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UPDATE 1-Alexza schizophrenia drug meets main goal; shares rise

Tue Sep 2, 2008 5:41pm EDT

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Sept 2 (Reuters) - Alexza Pharmaceuticals Inc (ALXA.O) said its drug for the treatment of schizophrenia met the main goal of a late-stage clinical trial, sending its shares up 11 percent.

The drug, AZ-004, is an inhalation product being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder.

Both the 5 mg and 10 mg doses of AZ-004 reduced agitation in schizophrenic patients in a statistically significant manner as compared to a dummy drug, the company said.

AZ-004, which combines Alexza's Staccato system with an antipsychotic compound loxapine, is being developed through Symphony Allegro, a partnership formed between Alexza and Symphony Capital LLC.

The Staccato system is a hand-held, chemically heated, single-dose inhaler.

In a conference call with analysts, a company executive said the drug also met all the secondary goals of the study.

The medical device developer, which initiated a second late-stage trial in bipolar disorder patients with acute agitation in July, said it still plans to submit marketing approval applications to the U.S. health regulators in early 2010.

Shares of the company rose to $6 in trading after the bell. They closed at $5.41 Tuesday on Nasdaq. (Reporting by Esha Dey in Bangalore; Editing by Deepak Kannan)



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