Forest Labs Bullish On Experimental Antipsychotic

In an earnings call with investment analysts on Tuesday, Larry Olanoff, Forest Labs' COO, spoke of the company's new atypical antipsychotic Cariprazine, which is currently in phase 2 clinical trials.

"Going further back into the question on Cariprazine, I would say that at this present time, we have very positive data in bipolar mania disorder, which potentially as a pivotal trial and clearly is justification going on with Phase III. That indication by itself is probably not commercially feasible, but it’s a nice add-on.

"We’re waiting on either the schizophrenia results or if the schizophrenia results are gray and perhaps are not definitive to move on, then we would consider perhaps then waiting for some of the additional trials we have ongoing in both bipolar depression, as well as in treatment resistant depression which would form a sufficient commercial core with bipolar mania to go forward in that way.

"As far as differentiation, it’s still early days. I can tell you based on the Phase II data we generated thus far, which is still fairly short term data, that we’re not seeing any major safety concerns, we’re not seeing anything substantial in the way of weight gain, we haven’t seen any major cardiovascular problems, and we see the kind of adverse event profile you’ve seen with the atypicals with regards to exter-parametal symptoms. That’s pretty much what I can say. I think the schizophrenia data coming out will further add to that initial assessment."

The drug has been trialed or is being trialed for acute mania, schizophrenia, major depression and bipolar depression. Interestingly, Olanoff's assertion that the company had a trial for mania isn't matched by what's in the clinicaltrials.gov database, so I wonder if we've got an unregistered study going on there. Anyway, I know very little about the new compound, but would expect the company to chase FDA approval in 2011 or 2012 if studies continue to pan out as they claim. Lexapro goes off-patent in early-2013, so you just know that Forest would love to have a depression indication for Cariprazine.