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Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status
Date:2/5/2008

MOUNTAIN VIEW, Calif., Feb. 5 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has initiated a Phase 1 clinical trial with AZ-007 (Staccato(R) zaleplon). AZ-007 is an inhalation product candidate being developed for the treatment of insomnia patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back asleep. This is the first clinical trial of AZ-007 being conducted under an IND filed recently with the U.S. Food and Drug Administration (FDA). Alexza believes the novel, non-invasive nature and possible rapid pharmacokinetic properties resulting from inhaled zaleplon administration via the Staccato system make AZ-007 a viable product candidate for clinical development in insomnia. Alexza also announced today a status update on its clinical pipeline, including confirming the initiation of its first AZ-004 Phase 3 clinical trial by the end of Q1 2008.

"This is a transitional year for Alexza, as we move into Phase 3 clinical development of AZ-004 and the early commercial planning for its manufacturing, regulatory submissions, and potential sales and marketing," said Thomas B. King, Alexza President and CEO. "In addition, we have five other product candidates in various stages of clinical development in four different therapeutic areas. With our own product candidates, and with our product partnerships with Endo Pharmaceuticals and Symphony Allegro, we look forward to solid progress in these clinical programs during 2008."

AZ-007 Phase 1 Clinical Trial Design

The AZ-007 Phase 1 clinical trial is projected to enroll approximately 40 healthy volunteers at a single U.S. clinical center. The purpose of this tri
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SOURCE Alexza Pharmaceuticals, Inc.
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