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Alexza Reports 2010 Fourth Quarter and Full Year Financial Results and Provides General Corporate Update
Date:3/15/2011

MOUNTAIN VIEW, Calif., March 15, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) reported today financial results for the fiscal quarter and year ended December 31, 2010, and provided a general corporate update.  Alexza recorded net income of $25.4 million in the fourth quarter of 2010, while posting a net loss of $1.5 million for the year ended December 31, 2010, as reported in accordance with accounting principles generally accepted in the United States (GAAP), compared to a net loss of $19.8 million and $56.1 million in the quarter and year ended December 31, 2009, respectively.  At December 31, 2010, Alexza had consolidated cash, cash equivalents and marketable securities of $41.4 million.

"All of Alexza has worked very hard over the past months to address the issues raised in the AZ-004 Complete Response Letter," said Thomas B. King, President and CEO of Alexza.  "Based on our End-of-Review meeting with the FDA, ongoing internal work and work with external consultants and advisors, we believe all of the issues raised in the CRL are resolvable.  We remain on track with our plan to resubmit the AZ-004 NDA in July 2011."

Alexza Corporate Update

The following key events occurred since the beginning of the fourth quarter of 2010:

  • Alexza received a Complete Response Letter (CRL) from the U. S. Food and Drug Administration (FDA) to Alexza's New Drug Application (NDA) for AZ-004 Staccato loxapine on October 8, 2010.
  • Alexza reacquired the U.S. and Canadian rights for AZ-004 from Biovail Laboratories International SRL (BLS), now a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.  All AZ-004 rights reverted to Alexza, effective January 16, 2011.
  • Alexza completed an End-of-Review meeting with the FDA for the AZ-004 NDA in December 2010, and received the FDA minutes from the
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    • SOURCE Alexza Pharmaceuticals, Inc.
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