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Alexza Reports 2008 First Quarter Financial Results and Updates Development of Product Candidates
Date:5/12/2008

f an in-clinic, multi-center, randomized,

double-blind, single administration, placebo-controlled Phase 2a

proof-of-concept clinical trial in 168 migraine patients with or

without aura. Three doses of AZ-104 (1.25, 2.5 and 5 mg) were

evaluated against placebo in the clinical trial. Using the IHS

4-point rating scale, the primary efficacy endpoint was pain-relief

response at 2 hours post-administration. AZ-104 met the primary

efficacy endpoint of the clinical trial for the two highest doses of

the drug compared to placebo. Statistically significant

improvements in pain response were observed in 76.7% of patients at

the 5 mg dose (p=0.02), 79.1% of patients at the 2.5 mg dose (p=0.01)

and 67.4% of patients at the 1.25 mg dose (p=0.18), compared to 51.3%

of patients receiving placebo. AZ-104 has been licensed to Symphony

Allegro and the Company has the right to repurchase all rights to this

product candidate.

-- AZ-002 (Staccato alprazolam). Alexza is developing AZ-002 for the

acute treatment of panic attacks associated with panic disorder. The

Company completed enrollment of its Phase 2a proof-of-concept clinical

trial in patients with panic disorder in April 2008. Alexza expects

to report initial results of this trial by the end of the second

quarter of 2008. AZ-002 has been licensed to Symphony Allegro and the

Company has the right to repurchase all rights to this product

candidate.

-- AZ-003 (Staccato fentanyl). Alexza is jointly developing AZ-003 with

Endo Pharmaceuticals Inc. for the treatment of breakthrough pain in

cancer and non-cancer patients. Endo is responsible for regulatory,

pre-clinical and clinical development, and for commercializing the

product in North America. Alexza is respons
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SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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1. Alexza Completes $10 Million Equity Financing with Bio*One Capital to Initiate Commercial Manufacturing in Singapore
2. Alexza to Announce 2007 Financial Results and Update Its Clinical Pipeline on Monday, March 17, 2008
3. Michael J. Simms Joins Alexza Pharmaceuticals as Senior Vice President, Operations and Manufacturing
4. Alexza Initiates First Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
5. Alexzas Corporate Presentation to be Webcast at the 10th Annual BIO CEO & Investor Conference
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10. The 4th Annual BIO Investor Forum to Webcast Alexzas Corporate Presentation
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