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Alexza Reports 2008 Third Quarter Financial Results and Updates Development of Product Candidates
Date:11/6/2008

The trial was an in-clinic, multicenter, randomized, double-blind, placebo-controlled study and tested AZ-004 at two dose levels, 5 and 10 mg. Patients could receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. Patients eligible for the study include those who are admitted through an emergency department and those who are already in-patients in a hospital setting, as long as they had acute agitation at the time of patient randomization. This study was the first AZ-004 study enrolling bipolar disorder patients.

In September 2008, the Company announced positive results from its first Phase 3 clinical trial of AZ-004 in schizophrenic patients with acute agitation. Both the 5 mg and the 10 mg doses of AZ-004 met the primary and secondary endpoints of the study. The administration of AZ-004 was generally safe and well tolerated in this patient population.

Alexza has completed five clinical trials with AZ-004, enrolling more than 800 patients to date, and has announced positive results from the first four of these studies. These four studies include a 50 subject Phase 1 study in healthy volunteers, a 129 patient Phase 2 study in agitated schizophrenic patients, a 32 patient multiple-dose tolerability and pharmacokinetic study in non-agitated schizophrenic patients, and a 344 patient Phase 3 study in schizophrenic patients with acute agitation. Alexza completed an end-of-Phase 2 meeting with the FDA for AZ-004 in September 2007 and believes it has a clear understanding of the development requirements for filing an NDA for AZ-004.

AZ-004 has been licensed to Symphony Allegro, Inc., or Symphony Allegro, and the Company has the right to repurchase all rights to this product candidate.

-- AZ-001 (Staccato prochlorperazine). Alexza is developing AZ-001 to treat patients suffering from acute migraine headaches. During the third quarter of 2008, Alexza conducted an end-of-Phase 2 meeting with the FDA. The Company
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SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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Related medicine news :

1. Alexza to Initiate the First Phase 3 Trial for AZ-004 (Staccato(R) Loxapine) in Late Q1 2008
2. Alexza and Autoliv Announce Commercial Manufacturing and Supply Agreement for Heat Packages Used in Single-Dose Staccato(R) System
3. Alexzas Corporate Presentation to be Webcast at the Cowen & Company 28th Annual Health Care Conference
4. Alexza Secures $50 Million Committed Equity Financing Facility With Azimuth Opportunity, Ltd.
5. Alexza to Webcast Investor and Analyst Day Presentations
6. Alexzas Corporate Presentation to be Webcast at the Seventh Annual JMP Securities Research Conference and the 2008 Citi Investment Research Global Healthcare Conference
7. Carlos A. Parra Joins Alexza Pharmaceuticals as Vice President, Quality
8. Jeffrey S. Williams Rejoins Alexza Pharmaceuticals as President, Alexza Singapore Pte. Ltd.
9. Anthony Clarke, PhD Joins Alexza Pharmaceuticals as Vice President, International Development Operations
10. Alexza to Announce 2008 Third Quarter Financial Results and Update Its Clinical Pipeline on Thursday, November 6, 2008
11. New Study Reports High Injury Rates for Hotel Workers, Even Higher Rates for Women and Nonwhites
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