EXHIBIT 99.1
(ALEXZA LOGO)
NEWS RELEASE — for immediate release
Alexza Reports 2007 Year-End Financial Results
and Updates Clinical Pipeline Status
Mountain View, California — March 17, 2008
- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) reported today financial results for its fourth quarter and year ended December 31, 2007, and provided an update on the Company’s progress with its six clinical-stage development programs.
“During 2007 and the first quarter of 2008, we moved all of our clinical programs forward. This year is an important transitional year for Alexza, as we initiate the Phase 3 clinical trials of our lead program, AZ-004 (Staccato® loxapine),” said Thomas B. King, Alexza President and CEO. “In addition, we are beginning the initial AZ-004 commercial planning for manufacturing, regulatory submissions, and potential sales and marketing. It is also important to note that we have five additional product candidates in various stages of clinical development in four different therapeutic areas. With our own programs, and with our partnerships with Endo Pharmaceuticals and Symphony Allegro, we look forward to solid progress in these development programs during 2008.”
Product Candidate Development and Corporate Goals Update
• AZ-004 (Staccato loxapine) is initially being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. In February 2008, the Company initiated a Phase 3 clinical trial that is designed to enroll approximately 300 schizophrenic patients with acute agitation at 25 U.S. clinical centers. The trial is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study and will test AZ-004 at two dose levels (5 and 10 mg). Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint for the study is the reduction in agitation as measured by the change from baseline in the PEC Score, measured at 2 hours after the first dose. The PEC Score is a commonly used endpoint in acute agitation studies and is the abbreviation for PANSS (Positive and Negative Symptom Scale) Excited Component Score. Various assessments of a patient’s agitation state will be conducted at serial time points using standard agitation scales over the first 4-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects will be recorded throughout the 24-hour period. A second Phase 3 clinical trial is projected to begin in Q3 2008. The design of the second study will be similar to the first trial, except that the patient population will be patients with bipolar disease. AZ-004 is being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital, LLC in 2006.

 


The following information was filed by Alexza Pharmaceuticals Inc. (ALXA) on Monday, March 17, 2008 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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