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Alexza Receives Complete Response Letter for Adasuve™ NDA
Date:5/3/2012

gram, 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 May 2012, Alexza received a second CRL outlining manufacturing deficiencies.

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 Company's development programs, please visit www.alexza.com.

Safe Harbor Statement
This news release and the planned conference call will contain forward-looking statements that involve significant risks and uncertainties. Any statement describing the Company's expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement. Such statements are subject to certai
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SOURCE Alexza Pharmaceuticals, Inc.
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