Alexza Reports 2008 Year-End Financial Results and Updates Clinical Pipel... (y has no direct ownership in Allegro it ...)

Alexza Reports 2008 Year-End Financial Results and Updates Clinical Pipeline Status

Date:3/10/2009

y has no direct ownership in Allegro, it reduces its net loss by the losses incurred by Allegro. "Loss attributed to noncontrolling interest in Symphony Allegro, Inc." reduced net loss for the quarter and year ended December 31, 2008 by $2.9 million and $18.6 million, and reduced net loss by $3.1 million and $10.8 million in the comparable periods in 2007.

Product Candidates Development Update

AZ-004 (Staccato loxapine). Alexza is developing AZ-004 for the acute treatment of agitation in patients with schizophrenia or bipolar disorder. AZ-004 is currently in Phase 3 clinical testing and the Company projects an NDA filing in early 2010.

In December 2008, the Company announced positive results from the second of its two Phase 3 clinical trials of AZ-004. This trial enrolled 314 acutely-agitated patients with bipolar I disorder at 17 U.S. clinical centers. The trial was designed as an in-clinic, multi-center, randomized, double-blind, placebo-controlled study, and tested AZ-004 at two dose levels, 5 mg and 10 mg. Patients were eligible to receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. Only one dose of study drug was allowed during the first 2 hours of the study period. Patients eligible for the study included those who were admitted through an emergency department and those who were already in-patients in a hospital setting, as long as they had acute agitation at the time of patient randomization. This study was the first AZ-004 study enrolling bipolar disorder patients. The primary endpoint for the study was a reduction of agitation, measured as the change from baseline in the PANSS, or Positive and Negative Symptom Scale, Excited Component Score, also known as the PEC score, measured at 2 hours after the first dose. The key secondary endpoint was the Clinical Global Impression-Improvement, or CGI-I, score,
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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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