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Alexza Reports 2010 Fourth Quarter and Full Year Financial Results and Provides General Corporate Update
Date:3/15/2011

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. (Click here to see an animation of how the Staccato system works.)

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 the AZ-004 NDA in December 2009.  In October 2010, the Company received a CRL from the FDA, regarding its NDA for AZ-004.  A CRL is issued by FDA's Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its present form.  The Company completed an end-of-review meeting with the FDA in late December 2010.  

The Company believes it has a clear understanding of the issues outlined in the CRL, is developing and executing a plan to address these issues, and currently projects a resubmission of the AZ-004 NDA in July 2011.  

For more information about Alexza, the Staccato technology or the Company's development programs, please visit www.alexza.com.

Safe Harbor Statement

Alexza's policy is to only provide guidance on product candidates and corporate goals for the future one to two fiscal quarters, and to provide, update or reconfirm its guid
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SOURCE Alexza Pharmaceuticals, Inc.
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1. Alexza to Announce 2010 Year-End Financial Results on Tuesday, March 15, 2011
2. Alexza Pharmaceuticals Completes End-of-Review Meeting With FDA for AZ-004 (Staccato® Loxapine) NDA
3. Alexza Pharmaceuticals Provides Regulatory Update for AZ-004 (Staccato® Loxapine)
4. Alexza Pharmaceuticals Reports 2010 Third Quarter Financial Results and Provides Business Update
5. Alexza Pharmaceuticals to Announce 2010 Third Quarter Financial Results on November 9, 2010
6. Alexza Pharmaceuticals Reacquires U.S. and Canadian Rights for AZ-004 (Staccato® Loxapine)
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11. Alexza Pharmaceuticals Appoints Joseph L. Turner to Its Board of Directors
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