Alexza
Pharmaceuticals, Inc. (Nasdaq: ALXA) announced that it has completed
the enrollment in its Phase 2a proof-of-concept clinical trial with AZ-002
(Staccato(R) alprazolam) in patients with panic disorder. AZ-002 is an
inhalation product candidate being developed for the acute treatment of
panic attacks associated with panic disorder. AZ-002 is being developed
through Symphony Allegro, a development collaboration formed between Alexza
and Symphony Capital in 2006.
The AZ-002 Phase 2a clinical trial was an in-clinic proof of concept
study. It was a four-center, randomized, double-blind, placebo-controlled
evaluation of 49 patients with panic disorder. The primary aim of the
clinical trial was to assess the safety and efficacy of a single dose of
AZ-002 in treating a pharmacologically-induced panic attack. Differences
versus placebo in the intensity and the duration of a panic attack,
measured at multiple time points during the study using psychological and
physiological measurements, will be used to assess the safety and efficacy
of AZ-002. Alexza projects that the initial results will be reported before
the end of Q2 2008.
About Panic Attacks
According to the National Institute of Mental Health, approximately 2.4
million people in the United States suffer from panic disorder, a condition
characterized by the frequent and sudden occurrence of panic attacks. The
physical and emotional symptoms of a panic attack have many variations, but
often begin rapidly, peak within 10 minutes and last about 30 minutes.
There are currently no drugs approved for the acute treatment of panic
attacks. Oral formulations of drugs like alprazolam are approved for
chronic use to treat panic disorder. These drugs are intended to reduce the
frequency of panic attacks, but they do not typically eliminate their
occurrence.
About AZ-002 (Staccato alprazolam)
AZ-002 is the combination of Alexza’s proprietary Staccato system with
alprazolam, a drug belonging to the class of compounds known as
benzodiazepines. In a dose-escalation Phase 1 clinical trial, AZ-002 was
generally well tolerated at all doses tested (0.125 to 2 mg) and there were
no serious adverse events. Across all doses, pharmacokinetic analyses
revealed that peak plasma levels were generally reached within the first
few minutes after dosing. Alexza believes the non-invasive nature and rapid
pharmacokinetic properties resulting from administration via the Staccato
system make AZ-002, if approved for marketing, a viable product candidate
for the acute treatment of panic attacks.
About Symphony Allegro
In December 2006, Alexza entered into a collaboration with Symphony
Capital LLC, a biotech-focused private equity firm. Under the terms of the
agreement, Alexza and Symphony Capital established Symphony Allegro, Inc.,
which is providing funding to Alexza to accelerate clinical and other
related development activities of Staccato alprazolam (AZ-002) and Staccato
loxapine (AZ-004 and AZ-104). Alexza has granted a license to certain
intellectual property rights for the selected product candidates. Through a
purchase option, Alexza retains the exclusive right, but not the
obligation, to acquire 100% of the equity of Symphony Allegro at specified
prices during the term of the agreement. If Alexza chooses not to exercise
the purchase option, Symphony Allegro retains the rights to the product
candidates. The term of the agreement is up to four years.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is an emerging specialty pharmaceutical company
focused on the development and commercialization of novel, proprietary
products for the treatment of acute and intermittent conditions. The
Company’s technology, the Staccato system, vaporizes unformulated drug to
form a condensation aerosol that allows rapid systemic drug delivery
through deep lung inhalation. The drug is quickly absorbed through the
lungs into the bloodstream, providing speed of therapeutic onset that is
comparable to intravenous administration, but with greater ease, patient
comfort and convenience.
Alexza has six product candidates in clinical development. Alexza’s
lead program, AZ-004 (Staccato loxapine) for the treatment of acute
agitation in schizophrenic or bipolar disorder patients, is in Phase 3
testing. AZ-001 (Staccato prochlorperazine) for the acute treatment of
migraine headaches has completed Phase 2 testing. AZ-104 (Staccato
loxapine) for the acute treatment of migraine headaches and AZ-002
(Staccato alprazolam) for the acute treatment of panic attacks associated
with panic disorder are in Phase 2 testing. Product candidates in Phase 1
testing include AZ-003 (Staccato fentanyl) for the treatment of
breakthrough pain, which is partnered with Endo Pharmaceuticals in North
generic lasix online buy America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. More
information, including this and past press releases from Alexza is
available online at
Safe Harbor Statement
This press release includes forward-looking statements regarding the
potential timing of the announcement of results of the AZ-002 Phase 2a
clinical trial, potential benefits of AZ-002, future development of the
Company’s product candidates and safety of the Company’s products and
technologies. Any statement describing the Company’s expectations or
beliefs 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 to certain risks and
uncertainties, particularly those inherent in the process of developing and
commercializing drugs. The Company’s forward-looking statements also
involve assumptions that, if they prove incorrect, would cause its results
to differ materially from those expressed or implied by such
forward-looking statements. These and other risks concerning Alexza’s
business are described in additional detail in the Company’s Annual Report
on Form 10-K for the year ended December 31, 2007, and the Company’s other
Periodic and Current Reports filed with the Securities and Exchange
Commission including the risks under the headings "Failure or delay in
commencing or completing clinical trials for our product candidates could
harm our business" and "If our product candidates do not meet safety and
efficacy endpoints in clinical trials, they will not receive regulatory
approval, and we will be unable to market them". Forward-looking statements
contained in this announcement are made as of this date and the Company
undertakes no obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise.
Alexza Pharmaceuticals, Inc.

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