Titan down on schizophrenia data

TTP was down $2.26 (58%) to $1.63 on 3.9 million shares on Monday after 150-patient cardiac safety study by partner Novartis (NVS; SWX:NOVN) showed that Zomaril iloperidone produced "roughly comparable" changes compared to one of two marketed drugs ( Geodon ziprasidone from Pfizer) on the primary endpoint of changes in QTc interval from baseline to week six. TTP said the data "may potentially limit the opportunity of iloperidone as first line therapy for schizophrenia." TTP also said the QTc limit seen was in the upper limits of what is acceptable by FDA standards.

TTP said in a conference call that NVS may potentially return rights to the compound. In addition, TTP said at least one more Phase III efficacy trial will be necessary to pursue regulatory approval. Last year, the companies delayed regulatory filing for Zomaril to the end of 2002 from early 2002 to include data from additional dosing studies (see BioCentury, July 30, 2001). The product is an antagonist of serotonin 5HT2 and dopamine D2 receptors. ...