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

MOUNTAIN VIEW, Calif., Dec. 7, 2010 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the Company has scheduled an End-of Review meeting with the U.S. Food and Drug Administration (FDA) in December to discuss the Complete Response Letter (CRL) regarding the Company's New Drug Application (NDA) for AZ-004 (Staccato loxapine).  Alexza has submitted an Information Package to the FDA in preparation for the meeting, with the responses or proposals to the issues raised in the CRL.  AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.

The Company anticipates the FDA meeting will be a comprehensive review of the issues identified by the FDA in the CRL, and Alexza's planned responses to those issues.  The Company's primary meeting goal is to clarify and fully understand the key issues, and to establish a plan to respond to those issues.  While the CRL follow-up meeting will be held in December, the Company does not expect the official FDA meeting minutes to be available until at least late January 2011.  The Company anticipates providing a further U.S. regulatory update on AZ-004 after receipt of the official FDA correspondence.

Alexza also announced today that it has met with the European Medicines Agency (EMA) and has received written confirmation that AZ-004 is eligible for submission of a Marketing Authorization Application (MAA) under the centralized registration procedure.  In addition, Alexza has been notified of the Rapporteur and Co-Rapporteur appointments for the AZ-004 review.  The Company believes that the comprehensive clinical development program for AZ-004 meets the requirements for the MAA filing.  Alexza expects to submit the MAA mid-year 2011.

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