Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product ...(pletion thereis no anticipated future wo...),Health

Date:8/6/2008

pletion, there is no anticipated future work on AZ-002 in acute panic. However, given the demonstrated safety profile, the successful and reproducible delivery of alprazolam, and the clear IV-like pharmacological effect demonstrated to date, Alexza and Symphony Allegro plan to work with key opinion leaders to explore opportunities to potentially study AZ-002 in other medical conditions. AZ-002 has been licensed to Symphony Allegro, and Alexza has the right to repurchase all rights to this product candidate.

-- AZ-003 or EN3294 (Staccato fentanyl). Alexza is jointly developing AZ-003 with Endo Pharmaceuticals, Inc., or Endo, for the treatment of breakthrough pain. Endo is responsible for regulatory, pre-clinical and clinical development, and for commercializing the product in North America. Alexza is responsible for the development of the Staccato Electric Multiple Dose device and the Company has the exclusive right to manufacture the product for clinical development and commercial supply.

-- AZ-007 (Staccato zaleplon). Alexza is developing AZ-007 for the treatment of insomnia in patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back asleep. The Company filed an IND in December 2007. In March 2008, the enrollment was completed of a Phase 1 clinical trial of 40 healthy volunteers, at a single site, in a trial designed to assess the safety, tolerability and pharmacokinetic parameters of a single dose of AZ-007. Using a double blind, randomized, dose-escalation trial design, four doses of AZ-007 (ranging from 0.5 to 4.0 mg) were compared to placebo. AZ-007 delivered an IV-like pharmacokinetic profile with a median time to peak venous concentration, or Tmax, of 1.6 minutes. Zaleplon exposure was dose proportional across the four doses studied, as calculated by power analysis. Pharmacodynamics, measured as sedation assessed on a 100 mm visual-analog scale, showed onset of effect a
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SOURCE Alexza Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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