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Alexza Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato® Loxapine) NDA
Date:10/11/2010

60;Because AZ-004 incorporates a novel delivery system, the CRL also included input from FDA's Center for Devices and Radiological Health (CDRH).  CDRH requested a human factors study and related analysis to validate that the product can be used effectively in the proposed clinical setting.  CDRH also requested further bench testing of the product under an additional "worst-case" manufacturing scenario.

"We are reviewing the Complete Response Letter and plan to meet with the FDA as soon as possible to discuss the Agency's pulmonary safety concern.  Alexza shares the agency's deep interest in patient safety, and believes the pulmonary data is supportive of the safety of AZ-004.  We look forward to discussing the appropriate way to address this issue," said Thomas B. King, Alexza President and CEO.  "We are also undertaking steps to address the other items raised in the CRL.  We appreciate the FDA's review of the first NDA for our novel Staccato technology, and we expect to work closely with FDA to resolve the issues raised in the Complete Response Letter.  Alexza continues to believe in the safety and efficacy of AZ-004 based on the comprehensive clinical development program we have conducted."

Conference Call Information

The Company will host an investor conference call and live webcast today, Monday, October 11, 2010 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-register to avoid pre-call delays at

SOURCE Alexza Pharmaceuticals, Inc.
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