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Alexza Announces AZ-004 (Staccato(R) Loxapine) PDUFA Goal Date of October 11, 2010
Date:2/11/2010

completed an end-of-Phase 2 meeting with the FDA for AZ-001 (Staccato prochlorperazine) and has completed two Phase 2 studies with AZ-104 (Staccato loxapine, low-dose). Both product candidates are being developed for the acute treatment of migraine headache.

AZ-002 (Staccato alprazolam) has completed Phase 1 testing and one Phase 2a proof-of-concept clinical trial.  Product candidates that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain, and AZ-007 (Staccato zaleplon) for the treatment of insomnia.  More information, including this and past press releases from Alexza, is available online at www.alexza.com.

Safe Harbor Statement

This press release includes forward-looking statements regarding the development, therapeutic potential and safety of AZ-004.  Any statement describing a product candidate or Alexza's goals, expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement.  Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs.  Alexza's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements.  These and other risks concerning Alexza's business are described in additional detail in Alexza's Annual Report on Form 10-K for the year ended December 31, 2008, and Alexza's other Periodic and Current Reports filed
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SOURCE Alexza Pharmaceuticals, Inc.
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1. Alexza Announces Submission of AZ-004 (Staccato(R) Loxapine) NDA
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3. Alexza to Announce 2009 Third Quarter Financial Results and Update Its AZ-004 NDA Status on Monday, November 9, 2009
4. Alexza Pharmaceuticals to Present at the Fourth Annual JMP Securities Healthcare Focus Conference
5. Alexza Announces Preliminary Results from its AZ-104 (Staccato(R) Loxapine) Phase 2b Trial in Patients with Migraine Headache
6. Alexza Reports 2009 First Quarter Financial Results and Updates Clinical Pipeline Status
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9. Alexzas AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
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11. Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product Candidates
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