UPDATE 2-Alexza migraine drug fails mid-stage trial, shares fall

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Mon Sep 14, 2009 2:13pm EDT

* AZ-104 did not meet main goal at 2 hours post-dose

* Differences with placebo not statistically significant

* Shares fall as much as 30 percent

(Recasts; adds analyst comments, details, updates share movement)

By Jennifer Robin Raj

BANGALORE, Sept 14 (Reuters) - Alexza Pharmaceuticals Inc (ALXA.O) said preliminary results from a mid-stage study showed its migraine drug failed to meet the primary goal of relieving pain after two hours of administering, sending its shares down as much as 30 percent.

"The negative results of AZ-104 in migraine were unexpected and reduce the probability of a migraine partnership in 2010, a potentially important source of non-dilutive funding," RBC Capital Markets analyst Jason Kantor said in a note.

In August, the company said that with its current resources it would be able to maintain its operations till the first quarter of 2010.

The 366-patient trial for AZ-104, using the company's Staccato drug-delivery technology, was designed to evaluate the treatment of a single migraine attack of moderate-to-severe intensity in each of the patients, with or without aura.

Two doses of AZ-104, 1.25 mg and 2.5 mg, and placebo were evaluated in the trial. Pain relief was observed in 56 percent of patients receiving the 2.5 mg dose and 54 percent of patients receiving the 1.25 mg dose, as compared to 45 percent of those who were given dummy drug.

"Numerically the results trended favorably and were dose dependent, but the magnitude was neither clinically nor statistically significant," analyst Kantor said, and cut his price target on the stock to $5 from $7.

There were no serious adverse events, and the drug was generally safe and well tolerated, the company said in a statement.

"The continued clean safety profile and accurate drug delivery of the Staccato device provide some support to the upcoming AZ-004 new drug application," Kantor added.

Alexza's technology, the Staccato system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation.

Alexza expects to file a marketing application for AZ-004, its treatment for agitation in schizophrenic or bipolar disorder patients, in early 2010.

Kantor said a partnership for AZ-004 by the first quarter of 2010 was likely and the drug should gain approval from U.S. health regulators by early 2011.

Shares of Alexza were down 11 percent at $2.57 in afternoon trade on Nasdaq. They had touched a low of $2.03 earlier in the session. (Editing by Aradhana Aravindan)

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