U.S. FDA Approves Alexza's ADASUVE® (loxapine) Inhalation Powder for the Acute Treatment of Agitation Associated with

U.S. FDA Approves Alexza's ADASUVE® (loxapine) Inhalation Powder for the Acute
Treatment of Agitation Associated with Schizophrenia or Bipolar I Disorder in
                                    Adults

PR Newswire

MOUNTAIN VIEW, Calif., Dec. 21, 2012

MOUNTAIN VIEW, Calif., Dec. 21, 2012 /PRNewswire/ --Alexza Pharmaceuticals,
Inc. (Nasdaq: ALXA) announced today that the U.S. Food and Drug Administration
(FDA) approved ADASUVE^® (loxapine) Inhalation Powder 10 mg for the acute
treatment of agitation associated with schizophrenia or bipolar I disorder in
adults. ADASUVE combines Alexza's proprietary Staccato^® delivery system with
the antipsychotic drug, loxapine. The Staccato system is a hand-held inhaler
that delivers a drug aerosol to the deep lung that results in rapid systemic
delivery and absorption of a drug. See below for Important Safety Information
about ADASUVE, including Boxed Warnings.

"The approval of ADASUVE is an important event in the treatment of agitation.
ADASUVE is the first approved non-injectable therapy for the acute treatment
of agitation in adults with schizophrenia and bipolar I disorder. As noted in
the consensus guidelines for Best Practices in the Evaluation and Treatment of
Agitation, we believe that the ability to deliver medications rapidly and
non-invasively will be important for patients and the professionals who care
for them," said Thomas B. King, President and CEO of Alexza. "This is a
landmark day for Alexza and we are proud of our accomplishments in developing
this unique product. We project that ADASUVE will be available for commercial
launch early in the third quarter of 2013."

"The data we have seen from the ADASUVE Phase 3 clinical trials in patients
with schizophrenia and bipolar I disorder are compelling," said Michael Lesem,
MD, Executive Medical Director, Claghorn-Lesem Research Clinic, Houston, TX
and a principal investigator in the ADASUVE clinical trials."I believe that
ADASUVE represents an important new and much needed therapeutic option in
treating agitation patients who will benefit from a non-coercive therapeutic
intervention that works quickly to relieve their symptoms."

The FDA approval is based on a clinical data package involving more than 1,600
patients and subjects. In two Phase 3 trials, ADASUVE was found to be
effective in the acute treatment of agitation in adults with schizophrenia or
bipolar I disorder. In these two studies, ADASUVE 10 mg met the primary
efficacy endpoint, with statistically significant reductions in agitation as
compared to placebo at the two-hour post-dose time point, as well as the
principal secondary endpoint. Of note, ADASUVE exhibited rapid effects in
agitated patients, with statistically significant reductions in agitation
apparent starting at 10 minutes following administration of a dose versus
placebo^1,2.

As part of the ADASUVE development program, Alexza identified a risk of
bronchospasm in certain asthma and chronic obstructive pulmonary disease
(COPD) patients following dosing with ADASUVE. It is important to note that
ADASUVE can cause bronchospasm that has the potential to lead to respiratory
distress and respiratory arrest. ADASUVE will be available only through a
restricted program under a Risk Evaluation and Mitigation Strategy (REMS)
called the ADASUVE REMS (described below). 

ADASUVE Partial Prescribing Information (U.S.)
Please click here for Full Prescribing Information, including Boxed WARNINGS,
or visit www.adasuve.com.

INDICATIONS AND USAGE

ADASUVE is a typical antipsychotic indicated for the acute treatment of
agitation associated with schizophrenia or bipolar I disorder in adults.
Efficacy was demonstrated in 2 trials in acute agitation: one in schizophrenia
and one in bipolar I disorder.
Limitations of Use: ADASUVE must be administered only in an enrolled
healthcare facility.

IMPORTANT SAFETY INFORMATION

WARNING: BRONCHOSPASMand INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS.

Bronchospasm:

  oADASUVE can cause bronchospasm that has the potential to lead to
    respiratory distress and respiratory arrest
  oADASUVE is available only through a restricted program under a Risk
    Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS
  oAdminister ADASUVE only in an enrolled healthcare facility that has
    immediate access on-site to equipment and personnel trained to manage
    acute bronchospasm, including advanced airway management (intubation and
    mechanical ventilation)

Increased Mortality in Elderly Patients with Dementia-Related Psychosis:

  oElderly patients with dementia-related psychosis treated with
    antipsychotic drugs are at an increased risk of death. ADASUVE is not
    approved for the treatment of patients with dementia-related psychosis

CONTRAINDICATIONS:

ADASUVE is contraindicated in patients with the following:

  oCurrent diagnosis or history of asthma, chronic obstructive pulmonary
    disease (COPD), or other lung disease associated with bronchospasm
  oAcute respiratory signs/ symptoms (e.g., wheezing)
  oCurrent use of medications to treat airways disease, such as asthma or
    COPD
  oHistory of bronchospasm following ADASUVE treatment
  oKnown hypersensitivity to loxapine and amoxapine

WARNINGS AND PRECAUTIONS:

  oNeuroleptic Malignant Syndrome: May develop in patients treated with
    antipsychotic drugs. Discontinue treatment
  oHypotension and Syncope: Use with caution in patients with known
    cardiovascular or cerebrovascular disease
  oSeizure: Use with caution in patients with a history of seizures or with
    conditions that lower the seizure threshold
  oPotential for Cognitive and Motor Impairment: Use caution when driving or
    operating machinery
  oCerebrovascular Adverse Reactions: Increased incidence of stroke and
    transient ischemic attack in elderly patients with dementia-related
    psychosis treated with antipsychotic drugs

ADVERSE REACTIONS:
The most common adverse reactions (incidence ≥ 2% and greater than placebo) in
clinical studies in patients with agitation treated with ADASUVE were
dysgeusia, sedation, throat irritation

ADASUVE will be available only through a restricted program under a Risk
Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS. ADASUVE
should only be administered in a healthcare facility enrolled in the ADASUVE
REMS program that has immediate access on-site to equipment and personnel
trained to manage acute bronchospasm, including advanced airway management
(intubation and mechanical ventilation). In addition to product labeling,
Alexza developed the ADASUVE REMS with the purpose of mitigating the risk of
bronchospasm. The ADASUVE REMS includes a communication plan and an "elements
to assure safe use" of the product, including provisions designed to ensure
that ADASUVE will only be dispensed in healthcare settings that are enrolled
in the ADASUVE REMS program.

