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Vanda Presents Phase III Iloperidone Efficacy Data
Date:12/12/2007

Findings also demonstrate favorable safety and tolerability profile

ROCKVILLE, Md., Dec. 12 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced today that data from four Phase III efficacy and safety trials demonstrate that iloperidone, an investigational atypical antipsychotic, is associated with significantly greater improvements in the symptoms of schizophrenia versus placebo and has a favorable safety and tolerability profile. These results were included as part of the recently filed New Drug Application (NDA) for iloperidone and were presented for the first time this week at a major psychiatric congress. Posters containing the data presented will be posted on Vanda's Web site, http://www.vandapharma.com, on Thursday, December 13, 2007. The U.S. Food and Drug Administration (FDA) accepted the NDA submitted by Vanda for marketing approval on November 26, 2007.

The Phase III study conducted by Vanda evaluated the efficacy of iloperidone versus placebo in patients with schizophrenia. The study was a randomized, double-blind, placebo-controlled, multi-center, four-week inpatient study that enrolled 604 patients. Following fixed-dose titration, inpatients were randomized to receive iloperidone at 24 mg/day, ziprasidone at 160 mg/day, or placebo. Patients treated with iloperidone had significantly greater improvements in Positive and Negative Syndrome Scale-Total (PANSS-T) scores than those on placebo and had PANSS-T improvement comparable to ziprasidone.

"There is a great need for new treatment options for schizophrenia, particularly as patients often discontinue treatment due to efficacy and tolerability issues, as seen in the NIMH-funded
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SOURCE Vanda Pharmaceuticals Inc.
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