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Alexza Announces Submission of AZ-004 (Staccato(R) Loxapine) NDA
Date:12/14/2009

the call is 86237542.

About Alexza Pharmaceuticals, Inc.

Alexza Pharmaceuticals is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexza's technology, the Staccato system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation. The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience.

AZ-004 (Staccato loxapine) is Alexza's lead program, which is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients. Alexza has completed and announced positive results from both of its AZ-004 Phase 3 clinical trials, and submitted a New Drug Application submission in December 2009.

Alexza has 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 d
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SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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1. Alexza Pharmaceuticals to Present at the 21st Annual Piper Jaffray Health Care Conference
2. Alexza to Announce 2009 Third Quarter Financial Results and Update Its AZ-004 NDA Status on Monday, November 9, 2009
3. Alexza Pharmaceuticals to Present at the Fourth Annual JMP Securities Healthcare Focus Conference
4. Alexza Announces Preliminary Results from its AZ-104 (Staccato(R) Loxapine) Phase 2b Trial in Patients with Migraine Headache
5. Alexza Reports 2009 First Quarter Financial Results and Updates Clinical Pipeline Status
6. Endo Pharmaceuticals and Alexza Pharmaceuticals Conclude Research Collaboration
7. Alexza Initiates AZ-104 (Staccato(R) Loxapine) Phase 2b Clinical Trial in Patients With Migraine Headaches
8. Alexzas AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
9. Alexzas AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
10. Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product Candidates
11. Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
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