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Alexza Pharmaceuticals Updates Staccato® Pipeline and Outlines Pipeline Development Strategy
Date:7/12/2010

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About the Staccato-based Product Candidate Development Strategy

In early 2009, Alexza consolidated its operations and reduced spending on its development pipeline, choosing a primary focus on the continued rapid development of AZ-004 (Staccato loxapine).  During 2009, all of the remaining pre-NDA clinical, non-clinical and manufacturing work for AZ-004 was completed, resulting in the NDA filing in December.  In early 2010, Alexza established its first commercial agreement for AZ-004 with Biovail for the U.S. and Canada, received notification of the AZ-004 PDUFA date and continued on the pathway towards AZ-004 commercialization, assuming regulatory approval for marketing.  In the first half of 2010, Alexza conducted a thorough review of its product pipeline, evaluating current and potential new Staccato-based product candidates.  The result of this review yielded three categories of Staccato-based product candidates: (1) those product candidates where Alexza believes it can add value through internal development, (2) those product candidates where Alexza has developed the product idea, but where a development partner is required, and (3) product candidates based on new ideas, primarily focused on new chemical entities, where the Staccato technology can facilitate better or more effective delivery and pharmacology.

"As we have previously stated, the Staccato system technology is a broad technology platform and Alexza has more product candidates than it can currently effectively develop," explained King.  "We embarked on a review of our pipeline to prioritize the product candidates we might develop ourselves and the product candidates we would develop through a partnership or collaboration.  Today we are announcing the first in what
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SOURCE Alexza Pharmaceuticals, Inc.
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