Forest Labs, Gedeon Richter plan 2012 filing for cariprazine

The latest studies examined the drug's role in the treatment of acute exacerbations of schizophrenia,
but the drug has also been shown to be effective in earlier phase III studies in bipolar mania.

In both schizophrenia studies, cariprazine achieved significant symptom improvement compared
to placebo-treated patients according to the widely-used Positive and Negative Syndrome Scale
(PANSS).

All doses tested in the trials showed statistically significant separation from placebo starting from
the second week of treatment and at each subsequent time point with the higher dose showing
separation as early as week one, according to the two companies, which say they will release
additional data from the trials in the coming weeks.
"By successfully meeting the primary endpoint in each of these studies, we now have three positive
schizophrenia trials and three positive bipolar mania trials," said Dr. Marco Taglietti, president
of Forest Research Institute. "We look forward to filing the New Drug Application (NDA) for both
indications in 2012."