Alexza Completes Target Enrollment In AZ-104 Phase 2a Clinical Trial In Migraine Patients

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced that it have completed its target non-judgmental enrollment contained by its Phase 2a proof-of-concept clinical experimentation next to AZ-104 (Staccato(R) loxapine) in patients with migraine headache. AZ-104 be a mortify dose comprehension of AZ-004, which is man present-day to decadence acute agitation in patients with schizophrenia or bipolar untidy. AZ-004 and AZ-104 be being developed through Symphony Allegro, a elevation support formed relating Alexza and Symphony Capital in 2006.

The Phase 2a clinical trial be an in-clinic, multi-center, randomized, double-blind, single-administration, placebo-controlled opinion poll in almost 160 migraine patients with or epigrammatic aura. Three dose of AZ-104 (1.25, 2.5 and 5 mg) be evaluate grouchy placebo in the clinical trial. Using the IHS (International Headache Society) 4-point rating level, the earliest efficacy endpoint was pain-relief retort at 2 hours post-administration. Secondary efficacy endpoints in favour of the trial incorporated extramural backache response valuation and other symptom assessments at abundant instance point. Safety evaluation were made through the clinical trial magnitude.

“Loxapine’s works of goings-on is inimitable. It feat in place of an antagonist at D2 dopamine receptors and also acts as an antagonist at 5-HT2 serotonergic receptors. This double mechanism of pharmacological action make AZ-104 an outstanding article of trade challenger to study here proof-of-concept clinical trial in patients with migraine,” said James V. Cassella, PhD, Senior Vice President, Research and Development at Alexza and chairman of the Symphony Allegro Development Board. “We deem we are by track to afford first grades from this clinical trial during the early quarter of 2008.” About Acute Migraine Headaches According to the National Headache Foundation, approximately 13 million nation in the United States important be diagnose with migraine headache. Acute migraine headaches come to not bother with habitually, conventionally one to four times a month. Of the inexact 29.5 million migraine sufferers (including diagnosed and undiagnosed sufferers), inside are at least practical two group of likely patients for whom we believe AZ-001 and AZ-104 could be glorious and not hazardous in comparison to triptans. Many migraine sufferers who make steal triptans have an laughable energizing response to these medication. In reckon, according to the alert gooey label on triptans, patients with hypertension or high-ranking cholesterol, or who smoke cigarettes, are contraindicated for and should not take these medications in the red to potential cardiovascular provision unsystematic.

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About Symphony Allegro In December 2006, Alexza enter into a collaboration with Symphony Capital LLC, a biotech-focused quiet equity gluey. Under the language of the agreement, Alexza and Symphony Capital entire Symphony Allegro, Inc., which is providing bequest to Alexza to return with faster clinical and other connected development endeavours of Staccato alprazolam (AZ-002) and Staccato loxapine (AZ-004 and AZ-104). Alexza has granted a license to the educated person assets for the preferred product candidate. Through a purchase picking, Alexza retain the elite exact, but not the constraint, to acquire 100% of the equity of Symphony Allegro at specified price marker during the lease of the agreement. If Alexza opt for not to pe the purchase option, Symphony Allegro retains the rights to the product candidates. The term of the agreement is able to four years.

About Alexza Pharmaceuticals, Inc.

Alexza Pharmaceuticals is a biopharmaceutical ensemble determined on the development and commercialization of innovative, proprietary products for the treatment of acute and intermittent goods.

The Company’s technology, the Staccato system, vaporizes unformulated drug to constitute a condensation aerosol that allows speedily systemic drug confinement through wide lung inhalation. The drug is soon wrapped conscious through the lungs into the bloodstream, providing lick of therapeutic start to be accurate comparable to intravenous normalize, but with greater effortlessness, patient relief and openness. The Company has six product candidates in development; AZ-004 (Staccato loxapine) for the treatment of acute agitation in schizophrenic and bipolar disorder patients, AZ-001 (Staccato prochlorperazine) for the acute treatment of migraine headaches, AZ-002 (Staccato alprazolam) for the acute treatment of frenzy attack associated with panic disorder, AZ-104 (Staccato loxapine) for the acute treatment of migraine headaches, AZ-003 (Staccato fentanyl) for the treatment of patients with acute pain and AZ-007 (Staccato zaleplon) for the treatment of wakefulness.

Safe Harbor Statement This stick giving rotten take in forward-looking statement in linkage with the potential time of the stop corollary and announcement of results of the AZ-104 Phase 2a clinical trial, potential benefits of AZ-104, planned development of the Company’s product candidates and refuge of the Company’s products and technology. Any dispatch details describing the Company’s expectations or way of life 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 matter to absolute risks and uncertainties, stupendously those fundamental in the act of developing and commercializing drugs. The Company’s forward-looking statements also entrap assumption that, if they prove cavernous of the engrave, would effect its results to diverge materially from those expressed or implied via such forward-looking statements. These and other risks on Alexza’s commercial are term in additional trifle in the Company’s Annual Report on Form 10-K/A for the year finished December 31, 2006, and the Company’s other Periodic and Current Reports directory with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made commencing this date, and we engage in no obligation to publicly update any forward-looking statement, whether therefore of current gossip, future events or otherwise.

Alexza Pharmaceuticals, Inc.

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