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Alexza to Announce 2012 First Quarter Financial Results on Thursday, May 10, 2012
Date:4/23/2012

za's technology, the Staccato® system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation. The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience. (Click here to see an animation of how the Staccato system works.)

ADASUVE™ (Staccato loxapine) is Alexza's lead program, which is being developed for the acute treatment of agitation in adults with schizophrenia or bipolar disorder. Alexza completed and announced positive results from both of its Phase 3 clinical trials and initially submitted the ADASUVE NDA in December 2009. In October 2010, the Company received a CRL from the FDA regarding the application.  The Company completed an end-of-review meeting with the FDA in December 2010, a REMS guidance meeting with the FDA in April 2011, and the ADASUVE NDA was resubmitted in August 2011. In December 2011, the ADASUVE NDA was the subject of an advisory committee meeting. In January 2012, Alexza received notice of a 90-day extension of the PDUFA goal date, from February 4, 2012 to May 4, 2012.

In October 2011, the Company established a commercial partnership for ADASUVE with Grupo Ferrer Internacional, S.A. Grupo Ferrer is a leading pharmaceutical company in Europe with extensive operations in the Americas, and is Alexza's partner in the commercialization of ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries. Alexza filed its ADASUVE Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in October 2011. 

For more information about Alexza, the Staccato system technology or the Comp
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SOURCE Alexza Pharmaceuticals, Inc.
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Related medicine technology :

1. Alexza and Grupo Ferrer Amend Adasuve™ Partnership
2. Alexza Announces Proposed Public Offering of Common Stock and Warrants
3. FDA Psychopharmacologic Drugs Advisory Committee Recommends Approval of Alexzas ADASUVE™
4. Alexza Presents Staccato® Loxapine Responder Analyses in Agitated Adult Patients with Schizophrenia or Bipolar Disease at the 2011 USPMHC Annual Conference
5. Alexza Reports 2011 Third Quarter Financial Results and Provides Business Update
6. Alexza Pharmaceuticals to Present at the Lazard Capital Markets 8th Annual Healthcare Conference
7. Alexza to Announce 2011 Third Quarter Financial Results on Monday, November 7, 2011
8. Alexza Announces the Adasuve™ (Staccato® Loxapine) PDAC Meeting Date of December 12, 2011
9. Alexza Pharmaceuticals to Present at the 18th Annual NewsMakers in the Biotech Industry Conference
10. Alexza and Grupo Ferrer Establish Partnership for the Commercialization of Adasuve™ (Staccato® Loxapine) in Europe and Latin America
11. Alexza Pharmaceuticals to Present at the Sixth Annual JMP Securities Healthcare Conference
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