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Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
Date:6/9/2008

Initial Trial Results Expected in Q3 2008 Conference Call to be Held on Monday, June 9, 2008 at 5:15 p.m. Eastern

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MOUNTAIN VIEW, Calif., June 9 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has completed enrollment of its first Phase 3 clinical trial with AZ-004 (Staccato(R) loxapine). AZ-004 is an inhalation product candidate being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. Alexza believes the novel, non-invasive nature and rapid pharmacokinetic (PK) properties resulting from inhaled loxapine administration via the Staccato system have the potential to make AZ-004 a viable product to treat acute agitation. AZ-004 is being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital, LLC in 2006.

"We initiated this first Phase 3 clinical trial of our lead program in late February, completed enrollment in less than four months, and project to have initial results in late September, which is six months ahead of our original schedule," said James V. Cassella, PhD, Alexza Senior Vice President, Research and Development and chairman of the Symphony Allegro Development Board. "We are pleased at the pace this trial enrolled and believe this indicates clinician enthusiasm for this novel drug candidate."

"With the early completed enrollment of our first AZ-004 Phase 3 study, we are sharpening our focus and accelerating our AZ-004 pre-commercialization activities for manufacturing, quality systems, regulatory submissions, and potential sales and marketing," said Thomas B. King, Alexza President and CEO. "We also remai
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SOURCE Alexza Pharmaceuticals, Inc.
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