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Alexza Announces Submission of AZ-004 (Staccato(R) Loxapine) NDA
Date:12/14/2009

MOUNTAIN VIEW, Calif., Dec. 14 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration (FDA). AZ-004 is an inhalation product candidate being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. The IND for Staccato loxapine was filed with the FDA in August 2005.

"AZ-004 has delivered a predictable and consistent safety and efficacy profile in treating patients with agitation," said James V. Cassella, PhD, Senior Vice President, Research and Development at Alexza. "We believe that AZ-004, if approved, has the potential to change the treatment practices for acute agitation, as the only product able to meet both the patients' desire for quickly and comfortably gaining control, and the clinicians' goal of rapidly and reliably calming an agitated patient."

"The data we have seen from the Staccato loxapine trials are compelling," said Michael Lesem, MD, Executive Medical Director, Claghorn-Lesem Research Clinic, Houston, TX. "The product exhibits a rapid and predictable reduction in agitation, and appears to have a favorable safety profile in these patient populations."

"We once again exceeded our corporate goal timeline with the AZ-004 NDA submission," said Thomas B. King, President and CEO of Alexza. "The continued concentrated effort of the entire Alexza team throughout 2009 has been nothing short of remarkable and allowed us to complete this landmark milestone for the company. We eagerly look forward to 2010, as we work toward the approval of this product candidate."

"When Alexza was founded, I had the vision that its proprietary technology had the potential to improve the therapeu
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SOURCE Alexza Pharmaceuticals, Inc.
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