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Alexza Pharmaceuticals to Present at the 18th Annual NewsMakers in the Biotech Industry Conference
Date:10/11/2011

nd initially submitted the ADASUVE NDA in December 2009.  In October 2010, the Company received a Complete Response Letter from the FDA regarding the application.  The Company completed an end-of-review meeting with the FDA in December 2010 and a Risk Evaluation and Mitigation Strategy (REMS) guidance meeting with the FDA in April 2011.  The ADASUVE NDA was resubmitted on August 4, 2011, and has a Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012.  The FDA has indicated that it will likely present the ADASUVE application to an Advisory Committee during the review period.  

Alexza also plans to file the ADASUVE Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the fourth quarter of 2011.  In October 2011, the Company established a commercial partnership for ADASUVE with Grupo Ferrer International, S.A.  Grupo Ferrer is a leading pharmaceutical company in Europe with extensive operations in the Americas, and is Alexza's partner in the registration, distribution and promotion of ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries.  

For more information about Alexza, the Staccato system technology or the Company's development programs, please visit www.alexza.com.

Safe Harbor Statement

The anticipated presentation 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 certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs, including the adequacy of the Company's capital to support the Company's operatio
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SOURCE Alexza Pharmaceuticals, Inc.
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