With the ADASUVE NDA approval, Alexza also has several post-approval
requirements, including a large observational clinical trial designed to
gather patient safety data based on the real-world use of ADASUVE, as well as
a clinical program addressing the safety and efficacy of ADASUVE in agitated
adolescent patients.

About Agitation Associated with Schizophrenia and Bipolar I Disorder
Agitation is a serious medical problem that can present in a number of
psychiatric disorders, including schizophrenia and bipolar I disorder. Of the
estimated 3.2 million patients treated for schizophrenia or bipolar I disorder
in the U.S.^3, about 90% suffer from agitation in their lifetime^4, due to the
natural course of underlying disease or non-compliance with chronic
medication. Patients average 11 to 12 episodes of agitation each year^5.

Agitation episodes may escalate unpredictably and, in some cases, necessitate
chemical or physical restraint to relieve the individual's distress and to
protect care providers and others in close proximity. Rapid, effective and
safe intervention is key to returning the agitated person to a less agitated
state.

About Alexza Pharmaceuticals, Inc.
Alexza is a pharmaceutical company focused on the research, development and
commercialization of novel, proprietary products for the acute treatment of
central nervous system conditions. Alexza's technology, the Staccato system,
vaporizes unformulated drug to form a condensation aerosol that, when inhaled,
is designed for rapid systemic drug delivery through deep lung inhalation.
(Click here to see an animation of how the Staccato system works.)

ADASUVE^® (Staccato loxapine) is Alexza's lead therapeutic program. Grupo
Ferrer Internacional, S.A is Alexza's commercial partner for ADASUVE in
Europe, Latin America, Russia and the Commonwealth of Independent States
countries. Alexza filed its ADASUVE Marketing Authorization Application with
the European Medicines Agency (EMA) in October 2011. In December 2012, Alexza
received a positive opinion from the EMA's Committee for Medicinal Products
for Human Use recommending the approval of ADASUVE in the European Union for
the rapid control of mild-to-moderate agitation in adult patients with
schizophrenia or bipolar disorder. Patients should receive regular treatment
immediately after control of acute agitation symptoms. The European
Commission is now expected to grant marketing authorization for ADASUVE in all
27 European Union Member States, plus Iceland, Lichtenstein and Norway. A
decision is expected from the European Commission in the first quarter of
2013.

For more information about Alexza, the Staccato system technology or the
Company's development programs, please visit www.alexza.com. For more
information about ADASUVE, please visit www.adasuve.com. ADASUVE^® and
Staccato^® are registered trademarks of Alexza Pharmaceuticals, Inc.

Safe Harbor Statement
This news release contains forward-looking statements that involve significant
risks and uncertainties. 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, including the ability for Alexza to effectively and profitably
commercialize ADASUVE in the US, the impact and risks of the ADASUVE
post-marketing studies and Risk Evaluation and Mitigation Strategy (REMs) on
the commercialization of ADASUVE the adequacy of the Company's capital to
support the Company's operations and the Company's ability to raise additional
funds and the potential terms of such potential financings. 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, 2011 and
the Company's other Periodic and Current Reports filed with the Securities and
Exchange Commission. 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.

References:

1.Lesem MD, Tran-Johnson TK, Riesenberg RA, Feifel D, Allen MH, Fishman R,
    Spyker DA, Kehne JH and Cassella JV. Rapid acute treatment of agitation
    in individuals with schizophrenia: multicentre, randomised,
    placebo-controlled study of inhaled loxapine. Br J Psychiatry. 2011
    Jan;198(1):51-8.
2.Kwentus J, Riesenberg RA, Marandi M, Manning RA, Allen MH, Fishman RS,
    Spyker DA, Kehne JH and Cassella JV. Rapid acute treatment of agitation in
    patients with bipolar I disorder: a multicenter, randomized,
    placebo-controlled clinical trial with inhaled loxapine. Bipolar Disord.
    2012 Feb;14(1):31-40.
3.Alexza data on file (Calculation: from NIMH prevalence; Saha 2005;
    Merikangas K. Lifetime and 12-month Prevalence of Bipolar Spectrum
    Disorder in the National Comorbidity Survey Replication. Arch Gen
    Psychiatry. 2007. 64(5):543-552.)
4.Alexza data on file (primary market research among caregivers of patients
    with schizophrenia (95% have agitation) and bipolar patients (87% have
    agitation))
5.Alexza data on file (primary market research among caregivers of patients
    with schizophrenia (have an average of 12 agitation episodes per year)
    and bipolar patients (have an average of 11 agitation episodes per year))

SOURCE Alexza Pharmaceuticals, Inc.

Website: http://www.alexza.com
Contact: Thomas B. King, President and CEO, +1-650-944-7634, tking@alexza.com;
or Karen L. Bergman and Michelle Corral, BCC Partners, +1-650-575-1509 or
+1-415-794-8662, kbergman@bccpartners.com or mcorral@bccpartners.com