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

believes it has a clear understanding of the NDA requirements for this product candidate. Consistent with previous guidance, Alexza is not planning on conducting any AZ-001 Phase 3 studies without a partner, and is continuing to seek partners for the Staccato migraine product candidates, AZ-001 and AZ-104.

-- 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. AZ-104 has completed a Phase 2a in-clinic study and Alexza plans to initiate an outpatient Phase 2b clinical trial in early 2009. In October 2008, Alexza submitted its updated IND for AZ-104 with the Division of Neurology Drug Products of the FDA.

AZ-104 has been licensed to Symphony Allegro, and the Company has the right to repurchase all rights to this product candidate

-- AZ-003 or EN3294 (Staccato fentanyl). Alexza is jointly developing Staccato fentanyl with Endo Pharmaceuticals, Inc., or Endo, for the treatment of breakthrough pain. Endo is responsible for regulatory, pre-clinical and clinical development, and for commercializing the product in North America. Alexza is responsible for the development of the Staccato Electric Multiple Dose device and has the exclusive right to manufacture the product for clinical development and commercial supply. During the third quarter of 2008, Alexza completed testing and released the first batch of EN3294 clinical trial material, or CTM, and shipped the CTM to Endo for use in the first EN3294 Phase 2 clinical trial. This CTM shipment resulted in revenue recognition during the third quarter.

-- AZ-007 (Staccato zaleplon). Alexza is developing AZ-007 for the treatment of insomnia in patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back asleep. AZ-007 has completed Phase 1 testing. No additional work is currently planned on AZ-007 for 2009.

-- AZ-002 (S
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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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