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Alexza Pharmaceuticals Completes End-of-Review Meeting With FDA for AZ-004 (Staccato® Loxapine) NDA
Date:1/18/2011

eview period will be 6 months.

The CRL also raised issues relating to the suitability of the stability studies undertaken by Alexza and certain other items relating to the Agency's pre-approval manufacturing inspection, which was completed in August 2010.  Alexza believes it understands these issues and that the issues can be adequately addressed in the AZ-004 NDA resubmission.

Since AZ-004 incorporates a novel delivery system, the CRL included input from FDA's Center for Devices and Radiological Health (CDRH).  In the CRL, CDRH requested a human factors study and related analysis to validate that the product can be used effectively in the proposed clinical setting.  Prior to the End-of-Review meeting, Alexza provided a human factors study draft protocol for review by CDRH, on which the FDA provided input and comments.  Alexza expects to finalize the protocol with the FDA and complete this study in the coming months.  Alexza is not required to conduct any additional efficacy or safety clinical trials.

CDRH also requested further bench testing of the product under an additional "worst-case" manufacturing scenario.  Alexza has completed this additional "worst-case" bench testing of the product, submitted data to the FDA and believes that this issue has been adequately addressed.

Conference Call Information

The Company will host an investor conference call and live webcast later today, Tuesday, January 18, 2011, at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time.  The conference call, live webcast and archived replay are open to all interested parties.

To access the conference call via the Internet, go to www.alexza.com, under the "Investor Relations" link.  Please join the call at least 15 minutes prior to the start of the call to ensure time for any software downloads that may be required.  Interested parties may also pre-regis
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SOURCE Alexza Pharmaceuticals, Inc.
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