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Alexza Provides Pipeline Update
Date:7/31/2014

008 and AZ-009 may offer these two distinct patient populations an advantage over products available today." 

Alexza believes that there are potential advantages from the co-development of AZ-008 and AZ-009, as the two product candidates may be able to utilize the same preclinical and toxicology program, Investigational New Drug (IND) submission and initial Phase 1 clinical trial.  Beginning with planned Phase 2 clinical studies, Alexza expects to separate the two product candidates into distinct clinical development programs for the two different patient populations.

Alexza used a variety of tools in its new product identification process, including crowd-sourcing and traditional market research methods, and competitive and clinical analyses for each potential program.  The new product candidates will be based on the single dose Staccato platform that is currently being produced in Alexza's commercial production facility as ADASUVE®.

AZ-002 (Staccato alprazolam) for Acute Repetitive Seizures
Epilepsy, a disorder of recurrent seizures, affects approximately 2.5 million Americans, making it the third most common neurological disorder in the United States.  Acute repetitive seizures (ARS) refers to seizures that are serial, clustered, or crescendo, and ones that are distinct from the patient's usual seizure pattern.  ARS occurs in a subset of patients with epilepsy who regularly experience breakthrough seizures, despite treatment with a regular regimen of anti-epileptic drugs.

Among the implications of ARS are concerns for patient safety.  Prolonged or recurrent seizure activity persisting for 30 minutes or more may result in serious injury, health impacts or death, that correlate directly with seizure duration.  ARS, if left untreated, has been reported to evolve into a state of persistent seizure, or status epilepticus, which has
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SOURCE Alexza Pharmaceuticals, Inc.
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