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Alexza Reports 2008 Year-End Financial Results and Updates Clinical Pipeline Status
Date:3/10/2009

ent, multi-center, randomized, double-blind, single-dose, placebo-controlled study intended to enroll 360 patients who have migraines, with or without aura. Two dose levels of AZ-104 are being evaluated in the clinical trial, 1.25mg and 2.5 mg. The primary efficacy endpoint for the trial is headache pain relief at 2 hours post-dose, using the standard IHS 4-point rating scale. Secondary efficacy endpoints for the trial include pain relief and other symptom assessments at various time points. Safety evaluations will also be made throughout the clinical trial period.

AZ-104 has been licensed to Symphony Allegro, and the Company has the right to repurchase all rights to this product candidate

  • AZ-001 (Staccato prochlorperazine). Alexza is developing AZ-001 to treat patients suffering from acute migraine headaches. During the third quarter of 2008, Alexza conducted an end-of-Phase 2 meeting with the FDA. The Company believes it has a clear understanding of the development requirements for filing an NDA for this product candidate. Consistent with previous guidance, Alexza is not planning on conducting any AZ-001 Phase 3 studies without a partner, and is continuing to seek partners for the Staccato migraine product candidates, AZ-001 and AZ-104.
  • 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. AZ-007 has completed Phase 1 testing. No additional work is currently planned on AZ-007 for 2009 without a partner.
  • AZ-003 (Staccato fentanyl). Alexza is developing AZ-003 for the treatment of patients with acute pain, including patients with breakthrough cancer pain and postoperative patients with acute pain episodes. In January 2009, Alexza mutually agreed with
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SOURCE Alexza Pharmaceuticals, Inc.
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Related medicine news :

1. Alexzas Corporate Presentation to be Webcast at the Cowen & Company 29th Annual Health Care Conference
2. Alexza to Announce 2008 Financial Results and Update Its Clinical Pipeline on Tuesday, March 10, 2009
3. Alexza Pharmaceuticals Promotes Peter D. Noymer, PhD to Vice President, Product R&D
4. Alexza Pharmaceuticals Announces Upcoming Conference Participation and Webcasts
5. Alexza Reports 2008 Third Quarter Financial Results and Updates Development of Product Candidates
6. Alexza to Announce 2008 Third Quarter Financial Results and Update Its Clinical Pipeline on Thursday, November 6, 2008
7. Anthony Clarke, PhD Joins Alexza Pharmaceuticals as Vice President, International Development Operations
8. Jeffrey S. Williams Rejoins Alexza Pharmaceuticals as President, Alexza Singapore Pte. Ltd.
9. Carlos A. Parra Joins Alexza Pharmaceuticals as Vice President, Quality
10. Alexzas Corporate Presentation to be Webcast at the Seventh Annual JMP Securities Research Conference and the 2008 Citi Investment Research Global Healthcare Conference
11. Alexza to Webcast Investor and Analyst Day Presentations
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