Forest Ready To File Antipsychotic Cariprazine With Bipolar Mania Results
This article was originally published in The Pink Sheet Daily
Success in a Phase III trial in schizophrenia, set to report in Q1 2012, would mean a double filing in mid-2012.
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Specialty pharma has data in hand to support a double filing of novel antipsychotic cariprazine this year for acute exacerbation of schizophrenia and bipolar mania, with studies ongoing to support two additional indications in MDD.
Although a significant portion of the U.S. population – approximately 6.5% or 15 million adults annually – suffers from depression, the antidepressant drug market is on the decline and sales are expected to decrease further over the next two years as two of the largest products on the market, Forest Laboratories’ Lexapro (escitalopram) and Eli Lilly & Co.’s Cymbalta (duloxetine), face patent expirations.
Forest Laboratories, Inc. has late-stage products lined up in its pipeline to help fill the gap left when Lexapro and Namenda go generic, but the burden on a specialty pharma to differentiate its products is a heavy one these days, and it will be a struggle to the finish to convince investors the cup is half full.