The CHMP Delivers a Positive Opinion Recommending Grant of Marketing Authorization for ADASUVE® (Staccato® Loxapine) in the

     The CHMP Delivers a Positive Opinion Recommending Grant of Marketing
    Authorization for ADASUVE® (Staccato® Loxapine) in the European Union

PR Newswire

MOUNTAIN VIEW, Calif. and BARCELONA, Spain, Dec. 14, 2012

MOUNTAIN VIEW, Calif. and BARCELONA, Spain, Dec. 14, 2012 /PRNewswire/ --
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) and Grupo Ferrer Internacional,
S.A., today announced that the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) adopted a positive opinion
recommending that ADASUVE (Staccato loxapine) be granted European Union (EU)
centralized marketing authorization. The CHMP recommends that ADASUVE be
authorized in the EU 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 recommendation by the CHMP is that ADASUVE should be
administered only in a hospital setting under the supervision of a healthcare
professional. Short-acting beta-agonist bronchodilator treatment should be
available for treatment of possible severe respiratory side-effects, such as

The positive opinion was based on Alexza's clinical development program that
included two randomized, multicenter Phase 3 pivotal studies of ADASUVE, which
enrolled 344 adult patients with schizophrenia and 314 adult patients with
bipolar disorder. These two clinical trials demonstrated statistically
significant reductions in agitation from baseline compared to placebo^1,2.
Alexza estimates that as many as 8 million adults in the EU alone suffer from
schizophrenia or bipolar disorder^3. Agitation is a common symptom for these

"The recommendation for approval from CHMP moves us one step closer to
bringing this novel treatment to patients with agitation," said James V.
Cassella, PhD, Executive Vice President and Chief Scientific Officer, Alexza
Pharmaceuticals. "We believe that ADASUVE may provide an important new
therapeutic option as the first rapid and non-invasive treatment to address
episodes of agitation."

The CHMP positive opinion will now be forwarded to the European Commission,
which has the authority to grant marketing authorization for medicinal
products in the EU. The marketing authorization expected to be delivered by
the European Commission would be applicable in all 27 EU Member States, plus
Iceland, Liechtenstein and Norway. A decision is expected from the European
Commission in the first quarter of 2013. Alexza filed the ADASUVE Marketing
Authorization Application (MAA) with the EMA in October 2011.

About ADASUVE (Staccato loxapine)
ADASUVE combines Alexza's proprietary Staccato system with loxapine, an
antipsychotic medicinal product. The Staccato system is a hand-held inhaler
that delivers a drug aerosol to the deep lung that results in IV-like
pharmacokinetics and rapid systemic effects. In two Phase 3 clinical trials
of more than 600 patients with schizophrenia or bipolar disorder, ADASUVE
provided statistically significant reduction in the symptoms of agitation
compared to placebo. The most common side effects observed in these clinical
trials were dysgeusia, sedation/somnolence and dizziness^1,2.

ADASUVE is not authorized for marketing in the US. Alexza has submitted a New
Drug Application (NDA) to the U.S. Food and Drug Administration, which is
currently under review with a Prescription Drug User Fee Act (PDUFA) goal date
of December 21, 2012.

About Grupo Ferrer Internacional, S.A.
Ferrer is partnered with Alexza for ADASUVE in Europe, Latin America, Russia
and the Commonwealth of Independent States. Ferrer is a privately-held
European R&D-based pharmaco-chemical and medical device company headquartered
in Barcelona, Spain. Founded in 1959, the group encompasses today 45
companies developing its activities in Europe, Latin America, Africa, Middle
East, Asia and the United States. In total, Ferrer's human healthcare
products are being commercialized in 93 countries through 26 direct
subsidiaries (including Joint Ventures) and 70 partners and distributors.

Ferrer carries out activities throughout the full value-chain of the pharma
business, from R&D to international marketing, including fine chemicals
development and both raw material and pharmaceutical product manufacturing.
For this purpose, Ferrer has research centres in Spain and Germany, as well as
manufacturing sites in Europe and Latin America.

For more information about Ferrer, visit the Company's web site at

About Alexza Pharmaceuticals, Inc.
Based in Mountain View, CA, 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. ADASUVE (Staccato
loxapine), Alexza's lead program, is currently under review in the United
States by the U.S. Food and Drug Administration for the acute treatment of
agitation associated with schizophrenia or bipolar I disorder in adults.

The Staccato system, vaporizes unformulated drug to form a condensation
aerosol that, when inhaled, allows for 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

ADASUVE^® and Staccato^® are registered trademarks ofAlexza Pharmaceuticals,

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 timing and prospects for regulatory approval to market
ADASUVE in the EU, U.S., Latin America, Russia and the Commonwealth of
Independent States countries, if approved for marketing, the ability for
Alexza and Ferrer to effectively and profitably commercialize ADASUVE in the
EU, 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.


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
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.Wittchen HU and Jacobi F. Size and burden of mental disorders in Europe-a
    critical review and appraisal of 27 studies. Eur Neuropsychopharmacol.
    2005 Aug;15(4):357-76.
4.Alexza data on file (primary market research among caregivers of patients
    with schizophrenia (95% have agitation) and bipolar patients (87% have

SOURCE Alexza Pharmaceuticals, Inc.

Contact: Thomas B. King, President and CEO, +1-650-944-7634,;
BCC Partners, Karen L. Bergman and Michelle Corral, +1-650-575-1509 or
+1-415-794-8662, or
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