Titan falls on Zomaril filing delay

TTP was off $15.30 (56%) to $11.95 on Tuesday after Monday's announcement that the company and partner Novartis (NVS; SWX:NOVN) plan to include new dosing studies in initial U.S. regulatory filings of Zomaril iloperidone, delaying the submission by one year (see BioCentury Extra, Monday July 23). NVS spokesperson Kamran Tavangar told BioCentury that these additional studies push back the Zomaril filing for schizophrenia from the end of 2001 or early 2002 to the end of 2002. Tavangar said the companies wanted to "go in with a very strong filing, where there is no doubt on the data with respect to efficacy." In a recent Phase III study, data from the low dose arm (12-16 mg/day) showed statistically significant improvement in symptoms compared to placebo at weeks 3, 4 and 5, but did not reach statistical significance in week 6. The high dose arm did show statistical significance at week 6. Moreover, he said the additional studies will include once-a-day dosing, which could enhance the compound's profile by simplifying the dosing regimen. He said if the companies were to file at the end of the year, the submission would have only included twice daily dosing data. ...