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Alexza and Biovail Form Collaboration to Develop and Commercialize AZ-004 (Staccato(R) Loxapine) in North America
Date:2/10/2010

ty of drug effect, but because they are invasive and can be frightening to patients, IM injections are usually the treatment option of last-resort.  Currently, no non-invasive therapies are available that work faster than 30 minutes to help agitated patients in need of treatment.

About AZ-004 (Staccato loxapine)

AZ-004 is an anti-agitation therapeutic that combines Alexza's proprietary Staccato system with loxapine, a drug belonging to the class of compounds known generally as antipsychotics.  Loxapine is currently available in an oral formulation in the U.S. for the management of the manifestations of schizophrenia.  The Staccato system is a hand-held, single-dose inhaler that delivers a drug aerosol to the deep lung that results in IV-like pharmacokinetics and rapid systemic effects.  

As an easy-to-use, patient-controlled, and highly reliable therapeutic that provides rapid reduction in agitation, the Company believes that AZ-004 meets the three key attributes for the treatment of acute agitation as specified in the American Association of Emergency Psychiatrists' Expert Consensus Guidelines for the Treatment of Behavioral Emergencies: speed of onset, reliability of medication delivery and patient preference.

About the Staccato System

Alexza's proprietary Staccato system was rationally designed to optimally treat acute and intermittent conditions.  A single breath triggers vaporization and delivers a dose of excipient-free aerosolized, highly bioavailable drug deep into the lungs, where it is quickly absorbed into the blood stream to begin providing therapeutic effect.  The Staccato system delivers medication that is comparable to intravenous administration but with greater ease, patient comfort and convenience.

The core of the hand-held Staccato system is a heat pack
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SOURCE Alexza Pharmaceuticals, Inc.
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