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Alexza Pharmaceuticals Provides Regulatory Update for AZ-004 (Staccato® Loxapine)
Date:12/7/2010

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. (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 is currently evaluating the FDA's comments in the CRL and has scheduled a meeting with the FDA in December 2010 to discuss the CRL.

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

Safe Harbor Statement

This press release includes forward-looking statements regarding the development and safety of the Company's product candidates and technologies.  Any statement describing the Company's expectations or beliefs is a forward-looking statement, as defined in the Private Se
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SOURCE Alexza Pharmaceuticals, Inc.
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