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"This is a transitional year for Alexza, as we move into Phase 3 clinicaldevelopment of AZ-004 and the early commercial planning for its manufacturing,regulatory submissions, and potential sales and marketing," said Thomas B.King, Alexza President and CEO. "In addition, we have five other productcandidates in various stages of clinical development in four differenttherapeutic areas. With our own product candidates, and with our productpartnerships with Endo Pharmaceuticals and Symphony Allegro, we look forwardto solid progress in these clinical programs during 2008."
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AZ-007 Phase 1 Clinical Trial Design
The AZ-007 Phase 1 clinical trial is projected to enroll approximately 40healthy volunteers at a single U.S. clinical center. The purpose of thistrial is to assess the safety, tolerability and pharmacokinetic parameters ofa single dose of AZ-007. Using a double blind, randomized, dose-escalationtrial design, four doses of AZ-007 (ranging from 0.5 to 4.0 mg) will becompared to placebo.
About Insomnia
Insomnia is a prevalent disorder that drives almost $5 billion inworldwide sales of prescription medications each year, with about 10 to 30% ofthe U.S. population experiencing either chronic or occasional insomnia. In alarge survey conducted by the National Sleep Foundation in 2005, resultsshowed that 54% of the respondents experienced a minimum of one symptom ofinsomnia at least a few nights a week. Of those, respondents complainedprimarily of waking up feeling unrefreshed (38%), waking up frequently duringthe night (32%), having difficulty falling asleep (21%), and waking up tooearly and not being able to get back to sleep (21%). There is a potentiallysignificant clinical need for rapid and predictable onset of sleep in patientswith insomnia, coupled with a predictable duration of sleep and rapid, clearawakening.
About AZ-007 (Staccato zaleplon)
AZ-007 is the combination of Alexza's proprietary Staccato system withzaleplon, a drug belonging to the class of compounds known generally asnon-benzodiazepine hypnotics. The Staccato system technology is a hand-held,chemically-heated, single dose inhaler designed to generate and deliverexcipient-free drug aerosol for deep lung delivery that results in IV-likepharmacokinetics.
The Company believes that AZ-007's unique delivery via the Staccato systemmay provide rapid sleep onset. Moreover, coupling the short half-life andshort duration of effect of zaleplon, with a lower dose enabled by theStaccato system technology, the overall product profile may match well with anunmet clinical need for patients with insomnia.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is a biopharmaceutical company focused on thedevelopment and commercialization of novel, proprietary products for thetreatment of acute and intermittent conditions. The Company's technology, theStaccato system, vaporizes unformulated drug to
