical studies in a patient population, which has in the past proven difficult to demonstrate positive results. We are enormously gratified that Lexapro now be available for the approximately 2 million depressed adolescents in the U.S. who can share the benefit which Lexapro has provided for depressed adult patients for the past seven years.

"We expect that this additional indication will further help to stabilize to position of Lexapro in the market as we begin to detail to psychiatrists who diagnose and treat adolescent patients with a depressive disorder."

I sure cannot wait to see the company's sales pitch to doctors, especially given that the drug had two failed clinical trials for adolescents and its positive trials had small effect sizes. But 2 million American teens and their parents remain to be confused about the drug's alleged benefits.

Even more interesting is that company officials also identified that they had set aside $170 million "in connection with the ongoing discussions with the U.S. Department of Justice investigations." Forest didn't say which specific investigations they meant, but it's a clear reference to the DOJ's current investigation of the company off-label marketing Lexapro for kids and of the company providing kickbacks to doctors. The drug was only recently approved for use in adolescents. Whether whatever deal the company reaches--or doesn't--with the feds works out to $170 million or not remains to be seen.

Stay tuned.