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Alexza Reports 2009 First Quarter Financial Results and Updates Clinical Pipeline Status
Date:5/7/2009

the pulmonary safety of AZ-004. The Company observed that AZ-004, administered twice within a 24-hour period, was safe and generally well tolerated in the study. There were no systematic differences in post-dose pulmonary function between AZ-004 and placebo, and no respiratory adverse events. In April 2009, Alexza initiated a thorough QTc study in healthy subjects and a smoker/non-smoker pharmacokinetic study in healthy subjects. The Company expects to initiate the remaining two studies during the current quarter and projects that all of the clinical work for the NDA will be completed by the end of the third quarter of 2009.

- AZ-104 (Staccato loxapine). Alexza is developing AZ-104 to treat patients suffering from acute migraine headaches. AZ-104 is a lower dose version of AZ-004. In January 2009, Alexza initiated an AZ-104 outpatient, multi-center, randomized, double-blind, single-dose, placebo-controlled study intended to enroll 360 patients who have migraines, with or without aura. Two dose levels of AZ-104 are being evaluated in the clinical trial, 1.25 mg and 2.5 mg. The primary efficacy endpoint for the trial is headache pain relief at 2 hours post-dose, using the standard IHS 4-point rating scale. Secondary efficacy endpoints for the trial include pain relief and other symptom assessments at various time points. Safety evaluations will also be made throughout the clinical trial period. Alexza projects that data from the Phase 2b study will be announced by the end of the third quarter of 2009

AZ-004 and AZ-104 have been licensed to Symphony Allegro, and the Company has the right to repurchase all rights to these product candidates.

Conference Call Information

Alexza will host a conference call today, May 7, 2009, at 5:30 p.m. Eastern Time. A replay of the call will be available for two weeks following the event. The conference call, replay and webcast are open to all
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SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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Related medicine technology :

1. Endo Pharmaceuticals and Alexza Pharmaceuticals Conclude Research Collaboration
2. Alexza Initiates AZ-104 (Staccato(R) Loxapine) Phase 2b Clinical Trial in Patients With Migraine Headaches
3. Alexzas AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
4. Alexzas AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
5. Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product Candidates
6. Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
7. Alexza Pharmaceuticals to Present AZ-104 Phase 2a Clinical Data at the American Headache Society Annual Scientific Meeting
8. Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
9. Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
10. Alexza Pharmaceuticals to Present AZ-004 Phase 2a Clinical Data at the American Psychiatric Association Annual Meeting
11. Alexza Completes Enrollment in Phase 2a Clinical Trial With AZ-002 (Staccato(R) Alprazolam) in Panic Disorder Patients
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