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Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status
Date:3/17/2008

duction in agitation as measured by the change from baseline in the PEC Score, measured at 2 hours after the first dose. The PEC Score is a commonly used endpoint in acute agitation studies and is the abbreviation for PANSS (Positive and Negative Symptom Scale) Excited Component Score. Various assessments of a patient's agitation state will be conducted at serial time points using standard agitation scales over the first 4-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects will be recorded throughout the 24- hour period. A second Phase 3 clinical trial is projected to begin in Q3 2008. The design of the second study will be similar to the first trial, except that the patient population will be patients with bipolar disease. AZ- 004 is being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital, LLC in 2006.

-- AZ-001 (Staccato prochlorperazine) is being developed for the acute treatment of migraine headaches. Alexza reported positive results from a 400 patient Phase 2b clinical trial for this product candidate in 2007. In December 2007, Alexza completed enrollment of a thorough QT clinical trial, in which two doses of AZ-001 (5 and 10 mg) were compared to active control (moxyfloxacin) and to placebo. With more than 40 subjects per treatment arm, the Company found that the active control produced a positive QT/QTc signal that verified the sensitivity of the clinical study trial design. Based on a preliminary analysis of the data from this study, neither of the two AZ-001 doses produced a QT/QTc prolongation that Alexza believes would be suggestive of an increased risk of cardiac arrhythmia. Alexza has also initiated a 28- day inhalation toxicology study in animals and expects to complete this study in Q2 2008. Alexza intends to request an End of Phase 2 meeting for AZ-001 with the U.S. Food and Drug Administration during Q2 2008.

-- AZ-104
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SOURCE Alexza Pharmaceuticals, Inc.
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