By Matthew Willett
Titan Pharmaceuticals Inc. said positive safety and efficacy results from a large-scale Phase III study of Zomaril (iloperidone) for treatment of schizophrenia conducted by Novartis Pharma AG indicated that both dose levels used in the study achieved a highly statistically significant reduction in symptoms as assessed by the Brief Psychiatric Rating Scale.
The global trial is one of seven studies under way including more than 3,200 patients designed to evaluate Zomaril, together called REALIZE (Research to Assess the Long-term Impact of Zomaril).
Titan shares (AMEX:TTP) rose $9.95 on the news Monday, closing at $57.20, a 21 percent jump.
Novartis, of Basel, Switzerland, and Titan, of South San Francisco, entered a collaboration for the development, manufacture and marketing of Zomaril worldwide, except in Japan, in 1997, and Novartis began Phase III trials in 1998. (See BioWorld Today, August 19, 1998, p. 1.)
Titan CEO Louis Bucalo said the results are the second to report in a seven-part trial battery.
"The overall program for Zomeril in the clinic contains a number of trials, several of which are long-term tolerance trials," Bucalo said. "Previously, we reported results from the first placebo-controlled study. This is the second placebo-controlled study, and both show the drug was effective." (See BioWorld Today, Dec. 2, 1999, p. 1.)
Should the trial schedule continue along the timeline set by Novartis and Titan, Bucalo said, Novartis should submit an NDA to the FDA in the second half of next year.
"We're well on track for the timeline we've set," he said. "Novartis will be able to file for potential approval next year in the second half. This additional data strengthened our belief in Zomeril as a unique and potential-filled product for the treatment of schizophrenia, and we look forward to completing testing and, potentially, an NDA filing in the second half of 2001."