FDAnews
www.fdanews.com/articles/62141-vanda-completes-enrollment-in-two-phase-iii-trials

VANDA COMPLETES ENROLLMENT IN TWO PHASE III TRIALS

August 30, 2006

Vanda Pharmaceuticals has completed enrollment in its iloperidone Phase III trial for the treatment of schizophrenia and its VEC-162 Phase III trial for the treatment of transient insomnia.

The iloperidone clinical trial is a randomized, double-blind, placebo-controlled study that enrolled 604 patients with schizophrenia. The VEC-162 trial is a randomized, double-blind, placebo-controlled transient insomnia trial that enrolled 412 healthy volunteers.

"In iloperidone, we look forward to providing schizophrenia patients a compound with a differentiated safety profile and unique pharmacogenetic tools for identifying optimal iloperidone responders. We believe that VEC-162 offers a novel way of treating insomnia, in particular those patients with circadian rhythm disorders," said Mihael Polymeropoulos, president and CEO of Vanda.

The company expects to report results of both trials in January 2007. If the iloperidone trial is successful, Vanda expects to file an application with the FDA by the end of 2007. The company will need to conduct additional Phase III trials to receive FDA approval of VEC-162 for insomnia.