NEWS RELEASE for immediate release
Alexza Reports 2007 Year-End Financial Results
and Updates Clinical Pipeline Status
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 Companys 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 patients 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.