Al­ler­gan, Richter steer past an­oth­er late-stage pile­up with cariprazine

Cariprazine’s hit-and-miss record in late-stage de­vel­op­ment has been ex­tend­ed by a sting­ing set­back. In­ves­ti­ga­tors for Al­ler­gan ($AGN) and its part­ner Gedeon Richter say that the drug flopped in a Phase III de­pres­sion study, but will nev­er­the­less go back in­to an­oth­er piv­otal study in search of more promis­ing re­sults.

Per­sis­tence in late-stage work is the on­ly rea­son this drug is still in the spot­light. Back in ear­ly 2015 I cov­ered their small, suc­cess­ful Phase III tri­al for cariprazine in schiz­o­phre­nia, which was good enough for the de­vel­op­ers to send back to the FDA for a lat­er ap­proval (as Vray­lar), even though they had re­ject­ed the drug in 2013. Richter has dogged­ly main­tained its faith in the drug af­ter once pro­ject­ing peak po­ten­tial sales at a block­buster rate of $2 bil­lion a year, which shrinks to $200 mil­lion in the hands of some an­a­lysts.

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