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Alexza to Initiate the First Phase 3 Trial for AZ-004 (Staccato(R) Loxapine) in Late Q1 2008
Date:9/18/2007

Conference Call Scheduled for Tuesday, September 18 at 5:00 p.m. EDT

PALO ALTO, Calif., Sept. 18 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced that it expects to begin the first of two Phase 3 trials for AZ-004 (Staccato(R) loxapine) late in the first quarter of 2008. AZ-004 is initially being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. The two Phase 3 trials are anticipated to each enroll approximately 300 patients. AZ-004 is being developed through Symphony Allegro, a product development collaboration formed between Alexza and Symphony Capital, LLC.

"Our AZ-004 development program continues to track 6 to 12 months ahead of our original schedule, which we outlined last September as we initiated our Phase 2a clinical trial," said Thomas B. King, President and CEO of Alexza. "We believe that the strength of the clinical data from our Phase 2a clinical trial, coupled with the speed with which that trial enrolled, has put us in position to initiate our Phase 3 trials significantly ahead of our original plans. AZ-004 is a product candidate we believe could fill an important unmet need in the acute treatment of agitation in schizophrenic and bipolar patients."

About AZ-004 (Staccato loxapine)

AZ-004 is the combination of Alexza's proprietary Staccato system with loxapine, a drug belonging to the class of compounds known as antipsychotics. AZ-004 combines drug delivery speed comparable to that of an intravenous injection, but with the simplicity, convenience and ease of administration of a simple, one-breath inhalation. In March 2007, Alexza reported the initial results of its Phase IIa clinical trial of A
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SOURCE Alexza Pharmaceuticals, Inc.
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